Phase 3
Completed N=118
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children
Pneumococcal Vaccines
Source: ClinicalTrials.gov NCT00824655 ↗
Enrolled (actual)
118
Serious AEs
1.3%
Results posted
Jul 2011
Primary outcomePrimary: Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose — 5.27; 5.06; 9.63; 8.75 mcg/mL
Summary
The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will also assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site will be assessed during the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose |
5.27; 5.06; 9.63; 8.75; 3.50; 3.33 | — |
| SECONDARY Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose |
99.1; 53.0; 99.1; 96.5; 95.7; 92.2 | — |
| SECONDARY GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose |
2.90; 0.40; 1.73; 4.70; 1.56; 3.01 | — |
| SECONDARY GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose |
0.66; 0.62; 0.83; 0.65; 0.74; 0.70 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy children previously immunized with 1 or 2 doses of Prevenar.
- Group 1: Male or female subjects between the age of >=140 and =336 and <=392 days of age at time of enrollment
- Available for entire study period.
Exclusion Criteria
- Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component.
- Previous vaccination with licensed or investigational pneumococcal vaccine other than Prevenar.
Data sourced from ClinicalTrials.gov (NCT00824655). 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.