Immunogenicity and Safety Study of Pneumococcal 7-Valent Conjugate Vaccine in Sickle Cell Disease Infants.

Phase 4TerminatedNCT00368186

Wyeth is now a wholly owned subsidiary of Pfizer51 enrolled

Overview

The primary objectives of this study were to assess the immunogenicity and the tolerance of the heptavalent pneumococcal conjugate vaccine (Prevenar) in young infants (2 months of age) with sickle cell disease when administred at 2,3, and 4 months of age.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Pneumococcal Infections

Interventions

Pneumo 23BIOLOGICAL

Eligibility

Sex: ALLMin age: 57 DaysMax age: 112 Days

Medical Language ↔ Plain English

Inclusion Criteria Infants with neonatal diagnosis of sickle cell disease and confirmed hemoglobin status by hemoglobin electrophoresis. Exclusion Criteria Previous immunization with pneumococcal-containing vaccines. History of pneumococcal invasive disease (meningitis, bacteremia, pneumonia). Known or suspected impairments of the immune system (including HIV infection) or recipients of immuno-suppressant agents. Other Exclusions apply.

Locations (1)

Unnamed facility

Paris, France

Outcomes

Primary Outcomes

Antibody responses to pneumococcal capsular polysaccharides antigens contained in PCV7 vaccine; local and systemic reactions.

Secondary Outcomes

Opsonophagocytic activity; S. pneumoniae nasopharyngeal carriage.

Data from ClinicalTrials.gov

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