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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
128
RSVpreF standard dose level
RSVpreF low dose level
University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama, United States
Stanford University Medical Center
Palo Alto, California, United States
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).
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Peninsula Research Associates
Rolling Hills Estates, California, United States
Bio-Medical Research LLC
Miami, Florida, United States
Velocity Clinical Research, Sioux City
Sioux City, Iowa, United States
Velocity Clinical Research, New Orleans
Metairie, Louisiana, United States
Velocity Clinical Research, Omaha
Omaha, Nebraska, United States
Rochester Clinical Research, LLC
Rochester, New York, United States
Duke Vaccine And Trials Unit
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
...and 7 more locations
Time frame: 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.
Time frame: 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.
Time frame: Within 6 months post Vaccination
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).
Time frame: 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).
Time frame: 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.
Time frame: Before vaccination and 1 Month after vaccination