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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01298544
First received: November 29, 2010
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Pneumococcal Disease
Procedure: Blood draw
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose [ Time Frame: Day 1 (36 months after toddler dose) ] [ Designated as safety issue: No ]
    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.


Enrollment: 335
Study Start Date: November 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
All subjects Procedure: Blood draw
One 5mL blood draw for immunogenicity at least 3 years post completion of clinical study 0887X-101518.

  Eligibility

Ages Eligible for Study:   4 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298544

Locations
China, Guangxi
Yangwan Hospital
Longan County, Guangxi, China, 532715
Qiaojian Town Hospital
Longan County, Guangxi, China, 532707
Chengxiang Town Hospital
Longan County, Guangxi, China, 532700
Longan County CDC
Longan County, Guangxi, China, 532700
Natong Town Hospital
Longan County, Guangxi, China, 532703
Yanjiang Town Hospital
Longan County, Guangxi, China, 532702
Nanyu Town Hospital
Longan County, Guangxi, China, 532701
Dingdang Town Hospital
Longan County, Guangxi, China, 532709
Gutan Village Hospital
Longan County, Guangxi, China, 532708
GuangXi Center for Disease Prevention and Control
Nanning, Guangxi, China, 530028
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01298544     History of Changes
Other Study ID Numbers: B1841009, 6114A1-4001
Study First Received: November 29, 2010
Results First Received: February 13, 2012
Last Updated: February 13, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Pfizer:
Vaccine
Prevenar
Pneumococcal disease

ClinicalTrials.gov processed this record on August 28, 2014