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

• ClinicalTrials.gov Identifier: NCT00969228
• Recruitment Status: Completed
• First Posted: September 1, 2009
• Results First Posted: November 28, 2011
• Last Update Posted: January 18, 2020
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

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.

Condition or disease	Intervention/treatment	Phase
Infections, Rotavirus; Rotavirus Vaccines	Biological: Rotarix ™; Biological: Placebo	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 684 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Actual Study Start Date: August 25, 2009
• Actual Primary Completion Date: July 23, 2010
• Actual Study Completion Date: July 23, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A [ Time Frame: One month after the second vaccine dose ]
   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 :

1. Serum Anti-rotavirus Immunoglobulin A Antibody Concentrations [ Time Frame: One month after the second vaccine dose ]
   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).
2. Number of Subjects Reporting Solicited Symptoms [ Time Frame: During the 8-day (Day 0 - Day 7) follow-up period after each vaccine dose. ]
   Solicited symptoms assessed include cough, diarrhoea, irritability, loss of appetite , fever and vomiting.
3. 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 ]
   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.
4. Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: Throughout the study period (2-3 months). ]
   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.
5. Number of Subjects Reporting Rotavirus Gastroenteritis Episode(s) [ Time Frame: From Dose 1 up to 1 month after Dose 2. ]

Eligibility Criteria

• Ages Eligible for Study: 6 Weeks to 12 Weeks (Child)
• Sexes Eligible for Study: All
• 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

Locations

Korea, Republic of

GSK Investigational Site

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, 130-702

GSK Investigational Site

Seoul, Korea, Republic of, 135-710

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, 150-719

GSK Investigational Site

Seoul, Korea, Republic of

GSK Investigational Site

Suwon, Kyonggi-do, Korea, Republic of, 443-721

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Additional Information:

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 Data/Documents: Clinical Study Report 

Identifier: 112269
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 112269
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: 112269
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: 112269
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 112269
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: 112269
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 112269
For additional information about this study please refer to the GSK Clinical Study Register

Publications:

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.

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.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00969228
• Other Study ID Numbers: 112269; 2015-001545-81 ( EudraCT Number )
• First Posted: September 1, 2009
• Results First Posted: November 28, 2011
• Last Update Posted: January 18, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• 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.
• URL: https://clinicalstudydatarequest.com/Posting.aspx?ID=276

Keywords provided by GlaxoSmithKline:

Gastroenteritis

Additional relevant MeSH terms:

Rotavirus Infections; Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections