Phase 3
Completed N=168
Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan
Vaccines · Pneumococcal Conjugate Vaccine
Source: ClinicalTrials.gov NCT00688870 ↗
Enrolled (actual)
168
Serious AEs
6.4%
Results posted
May 2011
Primary outcomePrimary: Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. — 98.8; 100.0; 100.0; 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 Taiwan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. |
98.8; 100.0; 100.0; 100.0; 98.8; 100.0 | — |
| SECONDARY Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose |
98.7; 100.0; 100.0; 100.0; 98.7; 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 vaccination with pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib vaccines
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
Data sourced from ClinicalTrials.gov (NCT00688870). 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.