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A Study to Evaluate the Safety, Tolerability and Immunogenicity of an Investigational RSV Vaccine Candidate (Ad26.RSV.preF) in Adults 18 to 50 Years of Age, and RSV-seropositive Toddlers 12 to 24 Months of Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03303625
Recruitment Status : Completed
First Posted : October 6, 2017
Results First Posted : June 23, 2023
Last Update Posted : June 23, 2023
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Other
Conditions Respiratory Syncytial Viruses
Respiratory Tract Infections
Interventions Biological: Ad26.RSV.preF (1*10^11 vp)
Biological: Ad26.RSV.preF (5*10^10 vp)
Drug: Placebo
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 0 (Adults): Ad26.RSV.preF Cohort 0 (Adults): Placebo Cohort 1 (Toddlers): Ad26.RSV.preF Cohort 1 (Toddlers): Placebo
Hide Arm/Group Description Adult participants aged greater than or equal to (>=) 18 years to less than or equal to (<=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29. Adult participants aged >=18 years to <=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29. Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29. RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.
Period Title: Overall Study
Started 8 4 24 12
Completed 6 4 24 12
Not Completed 2 0 0 0
Reason Not Completed
Withdrawal by Subject             2             0             0             0
Arm/Group Title Cohort 0 (Adults): Ad26.RSV.preF Cohort 0 (Adults): Placebo Cohort 1 (Toddlers): Ad26.RSV.preF Cohort 1 (Toddlers): Placebo Total
Hide Arm/Group Description Adult participants aged greater than or equal to (>=) 18 years to less than or equal to (<=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29. Adult participants aged >=18 years to <=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29. Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29. RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29. Total of all reporting groups
Overall Number of Baseline Participants 8 4 24 12 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 24 participants 12 participants 48 participants
<=18 years
0
   0.0%
0
   0.0%
24
 100.0%
12
 100.0%
36
  75.0%
Between 18 and 65 years
8
 100.0%
4
 100.0%
0
   0.0%
0
   0.0%
12
  25.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 24 participants 12 participants 48 participants
Female
6
  75.0%
2
  50.0%
13
  54.2%
8
  66.7%
29
  60.4%
Male
2
  25.0%
2
  50.0%
11
  45.8%
4
  33.3%
19
  39.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 24 participants 12 participants 48 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
6
  75.0%
4
 100.0%
24
 100.0%
11
  91.7%
45
  93.8%
More than one race
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
1
   2.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 8 participants 4 participants 24 participants 12 participants 48 participants
FINLAND
0
   0.0%
0
   0.0%
10
  41.7%
5
  41.7%
15
  31.3%
UNITED KINGDOM
8
 100.0%
4
 100.0%
13
  54.2%
6
  50.0%
31
  64.6%
UNITED STATES
0
   0.0%
0
   0.0%
1
   4.2%
1
   8.3%
2
   4.2%
1.Primary Outcome
Title Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination
Hide Description An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.
Time Frame For 7 days after first vaccination on Day 1 (Up to Day 7)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine.
Arm/Group Title Cohort 0 (Adults): Ad26.RSV.preF Cohort 0 (Adults): Placebo Cohort 1 (Toddlers): Ad26.RSV.preF Cohort 1 (Toddlers): Placebo
Hide Arm/Group Description:
Adult participants aged greater than or equal to (>=) 18 years to less than or equal to (<=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.
Adult participants aged >=18 years to <=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.
Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.
RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.
Overall Number of Participants Analyzed 8 4 24 12
Measure Type: Count of Participants
Unit of Measure: Participants
8
 100.0%
1
  25.0%
14
  58.3%
4
  33.3%
2.Primary Outcome
Title Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Second Vaccination
Hide Description An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.
Time Frame For 7 days after second vaccination on Day 29 (Up to Day 35)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine. Here, 'N' (number of participant analyzed) signifies number of participants evaluable for this outcome measure.
Arm/Group Title Cohort 0 (Adults): Ad26.RSV.preF Cohort 0 (Adults): Placebo Cohort 1 (Toddlers): Ad26.RSV.preF Cohort 1 (Toddlers): Placebo
Hide Arm/Group Description:
Adult participants aged greater than or equal to (>=) 18 years to less than or equal to (<=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.
Adult participants aged >=18 years to <=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.
Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.
RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.
Overall Number of Participants Analyzed 6 4 24 12
Measure Type: Count of Participants
Unit of Measure: Participants
6
 100.0%
0
   0.0%
14
  58.3%
4
  33.3%
3.Primary Outcome
Title Number of Participants With Solicited Systemic Adverse Events for 7 Days After First Vaccination
Hide Description An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature >=38 degree celsius [°C]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature >=38 °C).
Time Frame For 7 days after first vaccination on Day 1 (Up to Day 7)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine.
Arm/Group Title Cohort 0 (Adults): Ad26.RSV.preF Cohort 0 (Adults): Placebo Cohort 1 (Toddlers): Ad26.RSV.preF Cohort 1 (Toddlers): Placebo
Hide Arm/Group Description:
Adult participants aged greater than or equal to (>=) 18 years to less than or equal to (<=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.
Adult participants aged >=18 years to <=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.
Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.
RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.
Overall Number of Participants Analyzed 8 4 24 12
Measure Type: Count of Participants
Unit of Measure: Participants
8
 100.0%
1
  25.0%
23
  95.8%
10
  83.3%
4.Primary Outcome
Title Number of Participants With Solicited Systemic Adverse Events for 7 Days After Second Vaccination
Hide Description An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature >=38 degree celsius [°C]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature >=38 °C).
Time Frame For 7 days after second vaccination on Day 29 (Up to Day 35)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine. Here, 'N' (number of participant analyzed) signifies number of participants evaluable for this outcome measure.
Arm/Group Title Cohort 0 (Adults): Ad26.RSV.preF Cohort 0 (Adults): Placebo Cohort 1 (Toddlers): Ad26.RSV.preF Cohort 1 (Toddlers): Placebo
Hide Arm/Group Description:
Adult participants aged greater than or equal to (>=) 18 years to less than or equal to (<=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.
Adult participants aged >=18 years to <=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.
Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.
RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.
Overall Number of Participants Analyzed 6 4 24 12
Measure Type: Count of Participants
Unit of Measure: Participants
4
  66.7%
1
  25.0%
22
  91.7%
9
  75.0%
5.Primary Outcome
Title Number of Participants With Unsolicited Adverse Events for 28 Days After First Vaccination
Hide Description An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.
Time Frame For 28 days after first vaccination on Day 1 (Up to Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine.
Arm/Group Title Cohort 0 (Adults): Ad26.RSV.preF Cohort 0 (Adults): Placebo Cohort 1 (Toddlers): Ad26.RSV.preF Cohort 1 (Toddlers): Placebo
Hide Arm/Group Description:
Adult participants aged greater than or equal to (>=) 18 years to less than or equal to (<=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.
Adult participants aged >=18 years to <=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.
Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.
RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.
Overall Number of Participants Analyzed 8 4 24 12
Measure Type: Count of Participants
Unit of Measure: Participants
5
  62.5%
0
   0.0%
11
  45.8%
8
  66.7%
6.Primary Outcome
Title Number of Participants With Unsolicited Adverse Events for 28 Days After Second Vaccination
Hide Description An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.
Time Frame For 28 days after second vaccination on Day 29 (Up to Day 56)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine. Here, 'N' (number of participant analyzed) signifies number of participants evaluable for this outcome measure.
Arm/Group Title Cohort 0 (Adults): Ad26.RSV.preF Cohort 0 (Adults): Placebo Cohort 1 (Toddlers): Ad26.RSV.preF Cohort 1 (Toddlers): Placebo
Hide Arm/Group Description:
Adult participants aged greater than or equal to (>=) 18 years to less than or equal to (<=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.
Adult participants aged >=18 years to <=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.
Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.
RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.
Overall Number of Participants Analyzed 6 4 24 12
Measure Type: Count of Participants
Unit of Measure: Participants
4
  66.7%
1
  25.0%
12
  50.0%
6
  50.0%
7.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs)
Hide Description An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Time Frame From Day 1 (post-vaccination) to end of the study (up to 2 years 4 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine.
Arm/Group Title Cohort 0 (Adults): Ad26.RSV.preF Cohort 0 (Adults): Placebo Cohort 1 (Toddlers): Ad26.RSV.preF Cohort 1 (Toddlers): Placebo
Hide Arm/Group Description:
Adult participants aged greater than or equal to (>=) 18 years to less than or equal to (<=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.
Adult participants aged >=18 years to <=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.
Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.
RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.
Overall Number of Participants Analyzed 8 4 24 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   4.2%
2
  16.7%
8.Secondary Outcome
Title Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211
Hide Description RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay.
Time Frame Day 1 (predose), Post-dose on Days 29, 57 and 211
Hide Outcome Measure Data
Hide Analysis Population Description
The Per-protocol Immunogenicity (PPI) set included all randomized and vaccinated participants for whom immunogenicity data were available, excluding participant samples with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) signifies the number of participants evaluable at a specified timepoint.
Arm/Group Title Cohort 0 (Adults): Ad26.RSV.preF Cohort 0 (Adults): Placebo Cohort 1 (Toddlers): Ad26.RSV.preF Cohort 1 (Toddlers): Placebo
Hide Arm/Group Description:
Adult participants aged greater than or equal to (>=) 18 years to less than or equal to (<=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.
Adult participants aged >=18 years to <=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.
Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.
RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.
Overall Number of Participants Analyzed 8 3 17 9
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Day 1 (pre-dose) Number Analyzed 8 participants 3 participants 17 participants 9 participants
329
(252 to 431)
547
(86 to 3489)
121
(76 to 191)
187
(100 to 349)
Post dose 1: Day 29 Number Analyzed 6 participants 3 participants 17 participants 7 participants
1089
(483 to 2456)
603
(101 to 3596)
1608
(730 to 3544)
156
(68 to 358)
Post dose 2: Day 57 Number Analyzed 6 participants 3 participants 17 participants 8 participants
926
(485 to 1769)
566
(114 to 2805)
2235
(1586 to 3150)
198
(89 to 441)
Post dose 2: Day 211 Number Analyzed 6 participants 3 participants 16 participants 7 participants
704
(325 to 1526)
574
(139 to 2374)
1164
(734 to 1847)
165
(70 to 387)
9.Secondary Outcome
Title Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211
Hide Description GMT (ELISA units per liter [EU/L]) of RSV F protein in pre-fusion form as assessed by ELISA was reported.
Time Frame Pre-fusion on Days 1, 29, 57 and 211
Hide Outcome Measure Data
Hide Analysis Population Description
The PPI set included all randomized and vaccinated participants for whom immunogenicity data were available, excluding participant samples with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) signifies the number of participants evaluable at a specified timepoint.
Arm/Group Title Cohort 0 (Adults): Ad26.RSV.preF Cohort 0 (Adults): Placebo Cohort 1 (Toddlers): Ad26.RSV.preF Cohort 1 (Toddlers): Placebo
Hide Arm/Group Description:
Adult participants aged greater than or equal to (>=) 18 years to less than or equal to (<=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.
Adult participants aged >=18 years to <=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.
Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.
RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.
Overall Number of Participants Analyzed 8 3 17 9
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/L
Day 1 Number Analyzed 8 participants 3 participants 17 participants 9 participants
197
(132 to 295)
249
(50 to 1234)
59
(36 to 97)
113
(57 to 223)
Day 29 Number Analyzed 6 participants 3 participants 17 participants 8 participants
441
(304 to 639)
261
(60 to 1138)
1174
(524 to 2630)
106
(56 to 199)
Day 57 Number Analyzed 6 participants 3 participants 17 participants 8 participants
481
(317 to 729)
244
(60 to 992)
1918
(1497 to 2456)
148
(54 to 402)
Day 211 Number Analyzed 6 participants 3 participants 16 participants 7 participants
418
(264 to 664)
292
(45 to 1895)
924
(639 to 1334)
120
(39 to 370)
10.Secondary Outcome
Title Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211
Hide Description GMT (ELISA units per liter [EU/L]) of RSV F protein in post-fusion form as assessed by ELISA was reported.
Time Frame Post-fusion on Days 1, 29, 57 and 211
Hide Outcome Measure Data
Hide Analysis Population Description
The PPI set included all randomized and vaccinated participants for whom immunogenicity data were available, excluding participant samples with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) signifies the number of participants evaluable at a specified timepoint.
Arm/Group Title Cohort 0 (Adults): Ad26.RSV.preF Cohort 0 (Adults): Placebo Cohort 1 (Toddlers): Ad26.RSV.preF Cohort 1 (Toddlers): Placebo
Hide Arm/Group Description:
Adult participants aged greater than or equal to (>=) 18 years to less than or equal to (<=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.
Adult participants aged >=18 years to <=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.
Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.
RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.
Overall Number of Participants Analyzed 8 3 17 9
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/L
Day 1 Number Analyzed 8 participants 3 participants 17 participants 9 participants
196
(112 to 346)
191
(19 to 1879)
77
(48 to 125)
94
(46 to 190)
Day 29 Number Analyzed 6 participants 3 participants 17 participants 8 participants
328
(207 to 521)
207
(25 to 1738)
686
(371 to 1268)
86
(47 to 158)
Day 57 Number Analyzed 6 participants 3 participants 17 participants 8 participants
341
(198 to 589)
179
(23 to 1370)
863
(630 to 1184)
109
(52 to 232)
Day 211 Number Analyzed 6 participants 3 participants 16 participants 7 participants
268
(142 to 507)
181
(18 to 1870)
420
(306 to 576)
91
(33 to 256)
11.Secondary Outcome
Title Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57
Hide Description Total cytokine response (CD4, CD8, Th1 and Th2 Cytokines) after in vitro RSV F protein peptide stimulation was reported as the percentage of CD4+ and CD8+ T cells that produce at least 1 of 3 cytokines.
Time Frame Day 1 (predose) and Post-dose on Days, 29, and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PPI set: all randomized and vaccinated participants for whom immunogenicity data were available, excluding participant samples with major protocol deviations expecting to impact immunogenicity outcomes. 'N' (number of participants analyzed)=number of participants who were evaluable for this outcome measure, 'n' (number analyzed)=number of participants evaluable at specified timepoint and '0' in number analyzed field=none of participants were applicable for evaluation at specified time point.
Arm/Group Title Cohort 0 (Adults): Ad26.RSV.preF Cohort 0 (Adults): Placebo Cohort 1 (Toddlers): Ad26.RSV.preF Cohort 1 (Toddlers): Placebo
Hide Arm/Group Description:
Adult participants aged greater than or equal to (>=) 18 years to less than or equal to (<=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29.
Adult participants aged >=18 years to <=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29.
Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29.
RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.
Overall Number of Participants Analyzed 4 3 14 8
Median (Inter-Quartile Range)
Unit of Measure: Percentage of cytokine cell subsets
CD4: Day 1 Number Analyzed 4 participants 3 participants 13 participants 8 participants
0.058
(0.057 to 0.067)
0.054
(0.048 to 0.108)
0.030
(0.013 to 0.095)
0.050
(0.015 to 0.079)
CD4: Day 29 Number Analyzed 3 participants 3 participants 13 participants 8 participants
0.168
(0.100 to 0.210)
0.058
(0.051 to 0.082)
0.089
(0.062 to 0.131)
0.074
(0.056 to 0.123)
CD4: Day 57 Number Analyzed 4 participants 3 participants 0 participants 0 participants
0.148
(0.115 to 0.351)
0.039
(0.024 to 0.116)
CD8: Day 1 Number Analyzed 4 participants 3 participants 13 participants 8 participants
0.041
(0.033 to 0.084)
0.075
(0.005 to 0.141)
0.033
(0.024 to 0.049)
0.041
(0.025 to 0.081)
CD8: Day 29 Number Analyzed 3 participants 3 participants 14 participants 8 participants
0.145
(0.080 to 0.233)
0.092
(0.022 to 0.105)
0.077
(0.024 to 0.116)
0.053
(0.016 to 0.110)
CD8: Day 57 Number Analyzed 4 participants 3 participants 0 participants 0 participants
0.081
(0.070 to 0.211)
0.062
(0.003 to 0.185)
Th1: Day 1 Number Analyzed 4 participants 3 participants 13 participants 8 participants
0.045
(0.028 to 0.065)
0.054
(0.031 to 0.096)
0.007
(0.003 to 0.022)
0.018
(0.011 to 0.027)
Th1: Day 29 Number Analyzed 3 participants 3 participants 13 participants 8 participants
0.098
(0.040 to 0.146)
0.049
(0.037 to 0.057)
0.034
(0.025 to 0.078)
0.028
(0.017 to 0.055)
Th1: Day 57 Number Analyzed 4 participants 3 participants 0 participants 0 participants
0.112
(0.083 to 0.302)
0.039
(0.008 to 0.061)
Th2: Day 1 Number Analyzed 4 participants 3 participants 13 participants 8 participants
0.006
(0.001 to 0.016)
0.001
(0.001 to 0.002)
0.002
(0.001 to 0.004)
0.004
(0.001 to 0.005)
Th2: Day 29 Number Analyzed 3 participants 3 participants 13 participants 8 participants
0.003
(0.002 to 0.006)
0.001
(0.001 to 0.001)
0.005
(0.001 to 0.007)
0.003
(0.002 to 0.007)
Th2: Day 57 Number Analyzed 4 participants 3 participants 0 participants 0 participants
0.003
(0.001 to 0.022)
0.001
(0.001 to 0.001)
Time Frame From Day 1 (post-vaccination) up to end of the study (up to 2 years 4 months)
Adverse Event Reporting Description The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine.
 
Arm/Group Title Cohort 0 (Adults): Ad26.RSV.preF Cohort 0 (Adults): Placebo Cohort 1 (Toddlers): Ad26.RSV.preF Cohort 1 (Toddlers): Placebo
Hide Arm/Group Description Adult participants aged greater than or equal to (>=) 18 years to less than or equal to (<=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29. Adult participants aged >=18 years to <=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29. Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29. RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29.
All-Cause Mortality
Cohort 0 (Adults): Ad26.RSV.preF Cohort 0 (Adults): Placebo Cohort 1 (Toddlers): Ad26.RSV.preF Cohort 1 (Toddlers): Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/4 (0.00%)   0/24 (0.00%)   0/12 (0.00%) 
Hide Serious Adverse Events
Cohort 0 (Adults): Ad26.RSV.preF Cohort 0 (Adults): Placebo Cohort 1 (Toddlers): Ad26.RSV.preF Cohort 1 (Toddlers): Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/4 (0.00%)   1/24 (4.17%)   2/12 (16.67%) 
Infections and infestations         
Cellulitis * 1  0/8 (0.00%)  0/4 (0.00%)  1/24 (4.17%)  0/12 (0.00%) 
Nervous system disorders         
Syncope * 1  0/8 (0.00%)  0/4 (0.00%)  0/24 (0.00%)  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders         
Wheezing * 1  0/8 (0.00%)  0/4 (0.00%)  0/24 (0.00%)  1/12 (8.33%) 
1
Term from vocabulary, MedDRA Version 22.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Cohort 0 (Adults): Ad26.RSV.preF Cohort 0 (Adults): Placebo Cohort 1 (Toddlers): Ad26.RSV.preF Cohort 1 (Toddlers): Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/8 (75.00%)   1/4 (25.00%)   19/24 (79.17%)   10/12 (83.33%) 
Gastrointestinal disorders         
Abdominal Discomfort * 1  1/8 (12.50%)  0/4 (0.00%)  0/24 (0.00%)  0/12 (0.00%) 
Abdominal Pain * 1  1/8 (12.50%)  0/4 (0.00%)  0/24 (0.00%)  0/12 (0.00%) 
Constipation * 1  0/8 (0.00%)  0/4 (0.00%)  1/24 (4.17%)  0/12 (0.00%) 
Diarrhoea * 1  0/8 (0.00%)  0/4 (0.00%)  0/24 (0.00%)  2/12 (16.67%) 
Gastritis * 1  0/8 (0.00%)  0/4 (0.00%)  1/24 (4.17%)  0/12 (0.00%) 
Nausea * 1  1/8 (12.50%)  0/4 (0.00%)  0/24 (0.00%)  0/12 (0.00%) 
Odynophagia * 1  1/8 (12.50%)  0/4 (0.00%)  0/24 (0.00%)  0/12 (0.00%) 
Teething * 1  0/8 (0.00%)  0/4 (0.00%)  0/24 (0.00%)  1/12 (8.33%) 
Vomiting * 1  0/8 (0.00%)  0/4 (0.00%)  0/24 (0.00%)  1/12 (8.33%) 
General disorders         
Influenza Like Illness * 1  1/8 (12.50%)  0/4 (0.00%)  0/24 (0.00%)  0/12 (0.00%) 
Pyrexia * 1  0/8 (0.00%)  0/4 (0.00%)  0/24 (0.00%)  1/12 (8.33%) 
Immune system disorders         
Allergy to Animal * 1  0/8 (0.00%)  0/4 (0.00%)  0/24 (0.00%)  1/12 (8.33%) 
Infections and infestations         
Anal Infection * 1  0/8 (0.00%)  0/4 (0.00%)  1/24 (4.17%)  0/12 (0.00%) 
Body Tinea * 1  0/8 (0.00%)  0/4 (0.00%)  0/24 (0.00%)  1/12 (8.33%) 
Conjunctivitis * 1  1/8 (12.50%)  0/4 (0.00%)  0/24 (0.00%)  0/12 (0.00%) 
Enterovirus Infection * 1  0/8 (0.00%)  0/4 (0.00%)  0/24 (0.00%)  1/12 (8.33%) 
Hand-Foot-And-Mouth Disease * 1  0/8 (0.00%)  0/4 (0.00%)  1/24 (4.17%)  0/12 (0.00%) 
Oral Herpes * 1  0/8 (0.00%)  0/4 (0.00%)  1/24 (4.17%)  0/12 (0.00%) 
Otitis Externa * 1  1/8 (12.50%)  0/4 (0.00%)  0/24 (0.00%)  0/12 (0.00%) 
Otitis Media * 1  0/8 (0.00%)  0/4 (0.00%)  4/24 (16.67%)  0/12 (0.00%) 
Respiratory Tract Infection * 1  0/8 (0.00%)  0/4 (0.00%)  4/24 (16.67%)  4/12 (33.33%) 
Rhinitis * 1  0/8 (0.00%)  0/4 (0.00%)  0/24 (0.00%)  2/12 (16.67%) 
Sinusitis * 1  0/8 (0.00%)  0/4 (0.00%)  0/24 (0.00%)  1/12 (8.33%) 
Skin Bacterial Infection * 1  0/8 (0.00%)  0/4 (0.00%)  1/24 (4.17%)  0/12 (0.00%) 
Tinea Infection * 1  0/8 (0.00%)  0/4 (0.00%)  1/24 (4.17%)  0/12 (0.00%) 
Upper Respiratory Tract Infection * 1  3/8 (37.50%)  0/4 (0.00%)  8/24 (33.33%)  1/12 (8.33%) 
Urinary Tract Infection * 1  1/8 (12.50%)  0/4 (0.00%)  0/24 (0.00%)  0/12 (0.00%) 
Viral Infection * 1  0/8 (0.00%)  0/4 (0.00%)  1/24 (4.17%)  0/12 (0.00%) 
Viral Rash * 1  0/8 (0.00%)  0/4 (0.00%)  0/24 (0.00%)  1/12 (8.33%) 
Viral Upper Respiratory Tract Infection * 1  0/8 (0.00%)  0/4 (0.00%)  0/24 (0.00%)  2/12 (16.67%) 
Investigations         
Heart Rate Increased * 1  1/8 (12.50%)  0/4 (0.00%)  0/24 (0.00%)  0/12 (0.00%) 
Influenza B Virus Test Positive * 1  1/8 (12.50%)  0/4 (0.00%)  0/24 (0.00%)  0/12 (0.00%) 
Lymphocyte Count Decreased * 1  1/8 (12.50%)  0/4 (0.00%)  0/24 (0.00%)  0/12 (0.00%) 
Respiratory Syncytial Virus Test Positive * 1  0/8 (0.00%)  0/4 (0.00%)  0/24 (0.00%)  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  1/8 (12.50%)  0/4 (0.00%)  0/24 (0.00%)  0/12 (0.00%) 
Myalgia * 1  1/8 (12.50%)  0/4 (0.00%)  0/24 (0.00%)  0/12 (0.00%) 
Pain in Extremity * 1  0/8 (0.00%)  0/4 (0.00%)  1/24 (4.17%)  0/12 (0.00%) 
Nervous system disorders         
Headache * 1  3/8 (37.50%)  0/4 (0.00%)  0/24 (0.00%)  0/12 (0.00%) 
Lethargy * 1  1/8 (12.50%)  0/4 (0.00%)  0/24 (0.00%)  0/12 (0.00%) 
Loss of Consciousness * 1  1/8 (12.50%)  0/4 (0.00%)  0/24 (0.00%)  0/12 (0.00%) 
Psychiatric disorders         
Insomnia * 1  0/8 (0.00%)  0/4 (0.00%)  0/24 (0.00%)  1/12 (8.33%) 
Irritability * 1  0/8 (0.00%)  0/4 (0.00%)  0/24 (0.00%)  2/12 (16.67%) 
Renal and urinary disorders         
Dysuria * 1  1/8 (12.50%)  0/4 (0.00%)  0/24 (0.00%)  0/12 (0.00%) 
Pollakiuria * 1  1/8 (12.50%)  0/4 (0.00%)  0/24 (0.00%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  0/8 (0.00%)  0/4 (0.00%)  2/24 (8.33%)  1/12 (8.33%) 
Rales * 1  0/8 (0.00%)  0/4 (0.00%)  0/24 (0.00%)  1/12 (8.33%) 
Respiratory Tract Irritation * 1  1/8 (12.50%)  0/4 (0.00%)  0/24 (0.00%)  0/12 (0.00%) 
Rhinorrhoea * 1  0/8 (0.00%)  0/4 (0.00%)  1/24 (4.17%)  1/12 (8.33%) 
Rhonchi * 1  0/8 (0.00%)  0/4 (0.00%)  0/24 (0.00%)  1/12 (8.33%) 
Skin and subcutaneous tissue disorders         
Dermatitis Diaper * 1  0/8 (0.00%)  0/4 (0.00%)  0/24 (0.00%)  1/12 (8.33%) 
Miliaria * 1  0/8 (0.00%)  0/4 (0.00%)  0/24 (0.00%)  1/12 (8.33%) 
Pruritus * 1  0/8 (0.00%)  1/4 (25.00%)  0/24 (0.00%)  0/12 (0.00%) 
Rash * 1  0/8 (0.00%)  0/4 (0.00%)  1/24 (4.17%)  0/12 (0.00%) 
1
Term from vocabulary, MedDRA Version 22.1
*
Indicates events were collected by non-systematic assessment
[Not Specified]
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.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
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Name/Title: Trial Physician
Organization: Janssen Vaccines and Prevention B.V.
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT03303625    
Other Study ID Numbers: CR108371
2017-001345-27 ( EudraCT Number )
VAC18194RSV2001 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Submitted: October 3, 2017
First Posted: October 6, 2017
Results First Submitted: April 19, 2023
Results First Posted: June 23, 2023
Last Update Posted: June 23, 2023