Vaccines, Pneumococcal Conjugate Vaccine
Conditions
Keywords
pneumococcus conjugated vaccine
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
Interventions
BIOLOGICALpneumococcus conjugate vaccine
Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months.
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 9 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate tolerability of Prevenar* in that population. | 4 months |
Outcome results
None listed