Phase 4
N=1,199
13-valent Pneumococcal Conjugate Vaccine Study in Adults and Children in India
Prevention of Pneumonia and Invasive Disease Caused by the Serotypes in 13vPnC
Bottom Line
View on ClinicalTrials.gov: NCT02034877 ↗Enrolled (actual)
1,199
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination — 0; 7; 0; 0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 13-valent Pneumococcal conjugate vaccine (Biological); Blood sample collection (Procedure)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination |
0; 7; 0; 0 | — |
| PRIMARY Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination |
11; 11; 18; 10; 230; 212 | — |
| PRIMARY Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination |
176; 266; 118; 143; 7860; 6029 | — |
| PRIMARY Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination |
16.3; 24.0; 6.4; 14.4; 32.6; 27.6 | — |
| PRIMARY Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination |
6.7; 12.7; 50.8; 25.8; 60.2; 65.6 | — |
| PRIMARY Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination |
92.7; 94.9; 99.5; 95.8; 100.0; 100.0 | — |
Summary
This study is to describe the safety and immunogenicity of 13vPnC in Indian adults 50 to 65 years of age and in Indian children 6 to 17 years of age.
Eligibility Criteria
Inclusion Criteria
Indian adults subjects between 50 and 65 years of age and indian children between 6 and 17years of age, determined by clinical judgment to be eligible for 13vPnC vaccination.
Exclusion Criteria
Any contraindication to 13vPnC vaccination, vaccination with any pneumococcal vaccine within the last year
Data sourced from ClinicalTrials.gov (NCT02034877). 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.