At a glance
ClinicalIndex Comparison Record- ✓Age 24-31 months at Visit 1, 40-43 months at Visit 2, or 60-64 months at Visit 3 (for HibMenC and LicMenC groups)
- ✓Age 40-43 months at Visit 2 (for NoBoost UK group)
- ✓Healthy as established by medical history and clinical examination
- ✓Completed prior booster vaccination study 104056 (HibMenC and LicMenC groups)
- ✕Previous booster dose of Hib or meningococcal serogroup C (except booster study vaccines from study 104056)
- ✕History of Haemophilus influenzae type b or meningococcal disease
- ✕Previous booster dose of pertussis-containing vaccine (UK subjects in HibMenC and LicMenC groups only), except booster study vaccines from study 104056
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Assessment of Long-term Antibody Persistence After a Booster Dose of GSK Biologicals' Hib & Meningococcal C Vaccine (Menitorix™) 811936 Given at 12-15 Months of Age to Subjects Primed With 3 Doses of Menitorix™ at 2, 3, 4 Months of Age
In Brief
A Phase 4 clinical trial evaluating Menitorix and Infanrix IPV for Haemophilus Influenzae Type b and 2 related conditions. Completed, enrolled 288 participants across 9 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the long-term antibody persistence at 12, 24 and 48 months after the administration of a booster dose of Menitorix™, given at 12-15 months of age. The children had previously received 3 doses of Menitorix™ and Infanrix IPV™ or Meningitec™ and Pediacel™ in infancy. In addition, the antibody persistence is to be investigated in children of 40-43 months of age who received a 3-dose primary vaccination of a MenC conjugate vaccine and a Hib containing vaccine in infancy without a booster dose of MenC conjugate and Hib vaccine in the second year of life. This protocol posting deals with objectives \& outcome measures of the extension phases at 12, 24 and 48 months after the booster phase. The links to objectives and outcome measures of the primary phase \& booster phase at 12 to 15 months are provided below: https://www.gsk-studyregister.com/study/2747 (Primary phase) https://www.gsk-studyregister.com/study/2755 (Booster phase)
Study Details
Timeline
Interventions
Menitorix was only administered to subjects of the group Meningitic+Hiberix group at 40 to 43 months of age.
Infanrix IPV was administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.