Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine

Phase 3

Completed

• Conditions: Streptococcus Pneumoniae Vaccines; Infections, Streptococcal

• Registration Number: NCT00307541
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Evaluate the immune response of GSK Biologicals' 10-valent pneumococcal conjugate vaccine one month after completion of a 3-dose primary vaccination course administered at 2, 3, 4 months of age

Detailed Description

Test groups: 2 groups (60 subjects/group). 10Pn-PD-DiT group receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib; Control group receiving Prevenar + DTPa-HBV-IPV/Hib

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-10-27
• Study First Submitted: 2006-03-07
• Study First Submitted QC: 2006-03-23
• Study First Posted: 2006-03-28
• Primary Completion: 2006-04-07
• Study Completion: 2006-04-07
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-27
• Last Update Posted: 2020-01-02

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
1 month post-dose 3: Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 µg/mL

Secondary Outcome Measures

Name	Time	Method
Ab concns to protein D and seropositivity (S+) status
Antibody (Ab) concns >= 0.05 µg/mL
S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine
After each vaccination, occurrence of: solicited local, general symptoms within 4 days
Unsolicited adverse events within 31 days, SAEs (whole study period)
1 month post dose 3: For all vaccine pneumococcal serotypes: Opsono titres

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Berlin, Germany