Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

Completed · Phase 3

Conditions studied: Infections, Rotavirus, Rotavirus Vaccines

In brief

The purpose of this study is to evaluate the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose vaccination in healthy infants starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the study.

Key facts

Study ID

NCT02914184

Run by

GlaxoSmithKline

People needed

1612

Starts

2016-10-27

Expected to finish

2018-11-26

Last updated by the study team

2020-07-21

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects' parent(s)/LAR(s) who, in the opinion of the investigator can and will comply with the requirements of the protocol.
• Written informed consent obtained from the parent(s)/LAR(s) (Legally acceptable representatives) of the subject prior to performing any study specific procedure.
• A male or female infant between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination.
• Born full-term (i.e., between a gestation period of 37 weeks 0 days and 41 weeks 6 days).
• Healthy subjects as established by medical history and clinical examination before entering into the study.

You may not qualify if…

• 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 0), 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 in the period starting 30 days before the first dose of vaccine administration and ending at Visit 3, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study and other licensed routine childhood vaccinations.
• 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.
• 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 RV.
• Previous confirmed occurrence of RVGE.
• 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.
• Acute disease and/or fever at the time of enrolment.
• 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 (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.

Where it is running

• GSK Investigational Site — Anaheim, California, United States
• GSK Investigational Site — Paramount, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — San Jose, California, United States
• GSK Investigational Site — Nampa, Idaho, United States
• GSK Investigational Site — Newton, Kansas, United States
• GSK Investigational Site — Topeka, Kansas, United States
• GSK Investigational Site — Kansas City, Missouri, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — Erie, Pennsylvania, United States
• GSK Investigational Site — Cheraw, South Carolina, United States
• GSK Investigational Site — North Charleston, South Carolina, United States
• GSK Investigational Site — Layton, Utah, United States
• GSK Investigational Site — Murray, Utah, United States
• GSK Investigational Site — Orem, Utah, United States
• GSK Investigational Site — Provo, Utah, United States
• GSK Investigational Site — Syracuse, Utah, United States
• GSK Investigational Site — Marshfield, Wisconsin, United States
• GSK Investigational Site — San José, Provincia de San José, Costa Rica
• GSK Investigational Site — San José, Costa Rica
• GSK Investigational Site — Espoo, Finland
• GSK Investigational Site — Helsinki, Finland
• GSK Investigational Site — Helsinki, Finland
• GSK Investigational Site — Jarvenpaa, Finland
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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