Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Poliomyelitis

Diphtheria

Haemophilus Influenzae Type b (Hib)

Tetanus

Pertussis

Hepatitis B

Treatments

Biological: DTPa-IPV/Hib (Infanrix-IPV/Hib™)

Biological: HBV (Engerix™-B)

Biological: DTPa-HBV-IPV/Hib (Infanrix-hexa™)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01457495

217744/031

Details and patient eligibility

About

This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines administered at 3 and 5 months of age.

Enrollment

312 patients

Sex

All

Ages

12 to 16 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

A male or female between 12 and 16 weeks of age at the time of the first vaccination.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Written informed consent obtained from the parents or guardians of the subject after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.

Exclusion criteria

Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
Administration of chronic immunosuppressants or immune-modifying drugs during the study period.
Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose and ending one month after each dose.
Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib diseases.
History of/or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
History of allergic disease or reaction likely to be exacerbated by any component of the vaccine, including allergic reactions to neomycin and polymyxin B.
Major congenital defects or serious chronic illness.
Progressive neurological disorders.
Administration of immunoglobulins and/or any blood products since birth and during the study period.
Acute febrile illness at the time of planned vaccination.