A Study to Learn About the Safety and Immune Activity of... | NCT05900154 | Trialant
NCT05900154
Sponsor
Pfizer
Status
Completed
Last Update Posted
Mar 6, 2025Actual
Enrollment
128Actual
Phase
Phase 1
Conditions
RESPIRATORY SYNCYTIAL VIRUS (RSV)
Interventions
RSVpreF 120 µg
RSVpreF 60 µg
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT05900154
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C3671016
Secondary IDs
ID
Type
Description
Link
2024-000422-17
EudraCT Number
Brief Title
A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of Age
Official Title
A PHASE 1, OPEN-LABEL, AGE-DESCENDING, DOSE-FINDING 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
Acronym
PICASSO
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Feb 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 22, 2023Actual
Primary Completion Date
Feb 29, 2024Actual
Completion Date
Feb 29, 2024Actual
First Submitted Date
Jun 2, 2023
First Submission Date that Met QC Criteria
Jun 2, 2023
First Posted Date
Jun 12, 2023Actual
Results Waived
Not provided
Results First Submitted Date
Feb 12, 2025
Results First Submitted that Met QC Criteria
Feb 12, 2025
Results First Posted Date
Mar 6, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 12, 2025
Last Update Posted Date
Mar 6, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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.
This study will identify the dose level to be used in Phase 2/3 trials in this age cohort. All participants will receive one injection of RSVpreF. This study has four study visits, two in-clinic and two telehealth visits. Blood samples will be collected for testing. This study is about 6 months long for each participant and will be conducted in the United States.
Detailed Description
Not provided
Conditions Module
Conditions
RESPIRATORY SYNCYTIAL VIRUS (RSV)
Keywords
RESPIRATORY SYNCYTIAL VIRUS
RSV
RSV vaccine
Respiratory illness
Respiratory infection
Pediatric
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
128Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
standard dose in 5 to <18 years olds, healthy
Experimental
standard dose (120 µg)
Biological: RSVpreF 120 µg
standard dose in 5 to < 18 years olds, with chronic high risk conditions
Experimental
standard dose (120 µg)
Biological: RSVpreF 120 µg
standard dose in 2 to < 5 years olds
Experimental
standard dose (120 µg)
Biological: RSVpreF 120 µg
low dose in 5 to <18 years olds, healthy
Experimental
low dose (60 µg)
Biological: RSVpreF 60 µg
low dose in 5 to <18 years olds, with chronic high risk conditions
Experimental
low dose (60 µg)
Biological: RSVpreF 60 µg
low dose in 2 to < 5 years olds
Experimental
low dose (60 µg)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
RSVpreF 120 µg
Biological
RSVpreF standard dose level
standard dose in 2 to < 5 years olds
standard dose in 5 to < 18 years olds, with chronic high risk conditions
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Local reactions were collected in the electronic diary (e-diary) from Day 1 through Day 7 after vaccination. Local reactions included pain at injection site, redness, and swelling. For participants greater than or equal to (>=) 2 years to <12 years of age, redness and swelling were graded as mild: 0.5 to 2.0 centimeter (cm), moderate: >2.0 to 7.0 cm, and severe: > 7 cm; for participants >=12 years of age, mild: > 2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm, and severe: >10 cm. Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Day 1 through Day 7 after Vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Systemic events included fever, fatigue, headache, vomiting, diarrhea, muscle pain and joint pain and were recorded by participants using e-diary. Fever: oral temperature >= 38.0 degree Celsius (deg C) and categorized as >=38.0 to 38.4 deg C (mild), >38.4 to 38.9 deg C (moderate), and >38.9 to 40.0 deg C (severe). Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity), and severe (prevented daily routine activity). Vomiting was graded mild: 1-2 times in 24 hours (h), moderate: >2 times in 24h, and severe: required intravenous hydration. Diarrhea was graded mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h and severe: 6 or more loose stools in 24h.
Day 1 through Day 7 after Vaccination
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
AE was defined as any untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. AEs included serious and all non-serious AE. SAEs were defined as AE that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was congenital anomaly or birth defect; was suspected transmission via Pfizer product of infectious agent, pathogenic or nonpathogenic or was considered to be an important medical event. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were included.
Secondary Outcomes
Measure
Description
Time Frame
Geometric Mean Titer of the Neutralizing Titers for RSV A and RSV B Before Vaccination and 1 Month After Vaccination
Geometric mean titer (GMT) of neutralizing titers (NTs) of respiratory syncytial virus subgroup A and respiratory syncytial virus subgroup B (RSV A and RSV B) before vaccination and 1 month after vaccination were reported in this outcome measure. Assay results below the lower limit of quantification (LLOQ) were set to 0.5*LLOQ. GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants 2 to <18 years of age at enrollment
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
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.
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.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
2 Years
Maximum Age
17 Years
Standard Ages
Child
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Alabama at Birmingham - School of Medicine
Birmingham
Alabama
35233
United States
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
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.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Participants were divided into 2 age groups: 5 to less than (<) 18 years and 2 to < 5 years. Participants in 5 to <18 years age group were further stratified as healthy and with high-risk chronic medical conditions.
Recruitment Details
A total of 128 participants were enrolled, however 1 participant was assigned to a vaccine group but did not receive vaccination. Consequently, a total of 127 participants were vaccinated.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
RSVpreF 120 Micrograms (mcg): 5 to <18 Years [Healthy Participants]
Healthy participants of age 5 to <18 years received a single dose of respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) 120 mcg intramuscularly on Day 1.
FG001
RSVpreF 120 mcg: 5 to <18 Years [High Risk Participants]
Periods
Title
Milestones
Reasons Not Completed
Vaccination Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 11, 2024
Feb 12, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
This 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.
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
This study is open-label therefore no blinding requirements are in place since all participants will receive RSVPreF.
Who Masked
Not provided
Biological: RSVpreF 60 µg
standard dose in 5 to <18 years olds, healthy
RSVpreF 60 µg
Biological
RSVpreF low dose level
low dose in 2 to < 5 years olds
low dose in 5 to <18 years olds, healthy
low dose in 5 to <18 years olds, with chronic high risk conditions
Within 1 month post Vaccination
Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAEs were defined as an AE that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability or incapacity; was a congenital anomaly or birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic or that was considered to be an important medical event.
Within 6 months post Vaccination
Percentage of Participants Reporting Newly Diagnosed Chronic Medical Condition (NDCMCs) Throughout the Study
An NDCMC was defined as a disease or medical condition, which was not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Within 6 months post Vaccination
Before vaccination and 1 month after vaccination
Geometric Mean Fold Rise (GMFR) of the NTs for RSV A and RSV B From Before Vaccination to 1 Month After Vaccination
GMFR of neutralizing titers of RSV A and RSV B from before vaccination to 1 month after vaccination were reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student's t distribution).
From before vaccination to 1 month after vaccination
Median Frequencies of RSV F Antigen-Specific Cluster of Differentiation 4 (CD4+) Thymus-Derived Lymphocytes (T) Cells Expressing Interferon (IFN) Gamma and Interleukin-4 (IL-4) Before Vaccination and 1 Month After Vaccination
Median frequencies of RSV F antigen-specific CD4+ T cells expressing IFN gamma and IL-4 before vaccination and 1 month after vaccination were reported in this outcome measure. RSV F enzyme-linked immune absorbent spot assay (ELISpot) limit of detection (LOD) values were IFN gamma = 20 spot forming cell (SFC) per million peripheral blood mononuclear cell (PBMCs) and IL-4 = 4 SFC/million PBMCs. Assay results below LOD=0.5*LOD for analysis. Frequencies were defined as the count of the RSV F antigen-specific CD4+ T cells and median frequencies were defined as the median of the counts.
Before vaccination and 1 Month after vaccination
Stanford University Medical Center
Palo Alto
California
94304
United States
Peninsula Research Associates
Rolling Hills Estates
California
90274
United States
Bio-Medical Research LLC
Miami
Florida
33144
United States
Velocity Clinical Research, Sioux City
Sioux City
Iowa
51106
United States
Velocity Clinical Research, New Orleans
Metairie
Louisiana
70006
United States
Velocity Clinical Research, Omaha
Omaha
Nebraska
68134
United States
Rochester Clinical Research, LLC
Rochester
New York
14609
United States
Duke Vaccine And Trials Unit
Durham
North Carolina
27703
United States
Cincinnati Children's Hospital Medical Center
Cincinnati
Ohio
45229
United States
Senders Pediatrics
South Euclid
Ohio
44121
United States
Velocity Clinical Research, Providence
East Greenwich
Rhode Island
02818
United States
Innovo Research - Austin Regional Clinic
Austin
Texas
78726
United States
Velocity Clinical Research, Austin
Austin
Texas
78759
United States
Velocity Clinical Research, Salt Lake City
West Jordan
Utah
84088
United States
Seattle Children's - Building Cure
Seattle
Washington
98101
United States
Seattle Children's Hospital
Seattle
Washington
98105
United States
Participants who had high risk chronic medical conditions of age 5 to <18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
FG002
RSVpreF 120 mcg: 2 to < 5 Years
Participants of age 2 to <5 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
FG003
RSVpreF 60 mcg: 5 to <18 Years [Healthy Participants]
Healthy participants of age 5 to <18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
FG004
RSVpreF 60 mcg: 5 to <18 Years [High Risk Participants]
Participants who had high risk chronic medical conditions of age 5 to <18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
FG005
RSVpreF 60 mcg: 2 to < 5 Years
Participants of age 2 to <5 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
FG00025 subjects
FG00123 subjects
FG00224 subjects
FG00317 subjects
FG00418 subjects
FG00520 subjects
COMPLETED
FG00025 subjects
FG00123 subjects
FG00224 subjects
FG00317 subjects
FG00418 subjects
FG00520 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Follow-Up Period
Type
Comment
Milestone Data
STARTED
FG00025 subjects
FG00123 subjects
FG00224 subjects
FG00317 subjects
FG00418 subjects
FG00520 subjects
COMPLETED
FG00024 subjects
FG00121 subjects
FG00223 subjects
FG00317 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG003
Safety population included all enrolled participants who received the study intervention.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
RSVpreF 120 mcg: 5 to <18 Years [Healthy Participants]
Healthy participants of age 5 to <18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
BG001
RSVpreF 120 mcg: 5 to <18 Years [High Risk Participants]
Participants who had high risk chronic medical conditions of age 5 to <18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
BG002
RSVpreF 120 mcg: 2 to < 5 Years
Participants of age 2 to <5 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
BG003
RSVpreF 60 mcg: 5 to <18 Years [Healthy Participants]
Healthy participants of age 5 to <18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
BG004
RSVpreF 60 mcg: 5 to <18 Years [High Risk Participants]
Participants who had high risk chronic medical conditions of age 5 to <18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
BG005
RSVpreF 60 mcg: 2 to < 5 Years
Participants of age 2 to <5 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00025
BG00123
BG00224
BG00317
BG00418
BG00520
BG006127
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Children (2-11 years)
BG0009
BG00111
BG00224
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00015
BG00111
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0005
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Local reactions were collected in the electronic diary (e-diary) from Day 1 through Day 7 after vaccination. Local reactions included pain at injection site, redness, and swelling. For participants greater than or equal to (>=) 2 years to <12 years of age, redness and swelling were graded as mild: 0.5 to 2.0 centimeter (cm), moderate: >2.0 to 7.0 cm, and severe: > 7 cm; for participants >=12 years of age, mild: > 2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm, and severe: >10 cm. Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Safety population included all enrolled participants who received study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 through Day 7 after Vaccination
ID
Title
Description
OG000
RSVpreF 120 mcg: 5 to <18 Years [Healthy Participants]
Healthy participants of age 5 to <18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
OG001
RSVpreF 120 mcg: 5 to <18 Years [High Risk Participants]
Participants who had high risk chronic medical conditions of age 5 to <18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
OG002
RSVpreF 120 mcg: 2 to <5 Years
Participants of age 2 to <5 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
OG003
RSVpreF 60 mcg: 5 to <18 Years [Healthy Participants]
Healthy participants of age 5 to <18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
OG004
RSVpreF 60 mcg: 5 to <18 Years [High Risk Participants]
Participants who had high risk chronic medical conditions of age 5 to <18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
OG005
RSVpreF 60 mcg: 2 to <5 Years
Participants of age 2 to <5 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
Units
Counts
Participants
OG00025
OG00123
OG00224
OG003
Title
Denominators
Categories
Pain at injection site: Mild
Title
Measurements
OG00036.0(18.0 to 57.5)
OG00139.1(19.7 to 61.5)
OG0028.3(1.0 to 27.0)
Primary
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Systemic events included fever, fatigue, headache, vomiting, diarrhea, muscle pain and joint pain and were recorded by participants using e-diary. Fever: oral temperature >= 38.0 degree Celsius (deg C) and categorized as >=38.0 to 38.4 deg C (mild), >38.4 to 38.9 deg C (moderate), and >38.9 to 40.0 deg C (severe). Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity), and severe (prevented daily routine activity). Vomiting was graded mild: 1-2 times in 24 hours (h), moderate: >2 times in 24h, and severe: required intravenous hydration. Diarrhea was graded mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h and severe: 6 or more loose stools in 24h.
Safety population included all enrolled participants who received study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 through Day 7 after Vaccination
ID
Title
Description
OG000
RSVpreF 120 mcg: 5 to <18 Years [Healthy Participants]
Healthy participants of age 5 to <18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
OG001
RSVpreF 120 mcg: 5 to <18 Years [High Risk Participants]
Participants who had high risk chronic medical conditions of age 5 to <18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
Primary
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
AE was defined as any untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. AEs included serious and all non-serious AE. SAEs were defined as AE that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was congenital anomaly or birth defect; was suspected transmission via Pfizer product of infectious agent, pathogenic or nonpathogenic or was considered to be an important medical event. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were included.
Safety population included all enrolled participants who received study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 1 month post Vaccination
ID
Title
Description
OG000
RSVpreF 120 mcg: 5 to <18 Years [Healthy Participants]
Healthy participants of age 5 to <18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
OG001
RSVpreF 120 mcg: 5 to <18 Years [High Risk Participants]
Participants who had high risk chronic medical conditions of age 5 to <18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
Primary
Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAEs were defined as an AE that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability or incapacity; was a congenital anomaly or birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic or that was considered to be an important medical event.
Safety population included all enrolled participants who received study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 6 months post Vaccination
ID
Title
Description
OG000
RSVpreF 120 mcg: 5 to <18 Years [Healthy Participants]
Healthy participants of age 5 to <18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
OG001
RSVpreF 120 mcg: 5 to <18 Years [High Risk Participants]
Participants who had high risk chronic medical conditions of age 5 to <18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
OG002
Primary
Percentage of Participants Reporting Newly Diagnosed Chronic Medical Condition (NDCMCs) Throughout the Study
An NDCMC was defined as a disease or medical condition, which was not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Safety population included all enrolled participants who received study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 6 months post Vaccination
ID
Title
Description
OG000
RSVpreF 120 mcg: 5 to <18 Years [Healthy Participants]
Healthy participants of age 5 to <18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
OG001
RSVpreF 120 mcg: 5 to <18 Years [High Risk Participants]
Participants who had high risk chronic medical conditions of age 5 to <18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
OG002
RSVpreF 120 mcg: 2 to <5 Years
Participants of age 2 to <5 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
OG003
RSVpreF 60 mcg: 5 to <18 Years [Healthy Participants]
Secondary
Geometric Mean Titer of the Neutralizing Titers for RSV A and RSV B Before Vaccination and 1 Month After Vaccination
Geometric mean titer (GMT) of neutralizing titers (NTs) of respiratory syncytial virus subgroup A and respiratory syncytial virus subgroup B (RSV A and RSV B) before vaccination and 1 month after vaccination were reported in this outcome measure. Assay results below the lower limit of quantification (LLOQ) were set to 0.5*LLOQ. GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution).
Evaluable immunogenicity population (EIP) included all eligible participants who received the study intervention; had 1-month postvaccination blood collection 27 through 42 days after vaccination; had at least 1 valid and determinate assay result 1 month after vaccination; had no major protocol violations from vaccination through the 1-month postvaccination blood draw. Here, "Number Analyzed" signifies participants evaluable for the specified rows.
Posted
Geometric Mean
95% Confidence Interval
Titer
Before vaccination and 1 month after vaccination
ID
Title
Description
OG000
RSVpreF 120 mcg: 5 to <18 Years [Healthy Participants]
Healthy participants of age 5 to <18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
OG001
RSVpreF 120 mcg: 5 to <18 Years [High Risk Participants]
Participants who had high risk chronic medical conditions of age 5 to <18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
Secondary
Geometric Mean Fold Rise (GMFR) of the NTs for RSV A and RSV B From Before Vaccination to 1 Month After Vaccination
GMFR of neutralizing titers of RSV A and RSV B from before vaccination to 1 month after vaccination were reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student's t distribution).
EIP included all eligible participants who received the study intervention; had 1-month postvaccination blood collection 27 through 42 days after vaccination; had at least 1 valid and determinate assay result 1 month after vaccination; had no major protocol violations from vaccination through the 1-month postvaccination blood draw. Here, ''Number of Participants Analyzed'' signifies participants evaluable of this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
From before vaccination to 1 month after vaccination
ID
Title
Description
OG000
RSVpreF 120 mcg: 5 to <18 Years [Healthy Participants]
Healthy participants of age 5 to <18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
OG001
RSVpreF 120 mcg: 5 to <18 Years [High Risk Participants]
Participants who had high risk chronic medical conditions of age 5 to <18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
Secondary
Median Frequencies of RSV F Antigen-Specific Cluster of Differentiation 4 (CD4+) Thymus-Derived Lymphocytes (T) Cells Expressing Interferon (IFN) Gamma and Interleukin-4 (IL-4) Before Vaccination and 1 Month After Vaccination
Median frequencies of RSV F antigen-specific CD4+ T cells expressing IFN gamma and IL-4 before vaccination and 1 month after vaccination were reported in this outcome measure. RSV F enzyme-linked immune absorbent spot assay (ELISpot) limit of detection (LOD) values were IFN gamma = 20 spot forming cell (SFC) per million peripheral blood mononuclear cell (PBMCs) and IL-4 = 4 SFC/million PBMCs. Assay results below LOD=0.5*LOD for analysis. Frequencies were defined as the count of the RSV F antigen-specific CD4+ T cells and median frequencies were defined as the median of the counts.
EIP included all eligible participants who received the study intervention; had 1-month postvaccination blood collection 27 through 42 days after vaccination; had at least 1 valid and determinate assay result 1 month after vaccination; had no major protocol violations from vaccination through the 1-month postvaccination blood draw. Here, "Number of Participants Analyzed" = participants evaluable for this outcome measure and "Number Analyzed" = participants evaluable for specified rows.
Posted
Median
Full Range
SFC/million PBMCs
Before vaccination and 1 Month after vaccination
ID
Title
Description
OG000
RSVpreF 120 mcg: 5 to <18 Years [Healthy Participants]
Healthy participants of age 5 to <18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
OG001
Time Frame
Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Description
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Healthy RSVpreF 120 Micrograms (mcg)
Healthy participants with 5 to < 18 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
0
25
0
25
17
25
EG001
High Risk RSVpreF 120 mcg
High risk participants with 5 to < 18 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
0
23
1
23
15
23
EG002
2 to < 5 Years RSVpreF 120 mcg
Participants with 2 to < 5 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
0
24
0
24
9
24
EG003
Healthy RSVpreF 60 mcg
Healthy participants with 5 to < 18 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
0
17
0
17
12
17
EG004
High Risk RSVpreF 60 mcg
High risk participants with 5 to < 18 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
0
18
1
18
14
18
EG005
2 to < 5 Years RSVpreF 60 mcg
Participants with 2 to < 5 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
0
20
0
20
13
20
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected24 at risk
EG0030 events0 affected17 at risk
EG004
Food allergy
Immune system disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected23 at risk
EG0020 events0 affected24 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Headache (HEADACHE)
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0007 events7 affected25 at risk
EG0018 events8 affected23 at risk
EG0021 events1 affected24 at risk
EG0037 events7 affected17 at risk
EG0046 events6 affected18 at risk
EG0050 events0 affected20 at risk
Syncope
Nervous system disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected24 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected24 at risk
EG003
Diarrhoea (DIARRHEA)
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected25 at risk
EG0012 events2 affected23 at risk
EG0023 events3 affected24 at risk
EG003
Vomiting (VOMITING)
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected24 at risk
EG003
Erythema (REDNESS)
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0006 events6 affected25 at risk
EG0012 events2 affected23 at risk
EG0023 events3 affected24 at risk
EG003
Arthralgia (JOINT PAIN)
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected25 at risk
EG0011 events1 affected23 at risk
EG0020 events0 affected24 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected24 at risk
EG003
Myalgia (MUSCLE PAIN)
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0005 events5 affected25 at risk
EG0019 events9 affected23 at risk
EG0020 events0 affected24 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected24 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected24 at risk
EG003
Viral infection
Infections and infestations
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected23 at risk
EG0021 events1 affected24 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected24 at risk
EG003
Axillary pain
General disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected24 at risk
EG003
Fatigue
General disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0012 events2 affected23 at risk
EG0020 events0 affected24 at risk
EG003
Fatigue (FATIGUE)
General disorders
MedDRA 26.1
Systematic Assessment
EG0008 events8 affected25 at risk
EG00110 events10 affected23 at risk
EG0027 events7 affected24 at risk
EG003
Injection site erythema
General disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0012 events2 affected23 at risk
EG0020 events0 affected24 at risk
EG003
Injection site pain
General disorders
MedDRA 26.1
Non-systematic Assessment
EG0002 events2 affected25 at risk
EG0013 events3 affected23 at risk
EG0020 events0 affected24 at risk
EG003
Injection site pain (PAIN AT INJECTION SITE)
General disorders
MedDRA 26.1
Systematic Assessment
EG00012 events12 affected25 at risk
EG00111 events11 affected23 at risk
EG0022 events2 affected24 at risk
EG003
Injection site swelling
General disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected24 at risk
EG003
Pyrexia
General disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected23 at risk
EG0022 events2 affected24 at risk
EG003
Pyrexia (FEVER)
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected23 at risk
EG0021 events1 affected24 at risk
EG003
Swelling (SWELLING)
General disorders
MedDRA 26.1
Systematic Assessment
EG0003 events3 affected25 at risk
EG0012 events2 affected23 at risk
EG0021 events1 affected24 at risk
EG003
Food allergy
Immune system disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected23 at risk
EG0020 events0 affected24 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.