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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:
ClinicalTrials.gov Identifier:
NCT01298544
First Posted: February 17, 2011
Last Update Posted: March 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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
Intervention Model: Single Group Assignment
Masking: None (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) ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298544


Locations
China, Guangxi
Chengxiang Town Hospital
Longan County, Guangxi, China, 532700
Longan County CDC
Longan County, Guangxi, China, 532700
Nanyu Town Hospital
Longan County, Guangxi, China, 532701
Yanjiang Town Hospital
Longan County, Guangxi, China, 532702
Natong Town Hospital
Longan County, Guangxi, China, 532703
Qiaojian Town Hospital
Longan County, Guangxi, China, 532707
Gutan Village Hospital
Longan County, Guangxi, China, 532708
Dingdang Town Hospital
Longan County, Guangxi, China, 532709
Yangwan Hospital
Longan County, Guangxi, China, 532715
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01298544     History of Changes
Other Study ID Numbers: B1841009
6114A1-4001
First Submitted: November 29, 2010
First Posted: February 17, 2011
Results First Submitted: February 13, 2012
Results First Posted: March 16, 2012
Last Update Posted: March 16, 2012
Last Verified: February 2012

Keywords provided by Pfizer:
Vaccine
Prevenar
Pneumococcal disease

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Antibodies
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs