You are here

Our science / Clinical Trials / Find a Trial / NCT01193582

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

Back to Search Print Save as PDF Bookmark Trial

NCT01193582

Last updated on November 14, 2019
Back to Search Print Save as PDF Bookmark Trial

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Advanced Search

Based on your search, you may also be interested in

Pneumococcal Infections
Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age.
NCT03642847
All Genders
18+
Years
Multiple Sites
Pneumococcal Infections
Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age
NCT03313037
All Genders
60+
Years
Multiple Sites
Pneumococcal Infections
Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants
NCT03512288
All Genders
0+
Years
Multiple Sites
Pneumococcal Infections, COPD
Immunization To Prevent Acute COPD Exacerbations
NCT03276754
All Genders
18+
Years
Multiple Sites
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 DescriptionNot 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 DateSeptember 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now