Immunogenicity and Safety of a DTPa-HBV-IPV/Hib Vaccine Given at 2, 3 and 4 Months of Age - Full Text View

Purpose

The purpose of this study is to show that the immunogenicity of newly formulated DTPa-HBV-IPV/Hib vaccine is as good as the immunogenicity of the currently licensed formulation of the vaccine. The vaccine will be administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age and its safety and reactogenicity will also be assessed.

Condition	Intervention	Phase
Diphtheria Tetanus Pertussis Hepatitis B Poliomyelitis Haemophilus Infections	Biological: Infanrix hexa Vaccine	Phase II

MedlinePlus related topics:

Diphtheria Hepatitis Hepatitis B Polio and Post-Polio Syndrome Tetanus Whooping Cough

ChemIDplus related topics:

Infanrix hexa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Study to Evaluate the Immunogenicity and Safety of a New Formulation of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine as Compared to the Currently Licensed Infanrix Hexa in Healthy Infants (2,3,4 M)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Antibody concentration/response to all vaccine antigens after vaccination

Secondary Outcome Measures:

Solicited (D0-3); unsolicited events (D0-30); serious adverse events (SAEs) (full study)

Estimated Enrollment:	450
Study Start Date:	October 2006

Eligibility

Ages Eligible for Study:	8 Weeks to 12 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A healthy male or female between, and including, 8 and 12 weeks of age at the time of the first vaccination.
Written informed consent obtained from the parents/guardians of the subject.
Born after a normal gestation period of 36 to 42 weeks.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth until first primary vaccination dose.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Administration/planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first dose and ending 30 days after the last dose, with the exception of the human rotavirus (HRV) vaccine.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B and/or Haemophilus influenza type b (Hib) vaccination or disease.
Hepatitis B virus (HBV) vaccination at birth.
History of seizures or progressive neurological disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376779

Locations


Finland
	GSK Clinical Trials Call Center
	Tampere, Finland

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	Clinical Trials	GlaxoSmithKline

More Information

Study ID Numbers:	106786
First Received:	September 14, 2006
Last Updated:	September 24, 2007
ClinicalTrials.gov Identifier:	NCT00376779
Health Authority:	Finland: National Agency for Medicines

Keywords provided by GlaxoSmithKline:

Double-blind

phase 2

randomized

DTPa-HBV-IPV/Hib

GSK Biologicals

Finland

Haemophilus influenzae type b

Study placed in the following topic categories:

Bacterial Infections

Haemophilus Infections

Liver Diseases

Spinal Cord Diseases

Whooping Cough

Hepatitis, Viral, Human

Healthy

Tetanus

Whooping cough

Gram-Negative Bacterial Infections

Gram-Positive Bacterial Infections

Neuromuscular Diseases

Respiratory Tract Diseases

Respiratory Tract Infections

Hepatitis B

Motor Neuron Disease

Haemophilus influenzae

Cough

Picornaviridae Infections

Central Nervous System Diseases

Degenerative motor system disease

Diphtheria

Motor neuron disease

Hepatitis

Virus Diseases

Digestive System Diseases

Central Nervous System Infections

Poliomyelitis

Influenza, Human

DNA Virus Infections

Additional relevant MeSH terms:

Bordetella Infections

Pasteurellaceae Infections

RNA Virus Infections

Corynebacterium Infections

Nervous System Diseases

Central Nervous System Viral Diseases

Infection

Hepadnaviridae Infections

Actinomycetales Infections

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00376779