Immune Memory Evaluation in Children Following a Primary Vaccination With Pneumococcal Conjugate Vaccines.

Phase 3

Completed

• Conditions: Infections, Streptococcal

• Registration Number: NCT00333450
• Lead Sponsor: GlaxoSmithKline

Brief Summary

To evaluate the immunological memory against pneumococcal vaccine serotypes in children primed with conjugate vaccines by administering a booster dose of plain polysaccharide vaccine.

Detailed Description

2 groups (60 per group), booster of Pneumovax 23 after priming with Prevnar or GSK Biologicals' pneumococcal vaccine.

Study Timeline

• Study First Submitted: 2006-06-02
• Study First Submitted QC: 2006-06-02
• Study First Posted: 2006-06-05
• Study Start: 2006-08
• Study Completion: 2006-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Antibody concentrations against pneumococcal serotypes 1 month post-booster

Secondary Outcome Measures

Name	Time	Method
Immunogenicity pre and post-booster and safety (follow up of SAEs)

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Berlin, Germany