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

Pfizer

Status and phase

Completed

Phase 4

Conditions

Pneumococcal Disease

Treatments

Procedure: Blood draw

Study type

Interventional

Funder types

Industry

Identifiers

NCT01298544

B1841009

6114A1-4001

Details and patient eligibility

About

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.

Enrollment

335 patients

Sex

All

Ages

4 to 5 years old

Volunteers

Accepts Healthy Volunteers

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.