NCT01298544

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

A Phase 4, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Prevenar in Healthy Children in China Who Have Been Previously Immunized With a 4-dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 0887x-101518

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 335 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 4 Years – 5 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pneumococcal Disease

Interventions

Type	Name	Description
PROCEDURE	Blood draw	One 5mL blood draw for immunogenicity at least 3 years post completion of clinical study 0887X-101518.

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2011-02-17
• Last updated: 2018-12-19
• Results posted: 2012-03-16

Locations

10 sites across 1 country: China