NCT00323050

Study of a Booster Dose of Hib-MenC Conjugate Vaccine vs Infanrix Hexa When Given to 14 Month Old Subjects

Evaluate Immunogenicity,Safety & Reactogenicity of a Booster Dose of Hib-MenC Conjugate Vaccine When Given to Healthy Subjects Aged 13-14 Months Who Were Primed With 3 Doses of Hib-MenC vs a Booster Dose of Infanrix Hexa Given to Subjects Primed With 3 Doses of Infanrix Hexa and Meningitec

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 468 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 13 Months – 14 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC conjugate vaccine when given to healthy subjects aged 13 to 14 months who were primed with three doses of Hib-MenC compared to a booster dose of Infanrix hexa given to subjects primed with three doses of Infanrix hexa and Meningitec.

Detailed description

The study is open and Infanrix hexa will serve as active control. Subjects will receive one vaccine dose of either Hib-MenC or Infanrix hexa, and will have 2 blood samples taken: before and one month after vaccination. Subjects who will receive a booster dose of Hib-MenC were primed with 3 doses of Infanrix penta + Hib-MenC or 2 doses of NeisVac-C and Infanrix hexa / Infanrix IPV/Hib.

Conditions

• Neisseria Meningitidis
• Haemophilus Influenzae Type b

Interventions

Type	Name	Description
BIOLOGICAL	Haemophilus influenzae type b- and meningococcal (vaccine)

Timeline

• Start date: 2004-11-01
• Primary completion: 2005-03-01
• Completion: 2005-03-01
• First posted: 2006-05-09
• Last updated: 2016-09-16

Locations

16 sites across 1 country: Spain