Study to Assess the Safety of GSK Biologicals' Liquid Human Rotavirus Vaccine in Healthy Infants
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01107587
First received: April 20, 2010
Last updated: September 20, 2012
Last verified: February 2011
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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:
MedlinePlus related topics:
Gastroenteritis
Drug Information available for:
Rotarix
U.S. FDA Resources
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
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 May 23, 2013