Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants - Full Text View

Purpose

The aim of this study is to assess the immunogenicity, reactogenicity and safety of the human rotavirus (HRV) Rotarix ™ vaccine when administered in healthy infants aged approximately 6-12 weeks at the time of first vaccination.

Condition	Intervention	Phase
Rotavirus Infection Rotavirus Gastroenteritis	Biological: Rotarix ™ Biological: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Immunogenicity, Reactogenicity and Safety Study to Evaluate Two Doses of the Lyophilised Formulation of the Human Rotavirus (HRV) Vaccine When Administered to Healthy Korean Infants Previously Uninfected With HRV

Resource links provided by NLM:

MedlinePlus related topics: Gastroenteritis Rotavirus Infections

Drug Information available for: Rotarix

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A [ Time Frame: One month after the second vaccine dose ] [ Designated as safety issue: No ]
Seroconversion is defined as the appearance of antibodies with concentrations greater than or equal to 20 units per milliliter (U/mL) in the serum of subjects seronegative before vaccination.

Secondary Outcome Measures:

Serum Anti-rotavirus Immunoglobulin A Antibody Concentrations [ Time Frame: One month after the second vaccine dose ] [ Designated as safety issue: No ]
Concentrations are given as Geometric Mean Concentrations (GMCs). Note: In the Placebo Group the value was below the assay cut-off (20 units per milliliter).
Number of Subjects Reporting Solicited Symptoms [ Time Frame: During the 8-day (Day 0 - Day 7) follow-up period after each vaccine dose. ] [ Designated as safety issue: No ]
Solicited symptoms assessed include cough, diarrhoea, irritability, loss of appetite , fever and vomiting.
Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Day 0 - Day 30) follow-up period after each vaccine dose ] [ Designated as safety issue: No ]
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: Throughout the study period (2-3 months). ] [ Designated as safety issue: No ]
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.
Number of Subjects Reporting Rotavirus Gastroenteritis Episode(s) [ Time Frame: From Dose 1 up to 1 month after Dose 2. ] [ Designated as safety issue: No ]

Enrollment:	684
Study Start Date:	August 2009
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (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 or 2-month schedule.	Biological: Rotarix ™ Two oral doses
Placebo Comparator: Placebo Group Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.	Biological: Placebo Two oral doses

Eligibility

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

Criteria

Inclusion Criteria:

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.
A male or female between, and including, 6 to 12 weeks of age at the time of the first dose of the vaccination.
Written informed consent obtained from the parents or guardians of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Born after a normal gestation period of between 37 and 41 weeks + 6 days inclusive.
Subjects for whom the vaccination history is available from vaccination diary cards or medical charts.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine with the exception of the routine infant vaccines.
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.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal 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.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Gastroenteritis (GE) within 7 days preceding the study vaccine administration.
Previous confirmed occurrence of RV GE.
Previous vaccination with rotavirus vaccine or planned use during the study period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969228

Locations

Korea, Republic of
GSK Investigational Site
Busan, Korea, Republic of, 614-735
GSK Investigational Site
Daegu, Korea, Republic of, 701-600
GSK Investigational Site
Daegu, Korea, Republic of, 700-712
GSK Investigational Site
Daejeon, Korea, Republic of
GSK Investigational Site
Daejeon, Korea, Republic of, 301-723
GSK Investigational Site
Goyang, Korea, Republic of
GSK Investigational Site
Gwangju, Korea, Republic of, 501-717
GSK Investigational Site
Iksan, Korea, Republic of, 570-711
GSK Investigational Site
Incheon, Korea, Republic of, 400-711
GSK Investigational Site
Jeonju Jeonbuk, Korea, Republic of, 561-712
GSK Investigational Site
Kwangju, Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
GSK Investigational Site
Seoul, Korea, Republic of, 139-707
GSK Investigational Site
Seoul, Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 135-710
GSK Investigational Site
Seoul, Korea, Republic of, 150-719
GSK Investigational Site
Seoul, Korea, Republic of, 130-702
GSK Investigational Site
Suwon, Kyonggi-do, Korea, Republic of, 443-721

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00969228 History of Changes
Other Study ID Numbers:	112269
Study First Received:	August 20, 2009
Results First Received:	June 16, 2011
Last Updated:	December 2, 2011
Health Authority:	Korea: Korea Food & Drug Administration

Keywords provided by GlaxoSmithKline:

Gastroenteritis

Additional relevant MeSH terms:

Gastroenteritis
Rotavirus Infections
Gastrointestinal Diseases
Digestive System Diseases

Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013