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

Sponsored by:	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: Rotarix Biological: Placebo	Phase III

MedlinePlus related topics: Gastroenteritis

Drug Information available for: RotaTeq

U.S. FDA Resources

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

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. ]

Secondary Outcome Measures:

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. ]
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. ]
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. ]
Occurrence of hospitalisation due to RV GE caused by the circulating wild-type RV strains [ Time Frame: During the efficacy follow-up period. ]
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. ]
Occurrence of each type of solicited symptom [ Time Frame: Within the 8-day solicited follow-up period after each dose of HRV vaccine/Placebo. ]
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. ]
Occurrence of serious adverse events. [ Time Frame: Throughout the study period. ]
Serum anti-rotavirus IgA antibody concentration in a subset of subjects. [ Time Frame: One month after the second dose of HRV vaccine/Placebo. ]
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. ]

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

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

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

Japan
GSK Clinical Trial Call Center
Hiroshima, Japan

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trial

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Isabelle Harpigny )
Study ID Numbers:	107625
Study First Received:	May 29, 2007
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00480324
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Healthy
Gastroenteritis

ClinicalTrials.gov processed this record on January 13, 2009