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

ClinicalTrials.gov ID: NCT00197002

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT00197002
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: GlaxoSmithKline; Industry
Enrollment: 521 participants

Conditions and interventions

Conditions

Hepatitis A

Interventions

GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix) Biological
Prevnar™ Biological

Biological

Eligibility (public fields only)

Age range: 12 Months to 13 Months
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 11, 2003 (Actual)
Primary completion: Jan 16, 2006 (Actual)
Completion: Jan 16, 2006 (Actual)
Last update posted: Aug 6, 2018

2003 – 2006

United States locations

U.S. sites: 18
U.S. states: 13
U.S. cities: 16

Facility	City	State	ZIP	Site status
GSK Investigational Site	Centennial	Colorado	80112	—
GSK Investigational Site	Bardstown	Kentucky	40004	—
GSK Investigational Site	Louisville	Kentucky	40202	—
GSK Investigational Site	Boston	Massachusetts	02115	—
GSK Investigational Site	Boston	Massachusetts	02118	—
GSK Investigational Site	Kalamazoo	Michigan	49008	—
GSK Investigational Site	Omaha	Nebraska	68131	—
GSK Investigational Site	Las Vegas	Nevada	89014	—
GSK Investigational Site	North Las Vegas	Nevada	89025	—
GSK Investigational Site	Stony Brook	New York	11794	—
GSK Investigational Site	Chapel Hill	North Carolina	27514	—
GSK Investigational Site	University Heights	Ohio	44118	—
GSK Investigational Site	Pittsburgh	Pennsylvania	15241	—
GSK Investigational Site	Dallas	Texas	75235	—
GSK Investigational Site	San Antonio	Texas	78205-2489	—
GSK Investigational Site	Salt Lake City	Utah	84109	—
GSK Investigational Site	Salt Lake City	Utah	84121	—
GSK Investigational Site	Vancouver	Washington	98664	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00197002, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 6, 2018 · Synced Nov 13, 2026