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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

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Baolixiang Clinic
Baoli Town,Yongfu County, Guangxi, 541902 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 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

NCT01193582
Pfizer
Completed
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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A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria
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.

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Pneumococcal Infections
  • 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
  • Experimental: Group 1
    Intervention: Biological: Prevenar
  • Experimental: Group 2
    Intervention: Biological: Prevenar
  • Experimental: Group 3
    Intervention: Biological: Prevenar
  • Experimental: Group 4
    Intervention: Biological: Prevenar
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
505
September 2012
September 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
121 Days to 72 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01193582
B1841008
B1841008
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2013

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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