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Study Evaluating Prevenar Immunogenicity in High Risk Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00581620
Recruitment Status : Completed
First Posted : December 27, 2007
Last Update Posted : December 27, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition. To evaluate tolerability of Prevenar® in that population.

Condition or disease Intervention/treatment Phase
Vaccines, Pneumococcal Conjugate Vaccine Biological: pneumococcus conjugate vaccine Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: To Evaluate the Humoral Immune Response to a Conjugated Pneumococcus Vaccine 7-Valent (Prevenar®) in Children From High Risk Groups.
Study Start Date : November 2002
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: G1
G1: HIV+
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: G2
G2: Sicle Cell disease
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: G3
G3: neprotic symdrome
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: G4
G4: Chronic pulmonary disease
Biological: pneumococcus conjugate vaccine
Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months.



Primary Outcome Measures :
  1. To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. To evaluate tolerability of Prevenar* in that population. [ Time Frame: 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581620


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00581620     History of Changes
Other Study ID Numbers: 0887X-100974
First Posted: December 27, 2007    Key Record Dates
Last Update Posted: December 27, 2007
Last Verified: December 2007

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
pneumococcus conjugated vaccine

Additional relevant MeSH terms:
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs