Immunogenicity and safety study of GlaxoSmithKline Biologicals’ Infanrix hexa vaccine in healthy infants.

• Conditions: Primary immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-003428-34-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-04
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

Subjects who the investigator believes that their par-ent/guardian can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
Born after a gestation period of 36 to 42 weeks inclusive.
Healthy subjects as established by medical history before entering into the study.
Written informed consent obtained from the parent or guardian of the subject.
Are the trial subjects under 18? yes
Number of subjects for this age range: 224
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Use of any investigational or non-registered product within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs from birth until first primary vac-cination dose. For corticosteroids, this will mean predni-sone, or equivalent, more than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
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).
Major congenital defects or serious chronic illness.
Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Hib vaccination or disease.
Any confirmed or suspected immunosuppressive or im-munodeficient condition, based on medical history.
History of allergic disease or reactions likely to be exac-erbated by any component of the vaccines.
The following condition is temporary or self limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
Current febrile illness or axillary temperature of more than or equal to 37.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified