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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pneumococcal Disease

Intervention / Treatment
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* Procedure: Blood draw


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All subjects<br> | Procedure: Blood draw<br>* One 5mL blood draw for immunogenicity at least 3 years post completion of clinical study 0887X-101518.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose | Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). GMC (7vPnC, 7vPnC/DTaP, and DTap) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. | Day 1 (36 months after toddler dose) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccine, Prevenar, Pneumococcal disease