A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria

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NCT01193582

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Study Location
Baolixiang Clinic
Baoli Town,Yongfu County, Guangxi, 541902, China
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
121 + days
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy Chinese male or female subjects.

- Between 121 days to less than 72 months of age at the time of entry into the study.

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


- Receipt of previous vaccine against Pneumo


- Previous anaphylactic reaction to any vaccine or part of a vaccine


- Previous proven invasive Pneumo infection


- Receipt of investigational drug or device within the proceeding 28 days

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria
Official Title  ICMJE A Phase 4, Open-label Trial to Assess the Safety, Tolerability and Immunogenicity of Prevenar in Older Infants and Young Children in China Who Are Naive to Previous Pneumococcal Vaccination.
Brief Summary

A vaccine called Prevenar is already approved for use in China for vaccination of children younger than 6 years old against infections caused by Streptococcus pneumoniae.

This study is to measure the amount of antibodies (antibodies help people fight off diseases) Chinese children aged between 121 days and 6 years (72 months) produce when given Prevenar. The study will also provide more data on how safe and well tolerated Prevenar is in Chinese children.

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 Infections
Intervention  ICMJE
  • Biological: Prevenar

    Dosage form: intramuscular injection Dosage: 0.5 ml

    Frequency:

    4 doses starting from 121 to < 212 days of age

  • Biological: Prevenar

    Dosage form: intramuscular injection Dosage: 0.5 ml

    Frequency:

    3 doses starting from 212 days to < 12 months of age

  • Biological: Prevenar

    Dosage form: intramuscular injection Dosage: 0.5 ml

    Frequency:

    2 doses starting from 12 months to < 24 months of age

  • Biological: Prevenar

    Dosage form: intramuscular injection Dosage: 0.5 ml

    Frequency:

    1 dose starting from 24 months to < 72 months of age

Study Arms  ICMJE
  • Experimental: Group 1
    Intervention: Biological: Prevenar
  • Experimental: Group 2
    Intervention: Biological: Prevenar
  • Experimental: Group 3
    Intervention: Biological: Prevenar
  • Experimental: Group 4
    Intervention: Biological: Prevenar
Publications * Not Provided

*   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: August 31, 2010)		505
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy Chinese male or female subjects.
  • Between 121 days to less than 72 months of age at the time of entry into the study.

Exclusion Criteria:

  • Receipt of previous vaccine against Pneumo
  • Previous anaphylactic reaction to any vaccine or part of a vaccine
  • Previous proven invasive Pneumo infection
  • Receipt of investigational drug or device within the proceeding 28 days
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 121 Days to 72 Months   (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 NCT01193582
Other Study ID Numbers  ICMJE B1841008
B1841008
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 CenterPfizer
PRS Account Pfizer
Verification Date September 2013

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