Study to evaluate the immunogenicity, reactogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) liquid vaccine, when given to healthy infants, in Philippines

• Conditions: Healthy volunteers; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-001544-11-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: 375

Inclusion Criteria

•Subjects who 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.
•A male or female between, and including, 5-10 weeks of age at the time of the first dose of HRV liquid vaccine or placebo (parents must be able to provide a copy of birth certificate of the subject).
•Birth weight of the subject should be > 2000 grams.
•Written informed consent obtained from the parent or guardian 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: 375
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 (drug or vaccine) other than the study vaccine 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) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For cor-ticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•Planned administration/ administration of a vaccines not foreseen by the study protocol except for DTPw, HBV and OPV vaccines within 14 days before each dose of HRV liquid vaccine or placebo and ending 14 days after. BCG is administered at birth according to the local EPI. However, it can be administered at Visit 1.
•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).
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•History of allergic disease or reactions likely to be exacerbated by any component of the HRV liquid vaccine or placebo.
•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 (99.5°F) / Rectal temperature <38°C (100.4°F).Temperature greater than or equal to this cut-off warrants deferral of the vaccination pending recovery of the subject.
•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