Phase 2
Completed N=180
Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea
Pneumococcal Vaccine
Source: ClinicalTrials.gov NCT00689351 ↗
Enrolled (actual)
180
Serious AEs
8.4%
Results posted
Jan 2011
Primary outcomePrimary: Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series — 100.0; 100.0; 98.8; 100.0 percentage of participants
Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Korea.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series |
100.0; 100.0; 98.8; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy 2-month-old-infants (42 to 98 days)
- Available for the entire study period (14 months)
Exclusion Criteria
- Previous vaccine with pneumococcal, diptheria, tetanus, pertussis, polio or Hib vaccine
- A previous severe reaction to any vaccine or vaccine-related component
Data sourced from ClinicalTrials.gov (NCT00689351). 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.