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

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

• Registration Number: EUCTR2013-003427-10-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: 214

Inclusion Criteria

A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination.
Documented administration of a hepatitis B vaccine dose at birth.
Subjects who the investigator believes that their parent(s)/legally acceptable representatives can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
Written informed consent obtained from the parents/LARs of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Born after a gestation period of at least 36 weeks.
Are the trial subjects under 18? yes
Number of subjects for this age range: 214
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

Child in care.
Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone more than or equal to 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral human rotavirus vaccination which is al-lowed at any time during the study.
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.
Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Hib vaccination or disease, with the exception of a birth dose of hepatitis B vaccine and OPV as per local standard of care.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Family history of congenital or hereditary immunodefi-ciency.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Major congenital defects or serious chronic illness.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Acute disease and/or fever at the time of enrolment.
Fever is defined as temperature more than or equal to 37.5°C/99.5°F on oral, axillary or tympanic set-ting, or more than or equal to 38.0°C/100.4°F on rectal setting. The preferred route for recording temperature in this study will be oral/axillary.
Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.

Study & Design

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