Study of 2 Doses of Oral Live Attenuated Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00134732
First received: August 24, 2005
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age (estimated nearly 500,000 annual deaths worldwide). GlaxoSmithKline (GSK) Biologicals has developed a vaccine against human rotavirus gastroenteritis. This study will provide data for Korean regulatory authorities about the immunogenicity and safety of this vaccine in Korean children aged 2 months at the time of the first dose.


Condition Intervention Phase
Rotavirus Gastroenteritis
Biological: Live attenuated human rotavirus vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Assess the Immunogenicity, Safety & Reactogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants (6-12 Weeks of Age at First Dose) Previously Uninfected With Human Rotavirus

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percent who seroconverted (anti-rota serum IgA, 2 months post dose 2)

Secondary Outcome Measures:
  • Grade 2 and 3 fever, vomiting, diarrhea, solicited symptoms
  • Unsolicited events
  • Serious adverse events (SAEs)
  • Presence of rota in GE tools
  • Concentration IgA 2 months post dose 2

Estimated Enrollment: 150
Study Start Date: July 2005
Intervention Details:
    Biological: Live attenuated human rotavirus vaccine
    Other Name: Live attenuated human rotavirus vaccine
Detailed Description:

The study consists of two groups of children recruited in different centers in Korea. One group will receive the HRV vaccine and one group will receive the placebo. The vaccine or placebo will be administered starting at 2 months of age according to a two dose schedule (0, 2 months). The study will consist of three visits. At the first visit, one blood sample will be taken before vaccination and the first dose will be administered. At the second visit (2 months after first dose), the second vaccine will be administered. At the third visit (2 months after second dose), a blood sample will be taken. A 15-day (Day 0 - 14) follow-up period will be observed for general symptoms solicited in the study (fever, fussiness/irritability, diarrhea, vomiting, loss of appetite and cough/runny nose). A 43-day (Day 0 - 42) follow-up will be observed for other unsolicited symptoms. Serious adverse events will be followed-up throughout the study. A stool sample should be collected from the child at any point during the study if he/she develops any GE.

  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Free of obvious health problems, as established by medical history and physical examination, before entering into the study.
  • Subjects for whom the vaccination history is available from vaccination diary cards or medical charts or patient diary cards.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine or placebo, or planned use during the study period.
  • Planned administration of a vaccine (including routine paediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after.
  • Any clinically significant history of chronic gastrointestinal (GI) disease including any uncorrected congenital malformation of the GI tract or other serious medical condition, as determined by the investigator.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
  • Major congenital defects or serious chronic illnesses such as malignant disease (e.g. melanotic neuroectodermal tumor, malignant rhabdoid tumor, etc.), serious atopic dermatitis, conditions that are the result of premature birth, etc.
  • Acute disease at time of enrolment. (Acute disease is defined as the presence of moderate or severe illness with or without fever i.e. temperature >= 37.5°C as measured by an axillary thermometer or >= 38.0°C as measured by a rectal thermometer. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.)
  • GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
  • Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. Oral intake of immunoglobulins via, e.g., breastfeeding is allowed.
  • Chronic administration (defined as more than 14 days) 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.)
  • Previous confirmed occurrence of RV GE.
  • Household contact with an immunosuppressed individual
  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 ClinicalTrials.gov identifier: NCT00134732

Locations
Korea, Republic of
GSK Investigational Site
Bucheon-si,, Korea, Republic of, 420-767
GSK Investigational Site
Daejeon,, Korea, Republic of
GSK Investigational Site
Jeonju, Korea, Republic of, 561-712
GSK Investigational Site
Seoul, Korea, Republic of, 139-711
GSK Investigational Site
Seoul, Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 130-702
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Bhattacharya Sujit Kumar et al. Immune response in infants sero-positive at pre-vaccination: human rotavirus vaccine Rotarix™ - 5th World Congress WSPID, Bangkok, Thailand, 15-18 November 2007.

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00134732     History of Changes
Other Study ID Numbers: 103478
Study First Received: August 24, 2005
Last Updated: September 29, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by GlaxoSmithKline:
Prophylaxis of Rotavirus Gastroenteritis

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 22, 2014