Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Poliomyelitis

Diphtheria

Hepatitis B

Tetanus

Acellular Pertussis

Treatments

Biological: Study vaccines: IH+Hib-MenC/NVC; Control: IH+Meningitec

Study type

Interventional

Funder types

Industry

Identifiers

NCT00352963

217744/097

Details and patient eligibility

About

This study will evaluate the immunogenicity of the co-administration of different combinations of DTPa, IPV, hepatitis B, Hib and Men C vaccines during the first year of life.

Enrollment

480 patients

Sex

All

Ages

Under 7 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male or female infant between, & including, 0 & 7 days of age at the time of the inclusion. Born after a normal gestation period (between 36 & 42 weeks).
Written informed consent obtained from the parent/guardian of the subject.

Exclusion criteria

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned use during the study period.
Administration of immunosuppressants or other immune-modifying drugs from birth.
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 from birth and ending 30 days after the last dose except BCG vaccination if given before the 30-day period preceding the administration of the 1st dose of Infanrix penta™ or Infanrix hexa™ in combination with a meningococcal C vaccine.
Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib disease.
Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib vaccination.