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Study Evaluating Prevenar Immunogenicity in High Risk Children

Last updated on October 5, 2018

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Conjugate Vaccine Vaccines
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

Exclusion criteria
The factors, or reasons, that prevent a person from participating 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

NCT00581620
Pfizer
Completed
Study Evaluating Prevenar Immunogenicity in High Risk Children

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Study Evaluating Prevenar Immunogenicity in High Risk Children
To Evaluate the Humoral Immune Response to a Conjugated Pneumococcus Vaccine 7-Valent (Prevenar®) in Children From High Risk Groups.
To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition. To evaluate tolerability of Prevenar® in that population.
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
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Vaccines, Pneumococcal Conjugate Vaccine
Biological: pneumococcus conjugate vaccine
Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
September 2007
Not Provided

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
Sexes Eligible for Study: All
2 Months to 9 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00581620
0887X-100974
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

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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