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

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00379977

Purpose

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.

Condition	Intervention	Phase
Diphtheria Tetanus Pertussis Hib Disease	Biological: diphtheria, tetanus, pertussis & Hib vaccine	Phase III

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	Open, Primary Vaccination Study to Assess Safety and Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Administered to Healthy Chinese Infants at 3, 4 and 5 Months of Age.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Estimated Enrollment:	30
Study Start Date:	September 2006

Eligibility

Ages Eligible for Study:	90 Days to 120 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379977

Locations

China, Guangxi
GSK Investigational Site
Nanning, Guangxi, China, 530021

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	106345
Study First Received:	September 22, 2006
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00379977
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Cough
Whooping Cough

Healthy
Diphtheria
Tetanus
Whooping cough
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Bordetella Infections
Corynebacterium Infections
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 14, 2009