Study Evaluating Prevenar Immunogenicity in High Risk Children

NCT00581620

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vaccines, Pneumococcal Conjugate Vaccine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-9 months
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Children between 2 months to 9 years old.

- Children with HIV+; Sickle Cell disease; Neprotic symdrome; Chronic pulmonary disease

- No history of seizures

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Prevenar Immunogenicity in High Risk Children
Official Title  ICMJE To Evaluate the Humoral Immune Response to a Conjugated Pneumococcus Vaccine 7-Valent (Prevenar®) in Children From High Risk Groups.
Brief Summary To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition. To evaluate tolerability of Prevenar® in that population.
Detailed Description This study will require 24 months to be completed. Each child will participate for a period of time according to age of the 1st dose of vaccination: infants up to 6 months of age will be evaluated for 5 months; infants between 7 to 11 months will be evaluated for 3 months; children between 12 months up to 9 years of age will be evaluate for 2 months
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Vaccines, Pneumococcal Conjugate Vaccine
Intervention  ICMJE Biological: pneumococcus conjugate vaccine
Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months.
Study Arms  ICMJE
  • Active Comparator: G1
    G1: HIV+
    Intervention: Biological: pneumococcus conjugate vaccine
  • Active Comparator: G2
    G2: Sicle Cell disease
    Intervention: Biological: pneumococcus conjugate vaccine
  • Active Comparator: G3
    G3: neprotic symdrome
    Intervention: Biological: pneumococcus conjugate vaccine
  • Active Comparator: G4
    G4: Chronic pulmonary disease
    Intervention: Biological: pneumococcus conjugate vaccine
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: December 21, 2007)
160
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children between 2 months to 9 years old.
  • Children with HIV+; Sickle Cell disease; Neprotic symdrome; Chronic pulmonary disease
  • No history of seizures
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 2 Months to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00581620
Other Study ID Numbers  ICMJE 0887X-100974
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

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