A Study to Learn About the Safety and Immune Activity of RSVpreF in Children Who Are at High Risk of Getting RSV Disease (PICASSO)
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| ClinicalTrials.gov Identifier: NCT05900154 |
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Recruitment Status :
Recruiting
First Posted : June 12, 2023
Last Update Posted : August 1, 2023
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The purpose of this study is to learn about the safety and immune activity of the vaccine (called RSVpreF) in children 2 to <18 years of age who are at high risk of RSV disease.
Phase 1 will identify the dose level to be used in Phase 2/3. In this phase, all participants will receive one injection of RSVpreF. Phase 1 has four study visits, two in-clinic and two telehealth visits. Blood samples will be collected for testing. This phase is about 6 months long for each participant and will be conducted in the United States.
Phase 2/3 will evaluate the selected dose level from Phase 1 in a large number of children to collect more information about the safety of the vaccine and the amount of antibodies produced by the vaccine. In this Phase, all participants will receive either RSVpreF or placebo and will not know which they have received until the end of study. Phase 2/3 will have three scheduled in-clinic visits. Blood samples will be collected for testing. This phase is about 6 months long for each participant.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| RESPIRATORY SYNCYTIAL VIRUS (RSV) | Biological: RSVpreF 120 µg Biological: RSVpreF 60 µg Other: placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1980 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Phase 1 is an open-label dose-finding study. A single dose of RSVpreF 120 µg will be given to 40 participants in the 5 to <18 age group first. Upon safety review and approval, a dose of 60 µg will be given to 20 participants in the 2 to <5 age group. If, 60 µg is safe, another 20 participants in the 2 to <5- age group will receive the 120-µg dose. Approximately 60 to 120 participants are expected to be enrolled in the Phase 1. Phase 2/3 will evaluate the safety and immunogenicity of each selected dose level from Phase 1. Within each age group, participants will be randomized in a 2:1 ratio to receive active vaccine or placebo. If the same dose level is selected for both age groups, a total of 930 participants will be enrolled, with at least 75 with chronic medical conditions in the older age group. If different dose levels are selected for the 2 age groups, 930 participants in each age group will be enrolled. |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Masking Description: | Phase 1 is open-label therefore no blinding requirements are in place since all participants will receive RSVPreF. Phase 2/3 is double blind therefore all parties (participant, site staff and sponsor) will be blinded to study intervention. |
| Primary Purpose: | Prevention |
| Official Title: | A PHASE 1, OPEN-LABEL, AGE-DESCENDING, DOSE-FINDING STUDY AND A PHASE 2/3, PLACEBO-CONTROLLED, RANDOMIZED, DOUBLE-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE (RSVpreF) IN CHILDREN 2 TO <18 YEARS OF AGE AT HIGH RISK OF RSV DISEASE |
| Actual Study Start Date : | June 22, 2023 |
| Estimated Primary Completion Date : | April 23, 2024 |
| Estimated Study Completion Date : | September 24, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: standard dose in 5 to <18 years olds, healthy
standard dose (120 µg)
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Biological: RSVpreF 120 µg
RSVpreF standard dose level |
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Experimental: standard dose in 5 to < 18 years olds, with chronic high risk conditions
standard dose (120 µg)
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Biological: RSVpreF 120 µg
RSVpreF standard dose level |
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Experimental: standard dose in 2 to < 5 years olds
standard dose (120 µg)
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Biological: RSVpreF 120 µg
RSVpreF standard dose level |
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Experimental: low dose in 5 to <18 years olds, healthy
low dose (60 µg)
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Biological: RSVpreF 60 µg
RSVpreF low dose level |
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Experimental: low dose in 5 to <18 years olds, with chronic high risk conditions
low dose (60 µg)
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Biological: RSVpreF 60 µg
RSVpreF low dose level |
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Experimental: low dose in 2 to < 5 years olds
low dose (60 µg)
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Biological: RSVpreF 60 µg
RSVpreF low dose level |
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Experimental: RSVpreF standard dose
with dose selected from phase 1 to be used in phase 2/3
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Biological: RSVpreF 120 µg
RSVpreF standard dose level |
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Placebo Comparator: Placebo
Placebo
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Other: placebo
Placebo |
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Experimental: RSVpreF low dose
with dose selected from phase 1 to be used in phase 2/3
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Biological: RSVpreF 60 µg
RSVpreF low dose level |
- Phase 1: Primary Safety - The proportion of participants reporting local reactions [ Time Frame: Within 7 days following study administration intervention ]Local reactions include pain at injection site, redness and swelling reported on e-diaries.
- Phase 1: Primary Safety - The proportion of participants reporting systemic reactions [ Time Frame: Within 7 days following study administration intervention ]Systemic reactions: fever, fatigue/tiredness, headache, muscle pain, joint pain, vomiting, diarrhea reported on e-diaries.
- Phase 1: Primary Safety - The proportion of participants reporting Adverse Events (AEs) [ Time Frame: Through 1 month following study administration intervention ]An AE is any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs include both serious and non-serious adverse events.
- Phase 1: Primary Safety - The proportion of participants reporting Serious Adverse Events (SAEs) [ Time Frame: Throughout the study duration (approximately 6 months) ]SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
- Phase 1: Primary Safety - The proportion of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) [ Time Frame: Throughout the study duration (approximately 6 months) ]An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects.
- Phase 2/3: Primary Safety - The proportion of participants reporting local reactions [ Time Frame: Within 7 days following study administration intervention ]Local reactions include pain at injection site, redness and swelling reported on e-diaries.
- Phase 2/3: Primary Safety - The proportion of participants reporting systemic reactions [ Time Frame: Within 7 days following study administration intervention ]Systemic reactions: fever, fatigue/tiredness, headache, muscle pain, joint pain, vomiting, diarrhea reported on e-diaries.
- Phase 2/3: Primary Safety - The proportion of participants reporting Adverse Events (AEs) [ Time Frame: Through 1 month following study administration intervention ]An AE is any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs include both serious and non-serious adverse events.
- Phase 2/3: Primary Safety - The proportion of participants reporting Serious Adverse Events (SAEs) [ Time Frame: Throughout the study duration (approximately 6 months) ]SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
- Phase 2/3: Primary Safety - The proportion of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) [ Time Frame: Throughout the study duration (approximately 6 months) ]An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects.
- Phase 2/3: Primary Immunogenicity - GMT ratio (GMR), estimated by the ratio of the GMTs for RSV A and RSV B serum (Neutralizing Titers) NTs with RSVpreF in Study C3671016 participants to that in Study C3671013 adults ≥60 years of age. [ Time Frame: 1 month after vaccination ]RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs). GMT ratio (GMR) of the GMTs for RSV A and RSV B serum NTs with RSVpreF in Study C3671016 participants to that in Study C3671013 adults ≥60 years of age.
- Phase 1: Secondary Immunogenicity - GMT of NTs for RSV A and RSV B [ Time Frame: At each blood sampling visit (Day 1 before vaccination and 1-month after vaccination) ]RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs).
- Phase 1: Secondary Immunogenicity - GMFR of NTs for RSV A and RSV B [ Time Frame: At each blood sampling visit (Day 1 before vaccination and 1-month after vaccination) ]RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Fold Rise (GMFR).
- Phase 1: Secondary Immunogenicity - Median frequencies of RSV F antigen-specific CD4+ T cells expressing IFN gamma [ Time Frame: At each blood sampling visit (Day 1 before vaccination and 1-month after vaccination) ]As measured at the central laboratory, RSV F antigen-specific CD4+ T cells secreting IFN gamma
- Phase 1: Secondary Immunogenicity - Median frequencies of RSV F antigen-specific CD4+ T cells expressing IL-4 [ Time Frame: At each blood sampling visit (Day 1 before vaccination and 1-month after vaccination) ]As measured at the central laboratory, RSV F antigen-specific CD4+ T cells secreting IL-4
- Phase 2/3: Secondary Immunogenicity - GMT of NTs for RSV A and RSV B [ Time Frame: At each blood sampling visit (Day 1 before vaccination, 1-month and 6 month after vaccination) ]RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs).
- Phase 2/3: Secondary Immunogenicity - GMFR of NTs for RSV A and RSV B [ Time Frame: At each blood sampling visit (Day 1 before vaccination, 1-month and 6 month after vaccination) ]RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Fold Rise (GMFR).
- Phase 2/3: Secondary Immunogenicity - GMCs of IgG for RSV A and RSV B [ Time Frame: At each blood sampling visit (Day 1 before vaccination, 1-month and 6 month after vaccination) ]RSV A and RSV B prefusion F-binding IgG, expressed as Geometric Mean Concentrations (GMCs).
- Phase 2/3: Secondary Immunogenicity - GMFR of IgG for RSV A and RSV B [ Time Frame: At each blood sampling visit (Day 1 before vaccination, 1-month and 6 month after vaccination) ]RSV A and RSV B prefusion F-binding IgG, expressed as Geometric Mean Fold Rise (GMFR).
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| Ages Eligible for Study: | 2 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Participants 2 to <18 years of age at enrollment
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Phase 1 only: Participants 2 to <18 years of age should either be healthy or be considered by the investigator to be at high risk of RSV disease based on the presence of 1 of the following chronic medical conditions:
- Cystic fibrosis
- Medically treated asthma
- Other chronic respiratory diseases and malformations of the lung
- Down syndrome
- Neuromuscular disease
- Cerebral palsy
- Hemodynamically significant or symptomatic congenital heart disease
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Phase 2 and 3 only: Participants 5 to <18 years of age should be considered by the investigator to be at high risk of RSV disease based on the presence of 1 of the chronic medical conditions listed below. Participants 2 to <5 years of age may be enrolled with, but are not required to have, 1 of the following chronic medical conditions:
- Cystic fibrosis
- Medically treated asthma
- Other chronic respiratory diseases and malformations of the lung
- Down syndrome
- Neuromuscular disease
- Cerebral palsy
- Hemodynamically significant or symptomatic congenital heart disease
- Phase 1 only: All participants 2 to <5 years of age must be seropositive for RSV as confirmed by serology.
- Participants' parent(s)/legal guardian(s) and participants, as age appropriate, who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, and other study procedures, including collection of nasal swabs by participants' parent(s)/legal guardian(s) and by study staff when indicated.
- The participant's parent(s)/legal guardian is capable of giving signed informed consent as described in the protocol. Depending on the age of the participant and according to local requirements, participants will also be asked to provide assent as appropriate (verbal or written).
Exclusion Criteria:
- Immunocompromised individuals associated with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Individuals with a history of epilepsy or other seizure disorders, or a history of seizures and/or other neurological complications following vaccination.
- Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation. Children who may have been exposed to investigational RSV vaccines through maternal immunization will be permitted.
- Receipt of investigational or approved monoclonal antibodies against RSV within 6 months before study intervention administration, or planned receipt throughout the study.
- Receipt of blood/plasma products or immunoglobulins within 28 days before study intervention administration, or planned receipt throughout the study.
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Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study intervention administration, or planned receipt throughout the study.
Note: Systemic corticosteroids are defined as those administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent (eg, for cancer or an autoimmune disease). Inhaled/nebulized, intra-articular, intrabursal, or topical (skin, eyes, or ears) corticosteroids are permitted.
- Participation in other studies involving study intervention within 28 days prior to study entry and/or for the duration of study participation.
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05900154
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Study Director: | Pfizer CT.gov Call Center | Pfizer |
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT05900154 |
| Other Study ID Numbers: |
C3671016 2022-503134-32 ( EudraCT Number ) 2022-503134-32-00 ( Registry Identifier: CTIS (EU) ) |
| First Posted: | June 12, 2023 Key Record Dates |
| Last Update Posted: | August 1, 2023 |
| Last Verified: | July 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. |
| URL: | https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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RESPIRATORY SYNCYTIAL VIRUS RSV RSV vaccine |
Respiratory illness Respiratory infection Pediatric |