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' Human Rotavirus [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 Rotavirus Vaccines	Biological: Rotarix Biological: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
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:

Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains [ Time Frame: From 2 weeks after Dose 2 up to 2 years of age ] [ Designated as safety issue: No ]
Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.

Secondary Outcome Measures:

Number of Subjects Reporting Severe Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains [ Time Frame: From 2 weeks after Dose 2 up to 2 years of age ] [ Designated as safety issue: No ]
A subject was considered as reporting severe rotavirus gastroenteritis when the subject scored 11 or more on a 20-point scoring system (Vesikari scoring system).
Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of G1 Type [ Time Frame: From 2 weeks after Dose 2 up to 2 years of age ] [ Designated as safety issue: No ]
Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.

Severe RV GE was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system).
Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of Non-G1 Types [ Time Frame: From 2 weeks after Dose 2 up to 2 years of age ] [ Designated as safety issue: No ]
Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.

Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system).
Number of Subjects Hospitalized Due to Rotavirus (RV) Gastroenteritis (GE) Caused by the Circulating Wild-type RV Strains [ Time Frame: From 2 weeks after Dose 2 up to 2 years of age ] [ Designated as safety issue: No ]
Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.
Number of Subjects Reporting Any Rotavirus (RV) Gatroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains [ Time Frame: From Dose 1 up to 2 years of age ] [ Designated as safety issue: No ]
Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.

Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system).
Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody Concentration [ Time Frame: 2 months after Dose 2 ] [ Designated as safety issue: No ]
Anti-rotavirus immunoglobulin A antibody concentrations are given as geometric mean concentrations (GMCs). Arbitrary 'zero' values were set in the Placebo Group since the GMC was below the assay cut-off value (20 U/mL).
Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A (IgA) Antibodies [ Time Frame: 2 months after Dose 2 ] [ Designated as safety issue: No ]
Seroconversion was defined as the appearance of anti-rotavirus immunoglobulin A antibody concentration ≥ 20 units (U)/milliliter (mL) in subjects initially (i.e. prior to the first dose of rotarix) seronegative.
Number of Subjects Reporting Solicited Symptoms [ Time Frame: During the 8-day follow-up period after each dose ] [ Designated as safety issue: No ]
Solicited symptoms assessed include cough, diarrhoea, fever, irritability, loss of appetite and vomiting.
Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day follow-up period after each dose ] [ Designated as safety issue: No ]
Unsolicited adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: Up to 2 years of age ] [ Designated as safety issue: No ]
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

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

Arms	Assigned Interventions
Experimental: Rotarix Group Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.	Biological: Rotarix Two-dose oral vaccination.
Placebo Comparator: Placebo Group Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.	Biological: Placebo Two-dose oral administration.

Detailed Description:

Combined diphtheria and tetanus toxoids and acellular pertussis (DTPa) and Hepatitis B (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
Aichi, Japan, 451-0052
GSK Investigational Site
Chiba, Japan, 275-8580
GSK Investigational Site
Fukuoka, Japan, 802-8533
GSK Investigational Site
Hiroshima, Japan, 734-8530
GSK Investigational Site
Hiroshima, Japan, 730-8798
GSK Investigational Site
Hiroshima, Japan, 730-8518
GSK Investigational Site
Hiroshima, Japan, 737-0811
GSK Investigational Site
Hokkaido, Japan, 065-0033
GSK Investigational Site
Kagawa, Japan, 765-8501
GSK Investigational Site
Kanagawa, Japan, 247-8533
GSK Investigational Site
Miyagi, Japan, 983-8520
GSK Investigational Site
Miyagi, Japan, 981-3203
GSK Investigational Site
Nagano, Japan, 386-8610
GSK Investigational Site
Nagasaki, Japan, 856-8562
GSK Investigational Site
Niigata, Japan, 957-8588
GSK Investigational Site
Okayama, Japan, 701-0204
GSK Investigational Site
Okayama, Japan, 701-1192
GSK Investigational Site
Osaka, Japan, 591-8025
Sweden
GSK Investigational Site
Stockholm, Sweden, SE-118 83

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Publications:

Kawamura N et al. Efficacy of human rotavirus vaccine RIX4414 in Japanese infants from 2 weeks post dose 2 up to data lock point. Abstract presented at the 28th meeting of European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4-8 May 2010.

Responsible Party:	E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00480324 History of Changes
Other Study ID Numbers:	107625
Study First Received:	May 29, 2007
Results First Received:	March 30, 2010
Last Updated:	October 21, 2010
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on February 12, 2012