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A Phase IIIb, Open, Randomized, Controlled, Multicenter Study of the Immunogenicity and Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine Administered on a 0-6 Mth Schedule Concomitantly With Wyeth Lederle's Pneumococcal Conjugate Vaccine in Healthy Children 15 Months of Age
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jul 28, 2026
Report code
NCT00197002-Jul 28, 2026
NCT ID
NCT00197002
Status
COMPLETED
Phase
Phase 3b
Sponsor
GlaxoSmithKline
Executive brief
Investment-Ready Snapshot
The Phase IIIb trial conducted by GlaxoSmithKline (GSK) evaluates the immunogenicity and safety of the inactivated hepatitis A vaccine (Havrix) when co-administered with Wyeth Lederle's pneumococcal conjugate vaccine (Prevnar) in children aged 15 months. The study's completion in January 2006 positions GSK to leverage the findings for market expansion in pediatric vaccination, particularly in regions with high hepatitis A incidence. The dual vaccination approach may enhance market competitiveness against standalone vaccines, potentially increasing GSK's share in the pediatric vaccine market. The successful demonstration of non-inferiority in seropositivity rates could facilitate broader adoption in immunization schedules, impacting public health initiatives and vaccine procurement strategies.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT00197002
Indication
Hepatitis A
Modality
protein therapy
Target
Inactivated Hepatitis A Virus (HAV) and Pneumococcal Conjugate Vaccine (PCV) targets
Intervention
GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix), Prevnar™
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.