Phase 3 N=168 Randomized Double-blind Prevention

Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan

Vaccines · Pneumococcal Conjugate Vaccine

Bottom Line

View on ClinicalTrials.gov: NCT00688870 ↗

Enrolled (actual)

168

Serious AEs

6.4%

Results posted

May 2011

Primary outcome: 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 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 13-valent pneumococcal conjugate vaccine (13vPnC) (Biological); 7-valent pneumococcal conjugate vaccine (7vPnC) (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Primary completion: Jan 2010

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	—

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.

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.

View full record on ClinicalTrials.gov →

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.