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

NCT00969228 | Completed Phase 4 Results

• 2 other identifiers: 1122692015-001545-81
• Study Type: interventional
• Target: 684
• Locations: 1 country
• Sites: 18

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.

Conditions

Infections, Rotavirus; Rotavirus Vaccines

Keywords

Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Serum Anti-rotavirus Immunoglobulin A Antibody Concentrations

  One month after the second vaccine dose

• Number of Subjects Reporting Solicited Symptoms

  During the 8-day (Day 0 - Day 7) follow-up period after each vaccine dose.

• Number of Subjects Reporting Unsolicited Adverse Events (AEs)

  During the 31-day (Day 0 - Day 30) follow-up period after each vaccine dose

• Number of Subjects Reporting Serious Adverse Events (SAEs)

  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.

Study Arms (2)

Rotarix Group

EXPERIMENTAL

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

Biological: Rotarix ™

Placebo Group

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

Rotarix ™ BIOLOGICAL

Two oral doses

Rotarix Group

Placebo BIOLOGICAL

Two oral doses

Placebo Group

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (18)

GSK Investigational Site

Busan, 614-735, South Korea

Location

GSK Investigational Site

Daegu, 700-712, South Korea

Location

GSK Investigational Site

Daegu, 701-600, South Korea

Location

GSK Investigational Site

Daejeon, 301-723, South Korea

Location

GSK Investigational Site

Daejeon, South Korea

Location

GSK Investigational Site

Goyang, South Korea

Location

GSK Investigational Site

Gwangju, 501-717, South Korea

Location

GSK Investigational Site

Iksan, 570-711, South Korea

Location

GSK Investigational Site

Incheon, 400-711, South Korea

Location

GSK Investigational Site

Jeonju Jeonbuk, 561-712, South Korea

Location

GSK Investigational Site

Kwangju, South Korea

Location

GSK Investigational Site

Seoul, 130-702, South Korea

Location

GSK Investigational Site

Seoul, 135-710, South Korea

Location

GSK Investigational Site

Seoul, 138-736, South Korea

Location

GSK Investigational Site

Seoul, 139-707, South Korea

Location

GSK Investigational Site

Seoul, 150-719, South Korea

Location

GSK Investigational Site

Seoul, South Korea

Location

GSK Investigational Site

Suwon, Kyonggi-do, 443-721, South Korea

Location

Related Publications (3)

• 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.

  PMID: 22699440 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24047799 BACKGROUND

Related 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.

MeSH Terms

Conditions

Rotavirus Infections; Gastroenteritis

Interventions

RIX4414 vaccine

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2009
• First Posted: September 1, 2009
• Study Start: August 25, 2009
• Primary Completion: July 23, 2010
• Study Completion: July 23, 2010
• Last Updated: January 18, 2020
• Results First Posted: November 28, 2011

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

KR (18)