NCT00368186

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2001

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2006

Completed
Last Updated

August 24, 2006

Status Verified

August 1, 2006

First QC Date

August 21, 2006

Last Update Submit

August 23, 2006

Conditions

Pneumococcal Infections

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Opsonophagocytic activity; S. pneumoniae nasopharyngeal carriage.

Interventions

Pneumo 23BIOLOGICAL

Eligibility Criteria

Age57 Days - 112 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants with neonatal diagnosis of sickle cell disease and confirmed hemoglobin status by hemoglobin electrophoresis.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Paris, 75019, France

Location

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 21, 2006

First Posted

August 24, 2006

Study Start

May 1, 2001

Study Completion

November 1, 2002

Last Updated

August 24, 2006

Record last verified: 2006-08

Locations

FR(1)