Phase 3
N=666
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
Pneumococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT04530838 ↗Enrolled (actual)
666
Serious AEs
5.9%
Results posted
Apr 2023
Primary outcome: Primary: Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 — 58.2; 51.3; 26.3; 20.0 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
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 |
58.2; 51.3; 26.3; 20.0; 23.7; 11.1 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 2 |
52.9; 53.2; 24.7; 23.3; 31.1; 7.0 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 3 |
45.0; 51.1; 23.3; 33.8; 34.8; 8.4 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 4 |
37.2; 36.4; 20.8; 49.1; 49.1; 11.8 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 1 |
9.8; 12.9; 9.7; 9.3; 12.5; 9.7 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 2 |
20.2; 21.2; 18.1; 15.2; 17.6; 14.9 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 3 |
15.3; 19.9; 15.3; 13.5; 16.3; 12.6 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 4 |
42.7; 39.5; 38.2; 25.7; 29.1; 24.1 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 |
47.6; 55.4; 58.5 | — |
| PRIMARY Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4 |
40.4; 43.2; 43.9 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4 |
6.2; 4.0; 7.4 | — |
| PRIMARY Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 1 Month After Dose 4 |
10.7; 8.9; 8.3 | — |
| PRIMARY Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 |
97.7; 99.1; 92.0; 96.4; 99.1; 95.3 | — |
| SECONDARY Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 |
1.37; 2.21; 1.17; 1.29; 1.81; 1.10 | — |
| SECONDARY Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 |
2.79; 4.62; 2.78; 0.97; 1.44; 1.08 | — |
| SECONDARY Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 |
55; 126; 56; 11; 13; 10 | — |
| SECONDARY Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 |
99.1; 100.0; 98.6; 91.7; 98.6; 91.5 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 |
0.2; 0.2; 0.2; 0.1; 0.1; 0.1 | — |
| SECONDARY GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 |
2.0; 2.1; 2.4; 0.7; 0.8; 1.0 | — |
| SECONDARY GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 |
10.7; 12.1; 12.6; 7.5; 7.9; 8.9 | — |
Summary
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
Eligibility Criteria
Inclusion Criteria
- Japanese male or female infants ≥2 months to ≤6 months at the time of consent.
- Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for 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.
- History of microbiologically proven invasive disease caused by S pneumoniae.
- 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 and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Data sourced from ClinicalTrials.gov (NCT04530838). 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.