Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age
- Conditions
- Pneumococcal Disease
- Interventions
- Biological: 20vPnC
- Registration Number
- NCT04642079
- Lead Sponsor
- Pfizer
- Brief Summary
This study is designed to evaluate the safety and immunogenicity of 20vPnC in healthy children 15 months through 17 years of age
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 839
- Male or female children ≥15 months to <18 years of age at the time of consent.
- Healthy children determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
- For children <5 years of age, written documentation of receipt of at least 3 doses of 13vPnC. The last dose of 13vPnC must have been administered >2 months before enrolment into the study
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
- Major known congenital malformation or serious chronic disorder
- Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results
- Previous vaccination with any investigational pneumococcal vaccine or with PPSV23, or planned receipt through study participation
- Cohorts 3 and 4: Pregnant or breastfeeding female participants
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1: =>15 through 23 months of age 20vPnC 20vPnC Cohort 2: 2 through 4 years of age 20vPnC 20vPnC Cohort 3: 5 through 9 years of age 20vPnC 20vPnC Cohort 4: 10 through 17 years of age 20vPnC 20vPnC
- Primary Outcome Measures
Name Time Method Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1 Within 7 days after vaccination on Day 1 Systemic events for Cohort 1 included fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature \>=38.0 degrees Celsius (C) and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0-degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2 Before vaccination on Day 1 to 1 month after vaccination Pneumococcal serotype-specific IgG concentrations were measured from serum samples for the 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding 2-sided 95% CIs (based on Student's t distribution). Superiority of IgG concentration 1 month after 20vPnC to before vaccination for each serotype was demonstrated if the 95% lower CI of GMFR was \>1.
Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination Within 7 days after vaccination on Day 1 Local reactions included redness, swelling and, pain at the injection site, recorded by parent's/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. One measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: \> 0.0 to 2.0 cm, moderate: \>2.0 to 7.0 cm and severe: \>7.0 cm. Pain at the injection site was graded as mild: hurt if gently touched (cohort 1) and did not interfere with activity (cohort 2-4); moderate: hurt if gently touched with crying (cohort 1) and interfered with daily activity (cohort 2-4) and; severe: limited limb movement (cohort 1) and prevented daily activity (cohort 2-4). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method.
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 Within 7 days after vaccination on Day 1 Systemic events for Cohort 2-4 included fever, fatigue, headache, muscle pain and joint pain, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature \>=38.0 degrees C and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevents daily routine activity). 95% CI was based on Clopper and Pearson method.
Percentage of Participants Reporting Adverse Events (AEs) up to 1 Month After Vaccination From vaccination (on Day 1) up to 1 month after vaccination An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Percentage of Participants Reporting Serious Adverse Events (SAEs) up to 6 Months After Vaccination From vaccination (on Day 1) up to 6 months after vaccination An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.
Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 Months After Vaccination From vaccination (on Day 1) up to 6 months after vaccination An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method.
GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4 Before vaccination on Day 1 to 1 month after vaccination Pneumococcal serotype-specific OPA titers were measured from serum samples for 7 the additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution). Superiority of OPA titers 1 month after 20vPnC to before vaccination for each serotype was demonstrated if the 95% lower CI of the GMFR was \>1.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only At 1 Month after vaccination on Day 1 Pneumococcal serotype-specific IgG concentrations were measured from serum samples for the 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. Percentage of participants with predefined level (\>=0.35 micrograms per milliliter) of IgG concentration for the 7 additional 20vPnC serotypes was presented. 2-sided 95% CI was based on Clopper and Pearson method.
Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only Before vaccination on Day 1 to 1 month after vaccination Pneumococcal serotype-specific OPA titers were measured from serum samples for 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. Percentage of participants with \>=4-fold rise in serotype-specific OPA titers from before vaccination to 1 month after vaccination with 20vPnC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. OPA titers were measured in a randomized subset of samples in Cohort 2 for this outcome measure.
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination Before vaccination and 1 month after vaccination Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMCs the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding 2-sided 95% CIs (based on the Student's t distribution).
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 Before vaccination on Day 1 to 1 month after vaccination Pneumococcal serotype-specific IgG concentrations were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution).
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 Before vaccination on Day 1 to 1 month after vaccination Pneumococcal serotype-specific IgG concentrations were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution).
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination Before vaccination on Day 1 and 1 month after vaccination Pneumococcal serotype-specific OPA titers were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding 2-sided 95% CIs (based on the Student's t distribution). OPA titers were measured in a randomized subset of serum samples in Cohorts 1 and 2. OPA titers for the 13vPnC serotypes were measured in a randomized subset of serum samples in Cohorts 3 and 4.
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 Before vaccination on Day 1 to 1 month after vaccination Pneumococcal serotype-specific OPA titers were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution). OPA titers measured in a randomized subset of serum samples in Cohorts 1 and 2 for this outcome measure.
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 Before vaccination on Day 1 to 1 month after vaccination Pneumococcal serotype-specific OPA titers were measured for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution). OPA titers for the 13vPnC serotypes were measured in a randomized subset of serum samples in Cohorts 3 and 4.
Trial Locations
- Locations (38)
The Children's Clinic
🇺🇸Jonesboro, Arkansas, United States
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
Palmetto Pediatrics, PA
🇺🇸North Charleston, South Carolina, United States
Allegheny Health and Wellness Pavilion
🇺🇸Erie, Pennsylvania, United States
MedPharmics, LLC
🇺🇸Gulfport, Mississippi, United States
Velocity Clinical Research, Grand Island
🇺🇸Grand Island, Nebraska, United States
Dayton Clinical Research
🇺🇸Dayton, Ohio, United States
CopperView Medical Center
🇺🇸South Jordan, Utah, United States
Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
🇺🇸Charlottesville, Virginia, United States
J. Lewis Research, Inc. / Jordan River Family Medicine
🇺🇸South Jordan, Utah, United States
Pediatric Research of Charlottesville, LLC
🇺🇸Charlottesville, Virginia, United States
Ohio Pediatric Research Association Inc.
🇺🇸Dayton, Ohio, United States
MedPharmic's, LLC
🇺🇸Albuquerque, New Mexico, United States
PriMed Clinical Research
🇺🇸Dayton, Ohio, United States
Pediatric Care
🇺🇸Provo, Utah, United States
Wr-Crcn, Llc
🇺🇸Henderson, Nevada, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Wasatch Pediatrics, Cottonwood Office
🇺🇸Murray, Utah, United States
Midwest Children's Health Research Institute
🇺🇸Lincoln, Nebraska, United States
Lockman & Lubell Pediatric Associates
🇺🇸Fort Washington, Pennsylvania, United States
California Research Foundation
🇺🇸San Diego, California, United States
Pharmax Research Clinic, Inc.
🇺🇸Miami, Florida, United States
JBR Clinical Research
🇺🇸Salt Lake City, Utah, United States
Bio-Medical Research, LLC
🇺🇸Miami, Florida, United States
J. Lewis Research, Inc./ Foothill Family Clinic South
🇺🇸Salt Lake City, Utah, United States
Velocity Clinical Research, Sioux City
🇺🇸Omaha, Nebraska, United States
J. Lewis Research, Inc. / Foothill Family Clinic
🇺🇸Salt Lake City, Utah, United States
Northwest Arkansas Pediatrics
🇺🇸Fayetteville, Arkansas, United States
The Children's Clinic of Jonesboro, P.A.
🇺🇸Jonesboro, Arkansas, United States
Children's Health Center
🇺🇸Tampa, Florida, United States
Tekton Research, Inc
🇺🇸San Antonio, Texas, United States
Alliance for Multispecialty Research, LLC
🇺🇸Layton, Utah, United States
Meridian Clinical Research, LLC
🇺🇸Binghamton, New York, United States
Kentucky Pediatric/ Adult Research
🇺🇸Bardstown, Kentucky, United States
Benchmark Research
🇺🇸Austin, Texas, United States
Michael W. Simon, M.D., PSC
🇺🇸Lexington, Kentucky, United States
Velocity Clinical Research, Norfolk
🇺🇸Norfolk, Nebraska, United States
Wee Care Pediatrics
🇺🇸Syracuse, Utah, United States