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

An Open, Multicenter Clinical Trial to Investigate the Immunogenicity and Safety of the Pneumococcal 7-Valent Conjugate Vaccine (PREVENAR) in Sickle Cell Disease Infants.

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00368186

Enrollment

Registered

2006-08-24

Start date

2001-05-31

Completion date

2002-11-30

Last updated

2006-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Infections

Brief summary

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.

Interventions

BIOLOGICALPneumo 23

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

57 Days to 112 Days

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Opsonophagocytic activity; S. pneumoniae nasopharyngeal carriage.	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026