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
- Conditions
- Pneumococcal Disease
- Interventions
- Procedure: Blood draw
- Registration Number
- NCT01298544
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 335
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All subjects Blood draw -
- Primary Outcome Measures
Name Time Method Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose Day 1 (36 months after 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Longan County CDC
🇨🇳Longan County, Guangxi, China
Nanyu Town Hospital
🇨🇳Longan County, Guangxi, China
Dingdang Town Hospital
🇨🇳Longan County, Guangxi, China
Yanjiang Town Hospital
🇨🇳Longan County, Guangxi, China
Chengxiang Town Hospital
🇨🇳Longan County, Guangxi, China
Gutan Village Hospital
🇨🇳Longan County, Guangxi, China
Natong Town Hospital
🇨🇳Longan County, Guangxi, China
Qiaojian Town Hospital
🇨🇳Longan County, Guangxi, China
Yangwan Hospital
🇨🇳Longan County, Guangxi, China
GuangXi Center for Disease Prevention and Control
🇨🇳Nanning, Guangxi, China