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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Poliomyelitis

Haemophilus Influenzae Type b

Diphtheria

Hepatitis B

Tetanus

Acellular Pertussis

Treatments

Biological: Infanrix hexa Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00376779

106786

Details and patient eligibility

About

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.

Sex

All

Ages

8 to 12 weeks old

Volunteers

Accepts Healthy Volunteers

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.