Study to Assess the Safety of GSK Biologicals' Liquid Human Rotavirus Vaccine in Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01107587
First received: April 20, 2010
Last updated: September 20, 2012
Last verified: February 2011
  Purpose

The purpose of this study is to assess the reactogenicity and safety of GSK Biologicals' liquid human rotavirus vaccine in healthy infants aged 6 to 16 weeks at the time of the first dose of vaccination.


Condition Intervention Phase
Rotavirus Gastroenteritis
Biological: GSK Biologicals' human rotavirus vaccine 444563
Biological: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reactogenicity and Safety of Two Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Liquid Human Rotavirus (HRV) Vaccine 444563, in Healthy Infants

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of grade 3 solicited adverse events. [ Time Frame: Within the 8-day (Day 0 - 7) follow-up period after each vaccine dose. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of each solicited adverse event. [ Time Frame: Within the 8-day (Day 0 - 7) follow-up period after each vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events. [ Time Frame: Within the 31-day (Day 0 - 30) follow-up period after any vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events. [ Time Frame: Throughout the study period (Day 0 to Month 2). ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: April 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HRV group
Subjects will receive GSK Biologicals' human rotavirus vaccine 444563.
Biological: GSK Biologicals' human rotavirus vaccine 444563
Oral, two doses.
Placebo Comparator: Placebo Group
Subjects will receive placebo.
Biological: Placebo
Oral, two doses.

  Eligibility

Ages Eligible for Study:   6 Weeks to 16 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 infant of Chinese origin between, and including, 6 and 16 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.
  • Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth (for corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of the human rotavirus vaccine or placebo except for the routine childhood vaccinations.
  • Any clinically significant history of gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrolment..
  • History of confirmed rotavirus gastroenteritis.
  • Gastroenteritis within 7 days preceding the study vaccine or placebo administration.
  • Previous vaccination with rotavirus vaccine or planned to use during the study period.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107587

Locations
China, Guangxi
GSK Investigational Site
Liucheng County, Guangxi, China, 545200
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01107587     History of Changes
Other Study ID Numbers: 113518
Study First Received: April 20, 2010
Last Updated: September 20, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Human rotavirus vaccine

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 14, 2014