An open, multicentric, post-marketing surveillance (PMS) study to assess the safety and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-IPV/Hib vaccine administered at 3, 4, 5 and 18 months of age, in healthy infants

• Conditions: Healthy volunteers (Primary immunization of healthy infants at 3, 4 and 5 months of age with a booster dose at 18 months of age, against diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b diseases).; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-001512-35-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-09
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 4500

Inclusion Criteria

•Subjects must have been enrolled in the Rota-028 study.
•A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
•Written informed consent obtained from the parent or guardian of the subject.
•Free of obvious health problems as established by medical history and clinical examination before entering into the study.
•Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 2590
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

•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
•A family history of congenital or hereditary immunodeficiency.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•Major congenital defects or serious chronic illness.
•History of any neurologic disorders or seizures.
•Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever.) All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature < 37.5 °C.
•Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Study & Design

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