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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Haemophilus Influenzae Type b

Neisseria Meningitidis

Treatments

Biological: Haemophilus influenzae type b- and meningococcal (vaccine)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00323050

102547

Details and patient eligibility

About

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.

Full 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.

Enrollment

468 patients

Sex

All

Ages

13 to 14 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male or female between, and including, 13 and 14 months of age
Having participated in the primary vaccination study 217744/097.

Exclusion criteria

Previous vaccination against OR history of OR known exposure to diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b (Hib) and/or meningococcal serogroup C disease except if within the framework of study 217744/097
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
A family history of congenital or hereditary immunodeficiency
History of any neurologic disorders or seizures