Immunization of infants 6-14 weeks of age, with GlaxoSmithKline Biologicals’ Rotavirus vaccine to explore the existence of transmission of rotavirus vaccine strain between twins in a family.

• Conditions: Rotavirus (RV) gastroenteritis; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-001542-29-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-22
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Subjects with a live twin living in the same household who is also enrolled in this study.
Subjects born after a gestation period of = 32 weeks.
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (stool collection, return for follow-up visits, etc.) were to be enrolled in the study.
A male or female between, and including, 6 and 14 weeks of age at the time of the first study vaccination.
Written informed consent obtained from the parent or guardian of the subjects.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Discharged from hospital neonatal care stay.

Are the trial subjects under 18? yes
Number of subjects for this age range: 200
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(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Acute disease at time of enrolment. (Acute disease was defined as the presence of moderate or severe illness with or without fever i.e. temperature > 37.5°C as measured by an axillary thermometer or > 38.0°C as measured by a rectal thermometer).
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Contact with an immunosuppressed individual.
Concurrently participating in another clinical study, at any time during the study period, in which the subject had been or was exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Chronic administration (defined as more than 14 days) of immunosuppressants since birth (topical steroids were allowed).
Gastroenteritis within 7 days preceding the first study vaccine administration (warrants deferral of the vaccination).
Documented HIV-positive subject.

Study & Design

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