Phase 3
N=1,988
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
Pneumococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT04382326 ↗Enrolled (actual)
1,988
Serious AEs
3.8%
Results posted
Dec 2023
Primary outcome: Primary: Percentage of Participants With Local Reactions Within 7 Days After Dose 1 — 25.5; 24.6; 21.5; 22.3 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
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 1 |
25.5; 24.6; 21.5; 22.3; 4.0; 2.4 | — |
| PRIMARY Percentage of Participants With Local Reaction Within 7 Days After Dose 2 |
23.2; 26.4; 21.2; 23.1; 2.0; 3.4 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 3 |
25.4; 27.2; 21.1; 23.5; 4.3; 3.7 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 4 |
23.5; 26.6; 19.6; 22.0; 3.9; 4.7 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 1 |
10.3; 7.5; 7.3; 6.3; 2.2; 0.9 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 2 |
17.3; 16.3; 10.9; 10.0; 4.0; 4.2 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 3 |
12.6; 13.7; 7.7; 7.9; 3.4; 3.9 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 4 |
14.5; 14.0; 6.5; 7.7; 5.1; 3.2 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 |
36.6; 39.4 | — |
| PRIMARY Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4 |
15.1; 15.0 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 6 Months Following Dose 4 |
4.5; 3.1 | — |
| PRIMARY Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 6 Months Following Dose 4 |
5.0; 5.9 | — |
| PRIMARY Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 |
79.8; 88.4; 52.1; 67.6; 79.7; 88.2 | — |
| PRIMARY Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4 |
1.47; 2.12; 0.56; 0.85; 3.77; 4.84 | — |
| PRIMARY Percentage of Participants With Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens 1 Month After Dose 3 |
93.5; 97.8; 99.7; 99.4; 94.9; 95.0 | — |
| SECONDARY Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3 |
0.74; 1.14; 0.36; 0.51; 0.75; 1.08 | — |
| SECONDARY Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4 |
94.3; 97.2; 73.6; 85.8; 98.9; 99.1 | — |
| SECONDARY Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3 |
26; 34; 51; 63; 339; 280 | — |
| SECONDARY Serotype-specific OPA GMTs at 1 Month After Dose 4 |
36; 66; 62; 102; 621; 961 | — |
| SECONDARY Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4 |
0.3; 0.3; 0.2; 0.2; 0.3; 0.3 | — |
| SECONDARY Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4 |
7.3; 7.1; 8.5; 9.0; 15.4; 14.2 | — |
| SECONDARY Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4 |
2.0; 1.8; 1.6; 1.7; 5.1; 4.4 | — |
| SECONDARY Percentage of Participants With Alternative Prespecified Hib Antibody Level 1 Month After Dose 3 |
75.0; 72.0 | — |
| SECONDARY Geometric Mean Ratios (GMRs) of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigen (Measles) 1 Month After Dose 4 |
277.74; 215.41 | — |
| SECONDARY GMRs of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigen (Mumps) 1 Month After Dose 4 |
36.96; 34.19 | — |
| SECONDARY GMRs of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens (Rubella) 1 Month After Dose 4 |
49.63; 40.44 | — |
| SECONDARY GMRs of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigen (Varicella) 1 Month After Dose 4 |
233.05; 234.78 | — |
Summary
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
Eligibility Criteria
Inclusion Criteria
- Male or female infants born at >36 weeks of gestation and 2 months of age 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
- 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 receipt of >1 dose of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at >30 days old, or previous receipt of any licensed or investigational pneumococcal vaccine, or planned receipt through study participation
Data sourced from ClinicalTrials.gov (NCT04382326). 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.