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

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

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.

Study Overview

• Status: Completed
• Conditions: Infections, Rotavirus; Rotavirus Vaccines
• Intervention / Treatment: Biological: Rotarix ™; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 684
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 614-735
    • GSK Investigational Site
  • Daegu, Korea, Republic of, 700-712
    • GSK Investigational Site
  • Daegu, Korea, Republic of, 701-600
    • GSK Investigational Site
  • Daejeon, Korea, Republic of, 301-723
    • GSK Investigational Site
  • Daejeon, Korea, Republic of
    • 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, 150-719
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 138-736
    • GSK Investigational Site
  • Seoul, Korea, Republic of
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 135-710
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 130-702
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 139-707
    • GSK Investigational Site
  • Suwon, Kyonggi-do, Korea, Republic of, 443-721
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One month after the second vaccine dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	One month after the second vaccine dose
Number of Subjects Reporting Solicited Symptoms	Solicited symptoms assessed include cough, diarrhoea, irritability, loss of appetite , fever and vomiting.	During the 8-day (Day 0 - Day 7) follow-up period after each vaccine dose.
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.	During the 31-day (Day 0 - Day 30) follow-up period after each vaccine dose
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.	Throughout the study period (2-3 months).
Number of Subjects Reporting Rotavirus Gastroenteritis Episode(s)		From Dose 1 up to 1 month after Dose 2.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2009
• Primary Completion (Actual): July 23, 2010
• Study Completion (Actual): July 23, 2010

Study Registration Dates

• First Submitted: August 20, 2009
• First Submitted That Met QC Criteria: August 31, 2009
• First Posted (Estimate): September 1, 2009

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Gastroenteritis
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Reoviridae Infections; Rotavirus Infections
• Other Study ID Numbers: 112269; 2015-001545-81 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Study Data/Documents

1. Clinical Study Report
   Information identifier: 112269
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Statistical Analysis Plan
   Information identifier: 112269
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Dataset Specification
   Information identifier: 112269
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Annotated Case Report Form
   Information identifier: 112269
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: 112269
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Informed Consent Form
   Information identifier: 112269
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Individual Participant Data Set
   Information identifier: 112269
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register