Study Evaluating Prevenar Immunogenicity in High Risk Children

Wyeth

Status and phase: Completed; Phase 4

Conditions: Vaccines, Pneumococcal Conjugate Vaccine

Treatments: Biological: pneumococcus conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00581620

0887X-100974

Details and patient eligibility

About

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

Full 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

Enrollment: 160 patients

Sex: All

Ages: 2 months to 9 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 4 patient groups

G1

Active Comparator group

Description:

G1: HIV+

Treatment:

Biological: pneumococcus conjugate vaccine

G2

Active Comparator group

Description:

G2: Sicle Cell disease

Treatment:

Biological: pneumococcus conjugate vaccine

G3

Active Comparator group

Description:

G3: neprotic symdrome

Treatment:

Biological: pneumococcus conjugate vaccine

G4

Active Comparator group

Description:

G4: Chronic pulmonary disease

Treatment:

Biological: pneumococcus conjugate vaccine