Phase 3
N=1,712
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants
Vaccines, Pneumococcal
Bottom Line
View on ClinicalTrials.gov: NCT00444457 ↗Enrolled (actual)
1,712
Serious AEs
2.1%
Results posted
Jul 2010
Primary outcome: Primary: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series — 1.33; 1.34; 1.75; 2.89 GMC mcg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13-valent Pneumococcal Conjugate Vaccine (Biological); 7vPnC (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series |
1.33; 1.34; 1.75; 2.89; 2.15; 2.54 | — |
| PRIMARY Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series |
98.4; 98.5 | — |
| PRIMARY Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series |
100.0; 100.0; 98.9; 99.5; 100.0; 99.5 | — |
| PRIMARY Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series |
100.0; 100.0 | — |
| SECONDARY Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series |
97.6; 95.5; 98.5; 94.9; 89.5; 94.4 | — |
| SECONDARY Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose |
99.2; 99.1; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series |
70.7; 78.9; 55.7; 95.2; 68.7; 85.4 | — |
| SECONDARY Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose |
86.0; 87.4; 92.7; 99.5; 99.1; 99.7 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose |
2.29; 2.25; 3.06; 11.14; 9.33; 9.92 | — |
Summary
The purpose of this study will be to evaluate safety, tolerability and immunogenicity of three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied for consistency of the immune response, as well as for non-inferiority and safety as compared to 7-valent Pneumococcal Conjugate Vaccine.
Eligibility Criteria
Inclusion criteria
- Healthy 2 month old infants
- Available for the duration of the study and reachable by telephone
- Able to complete two blood drawing procedures during the study
Exclusion criteria
- Previous vaccination, contraindication or history of allergic reaction to vaccines or vaccine components
- Bleeding disorder, immune deficiency or significant chronic or congenital disease
- Previous receipt of blood products or immune globulin
Data sourced from ClinicalTrials.gov (NCT00444457). 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.