Phase 3 N=603 Randomized Quadruple-blind Prevention

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

Vaccines, Pneumococcal Conjugate Vaccine

Bottom Line

View on ClinicalTrials.gov: NCT00475033 ↗

Enrolled (actual)

603

Serious AEs

1.8%

Results posted

Jun 2010

Primary outcome: Primary: Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series — 96.8; 99.3 percentage of subjects

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 13-valent Pneumococcal Conjugate Vaccine (Biological); 7-valent pneumococcal conjugate vaccine (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Primary completion: May 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series	96.8; 99.3	—
PRIMARY Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series	361.16; 302.55	—
PRIMARY Percentage of Subjects Achieving Predefined Antibody Level to Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series	99.6; 99.6; 100.0; 100.0; 97.9; 96.8	—
PRIMARY Geometric Mean Concentration (GMC) of Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series	46.06; 40.37; 78.08; 69.52; 42.90; 40.69	—
PRIMARY Percentage of Subjects Achieving Predefined Antibody Level ≥0.15 Micrograms Per mL (μg/mL) for Polyribosylribitol Phosphate (PRP) in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series	97.8; 99.6	—
PRIMARY Geometric Mean Concentration (GMC) of PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series	2.87; 3.14	—
SECONDARY Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C SBA in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose of NeisVac-C®	100.0; 100.0	—
SECONDARY Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose	1379.75; 1083.96	—
SECONDARY Percentage of Subjects Achieving Predefined Antibody Level ≥1.0 μg/mL for PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series	81.6; 84.6	—

Summary

The purpose of this study will be to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy infants given with routine pediatric vaccinations in Canada. Immune responses induced by the infant series (NeisVac-C® and Pentacel®)and toddler dose(NeisVac-C®)of routine pediatric vaccines when administered with 13-valent pneumococcal conjugate vaccine will be studied for noninferiority to the immune responses when administered with 7-valent pneumococcal conjugate vaccine. Safety profile and immunogenicity of 13-valent pneumococcal conjugate vaccine will also be evaluated.

Eligibility Criteria

Inclusion Criteria

Healthy 2-month old infants (42 to 98 days)
Available for the duration of the study and reachable by telephone

Exclusion Criteria

Previous vaccination with licensed or investigational pneumococcal, Hib conjugate, diphtheria, tetanus, pertussis, polio, or meningococcal vaccine
Previous anaphylactic reaction to any vaccine or vaccine-related component.
Bleeding disorder, immune deficiency or suppression, or significant chronic or congenital disease
Receipt of blood products or gamma globulin

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00475033). 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.