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NCT01298544 Clinical Trial

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 Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01298544
Other study ID # B1841009
Secondary ID 6114A1-4001
Status Completed
Phase Phase 4
First received
Last updated
Start date November 2010
Est. completion date March 2011

Study information
Verified date November 2018
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 335
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 5 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood draw
One 5mL blood draw for immunogenicity at least 3 years post completion of clinical study 0887X-101518.

Locations
Country Name City State
China Chengxiang Town Hospital Longan County Guangxi
China Dingdang Town Hospital Longan County Guangxi
China Gutan Village Hospital Longan County Guangxi
China Longan County CDC Longan County Guangxi
China Nanyu Town 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 Yanjiang Town Hospital Longan County Guangxi
China GuangXi Center for Disease Prevention and Control Nanning Guangxi

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Other Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level =0.35 mcg/mL, 36 Months After the Toddler Dose Percentage of participants achieving predefined antibody threshold =0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). Exact 2-sided CI based on the observed proportion of participants. Day 1 (36 months after toddler dose)
Primary 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)
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