Phase 3
N=932
A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Infants and Young Children
Pneumococcal Infections · Pneumococcal Conjugate Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT03574389 ↗Enrolled (actual)
932
Serious AEs
2.2%
Results posted
Apr 2024
Primary outcome: Primary: The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 — 5.40; 3.75; 4.38; 4.40 mcg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13vPnC (Biological); Hib (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1 |
5.40; 3.75; 4.38; 4.40; 0.63; 1.19 | — |
| PRIMARY Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 2 |
66; 18; 20; 14; 4; 23 | — |
| PRIMARY Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 3 |
45; 10; 9; 26; 7; 4 | — |
| PRIMARY Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 4 |
48; 21; 17; 10 | — |
| PRIMARY Number of Participants With Adverse Event (AE) From the Signing of the Informed Consent Document (ICD) to 1 Month After the Last Vaccination in Cohorts 2, 3, 4 |
76; 29; 21; 1; 11; 1 | — |
| PRIMARY Number of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From 1 Month to 6 Months After the Last Vaccination in Cohorts 2, 3, 4 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With SAE From the Signing of the ICD to 6 Months After the Last Vaccination in Cohorts 2, 3, 4 |
5; 1; 2; 0; 2; 1 | — |
| SECONDARY The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1. |
201.7; 142.7; 93.3; 40.9; 112.9; 249.0 | — |
| SECONDARY The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. |
0.02; 0.02; 0.07; 0.07; 0.18; 0.21 | — |
| SECONDARY The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine. |
4.1; 4.2; 4.0; 4.2; 4.6; 5.5 | — |
| SECONDARY Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). |
100.0; 99.4; 4.2; 97.6; 10.4; 99.2 | — |
| SECONDARY Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC). |
100.0; 96.6; 5.9; 96.2; 7.1; 95.8 | — |
| SECONDARY Number of Participants With AE From the Signing of the ICD to 1 Month After the Infant Series in Cohort 1 |
14 | — |
| SECONDARY Number of Participants With NDCMCs From 1 Month After Vaccination 3 to Vaccination 4 in Cohort 1 |
— | — |
| SECONDARY Number of Participants With AE From Toddler Dose Until 1 Month After the Toddler Dose in Cohort 1 |
5 | — |
| SECONDARY Number of Participants With NDCMCs From 1 Month to 6 Months After the Toddler Dose in Cohort 1 |
— | — |
| SECONDARY Number of Participants With SAEs From the Signing of the ICD to 6 Months After the Toddler Dose in Cohort 1 |
9 | — |
| SECONDARY Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series) |
1.35; 0.88; 0.77; 0.79; 0.27; 0.22 | — |
Summary
The purpose of this study is to assess the safety and immunogenicity of 13-valent Pneumococcal conjugate vaccine in Chinese infant and young children.
Eligibility Criteria
Inclusion Criteria
- Evidence of a personally signed and dated ICD indicating that the parent(s)/legal guardian has been informed of all pertinent aspects of the study.
- Aged 6 weeks (42 days) to <6 years at the time of consent.
- Healthy infants and children as determined by medical history, physical examination, and judgment of the investigator.
Exclusion Criteria
- Participation in other studies involving investigational drug(s)/vaccine(s) since birth (Cohort 1 only) or in the 6 months prior to study entry (Cohorts 2, 3, and 4) and/or during study participation.
- Other acute or chronic medical or psychiatric condition, including recent 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 subject inappropriate for entry into this study.
- Vaccination with licensed or investigational pneumococcal vaccine.
- Previous vaccination with licensed or investigational Hib vaccine.
Data sourced from ClinicalTrials.gov (NCT03574389). 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.