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

GlaxoSmithKline468 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

468

Conditions

Neisseria Meningitidis Haemophilus Influenzae Type b

Interventions

Haemophilus influenzae type b- and meningococcal (vaccine)BIOLOGICAL

Eligibility

Sex: ALLMin age: 13 MonthsMax age: 14 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (16)

GSK Investigational Site

Alcorcón, Spain

GSK Investigational Site

Almeira, Spain

GSK Investigational Site

Barcelona, Spain

Outcomes

Primary Outcomes

Percentage (%) of subjects with anti-PRP antibody concentrations (conc) ≥1µg/ml and % of subjects with SBA-MenC titers ≥ 128 one month post vaccination.

Secondary Outcomes

Pre & 1M post vacc, S+/SP & conc/titer: SBA-MenC, anti-PSC,-PRP,-T & anti-PRP ≥ 1,-PSC ≥ 2, SBA-MenC ≥ 128

Pre vacc, S+/SP & conc/titer: anti-D,-PT,-FHA,-PRN,-HBs, -polio 1,2,3

Loc, gen sympt: D 0-3, unsol sympt: D 0-30 post vacc.

SAEs for whole study

Data from ClinicalTrials.gov

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