Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

• ClinicalTrials.gov Identifier: NCT04886596
• Recruitment Status: Active, not recruiting
• First Posted: May 14, 2021
• Results First Posted: August 4, 2023
• Last Update Posted: April 16, 2024
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Respiratory Syncytial Virus Infections
• Interventions: Biological: Placebo; Biological: RSVPreF3 OA vaccine
• Enrollment: 26668

Participant Flow

Recruitment Details

Pre-assignment Details

Out of 26668 participants enrolled, 1699 participants did not receive vaccination as they did not meet the eligibility criteria or they were lost to follow-up, therefore only 24966 participants were included in the Exposed Set and started the study. Three participants enrolled were encoded in database after the database freeze of Season 1 analysis. The results will be updated after end of study has occurred with the actual number of participants analyzed or similar as accurate.

Arm/Group Title	RSVPreF3 Group	Placebo Group
Arm/Group Description	Participants in this group received a single dose the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants will be re-randomized into 2 groups: participants in one receiving an additional dose of RSVPreF3 OA vaccine every subsequent year; participants in the other receiving a dose of placebo every subsequent year.	Participants in this group received 1 dose of placebo at Day 1 and will receive an additional dose of placebo every subsequent year.
Period Title: Overall Study
Started	12467	12499
Completed	0	0
Not Completed	12467	12499
Reason Not Completed
Adverse Event	73	78
Lost to Follow-up	104	104
Ongoing	12095	12107
Consent withdrawal, not due to an (S)AE	162	173
Migrated / Moved from the study area	17	14
Unknown reason	16	23

Baseline Characteristics

Arm/Group Title		RSVPreF3 Group	Placebo Group	Total
Arm/Group Description		Participants in this group received a single dose the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants will be re-randomized into 2 groups: participants in one receiving an additional dose of RSVPreF3 OA vaccine every subsequent year; participants in the other receiving a dose of placebo every subsequent year.	Participants in this group received 1 dose of placebo at Day 1 and will receive an additional dose of placebo every subsequent year.	Total of all reporting groups
Overall Number of Baseline Participants		12467	12499	24966
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	12467 participants	12499 participants	24966 participants
		69.5 (6.5)	69.6 (6.4)	69.5 (6.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12467 participants	12499 participants	24966 participants
	Female	6488 52.0%	6427 51.4%	12915 51.7%
	Male	5979 48.0%	6072 48.6%	12051 48.3%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	12467 participants	12499 participants	24966 participants
American Indian Or Alaska Native		44 0.4%	35 0.3%	79 0.3%
Asian		953 7.6%	956 7.6%	1909 7.6%
Black Or African American		1064 8.5%	1101 8.8%	2165 8.7%
Native Hawaiian Or Other Pacific Islander		11 0.1%	6 0.0%	17 0.1%
Other - Unspecified		508 4.1%	469 3.8%	977 3.9%
White		9887 79.3%	9932 79.5%	19819 79.4%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Lower Respiratory Tract Disease (LRTD) During the First Season Following a Single Dose of the RSVPreF3 OA Vaccine
Description	First episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated LRTD during the first season was assessed. The case definition for RSV-confirmed LRTD is as follows: Presence of at least one RSV-positive swab detected by RT-PCR.
Time Frame	From Day 15 post-vaccination up to end of season 1 in the Northern Hemisphere (NH) [assessed approximately 6.7 months per participant]

Outcome Measure Data

Analysis Population Description

Analysis was performed on the modified Exposed Set (mES), which included all participants who received at least the first dose of the study intervention and who do not report an RSV-confirmed Acute Respiratory Illness (ARI) prior to 2 weeks (<Day 15) after each vaccination.

Arm/Group Title	RSVPreF3 Group	Placebo Group
Arm/Group Description:	Participants in this group received a single dose the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants will be re-randomized into 2 groups: participants in one receiving an additional dose of RSVPreF3 OA vaccine every subsequent year; participants in the other receiving a dose of placebo every subsequent year.	Participants in this group received 1 dose of placebo at Day 1 and will receive an additional dose of placebo every subsequent year.
Overall Number of Participants Analyzed	12466	12494
Measure Type: Count of Participants; Unit of Measure: Participants
	7 0.1%	40 0.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RSVPreF3 Group, Placebo Group
	Comments	To demonstrate Vaccine efficacy (VE) of RSVPreF3 vaccine by comparing incidence rates of first occurrence of RT-PCR confirmed RSV LRTD in RSVPreF3 group vs Placebo Group.
	Type of Statistical Test	Other
	Comments	VE is demonstrated if the lower limit (LL) of the 2-sided confidence interval (CI) for vaccine efficacy (VE) is above 20%.
Method of Estimation	Estimation Parameter	VE
	Estimated Value	82.58
	Confidence Interval	(2-Sided) 96.95%; 57.89 to 94.08
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following a Single Dose of the RSVPreF3 OA Vaccine
Description	Efficacy of a single dose of the RSVPreF3 OA vaccine will be assessed against RSV A and/or B confirmed LRTD over several seasons according to the case definition. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame	From Day 15 post first vaccination up to end of season 2 and up to end of season 3 in the Northern Hemishpere (NH) (assessed approximately over 2 and 3 years in NH, and 1.5-2 and 2.5-3 years in Southern Hemisphere [SH])

Outcome Measure Data Not Reported

3. Secondary Outcome

Title	Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine
Description	Efficacy of annual revaccination doses of the RSVPreF3 OA vaccine will be assessed against RSV A and/or B confirmed LRTD over several seasons according to the case definition. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Participants in RSVPreF3 groups will be randomized before Season 2 into 2 sub-groups (RSV_annual group and RSV_1dose group). Results for RSV_annual group and RSV_1dose group of subsequent seasons will be updated during final posting.
Time Frame	From Day 15 post first vaccination up to end of season 2 and up to end of season 3 in the Northern Hemisphere (NH) (assessed approximately over 2 and 3 years in NH, and 1.5-2 and 2.5-3 years in Southern Hemisphere [SH])

Outcome Measure Data Not Reported

4. Secondary Outcome

Title	Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine
Description	Efficacy of a single dose of the RSVPreF3 OA vaccine was assessed against LRTD episode caused by RSV A and B subtype over 3 seasons according to the case definition. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame	From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (assessed approximately over 3 years in the NH and 2.5-3 years in Southern Hemisphere [SH])

Outcome Measure Data Not Reported

5. Secondary Outcome

Title	Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine
Description	Efficacy of annual revaccination doses of the RSVPreF3 OA vaccine will be assessed against LRTD episode caused by RSV A and B subtype over 3 seasons according to the case definition. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Participants in RSVPreF3 groups will be randomized before Season 2 into 2 sub-groups (RSV_annual group and RSV_1dose group). Results for RSV_annual group and RSV_1dose group of subsequent seasons will be updated during final posting.
Time Frame	From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (approximately 3 years for NH and 2.5-3 years for Southern Hemisphere [SH])

Outcome Measure Data Not Reported

6. Secondary Outcome

Title	Number of Participants With First Episode of RT-PCR Confirmed LRTD Caused by Other Respiratory Pathogens Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine
Description	Efficacy of a single dose of the RSVPreF3 OA vaccine will be assessed against LRTD episode caused by other respiratory pathogens over 3 seasons according to the case definition. A LRTD caused by other respiratory pathogens is characterized by at least one positive swab for other respiratory pathogens detected by RT-PCR. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame	From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (approximately 3 years for NH and 2.5-3 years for Southern Hemisphere [SH])

Outcome Measure Data Not Reported

7. Secondary Outcome

Title	Number of Participants With First Episode of RT-PCR Confirmed LRTD Caused by Other Respiratory Pathogens Over 3 Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine
Description	Efficacy of annual revaccination doses of the RSVPreF3 OA vaccine will be assessed against LRTD episode caused by other respiratory pathogens over 3 seasons according to the case definition. A LRTD caused by other respiratory pathogens is characterized by at least one positive swab for other respiratory pathogens detected by RT-PCR. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Participants in RSVPreF3 groups will be randomized before Season 2 into 2 sub-groups (RSV_annual group and RSV_1dose group). Results for RSV_annual group and RSV_1dose group of subsequent seasons will be updated during final posting.
Time Frame	From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (approximately 3 years for NH and 2.5-3 years for Southern Hemisphere [SH])

Outcome Measure Data Not Reported

8. Secondary Outcome

Title	Number of Participants With First Episode of RT-PCR Confirmed RSV A and /or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description	Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses was assessed against RSV A and/or B confirmed LRTD episode according to the case definition, in the following age categories: ≥65 YOA, ≥70 YOA and ≥80 YOA. Results for LRTD by age will be updated at the final results disclosure stage.
Time Frame	From Day 15 post first dose to the first occurrence of RSV LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])

Outcome Measure Data Not Reported

9. Secondary Outcome

Title	Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by RSV Season Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description	Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses will be assessed against RSV A and/or B confirmed LRTD episode according to the case definition, by RSV season as follows: VE after each season includes the first occurrence of episodes reported from at least one-month post vaccination at first season, and for the next seasons, excluding analysis of participants who already reported a case in the previous season. The RSV season may be extended based on epidemiology data. Results for LRTD by Season will be updated at the final results disclosure stage.
Time Frame	From Day 15 post first-vaccination or start of the RSV season to the first occurrence of RSV-confirmed LRTD at each RSV season (assessed approximately over 7 months at each season

Outcome Measure Data Not Reported

10. Secondary Outcome

Title	Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Year Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description	Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses will be assessed against RSV A and/or B confirmed LRTD episode according to the case definition, by years after vaccination as follows: VE at each year includes the first occurrence of episodes reported from at least one month post vaccination at first year, and for the next years, excluding analysis of participants who already reported a case in the previous year. Results for LRTD by year will be updated during final result posting stage.
Time Frame	From Day 15 post first and each revaccination dose up to next dose or end of study (assessed approximately over a year after each vaccination)

Outcome Measure Data Not Reported

11. Secondary Outcome

Title	Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description	Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and/or B associated LRTD episode by baseline comorbidities (such as COPD, asthma, any chronic respiratory or pulmonary disease, diabetes mellitus type 1 or 2, chronic heart failure and advanced liver or renal disease) and according to Charlson Comorbidity Index. Low/medium Risk = Participants with co-morbidity score at baseline less than or equal to 3 (Charlson Index); High Risk = Participants with co-morbidity score at baseline greater than 3 (Charlson Index). Results for LRTD by baseline comorbidities will be updated at the final results disclosure stage.
Time Frame	From Day 15 post first and each revaccination dose to first occurrence of RSV LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])

Outcome Measure Data Not Reported

12. Secondary Outcome

Title	Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description	Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and /or B associated LRTD episode according to the case definition, by baseline frailty status of frail, pre-frail and fit. Frail = Participants with a walking speed <0.4m/s or who were not able to perform the test; Pre-Frail = Participants with a walking speed between 0.4-0.99 m/s; Fit = Participants with a walking speed >=1 m/s. Results for LRTD by baseline frailty status will be updated at the final results disclosure stage.
Time Frame	From Day 15 post first and each revaccination dose to first occurrence of RSV LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])

Outcome Measure Data Not Reported

13. Secondary Outcome

Title	Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description	Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and/or B associated severe LRTD episode. An RT-PCR confirmed case of RSV-associated severe LRTD is characterized by presence of lower respiratory signs or an LRTD episode assessed as severe by the investigator (case definition 1) or presence of an LRTD with need for oxygen supplementation or need for positive airway pressure therapy or need for other types of mechanical ventilation (case definition 2) and with at least one RSV positive swab detected by RT-PCR. Results for severe LRTD will be updated at the final results disclosure stage.
Time Frame	From Day 15 post first and each revaccination dose to the first occurrence of RSV severe LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])

Outcome Measure Data Not Reported

14. Secondary Outcome

Title	Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Acute Respiratory Illness (ARI) Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description	Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV confirmed A and/or B associated ARI episode. A case of RT-PCR confirmed RSV-associated ARI is characterized by the presence of respiratory symptoms/signs for at least 24 hours OR respiratory symptom/sign + systemic symptom/sign for at least 24 hours with at least one RSV-positive swab detected by RT-PCR. Results for RSV A and/or B Associated ARI will be updated at the final results disclosure stage.
Time Frame	From Day 15 post first and each revaccination dose to first occurrence of RSV ARI (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])

Outcome Measure Data Not Reported

15. Secondary Outcome

Title	Number of Participants With First Episode of Any ARI or Any LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description	Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses will be assessed against any ARI and any LRTD. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame	From Day 15 post first vaccination up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])

Outcome Measure Data Not Reported

16. Secondary Outcome

Title	Number of Hospitalizations Due to Respiratory Diseases or Due to a Complication Related to Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description	A diagnosis of respiratory disease include: acute respiratory illnesses, other diseases of upper respiratory tract, pneumonia and influenza, chronic obstructive pulmonary disease and allied conditions, pneumoconioses and other lung diseases due to external agents, other diseases of respiratory system. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame	From start of the first RSV season up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])

Outcome Measure Data Not Reported

17. Secondary Outcome

Title	Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description	RSV infection was confirmed by RT-PCR. Results for this outcome measure is not disclosed at this stage in order to maintain blinding within the ongoing trial. Data will be added at the final results posting stage.
Time Frame	From start of the first RSV season up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])

Outcome Measure Data Not Reported

18. Secondary Outcome

Title	Number of Complications Related to ARI and RSV-confirmed ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description	RSV infection is confirmed by RT-PCR. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame	From start of the first RSV season up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])

Outcome Measure Data Not Reported

19. Secondary Outcome

Title	Maximum Influenza Patient- Reported Outcome (Flu-PRO) Chest Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description	The Health Related -Quality of life (HR-QOL) score is measured by Flu-PRO questionnaire. The Flu-PRO is a 32 items daily diary, which assesses influenza signs across 6 body systems- Nose, throat, eyes, chest/respiratory, gastrointestinal and body/systemic. The FLU-PRO total score is computed as the mean score across all 32 items, with the total scores ranging from 0 (symptom free) to 4 (very severe symptoms). Results for the entire study period will be updated at the final results disclosure stage.
Time Frame	During the first 7 days from the onset of ARI symptoms (assessed from 2 weeks post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)

Outcome Measure Data Not Reported

20. Secondary Outcome

Title	Least Square Mean Flu-PRO Total Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description	Individual questions are assessed on the 5-point response categories and Flu-PRO total score is tabulated. Participants in RSVPreF3 groups will be randomized before Season 2 into 2 sub-groups (RSV_annual group and RSV_1dose group). Results for RSV_annual group and RSV_1dose group of subsequent seasons will be updated during final posting.
Time Frame	During the first 7 days from the onset of ARI symptoms (assessed from 2 weeks post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)

Outcome Measure Data Not Reported

21. Secondary Outcome

Title	EuroQol 5-dimension Health Questionnaire (EQ-5D) Utility Score for Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description	The EQ-5D is a general health utility questionnaire with health states, defined through 5 dimensions- mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression. The health states indicated in these 5 dimensions are converted and presented as a single mean index value as recommended by EuroQol group. Values range from 0 (worst) to 1 (full health). Results for the entire study period will be updated at the final results disclosure stage.
Time Frame	At the ARI visit (assessed from 2 weeks post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)

Outcome Measure Data Not Reported

22. Secondary Outcome

Title	Short Form-12 (SF-12) Physical Functioning Score for Participants With RT-PCR Confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description	SF-12 is a health survey with 12 questions, covering 8 domains- physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. Summary scores are computed from these domains for the physical and mental component. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame	At the ARI visit (assessed from one-month post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)

Outcome Measure Data Not Reported

23. Secondary Outcome

Title	Duration of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes
Description	The duration in days of RT-PCR confirmed RSV ARI and LRTD episodes will be described. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame	Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])

Outcome Measure Data Not Reported

24. Secondary Outcome

Title	Number of Participants With Each Reported Symptom/Sign of RT-PCR Confirmed RSV A and/or B ARI Episodes
Description	RSV infection is confirmed by RT-PCR. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame	Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])

Outcome Measure Data Not Reported

25. Secondary Outcome

Title	Number of Participants With Each Reported Symptom/Sign of RT-PCR Confirmed RSV A and/or B LRTD Episodes
Description	RSV infection is confirmed by RT-PCR. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame	Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])

Outcome Measure Data Not Reported

26. Secondary Outcome

Title	Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity
Description	RSV A and/or B ARI and LRTD episodes assessed as 'severe' by the investigator. Severe is defined as "An ARI/LRTD episode which prevents normal, everyday activities. Such an event would, for example, prevent attendance at work and would necessitate the administration of corrective therapy". Number of subjects with Severe ARI and Severe LRTD episodes has not been disclosed at this stage in order to maintain blinding within the ongoing trial. It will be added at the final results posting stage. Results for the entire study period will be updated at the final results disclosure stage
Time Frame	Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])

Outcome Measure Data Not Reported

27. Secondary Outcome

Title	RSVPreF3 Specific Immunoglobulin G (IgG) Antibody Concentrations
Description	The RSV IgG antibody concentrations are measures as Geometric Mean Concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL).
Time Frame	At Day 1 (Pre-Dose 1) and Day 31

Outcome Measure Data

Analysis Population Description

Analysis is performed on the Per Protocol Set for immunogenicity (PPSi) for participants included in the immunogenicity subset. The immunogenicity subset includes participants from the pooled RSVPre3 groups and placebo groups, including participants from NH and SH.

Arm/Group Title		RSVPreF3 Group	Placebo Group
Arm/Group Description:		Participants in this group received a single dose the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants will be re-randomized into 2 groups: participants in one receiving an additional dose of RSVPreF3 OA vaccine every subsequent year; participants in the other receiving a dose of placebo every subsequent year.	Participants in this group received 1 dose of placebo at Day 1 and will receive an additional dose of placebo every subsequent year.
Overall Number of Participants Analyzed		885	892
Geometric Mean (95% Confidence Interval); Unit of Measure: EU/mL
PRE(D1)	Number Analyzed	885 participants	892 participants
		7041.1; (6719.7 to 7377.8)	7090.1; (6785.6 to 7408.1)
PI(D31)	Number Analyzed	848 participants	846 participants
		91729.9; (87514.2 to 96148.7)	7044.5; (6726.5 to 7377.5)

28. Secondary Outcome

Title	RSVPreF3 Specific Immunoglobulin G (IgG) Antibody Concentrations
Description	The RSV IgG antibody concentrations are measures as Geometric Mean Concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL). The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame	Pre-season 2 (approximately 10-17 months post day 1 in NH; 12-21 months post day 1 in SH) and pre-season 3 (approximately 24-27 months post day 1, only in NH)

Outcome Measure Data Not Reported

29. Secondary Outcome

Title	RSV A Neutralizing Antibody Titers
Description	RSV A neutralizing antibodies are given as Geometric Mean Titers (GMTs) and expressed as Estimated Dilution 60 (ED60).
Time Frame	At Day 1 (Pre-Dose 1) and Day 31

Outcome Measure Data

Analysis Population Description

Analysis is performed on the Per Protocol Set for immunogenicity (PPSi) for participants included in the immunogenicity subset. The immunogenicity subset includes participants from the pooled RSVPre3 groups and placebo groups, including participants from NH and SH.

Arm/Group Title		RSVPreF3 Group	Placebo Group
Arm/Group Description:		Participants in this group received a single dose the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants will be re-randomized into 2 groups: participants in one receiving an additional dose of RSVPreF3 OA vaccine every subsequent year; participants in the other receiving a dose of placebo every subsequent year.	Participants in this group received 1 dose of placebo at Day 1 and will receive an additional dose of placebo every subsequent year.
Overall Number of Participants Analyzed		885	892
Geometric Mean (95% Confidence Interval); Unit of Measure: Titers
PRE (Day 1)	Number Analyzed	885 participants	892 participants
		918; (865.7 to 973.5)	928.6; (877.5 to 982.6)
PI (Day 31)	Number Analyzed	848 participants	846 participants
		9329.7; (8699.3 to 10005.8)	873.6; (822.6 to 927.8)

30. Secondary Outcome

Title	RSV A Neutralizing Antibody Titers
Description	RSV A neutralizing antibodies are given as Geometric Mean Titers (GMTs) and expressed as Estimated Dilution 60 (ED60). The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame	Pre-season 2 (approximately 10-17 months post day 1 in NH; 12-21 months post day 1 in SH) and pre-season 3 (approximately 24-27 months post day 1, only in NH)

Outcome Measure Data Not Reported

31. Secondary Outcome

Title	RSV B Neutralizing Antibody Titers
Description	RSV B neutralizing antibodies are given as GMTs.
Time Frame	At Day 1 (Pre-Dose 1) and Day 31

Outcome Measure Data

Analysis Population Description

Analysis is performed on the Per Protocol Set for immunogenicity (PPSi) for participants included in the immunogenicity subset. The immunogenicity subset includes participants from the pooled RSVPre3 groups and placebo groups, including participants from NH and SH.

Arm/Group Title		RSVPreF3 Group	Placebo Group
Arm/Group Description:		Participants in this group received a single dose the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants will be re-randomized into 2 groups: participants in one receiving an additional dose of RSVPreF3 OA vaccine every subsequent year; participants in the other receiving a dose of placebo every subsequent year.	Participants in this group received 1 dose of placebo at Day 1 and will receive an additional dose of placebo every subsequent year.
Overall Number of Participants Analyzed		885	892
Geometric Mean (95% Confidence Interval); Unit of Measure: Titers
PRE (Day 1)	Number Analyzed	885 participants	892 participants
		1195.8; (1130.5 to 1264.8)	1244.1; (1174.4 to 1317.9)
PI (Day 31)	Number Analyzed	848 participants	846 participants
		10178.9; (9564.1 to 10833.1)	1263.1; (1185 to 1346.3)

32. Secondary Outcome

Title	RSV B Neutralizing Antibody Titers
Description	RSV B neutralizing antibodies are given as GMTs. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame	Pre-season 2 (approximately 10-17 months post day 1 in NH; 12-21 months post day 1 in SH) and pre-season 3 (approximately 24-27 months post day 1, only in NH)

Outcome Measure Data Not Reported

33. Secondary Outcome

Title	Number of Participants With Any, Grade 3 Solicited Administration Site Adverse Events
Description	Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. Grade 3 AE = an AE which prevented normal, everyday activities. The assessed administration site events include pain, erythema and swelling. Number of participants with grade 3 AEs has not been disclosed at this stage in order to maintain blinding within the ongoing trial. Those will be added at the final results posting stage.
Time Frame	During the 4-day follow up period after first vaccination (vaccine administered on Day 1)

Outcome Measure Data

Analysis Population Description

Analysis is performed on the solicited safety set from reactogenicity subset, which includes participants from the pooled RSVPreF3 groups and placebo groups in the NH and SH, who receive at least the first dose of the study intervention and have solicited administration site data during the 4-day follow up period after first vaccination.

Arm/Group Title	RSVPreF3 Group	Placebo Group
Arm/Group Description:	Participants in this group received a single dose the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants will be re-randomized into 2 groups: participants in one receiving an additional dose of RSVPreF3 OA vaccine every subsequent year; participants in the other receiving a dose of placebo every subsequent year.	Participants in this group received 1 dose of placebo at Day 1 and will receive an additional dose of placebo every subsequent year.
Overall Number of Participants Analyzed	879	874
Measure Type: Count of Participants; Unit of Measure: Participants
Any Erythema	66 7.5%	7 0.8%
Any Pain	535 60.9%	81 9.3%
Any Swelling	48 5.5%	5 0.6%

34. Secondary Outcome

Title	Number of Participants With Any, Grade 3 Solicited Administration Site Adverse Events
Description	Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. Grade 3 AE = an AE which prevented normal, everyday activities. The assessed administration site events include pain, erythema and swelling. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame	During the 4-day follow up period after second vaccination (vaccine administered pre-season 2)

Outcome Measure Data Not Reported

35. Secondary Outcome

Title	Number of Participants With Any, Grade 3 Solicited Administration Site Adverse Events
Description	Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. Grade 3 AE = an AE which prevented normal, everyday activities. The assessed administration site events include pain, erythema and swelling. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame	During the 4-day follow up period after the third vaccination (administered pre-season 3-only applicable for participants in Northern Hemisphere [NH]))

Outcome Measure Data Not Reported

36. Secondary Outcome

Title	Number of Participants With Any, Grade 3 Solicited Systemic Adverse Events
Description	The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic). Number of subjects with Grade 3 Fever and Grade 3 Headache has not been disclosed at this stage in order to maintain blinding within the ongoing trial. It will be added at the final results posting stage.
Time Frame	During the 4-day follow up period after first vaccination (vaccine administered on Day 1)

Outcome Measure Data

Analysis Population Description

Analysis is performed on the solicited safety set from reactogenicity subset, which includes participants from the pooled RSVPreF3 groups and placebo groups in the NH and SH, who receive at least the first dose of the study intervention and have solicited systemic data during the 4-day follow up period after first vaccination.

Arm/Group Title		RSVPreF3 Group	Placebo Group
Arm/Group Description:		Participants in this group received a single dose the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants will be re-randomized into 2 groups: participants in one receiving an additional dose of RSVPreF3 OA vaccine every subsequent year; participants in the other receiving a dose of placebo every subsequent year.	Participants in this group received 1 dose of placebo at Day 1 and will receive an additional dose of placebo every subsequent year.
Overall Number of Participants Analyzed		879	878
Measure Type: Count of Participants; Unit of Measure: Participants
Any Arthralgia	Number Analyzed	879 participants	878 participants
		159 18.1%	56 6.4%
Grade 3 Arthralgia	Number Analyzed	879 participants	878 participants
		11 1.3%	5 0.6%
Any Fatigue	Number Analyzed	879 participants	878 participants
		295 33.6%	141 16.1%
Grade 3 Fatigue	Number Analyzed	879 participants	878 participants
		15 1.7%	4 0.5%
Any Fever	Number Analyzed	879 participants	878 participants
		18 2.0%	3 0.3%
Any Headache	Number Analyzed	879 participants	878 participants
		239 27.2%	111 12.6%
Any Myalgia	Number Analyzed	879 participants	878 participants
		254 28.9%	72 8.2%
Grade 3 Myalgia	Number Analyzed	295 participants	141 participants
		12 4.1%	3 2.1%

37. Secondary Outcome

Title	Number of Participants With Any, Grade 3 Solicited Systemic Adverse Events
Description	The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic). The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame	During the 4-day follow up period after second vaccination (vaccine or placebo administered pre-season 2)

Outcome Measure Data Not Reported

38. Secondary Outcome

Title	Number of Participants With Any, Grade 3 Solicited Systemic Adverse Events
Description	The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic). The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame	During the 4-day follow up period after third vaccination (vaccine or placebo administered pre-season 3-only applicable for participants in Northern Hemisphere)

Outcome Measure Data Not Reported

39. Secondary Outcome

Title	Number of Days With Solicited Administration Site Adverse Events
Description	Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. The assessed administration site events include pain, erythema and swelling.
Time Frame	During the 4-day follow up period after first vaccination (vaccine or placebo administered on Day 1)

Outcome Measure Data

Analysis Population Description

Analysis was performed on participants from the solicited safety set, from reactogenicity subset, who presented at least one solicited administration site event within 4 days following the first vaccination.

Arm/Group Title		RSVPreF3 Group	Placebo Group
Arm/Group Description:		Participants in this group received a single dose the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants will be re-randomized into 2 groups: participants in one receiving an additional dose of RSVPreF3 OA vaccine every subsequent year; participants in the other receiving a dose of placebo every subsequent year.	Participants in this group received 1 dose of placebo at Day 1 and will receive an additional dose of placebo every subsequent year.
Overall Number of Participants Analyzed		535	81
Median (Inter-Quartile Range); Unit of Measure: Days
Erythema	Number Analyzed	66 participants	7 participants
		2; (1 to 3)	2; (1 to 4)
Pain	Number Analyzed	535 participants	81 participants
		2; (1 to 3)	1; (1 to 2)
Swelling	Number Analyzed	48 participants	5 participants
		2; (1 to 3)	4; (3 to 4)

40. Secondary Outcome

Title	Number of Days With Solicited Administration Site Adverse Events
Description	Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. The assessed administration site events include pain, erythema and swelling. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame	During the 4-day follow up period after second vaccination (vaccine administered pre-season 2)

Outcome Measure Data Not Reported

41. Secondary Outcome

Title	Number of Days With Solicited Administration Site Adverse Events
Description	Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. The assessed administration site events include pain, erythema and swelling. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame	During the 4-day follow up period after third vaccination (vaccine administered pre-season 3-only applicable for participants in Northern Hemisphere [NH]))

Outcome Measure Data Not Reported

42. Secondary Outcome

Title	Number of Days With Solicited Systemic Adverse Events
Description	The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic).
Time Frame	During the 4-day follow up period after first vaccination (vaccine or placebo administered on Day 1)

Outcome Measure Data

Analysis Population Description

Analysis was performed on participants from the solicited safety set, from reactogenicity subset, who presented at least one solicited systemic event within 4 days following the first vaccination.

Arm/Group Title		RSVPreF3 Group	Placebo Group
Arm/Group Description:		Participants in this group received a single dose the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants will be re-randomized into 2 groups: participants in one receiving an additional dose of RSVPreF3 OA vaccine every subsequent year; participants in the other receiving a dose of placebo every subsequent year.	Participants in this group received 1 dose of placebo at Day 1 and will receive an additional dose of placebo every subsequent year.
Overall Number of Participants Analyzed		295	141
Median (Inter-Quartile Range); Unit of Measure: Days
Arthralgia	Number Analyzed	159 participants	56 participants
		2; (1 to 3)	2; (1 to 3)
Fatigue	Number Analyzed	295 participants	141 participants
		2; (1 to 3)	1; (1 to 3)
Fever	Number Analyzed	18 participants	3 participants
		1; (1 to 1)	1; (1 to 2)
Headache	Number Analyzed	239 participants	111 participants
		1; (1 to 2)	1; (1 to 2)
Myalgia	Number Analyzed	254 participants	72 participants
		2; (1 to 3)	1; (1 to 2)

43. Secondary Outcome

Title	Number of Days With Solicited Systemic Adverse Events
Description	The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic). The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame	During the 4-day follow up period after second vaccination (vaccine or placebo administered pre-season 2)

Outcome Measure Data Not Reported

44. Secondary Outcome

Title	Number of Days With Solicited Systemic Adverse Events
Description	The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic). The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame	During the 4-day follow up period after third vaccination (vaccine or placebo administered pre-season 3-only applicable for participants in Northern Hemisphere [NH])

Outcome Measure Data Not Reported

45. Secondary Outcome

Title	Number of Participants With Any Unsolicited AEs
Description	An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame	During the 30-day follow up period after first vaccination (vaccine or placebo administered on Day 1)

Outcome Measure Data

Analysis Population Description

Analysis is performed on the Exposed Set (ES Dose 1/Dose 2/Dose 3 depending on the dose analyzed) which includes participants who receive at least the first dose of the study intervention and for whom the allocation of group is done in function of the administered intervention.

Arm/Group Title	RSVPreF3 Group	Placebo Group
Arm/Group Description:	Participants in this group received a single dose the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants will be re-randomized into 2 groups: participants in one receiving an additional dose of RSVPreF3 OA vaccine every subsequent year; participants in the other receiving a dose of placebo every subsequent year.	Participants in this group received 1 dose of placebo at Day 1 and will receive an additional dose of placebo every subsequent year.
Overall Number of Participants Analyzed	12467	12499
Measure Type: Count of Participants; Unit of Measure: Participants
	4117 33.0%	2229 17.8%

46. Secondary Outcome

Title	Number of Participants With Any Unsolicited AEs
Description	An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame	During the 30-day follow up period after second vaccination (vaccine administered pre-season 2)

Outcome Measure Data Not Reported

47. Secondary Outcome

Title	Number of Participants With Any Unsolicited AEs
Description	An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame	During the 30-day follow up period after third vaccination (vaccine or placebo administered pre-season 3-only applicable for participants in Northern Hemisphere [NH])

Outcome Measure Data Not Reported

48. Secondary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs)
Description	An SAE is defined as any untoward medical occurrence that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame	From the day of the vaccination up to 6 months after each vaccination (vaccine or placebo administered on Day 1, pre-season 2 and pre-season 3-only applicable for participants in Northern Hemisphere [NH])

Outcome Measure Data Not Reported

49. Secondary Outcome

Title	Number of Participants With Potential Immune Mediated Diseases (pIMDs)
Description	pIMDs are a subset of Adverse Events of Specific Interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame	From the day of the vaccination up to 6 months after each vaccination (vaccine or placebo administered on Day 1, pre-season 2 and pre-season 3-only applicable for participants in Northern Hemisphere [NH])

Outcome Measure Data Not Reported

50. Secondary Outcome

Title	Number of Participants With Related SAEs and Fatal SAEs
Description	Related SAEs and fatal SAEs that occur throughout the study are assessed. Related SAEs= Any SAE related to investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator. Fatal SAEs= Any SAEs leading to deaths. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame	From Day 1 up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])

Outcome Measure Data Not Reported

51. Secondary Outcome

Title	Number of Participants With Related pIMDs
Description	pIMDs are a subset of Adverse Events of Specific Interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related pIMD = pIMD assessed by the investigator as related to the study vaccination. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame	From Day 1 up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])

Outcome Measure Data Not Reported

Adverse Events

Time Frame	SAEs were collected from Day 1 to end of Season 1 (approximately 6.7 months). Solicited symptoms collected during 4 days post vaccination and unsolicited symptoms were collected during the 30 days post vaccination.
Adverse Event Reporting Description	Only those AEs are disclosed at this stage, that would not compromise the blinding of the ongoing study. Once data are unblinded at the end of the study, the specific Adverse Event terms will be added and the corresponding number of participants affected will be updated.
Arm/Group Title	RSVPreF3 Group		Placebo Group
Arm/Group Description	Participants in this group received a single dose the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants will be re-randomized into 2 groups: participants in one receiving an additional dose of RSVPreF3 OA vaccine every subsequent year; participants in the other receiving a dose of placebo every subsequent year.		Participants in this group received 1 dose of placebo at Day 1 and will receive an additional dose of placebo every subsequent year.
All-Cause Mortality
	RSVPreF3 Group		Placebo Group
	Affected / at Risk (%)		Affected / at Risk (%)
Total	49/12467 (0.39%)		58/12499 (0.46%)
Serious Adverse Events
	RSVPreF3 Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	608/12467 (4.88%)		607/12499 (4.86%)
General disorders
All SAEs †	608/12467 (4.88%)	777	607/12499 (4.86%)	803
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	RSVPreF3 Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4589/12467 (36.81%)		2348/12499 (18.79%)
Blood and lymphatic system disorders
Lymphadenopathy †	15/12467 (0.12%)	16	4/12499 (0.03%)	4
Anaemia †	3/12467 (0.02%)	3	5/12499 (0.04%)	5
Iron deficiency anaemia †	2/12467 (0.02%)	2	4/12499 (0.03%)	4
Lymph node pain †	3/12467 (0.02%)	4	2/12499 (0.02%)	2
Cardiac disorders
Palpitations †	8/12467 (0.06%)	8	8/12499 (0.06%)	8
Angina pectoris †	7/12467 (0.06%)	8	3/12499 (0.02%)	3
Tachycardia †	4/12467 (0.03%)	4	2/12499 (0.02%)	2
Atrial fibrillation †	3/12467 (0.02%)	3	3/12499 (0.02%)	3
Arrhythmia †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Bradycardia †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Cardiac failure †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Ear and labyrinth disorders
Vertigo †	19/12467 (0.15%)	19	14/12499 (0.11%)	15
Ear pain †	11/12467 (0.09%)	11	14/12499 (0.11%)	14
Tinnitus †	6/12467 (0.05%)	6	8/12499 (0.06%)	8
Hypoacusis †	3/12467 (0.02%)	3	1/12499 (0.01%)	2
Vertigo positional †	2/12467 (0.02%)	2	2/12499 (0.02%)	2
Cerumen impaction †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Deafness †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Ear congestion †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Endocrine disorders
Hyperthyroidism †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Thyroid mass †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Hypothyroidism †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Eye disorders
Eye pain †	10/12467 (0.08%)	10	5/12499 (0.04%)	5
Lacrimation increased †	6/12467 (0.05%)	6	6/12499 (0.05%)	8
Eye pruritus †	1/12467 (0.01%)	1	8/12499 (0.06%)	8
Vision blurred †	3/12467 (0.02%)	3	2/12499 (0.02%)	2
Dry eye †	2/12467 (0.02%)	2	3/12499 (0.02%)	3
Cataract †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Blepharitis †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Eye haemorrhage †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Macular degeneration †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Retinal detachment †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Swelling of eyelid †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Gastrointestinal disorders
Diarrhoea †	94/12467 (0.75%)	97	98/12499 (0.78%)	101
Nausea †	85/12467 (0.68%)	87	32/12499 (0.26%)	33
Abdominal pain upper †	28/12467 (0.22%)	29	29/12499 (0.23%)	32
Vomiting †	23/12467 (0.18%)	23	19/12499 (0.15%)	19
Abdominal pain †	23/12467 (0.18%)	24	9/12499 (0.07%)	9
Toothache †	15/12467 (0.12%)	15	16/12499 (0.13%)	16
Gastrooesophageal reflux disease †	6/12467 (0.05%)	6	14/12499 (0.11%)	14
Dyspepsia †	5/12467 (0.04%)	6	13/12499 (0.10%)	13
Constipation †	12/12467 (0.10%)	12	5/12499 (0.04%)	6
Abdominal discomfort †	8/12467 (0.06%)	8	8/12499 (0.06%)	8
Dry mouth †	5/12467 (0.04%)	5	6/12499 (0.05%)	6
Gastritis †	6/12467 (0.05%)	6	3/12499 (0.02%)	3
Abdominal pain lower †	3/12467 (0.02%)	3	2/12499 (0.02%)	2
Flatulence †	3/12467 (0.02%)	3	2/12499 (0.02%)	2
Dysphagia †	3/12467 (0.02%)	3	1/12499 (0.01%)	1
Faeces soft †	2/12467 (0.02%)	2	2/12499 (0.02%)	2
Food poisoning †	2/12467 (0.02%)	2	2/12499 (0.02%)	2
Frequent bowel movements †	1/12467 (0.01%)	1	3/12499 (0.02%)	3
Dental caries †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Gingival pain †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Stomatitis †	2/12467 (0.02%)	2	1/12499 (0.01%)	2
Mouth ulceration †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Umbilical hernia †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Diverticulum †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Enteritis †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Periodontal disease †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
General disorders
Fatigue †	612/12467 (4.91%)	624	272/12499 (2.18%)	281
Injection site erythema †	518/12467 (4.15%)	521	34/12499 (0.27%)	35
Injection site swelling †	367/12467 (2.94%)	368	24/12499 (0.19%)	24
Pyrexia †	233/12467 (1.87%)	235	41/12499 (0.33%)	41
Pain †	116/12467 (0.93%)	116	33/12499 (0.26%)	34
Vaccination site pain †	115/12467 (0.92%)	115	6/12499 (0.05%)	7
Chills †	85/12467 (0.68%)	87	29/12499 (0.23%)	31
Injection site pruritus †	80/12467 (0.64%)	80	16/12499 (0.13%)	16
Injection site warmth †	79/12467 (0.63%)	79	5/12499 (0.04%)	5
Malaise †	58/12467 (0.47%)	60	14/12499 (0.11%)	14
Injection site joint pain †	65/12467 (0.52%)	66	5/12499 (0.04%)	5
Asthenia †	49/12467 (0.39%)	49	19/12499 (0.15%)	19
Injection site reaction †	53/12467 (0.43%)	53	12/12499 (0.10%)	12
Administration site pain †	49/12467 (0.39%)	49	4/12499 (0.03%)	4
Injection site bruising †	32/12467 (0.26%)	32	19/12499 (0.15%)	19
Feeling hot †	38/12467 (0.30%)	38	7/12499 (0.06%)	7
Injection site discomfort †	26/12467 (0.21%)	26	4/12499 (0.03%)	4
Influenza like illness †	12/12467 (0.10%)	13	13/12499 (0.10%)	13
Chest pain †	14/12467 (0.11%)	14	9/12499 (0.07%)	10
Injection site induration †	18/12467 (0.14%)	18	2/12499 (0.02%)	2
Vaccination site erythema †	18/12467 (0.14%)	18	1/12499 (0.01%)	1
Discomfort †	14/12467 (0.11%)	14	3/12499 (0.02%)	3
Feeling cold †	13/12467 (0.10%)	13	3/12499 (0.02%)	4
Injection site rash †	11/12467 (0.09%)	11	5/12499 (0.04%)	5
Injection site movement impairment †	12/12467 (0.10%)	12	1/12499 (0.01%)	1
Injection site haematoma †	6/12467 (0.05%)	6	7/12499 (0.06%)	7
Chest discomfort †	8/12467 (0.06%)	8	4/12499 (0.03%)	4
Peripheral swelling †	5/12467 (0.04%)	5	7/12499 (0.06%)	7
Axillary pain †	9/12467 (0.07%)	9	2/12499 (0.02%)	2
Injection site mass †	8/12467 (0.06%)	8	3/12499 (0.02%)	3
Injection site inflammation †	9/12467 (0.07%)	9	1/12499 (0.01%)	1
Swelling †	6/12467 (0.05%)	6	4/12499 (0.03%)	4
Oedema peripheral †	1/12467 (0.01%)	1	7/12499 (0.06%)	7
Feeling abnormal †	5/12467 (0.04%)	5	2/12499 (0.02%)	2
Administration site swelling †	4/12467 (0.03%)	4	1/12499 (0.01%)	1
Injection site haemorrhage †	4/12467 (0.03%)	4	1/12499 (0.01%)	1
Injection site nodule †	4/12467 (0.03%)	4	1/12499 (0.01%)	1
Injection site hypoaesthesia †	3/12467 (0.02%)	3	2/12499 (0.02%)	2
Vaccination site bruising †	3/12467 (0.02%)	3	2/12499 (0.02%)	2
Injection site urticaria †	3/12467 (0.02%)	3	1/12499 (0.01%)	1
Secretion discharge †	2/12467 (0.02%)	2	2/12499 (0.02%)	2
Vessel puncture site bruise †	2/12467 (0.02%)	2	2/12499 (0.02%)	2
Non-cardiac chest pain †	1/12467 (0.01%)	1	3/12499 (0.02%)	3
Administration site warmth †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Ill-defined disorder †	2/12467 (0.02%)	3	1/12499 (0.01%)	1
Injection site hyperaesthesia †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Injection site irritation †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Temperature regulation disorder †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Facial pain †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Injection site discolouration †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Injection site extravasation †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Thirst †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Other Disorder †	7/12467 (0.06%)	7	5/12499 (0.04%)	5
Immune system disorders
Seasonal allergy †	12/12467 (0.10%)	12	7/12499 (0.06%)	7
Immunisation reaction †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Infections and infestations
Upper respiratory tract infection †	78/12467 (0.63%)	79	96/12499 (0.77%)	98
Nasopharyngitis †	64/12467 (0.51%)	64	76/12499 (0.61%)	76
Urinary tract infection †	34/12467 (0.27%)	34	39/12499 (0.31%)	41
COVID-19 †	32/12467 (0.26%)	32	34/12499 (0.27%)	34
Rhinitis †	26/12467 (0.21%)	29	27/12499 (0.22%)	27
Bronchitis †	18/12467 (0.14%)	18	25/12499 (0.20%)	25
Respiratory tract infection †	20/12467 (0.16%)	20	17/12499 (0.14%)	17
Oral herpes †	20/12467 (0.16%)	20	15/12499 (0.12%)	15
Sinusitis †	15/12467 (0.12%)	15	20/12499 (0.16%)	20
Herpes zoster †	8/12467 (0.06%)	8	11/12499 (0.09%)	11
Conjunctivitis †	8/12467 (0.06%)	8	10/12499 (0.08%)	10
Lower respiratory tract infection †	6/12467 (0.05%)	6	12/12499 (0.10%)	12
Gastroenteritis †	9/12467 (0.07%)	10	4/12499 (0.03%)	4
Cellulitis †	9/12467 (0.07%)	9	3/12499 (0.02%)	3
Cystitis †	9/12467 (0.07%)	9	3/12499 (0.02%)	3
Pharyngitis †	7/12467 (0.06%)	8	5/12499 (0.04%)	5
Tooth infection †	5/12467 (0.04%)	5	6/12499 (0.05%)	6
Viral infection †	6/12467 (0.05%)	6	4/12499 (0.03%)	4
Viral upper respiratory tract infection †	6/12467 (0.05%)	6	4/12499 (0.03%)	4
Diverticulitis †	5/12467 (0.04%)	5	5/12499 (0.04%)	5
Tooth abscess †	3/12467 (0.02%)	3	7/12499 (0.06%)	7
Gingivitis †	7/12467 (0.06%)	7	2/12499 (0.02%)	2
Respiratory tract infection viral †	6/12467 (0.05%)	6	3/12499 (0.02%)	3
Pneumonia †	2/12467 (0.02%)	2	6/12499 (0.05%)	6
Localised infection †	5/12467 (0.04%)	5	2/12499 (0.02%)	2
Herpes simplex †	4/12467 (0.03%)	4	3/12499 (0.02%)	3
Influenza †	3/12467 (0.02%)	3	4/12499 (0.03%)	4
Ear infection †	3/12467 (0.02%)	3	3/12499 (0.02%)	3
Otitis externa †	2/12467 (0.02%)	2	3/12499 (0.02%)	3
Herpes virus infection †	3/12467 (0.02%)	3	1/12499 (0.01%)	1
Hordeolum †	3/12467 (0.02%)	3	1/12499 (0.01%)	1
Oral candidiasis †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Tinea cruris †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Acute sinusitis †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Erysipelas †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Fungal infection †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Gastroenteritis viral †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Laryngitis †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Otitis media †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Wound infection †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Arthritis infective †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Bacterial vaginosis †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Helicobacter infection †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Impetigo †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Infected bite †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Otitis media acute †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Subcutaneous abscess †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Tinea pedis †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Injury, poisoning and procedural complications
Contusion †	14/12467 (0.11%)	14	17/12499 (0.14%)	18
Arthropod bite †	14/12467 (0.11%)	15	10/12499 (0.08%)	10
Fall †	12/12467 (0.10%)	12	8/12499 (0.06%)	8
Skin laceration †	7/12467 (0.06%)	7	9/12499 (0.07%)	9
Muscle strain †	6/12467 (0.05%)	6	10/12499 (0.08%)	10
Arthropod sting †	5/12467 (0.04%)	5	6/12499 (0.05%)	8
Limb injury †	4/12467 (0.03%)	4	7/12499 (0.06%)	7
Procedural pain †	5/12467 (0.04%)	5	4/12499 (0.03%)	4
Foot fracture †	5/12467 (0.04%)	5	3/12499 (0.02%)	3
Ligament sprain †	4/12467 (0.03%)	5	4/12499 (0.03%)	4
Head injury †	3/12467 (0.02%)	3	4/12499 (0.03%)	4
Tooth fracture †	3/12467 (0.02%)	3	4/12499 (0.03%)	4
Skin abrasion †	1/12467 (0.01%)	1	4/12499 (0.03%)	4
Road traffic accident †	2/12467 (0.02%)	2	2/12499 (0.02%)	2
Bone contusion †	1/12467 (0.01%)	1	3/12499 (0.02%)	3
Joint injury †	1/12467 (0.01%)	1	3/12499 (0.02%)	3
Thermal burn †	1/12467 (0.01%)	1	3/12499 (0.02%)	3
Hand fracture †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Radius fracture †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Soft tissue injury †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Wrist fracture †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Concussion †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Epicondylitis †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Facial bones fracture †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Joint dislocation †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Meniscus injury †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Multiple injuries †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Tendon rupture †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Investigations
Body temperature increased †	32/12467 (0.26%)	32	3/12499 (0.02%)	3
Blood pressure increased †	7/12467 (0.06%)	7	2/12499 (0.02%)	2
Weight decreased †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Blood cholesterol increased †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Blood pressure decreased †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Occult blood positive †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Prostatic specific antigen increased †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Weight increased †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Metabolism and nutrition disorders
Decreased appetite †	20/12467 (0.16%)	21	13/12499 (0.10%)	13
Gout †	5/12467 (0.04%)	5	5/12499 (0.04%)	5
Type 2 diabetes mellitus †	4/12467 (0.03%)	4	4/12499 (0.03%)	4
Vitamin D deficiency †	5/12467 (0.04%)	5	2/12499 (0.02%)	2
Hypercholesterolaemia †	1/12467 (0.01%)	1	5/12499 (0.04%)	5
Hypoglycaemia †	2/12467 (0.02%)	2	3/12499 (0.02%)	4
Diabetes mellitus †	3/12467 (0.02%)	3	1/12499 (0.01%)	1
Iron deficiency †	3/12467 (0.02%)	3	1/12499 (0.01%)	1
Hyperlipidaemia †	2/12467 (0.02%)	2	2/12499 (0.02%)	2
Glucose tolerance impaired †	1/12467 (0.01%)	1	3/12499 (0.02%)	3
Hyperglycaemia †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Hyperkalaemia †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Musculoskeletal and connective tissue disorders
Myalgia †	402/12467 (3.22%)	407	123/12499 (0.98%)	127
Arthralgia †	283/12467 (2.27%)	291	148/12499 (1.18%)	156
Back pain †	72/12467 (0.58%)	75	78/12499 (0.62%)	83
Pain in extremity †	83/12467 (0.67%)	86	36/12499 (0.29%)	38
Neck pain †	32/12467 (0.26%)	36	22/12499 (0.18%)	22
Muscle spasms †	24/12467 (0.19%)	25	8/12499 (0.06%)	8
Musculoskeletal stiffness †	17/12467 (0.14%)	17	12/12499 (0.10%)	12
Osteoarthritis †	14/12467 (0.11%)	14	7/12499 (0.06%)	7
Musculoskeletal chest pain †	10/12467 (0.08%)	10	5/12499 (0.04%)	6
Musculoskeletal pain †	7/12467 (0.06%)	7	4/12499 (0.03%)	4
Bursitis †	7/12467 (0.06%)	7	3/12499 (0.02%)	3
Joint swelling †	4/12467 (0.03%)	4	5/12499 (0.04%)	5
Bone pain †	6/12467 (0.05%)	6	2/12499 (0.02%)	2
Arthritis †	6/12467 (0.05%)	6	1/12499 (0.01%)	1
Muscular weakness †	6/12467 (0.05%)	6	1/12499 (0.01%)	1
Rotator cuff syndrome †	5/12467 (0.04%)	5	1/12499 (0.01%)	1
Limb discomfort †	4/12467 (0.03%)	4	2/12499 (0.02%)	2
Musculoskeletal discomfort †	4/12467 (0.03%)	4	2/12499 (0.02%)	2
Spinal osteoarthritis †	2/12467 (0.02%)	2	4/12499 (0.03%)	4
Intervertebral disc protrusion †	2/12467 (0.02%)	2	3/12499 (0.02%)	3
Spinal pain †	3/12467 (0.02%)	3	1/12499 (0.01%)	1
Muscle tightness †	2/12467 (0.02%)	2	2/12499 (0.02%)	2
Osteoporosis †	2/12467 (0.02%)	2	2/12499 (0.02%)	2
Muscle fatigue †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Osteopenia †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Greater trochanteric pain syndrome †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Plantar fasciitis †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Joint stiffness †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Osteochondrosis †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Pain in jaw †	1/12467 (0.01%)	1	1/12499 (0.01%)	2
Polyarthritis †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Spinal stenosis †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Tendonitis †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Trigger finger †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma †	5/12467 (0.04%)	6	2/12499 (0.02%)	2
Squamous cell carcinoma of skin †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Skin papilloma †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Squamous cell carcinoma †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Nervous system disorders
Headache †	885/12467 (7.10%)	962	470/12499 (3.76%)	504
Dizziness †	70/12467 (0.56%)	73	52/12499 (0.42%)	53
Lethargy †	21/12467 (0.17%)	22	5/12499 (0.04%)	5
Sciatica †	10/12467 (0.08%)	10	13/12499 (0.10%)	13
Somnolence †	15/12467 (0.12%)	15	5/12499 (0.04%)	5
Hypoaesthesia †	11/12467 (0.09%)	11	9/12499 (0.07%)	9
Paraesthesia †	11/12467 (0.09%)	11	5/12499 (0.04%)	5
Migraine †	7/12467 (0.06%)	7	6/12499 (0.05%)	6
Dysgeusia †	6/12467 (0.05%)	6	5/12499 (0.04%)	5
Syncope †	6/12467 (0.05%)	6	3/12499 (0.02%)	3
Sinus headache †	3/12467 (0.02%)	4	5/12499 (0.04%)	5
Tension headache †	2/12467 (0.02%)	2	6/12499 (0.05%)	7
Balance disorder †	2/12467 (0.02%)	2	3/12499 (0.02%)	3
Restless legs syndrome †	2/12467 (0.02%)	2	3/12499 (0.02%)	3
Tremor †	2/12467 (0.02%)	2	2/12499 (0.02%)	2
Disturbance in attention †	1/12467 (0.01%)	1	3/12499 (0.02%)	3
Burning sensation †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Dizziness postural †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Intercostal neuralgia †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Nerve compression †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Psychiatric disorders
Insomnia †	16/12467 (0.13%)	16	16/12499 (0.13%)	16
Anxiety †	10/12467 (0.08%)	11	2/12499 (0.02%)	2
Sleep disorder †	5/12467 (0.04%)	5	1/12499 (0.01%)	1
Depression †	3/12467 (0.02%)	3	2/12499 (0.02%)	2
Restlessness †	3/12467 (0.02%)	3	1/12499 (0.01%)	1
Confusional state †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Panic attack †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Nightmare †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Renal and urinary disorders
Nephrolithiasis †	3/12467 (0.02%)	3	5/12499 (0.04%)	5
Pollakiuria †	4/12467 (0.03%)	4	1/12499 (0.01%)	1
Haematuria †	3/12467 (0.02%)	3	1/12499 (0.01%)	1
Dysuria †	2/12467 (0.02%)	2	2/12499 (0.02%)	2
Micturition urgency †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Reproductive system and breast disorders
Benign prostatic hyperplasia †	1/12467 (0.01%)	1	4/12499 (0.03%)	4
Breast pain †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Vulvovaginal pruritus †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea †	141/12467 (1.13%)	142	108/12499 (0.86%)	118
Oropharyngeal pain †	124/12467 (0.99%)	128	108/12499 (0.86%)	114
Cough †	116/12467 (0.93%)	117	90/12499 (0.72%)	93
Nasal congestion †	48/12467 (0.39%)	50	54/12499 (0.43%)	60
Sneezing †	30/12467 (0.24%)	30	24/12499 (0.19%)	24
Productive cough †	24/12467 (0.19%)	24	24/12499 (0.19%)	24
Dyspnoea †	26/12467 (0.21%)	28	21/12499 (0.17%)	22
Throat irritation †	11/12467 (0.09%)	11	17/12499 (0.14%)	19
Chronic obstructive pulmonary disease †	11/12467 (0.09%)	11	16/12499 (0.13%)	17
Asthma †	13/12467 (0.10%)	13	8/12499 (0.06%)	10
Respiratory disorder †	10/12467 (0.08%)	10	5/12499 (0.04%)	5
Epistaxis †	7/12467 (0.06%)	7	7/12499 (0.06%)	7
Dysphonia †	10/12467 (0.08%)	10	3/12499 (0.02%)	3
Sinus congestion †	7/12467 (0.06%)	7	4/12499 (0.03%)	4
Increased upper airway secretion †	6/12467 (0.05%)	6	3/12499 (0.02%)	3
Rhinitis allergic †	5/12467 (0.04%)	5	3/12499 (0.02%)	3
Paranasal sinus discomfort †	5/12467 (0.04%)	5	2/12499 (0.02%)	5
Wheezing †	2/12467 (0.02%)	2	4/12499 (0.03%)	4
Nasal discomfort †	3/12467 (0.02%)	3	2/12499 (0.02%)	2
Upper respiratory tract inflammation †	2/12467 (0.02%)	2	3/12499 (0.02%)	5
Dry throat †	2/12467 (0.02%)	2	2/12499 (0.02%)	2
Dyspnoea exertional †	2/12467 (0.02%)	2	2/12499 (0.02%)	2
Lower respiratory tract congestion †	2/12467 (0.02%)	2	2/12499 (0.02%)	2
Paranasal sinus hypersecretion †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Aphonia †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Oropharyngeal discomfort †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Respiratory tract congestion †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
Bronchiectasis †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Nasal obstruction †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Pharyngeal swelling †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Pleuritic pain †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Sinus pain †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Skin and subcutaneous tissue disorders
Rash †	31/12467 (0.25%)	31	10/12499 (0.08%)	10
Pruritus †	20/12467 (0.16%)	20	19/12499 (0.15%)	19
Hyperhidrosis †	16/12467 (0.13%)	16	11/12499 (0.09%)	11
Erythema †	6/12467 (0.05%)	6	7/12499 (0.06%)	7
Urticaria †	5/12467 (0.04%)	5	5/12499 (0.04%)	5
Dermatitis †	4/12467 (0.03%)	4	5/12499 (0.04%)	5
Night sweats †	6/12467 (0.05%)	6	2/12499 (0.02%)	2
Dermatitis contact †	4/12467 (0.03%)	4	4/12499 (0.03%)	4
Eczema †	5/12467 (0.04%)	5	2/12499 (0.02%)	3
Rash pruritic †	4/12467 (0.03%)	4	1/12499 (0.01%)	4
Dermatitis allergic †	3/12467 (0.02%)	3	2/12499 (0.02%)	2
Pain of skin †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Skin lesion †	2/12467 (0.02%)	2	1/12499 (0.01%)	1
Skin irritation †	1/12467 (0.01%)	1	1/12499 (0.01%)	1
Vascular disorders
Hypertension †	21/12467 (0.17%)	22	20/12499 (0.16%)	20
Hot flush †	5/12467 (0.04%)	5	6/12499 (0.05%)	6
Haematoma †	2/12467 (0.02%)	2	5/12499 (0.04%)	5
Flushing †	5/12467 (0.04%)	5	1/12499 (0.01%)	2
Hypotension †	3/12467 (0.02%)	3	1/12499 (0.01%)	1
Varicose vein †	1/12467 (0.01%)	1	2/12499 (0.02%)	2
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

• Name/Title: GSK Response Center
• Organization: GlaxoSmithKline
• Phone: 866-435-7343
• EMail: GSKClinicalSupportHD@gsk.com

Publications:

Ison MG, Papi A, Athan E, Feldman RG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Verheust C, Dezutter N, Gruselle O, Fissette L, David MP, Kostanyan L, Hulstrom V, Olivier A, Van der Wielen M, Descamps D; AReSVi-006 study group. Efficacy and safety of respiratory syncytial virus prefusion F protein vaccine (RSVPreF3 OA) in older adults over 2 RSV seasons. Clin Infect Dis. 2024 Jan 22:ciae010. doi: 10.1093/cid/ciae010. Online ahead of print.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT04886596
• Other Study ID Numbers: 212494; 2020-000753-28 ( EudraCT Number )
• First Submitted: April 29, 2021
• First Posted: May 14, 2021
• Results First Submitted: April 10, 2023
• Results First Posted: August 4, 2023
• Last Update Posted: April 16, 2024