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Trial record 1 of 1 for:    NCT01298544
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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

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ClinicalTrials.gov Identifier: NCT01298544
Recruitment Status : Completed
First Posted : February 17, 2011
Results First Posted : March 16, 2012
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 29, 2010
First Posted Date  ICMJE February 17, 2011
Results First Submitted Date  ICMJE February 13, 2012
Results First Posted Date  ICMJE March 16, 2012
Last Update Posted Date December 19, 2018
Study Start Date  ICMJE November 2010
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 16, 2011)
The primary endpoint is the serotype-specific IgG concentration at the blood draw. [ Time Frame: Visit 1 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: February 13, 2012)
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose [ Time Frame: Day 1 (36 months after 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Disease
Intervention  ICMJE Procedure: Blood draw
One 5mL blood draw for immunogenicity at least 3 years post completion of clinical study 0887X-101518.
Study Arms  ICMJE All subjects
Intervention: Procedure: Blood draw
Publications * Li R, Fang KX, Young M Jr, Zhou X, Chen Z, Liang JZ, Giardina PC, Scott DA. Long-term antibody persistence study (3 years after last dose) of the 7-valent pneumococcal conjugate vaccine in young children in China. Vaccine. 2016 Oct 17;34(44):5359-5365. doi: 10.1016/j.vaccine.2016.08.070. Epub 2016 Sep 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2012)
335
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2011)
400
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01298544
Other Study ID Numbers  ICMJE B1841009
6114A1-4001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP