Study Evaluating Prevenar Immunogenicity in High Risk Children
To Evaluate the Humoral Immune Response to a Conjugated Pneumococcus Vaccine 7-Valent (Prevenar®) in Children From High Risk Groups.
1 other identifier
interventional
160
0 countries
N/A
Brief Summary
To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition. To evaluate tolerability of Prevenar® in that population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2002
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
December 27, 2007
CompletedDecember 27, 2007
December 1, 2007
December 21, 2007
December 21, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition
4 months
Secondary Outcomes (1)
To evaluate tolerability of Prevenar* in that population.
4 months
Study Arms (4)
G1
ACTIVE COMPARATORG1: HIV+
G2
ACTIVE COMPARATORG2: Sicle Cell disease
G3
ACTIVE COMPARATORG3: neprotic symdrome
G4
ACTIVE COMPARATORG4: Chronic pulmonary disease
Interventions
Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months.
Eligibility Criteria
You may qualify if:
- Children between 2 months to 9 years old.
- Children with HIV+; Sickle Cell disease; Neprotic symdrome; Chronic pulmonary disease
- No history of seizures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 21, 2007
First Posted
December 27, 2007
Study Start
November 1, 2002
Study Completion
September 1, 2007
Last Updated
December 27, 2007
Record last verified: 2007-12