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
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.
Indication: Hepatitis A
Modality: protein therapy
Target: Inactivated Hepatitis A Virus (HAV) and Pneumococcal Conjugate Vaccine (PCV) targets
Sponsor: GlaxoSmithKline
Source URL: ClinicalTrials.gov
Source updated: Detailed source ingestion pending
Ingested: Jul 10, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: Inactivated Hepatitis A Virus (HAV) and Pneumococcal Conjugate Vaccine (PCV) targets
View original source fields
Condition raw: Hepatitis A
Condition normalized: Hepatitis A
Modality raw: protein therapy
Modality normalized: protein therapy
Target raw: Inactivated Hepatitis A Virus (HAV) and Pneumococcal Conjugate Vaccine (PCV) targets
Target normalized: Inactivated Hepatitis A Virus (HAV) and Pneumococcal Conjugate Vaccine (PCV) targets