Phase 4
Completed 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
Source: ClinicalTrials.gov NCT02034877 ↗
Enrolled (actual)
1,199
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: 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
◆ Published Evidence
Established
21citations · ~2 / year
Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age in India: An open-label trial.
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.
Linked Publications (2)
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Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age in India: An open-label trial.
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Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Children 6-17 Years of Age in India: An Open-label Trial.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.