Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants. - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00480324

Purpose

This study is undertaken to provide the regulatory authorities in Japan with immunogenicity, efficacy, safety and reactogenicity data of GSK Biologicals' HRV vaccine, given as a 2-dose primary vaccination, in healthy Japanese infants aged approximately 2 months at the time of the first dose and previously uninfected with HRV. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Condition	Intervention	Phase
Gastroenteritis Caused by Rotavirus	Biological: Placebo Biological: Rotarix	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy, Safety, Reactogenicity and Immunogenicity Study of the Lyophilised Formulation of Rotarix Vaccine in Healthy Japanese Infants

Resource links provided by NLM:

MedlinePlus related topics: Gastroenteritis

Drug Information available for: RotaTeq

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of any rotavirus (RV) gastroenteritis (GE) leading to medical intervention and caused by the circulating wild-type RV strains. [ Time Frame: During the efficacy follow-up period. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Serum anti-rotavirus IgA antibody concentration in a subset of subjects. [ Time Frame: One month after the second dose of HRV vaccine/Placebo. ] [ Designated as safety issue: No ]
Occurrence of any RV GE and severe RV GE leading to medical intervention and caused by the circulating wild-type RV strains of G1 serotype [ Time Frame: During the efficacy follow-up period. ] [ Designated as safety issue: No ]
Occurrence of any RV GE and severe RV GE leading to medical intervention and caused by the circulating wild-type RV strains of non-G1 serotypes. [ Time Frame: During the efficacy follow-up period. ] [ Designated as safety issue: No ]
Occurrence of hospitalisation due to RV GE caused by the circulating wild-type RV strains [ Time Frame: During the efficacy follow-up period. ] [ Designated as safety issue: No ]
Occurrence of any RV GE and severe RV GE leading to medical intervention and caused by the circulating wild-type RV strains (G1 and non-G1 RV types). [ Time Frame: During the period starting from Dose 1 up to Visit 5. ] [ Designated as safety issue: No ]
Occurrence of each type of solicited symptom [ Time Frame: Within the 8-day solicited follow-up period after each dose of HRV vaccine/Placebo. ] [ Designated as safety issue: No ]
Occurrence of unsolicited adverse events according to Medical Dictionary for Regulatory Activities (MedDRA) classification. [ Time Frame: Within 31 days after any dose of HRV vaccine/Placebo. ] [ Designated as safety issue: No ]
Occurrence of severe RV GE leading to a medical intervention and caused by the circulating wild-type RV strains. [ Time Frame: During the efficacy follow-up period. ] [ Designated as safety issue: No ]
Occurrence of serious adverse events. [ Time Frame: Throughout the study period. ] [ Designated as safety issue: No ]
Seroconversion in terms of anti-rotavirus IgA antibody in a subset of subjects. [ Time Frame: One month after the second dose of HRV vaccine/Placebo. ] [ Designated as safety issue: No ]

Enrollment:	765
Study Start Date:	June 2007
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group B: Placebo Comparator	Biological: Placebo Two-dose oral administration.
Group A: Experimental	Biological: Rotarix Two-dose oral vaccination.

Detailed Description:

DTPa and HBV vaccines are allowed to be co-administered along with Rotarix vaccine/Placebo.

Eligibility

Ages Eligible for Study:	6 Weeks to 14 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male or female infant between, and including, 6 and 14 weeks (42-104 days) of age at the time of the first vaccination.
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study
Healthy subjects as established by medical history and clinical examination before entering into the study.
Written informed consent obtained from the parent or guardian of the subject.
Born between a gestation period of 36 and 42 weeks inclusive.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period.
History of use of experimental rotavirus vaccine.
Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
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).
Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for intussusception.
Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition determined by the investigator.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Previous confirmed occurrence of RV GE.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
A family history of congenital or hereditary immunodeficiency.
Acute disease at the time of enrolment.
Gastroenteritis within 7 days preceding the study vaccine administration.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480324

Locations

United States, South Carolina
GSK Investigational Site
Union, South Carolina, United States, 29379
Japan
GSK Investigational Site
Fukuoka, Japan, 802-8533
GSK Investigational Site
Chiba, Japan, 275-8580
GSK Investigational Site
Hokkaido, Japan, 065-0033
GSK Investigational Site
Aichi, Japan, 451-0052
GSK Investigational Site
Okayama, Japan, 701-0204
GSK Investigational Site
Miyagi, Japan, 983-8520
GSK Investigational Site
Okayama, Japan, 701-1192
GSK Investigational Site
Nagasaki, Japan, 856-8562
GSK Investigational Site
Hiroshima, Japan, 734-8530
GSK Investigational Site
Kanagawa, Japan, 247-8533
GSK Investigational Site
Hiroshima, Japan, 737-0811
GSK Investigational Site
Kagawa, Japan, 765-8501
GSK Investigational Site
Nagano, Japan, 386-8610
GSK Investigational Site
Hiroshima, Japan, 730-8518
GSK Investigational Site
Osaka, Japan, 591-8025
GSK Investigational Site
Niigata, Japan, 957-8588
GSK Investigational Site
Miyagi, Japan, 981-3203
GSK Investigational Site
Hiroshima, Japan, 730-8798
Sweden
GSK Investigational Site
STOCKHOLM, Sweden, SE-118 83

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	107625
Study First Received:	May 29, 2007
Last Updated:	September 11, 2009
ClinicalTrials.gov Identifier:	NCT00480324 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Digestive System Diseases
Gastrointestinal Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on November 05, 2009