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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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NCT01298544

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Chengxiang Town Hospital
Longan County, Guangxi, 532700 China
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
4-5 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01298544
Pfizer
Completed
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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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
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
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Pneumococcal Disease
Procedure: Blood draw
One 5mL blood draw for immunogenicity at least 3 years post completion of clinical study 0887X-101518.
All subjects
Intervention: Procedure: Blood draw
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.
 
Completed
335
March 2011
March 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
4 Years to 5 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01298544
B1841009
6114A1-4001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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