Study Evaluating Prevenar Immunogenicity in High Risk Children

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00581620
• Collaborator: (none)
• Enrollment: 160
• Arms: 4
• Duration (Months): 58

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Nov 1, 2002
• Actual Study Completion Date: Sep 1, 2007

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition [4 months]

Secondary Outcome Measures

1. To evaluate tolerability of Prevenar* in that population. [4 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Months to 9 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00581620
• Other Study ID Numbers: 0887X-100974
• First Posted: Dec 27, 2007
• Last Update Posted: Dec 27, 2007
• Last Verified: Dec 1, 2007

• Keywords provided by , ,: pneumococcus conjugated vaccine

Study Results

No Results Posted as of Dec 27, 2007