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Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants

Primary Purpose

Infections, Rotavirus, Rotavirus Vaccines

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rotarix ™
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections, Rotavirus focused on measuring Gastroenteritis

Eligibility Criteria

6 Weeks - 12 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rotarix Group

Placebo Group

Arm Description

Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.

Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.

Outcomes

Primary Outcome Measures

Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A
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
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
Solicited symptoms assessed include cough, diarrhoea, irritability, loss of appetite , fever and vomiting.
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
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)
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)

Full Information

First Posted
August 20, 2009
Last Updated
January 3, 2020
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00969228
Brief Title
Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 25, 2009 (Actual)
Primary Completion Date
July 23, 2010 (Actual)
Study Completion Date
July 23, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Rotavirus, Rotavirus Vaccines
Keywords
Gastroenteritis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
684 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rotarix Group
Arm Type
Experimental
Arm Description
Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
Intervention Type
Biological
Intervention Name(s)
Rotarix ™
Intervention Description
Two oral doses
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Two oral doses
Primary Outcome Measure Information:
Title
Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A
Description
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.
Time Frame
One month after the second vaccine dose
Secondary Outcome Measure Information:
Title
Serum Anti-rotavirus Immunoglobulin A Antibody Concentrations
Description
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).
Time Frame
One month after the second vaccine dose
Title
Number of Subjects Reporting Solicited Symptoms
Description
Solicited symptoms assessed include cough, diarrhoea, irritability, loss of appetite , fever and vomiting.
Time Frame
During the 8-day (Day 0 - Day 7) follow-up period after each vaccine dose.
Title
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Description
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.
Time Frame
During the 31-day (Day 0 - Day 30) follow-up period after each vaccine dose
Title
Number of Subjects Reporting Serious Adverse Events (SAEs)
Description
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.
Time Frame
Throughout the study period (2-3 months).
Title
Number of Subjects Reporting Rotavirus Gastroenteritis Episode(s)
Time Frame
From Dose 1 up to 1 month after Dose 2.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Daegu
ZIP/Postal Code
701-600
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Daejeon
ZIP/Postal Code
301-723
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Daejeon
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Goyang
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Gwangju
ZIP/Postal Code
501-717
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Iksan
ZIP/Postal Code
570-711
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Jeonju Jeonbuk
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Kwangju
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
139-707
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
150-719
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Suwon, Kyonggi-do
ZIP/Postal Code
443-721
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
https://clinicalstudydatarequest.com/Posting.aspx?ID=276
Citations:
PubMed Identifier
22699440
Citation
Kim JS, Bae CW, Lee KY, Park MS, Choi YY, Kim KN, Kim JD, Park WS, Sin JB, Kim EA, Lee SG, Kim CS, Cha SH, Hong YJ, Shin SM, Shim GH, Choi KM, Yang JW, Liu A, Suryakiran PV, Han HH. Immunogenicity, reactogenicity and safety of a human rotavirus vaccine (RIX4414) in Korean infants: a randomized, double-blind, placebo-controlled, phase IV study. Hum Vaccin Immunother. 2012 Jun;8(6):806-12. doi: 10.4161/hv.19853. Epub 2012 Jun 1.
Results Reference
background
Citation
Kim JS et al. Assessment of immunogenicity, reactogenicity and safety of human rotavirus vaccine RIX4414 in Korean infants. Abstract presented at the Korean Society of Pediatric Infectious Diseases - 2011 Autumn Conference (KSPID). Seoul, S Korea, 12-15 November 2011.
Results Reference
background
PubMed Identifier
24047799
Citation
Buyse H, Vinals C, Karkada N, Han HH. The human rotavirus vaccine Rotarix in infants: an integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 2014;10(1):19-24. doi: 10.4161/hv.26476. Epub 2013 Oct 8.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112269
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112269
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112269
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112269
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112269
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112269
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112269
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants

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