NCT00197002

Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 521 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Months – 13 Months
• Healthy volunteers: Accepted

Summary

This is a study to evaluate the immunogenicity and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a pneumococcal conjugate vaccine in children as young as 15 months of age.

Detailed description

An open, controlled comparison of Havrix administered alone or with Prevnar. The three groups evaluated are: 1) Havrix alone, 2) Havrix plus Prevnar and 3) Prevnar followed by Havrix one month later.

Conditions

• Hepatitis A

Interventions

Type	Name	Description
BIOLOGICAL	GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix)	Two doses, administered intramuscularly in the right anterolateral thigh.
BIOLOGICAL	Prevnar™	One dose, administered intramuscularly in the left anterolateral thigh.

Timeline

• Start date: 2003-09-11
• Primary completion: 2006-01-16
• Completion: 2006-01-16
• First posted: 2005-09-20
• Last updated: 2018-08-06
• Results posted: 2017-02-20

Locations

18 sites across 1 country: United States