Phase 3
N=1,255
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
Pneumococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT04546425 ↗Enrolled (actual)
1,255
Serious AEs
5.9%
Results posted
May 2023
Primary outcome: Primary: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population — 20.7; 22.7; 4.5; 4.8 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 Within 7 Days After Dose 1: Primary Study Population |
20.7; 22.7; 4.5; 4.8; 0; 0 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population |
24.8; 22.9; 3.7; 5.1; 0; 0.2 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population |
23.3; 25.1; 13.4; 8.5; 0.2; 0.2 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population |
7.5; 6.8; 1.3; 1.3; 0; 0.3 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population |
11.7; 11.6; 2.5; 2.0; 0.7; 0.3 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population |
13.4; 13.5; 6.9; 7.0; 3.6; 3.2 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 2: Primary Study Population |
13.8; 14.4 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) From Dose 3 to 1 Month After Dose 3: Primary Study Population |
15.5; 16.5 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 3: Primary Study Population |
5.7; 6.6 | — |
| PRIMARY Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Dose 1 to 1 Month After Dose 3: Primary Study Population |
1.0; 1.0 | — |
| PRIMARY Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population |
70.7; 84.2; 58.0; 75.8; 68.6; 79.5 | — |
| PRIMARY Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population |
0.57; 0.93; 0.41; 0.58; 0.55; 0.92 | — |
| PRIMARY GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population |
1.71; 2.53; 0.72; 1.09; 4.11; 5.36 | — |
| PRIMARY Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population |
99.6; 99.8; 99.4; 100.0; 92.9; 95.2 | — |
| PRIMARY GMC of Measles Virus Antibody 1 Month After Dose 3: Primary Study Population |
228.63; 216.72 | — |
| PRIMARY GMC of Mumps Virus Antibody 1 Month After Dose 3: Primary Study Population |
36.81; 35.25 | — |
| PRIMARY GMC of Rubella Virus Antibody 1 Month After Dose 3: Primary Study Population |
31.81; 38.20 | — |
| PRIMARY GMC of Varicella Virus Antibody 1 Month After Dose 3: Primary Study Population |
195.58; 157.60 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort |
4.2; 7.4; 4.2; 3.7; 0; 0 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort |
0; 3.7; 4.3; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort |
0; 4.0; 4.5; 0; 0; 4.0 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort |
4.2; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort |
0; 11.1; 4.3; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort |
0; 0; 0; 4.0; 4.5; 0 | — |
| PRIMARY Percentage of Participants With AEs From Dose 1 to 1 Month After Dose 2: Russian Cohort |
8.3; 3.7 | — |
| PRIMARY Percentage of Participants With AEs From Dose 3 to 1 Month After Dose 3: Russian Cohort |
4.5; 0 | — |
| PRIMARY Percentage of Participants With SAEs From Dose 1 to 1 Month After Dose 3: Russian Cohort |
0; 0 | — |
| PRIMARY Percentage of Participants With NDCMC From Dose 1 to 1 Month After Dose 3: Russian Cohort |
0; 0 | — |
| PRIMARY Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort |
70.8; 77.8; 37.5; 59.3; 75.0; 74.1 | — |
| PRIMARY GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort |
0.76; 1.04; 0.28; 0.47; 0.67; 1.00 | — |
| PRIMARY GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort |
1.61; 1.65; 0.84; 0.57; 3.05; 3.04 | — |
| SECONDARY Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population |
97.2; 98.2; 82.6; 93.2; 99.2; 99.2 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population |
14; 23; 31; 40; 333; 391 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population |
54; 101; 99; 129; 904; 992 | — |
| SECONDARY Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population |
13.9; 13.9; 13.7; 15.2; 29.8; 27.7 | — |
| SECONDARY Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population |
85.0; 89.5; 95.5; 98.5; 94.5; 95.0 | — |
| SECONDARY Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort |
90.9; 83.3; 68.2; 50.0; 95.5; 100.0 | — |
| SECONDARY GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort |
17; 33; 79; 31; 166; 163 | — |
| SECONDARY GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort |
85; 93; 126; 107; 310; 429 | — |
Summary
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-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 and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
Data sourced from ClinicalTrials.gov (NCT04546425). 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.