This study will evaluate the immunogenicity, reactogenicity and safety of the routine infant vaccines Pediarix, Hiberix and Prevenar 13 when co-administered with GlaxoSmithKline (GSK) Biologicals’ liquid human rotavirus vaccine (HRV) as compared to GSK’s licensed lyophilized vaccine

Phase 1

• Conditions: PCV-free HRV vaccine is indicated to prevent gastroenteritis (GE) caused by rotavirus (RV); Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-003210-27-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-20
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 1280

Inclusion Criteria

• Subjects’ parent(s)/[LAR(s)] who, in the opinion of the investigator can and will comply with the requirements of the protocol.
• A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination.
• Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
• 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: 1280
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 during the period starting 30 days before the first dose of study vaccines (Day-29 to Day 1), or planned use during the study period.
• Chronic administration 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 immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Administration of long-acting immune-modifying drugs at any time during the study period.
• Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of vaccine ad-ministration and ending at Visit 4, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study, if administered at a site which is different from the sites used to administer the co-administered vaccines.
• 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 vaccine/product.
• Uncorrected congenital malformation of the gastrointestinal tract that would predispose for Intussusception (IS).
• History of IS.
• Very prematurely born infants (born =28 weeks of gestation).
• Family history of congenital or hereditary immunodeficiency.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Major congenital defects or serious chronic illness.
• Previous vaccination against Haemophilus type b (Hib), diphtheria, tetanus, pertussis, pneumococcus, RV and/or poliovirus.
• Previous confirmed occurrence of RV GE, Hib, diphtheria, tetanus, pertussis, pneumococcus, hepatitis B and/or polio disease.
• Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
• GE within 7 days preceding the study vaccine administration.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• Hypersensitivity to latex.
• History of any neurological disorders or seizures.
• History of severe combined immunodeficiency (SCID).
• Acute disease and/or fever at the time of enrollment.
(Fever is defined as temperature 38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity, the axilla and the rectum.
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