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Clinical Trials/CTRI/2014/06/004654
CTRI/2014/06/004654
Active, not recruiting
Phase 3

A phase III, randomized, open study to assess the immunogenicity, reactogenicity and safety of two different formulations of GlaxoSmithKline (GSK) Biologicalsâ?? oral live attenuated human rotavirus (HRV) vaccine, Rotarix, when given as a two-dose primary vaccination, in healthy infants with no previous history of rotavirus illness or vaccination.

GlaxoSmithKline Biologicals0 sites450 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
GlaxoSmithKline Biologicals
Enrollment
450
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
  • •A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination.
  • •Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
  • •Healthy subjects as established by medical history and clinical examination before entering into the study.
  • •Birth weight \>2000 g.

Exclusion Criteria

  • •Child in care
  • •Use of any investigational or non\-registered product (drug or vaccine) 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 (defined as more than 14 days in total) 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 any chronic drug therapy to be continued 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, according to the local immunization practice.
  • •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).
  • •History of confirmed RV GE.
  • •Previous vaccination against RV.
  • •Any confirmed or suspected immunosuppressive or immunodeficient condition, (including Severe Combined Immunodeficiency \[SCID] disorder) based on medical history and physical examination (no laboratory testing required).
  • •Uncorrected congenital malformation (such as Meckelâ??s diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS).

Outcomes

Primary Outcomes

Not specified

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