Study Evaluating Prevenar Immunogenicity in High Risk Children
Phase 4
Completed
- Conditions
- Vaccines, Pneumococcal Conjugate Vaccine
- Interventions
- Biological: pneumococcus conjugate vaccine
- Registration Number
- NCT00581620
- Lead Sponsor
- 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description G2 pneumococcus conjugate vaccine G2: Sicle Cell disease G4 pneumococcus conjugate vaccine G4: Chronic pulmonary disease G3 pneumococcus conjugate vaccine G3: neprotic symdrome G1 pneumococcus conjugate vaccine G1: HIV+
- Primary Outcome Measures
Name Time Method To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition 4 months
- Secondary Outcome Measures
Name Time Method To evaluate tolerability of Prevenar* in that population. 4 months