Phase 3
N=1,511
20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants
Pneumococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT04379713 ↗Enrolled (actual)
1,511
Serious AEs
4.8%
Results posted
Jun 2023
Primary outcome: Primary: Percentage of Participants With Local Reactions Within 7 Days After Dose 1 — 18.0; 16.5; 3.7; 3.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 20-valent pneumococcal conjugate vaccine (Biological); 13-valent pneumococcal conjugate vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 1 |
18.0; 16.5; 3.7; 3.0; 0; 0 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 2 |
20.4; 19.4; 3.2; 3.9; 0; 0 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 3 |
19.4; 17.0; 3.8; 3.1; 0; 0.2 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 4 |
15.1; 19.4; 5.9; 2.4; 0.1; 0 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 1 |
6.3; 7.8; 2.3; 1.8; 0.7; 0.2 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 2 |
10.6; 8.5; 3.6; 2.7; 1.4; 0.2 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 3 |
7.4; 8.2; 2.9; 0.6; 1.3; 1.0 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 4 |
9.8; 9.5; 4.5; 4.2; 3.7; 3.1 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 |
29.6; 27.6 | — |
| PRIMARY Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4 |
15.1; 15.8 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 6 Months After Dose 4 |
4.4; 5.6 | — |
| PRIMARY Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 6 Months After Dose 4 |
2.8; 2.8 | — |
Summary
This study is designed to evaluate the safety and tolerability of 20vPnC in healthy infants.
Eligibility Criteria
Inclusion Criteria
- Male or female infants born at ≥34 weeks of gestation and who are 2 months of age (≥42 to ≤98 days) at the time of consent (the day of birth is considered day of life 1).
- Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Exclusion Criteria
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
- Major known congenital malformation or serious chronic disorder.
Data sourced from ClinicalTrials.gov (NCT04379713). 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.