Study to Assess the Safety & Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Given at 3, 4 and 5 Months of Age

GlaxoSmithKline30 enrolled

Overview

This study will evaluate the safety and reactogenicity of GSK Biologicals' Diphtheria Tetanus acellular Pertussis/Haemophilus influenzae type b vaccine given to Chinese infants at 3, 4 and 5 months of age.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Tetanus Haemophilus Influenzae Type b Acellular Pertussis Diphtheria

Interventions

diphtheria, tetanus, pertussis & Hib vaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 90 DaysMax age: 120 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * A male or female between, and including, 90 and 120 days of age at the time of the first vaccination Written informed consent obtained from the parent or guardian of the subject Exclusion Criteria: * subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate, subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b (Hib) diseases can not participate.

Locations (1)

GSK Investigational Site

Nanning, Guangxi, China

Outcomes

Primary Outcomes

Occurrence of solicited symptoms during the 4 days following vaccination, unsolicited symptoms during the 31 days following vaccination and serious adverse events

Data from ClinicalTrials.gov

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