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

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

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.


Ages Eligible for Study:   6 Weeks to 16 Weeks   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01107587

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

Responsible Party: GlaxoSmithKline 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:
Gastrointestinal Diseases
Digestive System Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on September 27, 2016