At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 521 enrolled
Drug / intervention
GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix) +1 morebiological
Likely dose
Havrix (hepatitis A vaccine): two doses administered intramuscularly; Prevnar (pneumococcal conjugate vaccine): one dose administered intramuscularlyAI-extracted
Key inclusion· 3
- ✓Male or female child 12 or 13 months of age at enrollment
- ✓Free of obvious health problems
- ✓Must have previously received three doses of Prevnar in first year of life
Key exclusion· 13
- ✕Any investigational or non-registered drug or vaccine within 42 days before first dose or planned during study
- ✕Chronic immunosuppressant or immune-modifying drug use within 6 months prior to vaccination or planned during study (systemic corticosteroids ≥0.5 mg/kg/day equivalent prednisone excluded; inhaled, nasal, topical allowed)
- ✕Fourth dose of Prevnar already received prior to study enrollment
- ✕Any vaccine not specified in study protocol within 42 days before and 30 days after each study vaccine dose
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix) and Prevnar™ for Hepatitis A. Completed, enrolled 521 participants across 18 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis A
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2003
First PostedSep 2005
Primary CompletionJan 2006
TodayJul 2026
First PostedSep 20, 2005
Enrollment StartSep 11, 2003
Primary CompletionJan 16, 2006
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.8 years ago
Interventions
GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix)biological
Two doses, administered intramuscularly in the right anterolateral thigh.
Prevnar™biological
One dose, administered intramuscularly in the left anterolateral thigh.