Study Evaluating Prevenar Immunogenicity in High Risk Children

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00581620
First received: December 21, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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


Condition Intervention Phase
Vaccines, Pneumococcal Conjugate Vaccine
Biological: pneumococcus conjugate vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate tolerability of Prevenar* in that population. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Enrollment: 160
Study Start Date: November 2002
Study Completion Date: September 2007
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   2 Months to 9 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00581620     History of Changes
Other Study ID Numbers: 0887X-100974
Study First Received: December 21, 2007
Last Updated: December 21, 2007
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on April 23, 2014