Phase 2
N=460
Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants
Pneumococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT03512288 ↗Enrolled (actual)
460
Serious AEs
3.7%
Results posted
Mar 2021
Primary outcome: Primary: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 — 24.9; 25.4; 22.3; 23.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Multivalent (Biological); 13vPnC (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 |
24.9; 25.4; 22.3; 23.7; 2.6; 1.8 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 |
24.7; 28.4; 21.9; 24.0; 2.8; 4.4 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 |
26.9; 26.5; 26.4; 23.0; 0.5; 3.4 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 |
25.8; 30.3; 24.2; 25.4; 1.6; 4.9 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 |
14.4; 9.8; 10.0; 6.3; 3.9; 2.2 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 |
17.2; 23.0; 10.2; 12.7; 4.2; 7.8 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 |
17.9; 18.1; 10.0; 9.8; 4.5; 4.9 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 |
12.4; 14.6; 5.9; 4.3; 3.2; 7.0 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) From Vaccination 1 to 1 Month After Vaccination 3 |
61.0; 56.4 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) From Vaccination 4 to 1 Month After Vaccination 4 |
18.3; 25.3 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination 1 to 6 Months Following Vaccination 4 |
5.2; 2.2 | — |
| PRIMARY Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination 1 to 6 Months Following Vaccination 4 |
5.2; 3.5 | — |
| SECONDARY Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3 |
87.8; 87.7; 65.1; 75.4; 87.8; 91.4 | — |
| SECONDARY Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3 |
0.92; 1.16; 0.43; 0.56; 1.36; 1.64 | — |
| SECONDARY Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4 |
2.65; 3.63; 1.15; 1.49; 7.16; 9.45 | — |
Summary
A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants
Eligibility Criteria
Inclusion Criteria
- Male or female infant born at >36 weeks of gestation and aged 2 months (42 to 98 days) at the time of consent (the day of birth is considered day of life 1).
- Healthy infant determined by medical history, physical examination, and clinical judgment to be eligible for the study.
Exclusion Criteria
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- Prior receipt of diphtheria, tetanus, pertussis, or polio vaccines.
- Previous receipt of >1 dose of hepatitis B vaccine.
- Prior hepatitis B vaccine must have been administered at age <30 days.
- Major known congenital malformation or serious chronic disorder. Receipt of blood/plasma products or immunoglobulins
Data sourced from ClinicalTrials.gov (NCT03512288). 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.