Phase 4 Completed N=335 Prevention

A Study to Assess the Antibody Response of Healthy Chinese Children Who Have Been Vaccinated Previously With 4-doses of Prevenar (a Pneumococcal Vaccine) as Babies and Toddlers

Pneumococcal Disease

Source: ClinicalTrials.gov NCT01298544 ↗

Enrolled (actual)

335

Serious AEs

0.0%

Results posted

Mar 2012

Primary outcomePrimary: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose — 0.98; 0.66; 0.41; 11.35 microgram per milliliter (mcg/mL)

Summary

In 2005, Wyeth conducted study 0887X-101518 (NCT00488826) in which Chinese infants received either Prevenar alone (Group 1), Prevenar given with a Diphtheria, Tetanus and acellular Pertussis (DTaP) vaccine (Group 2) or DTaP alone (Group 3). This follow up study (at least 3 years after the last vaccination) will assess the antibody concentrations in children who previously completed Wyeth study 0887X-101518.

Outcome Measures

Outcome	Result	p-value
PRIMARY Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose	0.98; 0.66; 0.41; 11.35; 9.24; 3.37	—

Eligibility Criteria

Inclusion Criteria

Male or female subjects who participated in and completed Wyeth study 0887X 101518.
Healthy subject as determined by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria

Vaccination with any licensed or investigational pneumococcal vaccine since completion of Wyeth study 0887X 101518.
History of culture proven invasive disease caused by S pneumoniae since the completion of Wyeth study 0887X 101518.
Known or suspected immune deficiency or suppression since participation in Wyeth study 0887X 101518.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01298544). 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.