Safety and immunogenicity of new formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) in primary infant vaccination.

• Conditions: Primary immunization of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib) diseases.; MedDRA version: 13.1Level: PTClassification code 10043376Term: TetanusSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 13.1Level: LLTClassification code 10018952Term: Haemophilus influenzae infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 13.1Level: PTClassification code 10034738Term: PertussisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 13.1Level: PTClassification code 10019731Term: Hepatitis BSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 13.1Level: PTClassification code 10013023Term: DiphtheriaSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 13.1Level: PTClassification code 10036012Term: PoliomyelitisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2010-021569-58-FI
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

- A male or female between, and including, 60 and 90 days of age at the time of the first vaccination.
- Born after a gestation period of 37 to 42 weeks inclusive.
- Subjects who the investigator believes that their parent(s)/LAR(s) 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 parent(s)/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 720
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 (drug or vaccine) other than the study vaccines 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 in total) of
immunosuppressants or other immune-modifying drugs since birth. For
corticosteroids, this will mean prednisone = 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 rotavirus vaccination which is allowed 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 (pharmaceutical product or device).
-Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Hib and/or pneumococcal vaccination or disease, with the exception of hepatitis B vaccination at birth.
-Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
-Family history of congenital or hereditary immunodeficiency.
-History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
-Major congenital defects or serious chronic illness.
-History of any neurological disorders or seizures.
-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.
Acute disease is defined as the presence of a moderate or severe illness with or without fever.
-Fever is defined as temperature = 37.5°C on axillary, oral or tympanic setting, or = 38.0°C on rectal setting. The preferred route for recording temperature in this study will be axillary or rectal.
-Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) 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