Phase 3 N=839 Prevention

Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age

Pneumococcal Disease

Bottom Line

View on ClinicalTrials.gov: NCT04642079 ↗

Enrolled (actual)

839

Serious AEs

0.6%

Results posted

Apr 2023

Primary outcome: Primary: Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination — 37.7; 39.1; 37.2; 15.1 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 20vPnC (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Apr 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination	37.7; 39.1; 37.2; 15.1; 30.4; 22.8	—
PRIMARY Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1	11.8; 5.9; 2.9; 2.9; 0; 25.0	—
PRIMARY Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4	3.3; 0.5; 0; 1.4; 0.5; 0	—
PRIMARY Percentage of Participants Reporting Adverse Events (AEs) up to 1 Month After Vaccination	23.9; 7.9; 6.5; 4.4	—
PRIMARY Percentage of Participants Reporting Serious Adverse Events (SAEs) up to 6 Months After Vaccination	1.0; 0; 0; 1.5	—
PRIMARY Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 Months After Vaccination	3.3; 0.5; 0.5; 1.0	—
PRIMARY 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	113.4; 107.0; 83.2; 106.7; 62.7; 43.6	—
PRIMARY 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	106.5; 86.3; 30.6; 33.5; 11.6; 14.9	—
SECONDARY 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	100.0; 83.2; 93.2; 40.0; 83.7; 98.9	—
SECONDARY 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	93.2; 92.2; 89.1; 84.9; 80.6; 81.7	—
SECONDARY Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination	0.43; 0.20; 0.12; 0.09; 1.46; 4.21	—
SECONDARY GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2	3.4; 20.6; 3.9; 14.9; 4.3; 27.6	—
SECONDARY GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4	49.4; 44.2; 5.9; 4.3; 74.1; 52.0	—
SECONDARY Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination	14; 12; 10; 11; 57; 360	—
SECONDARY GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2	4.1; 29.8; 3.7; 9.6; 13.2; 50.0	—
SECONDARY GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4	55.2; 37.3; 5.3; 5.8; 50.2; 65.6	—

Summary

This study is designed to evaluate the safety and immunogenicity of 20vPnC in healthy children 15 months through 17 years of age

Eligibility Criteria

Inclusion Criteria

Male or female children ≥15 months to 2 months before enrolment into the study

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04642079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.