Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants

NCT00480324 | Completed Phase 3 Results

• 2 other identifiers: 1076252015-001543-36
• Study Type: interventional
• Target: 765
• Locations: 1 country
• Sites: 20

Brief Summary

This study is undertaken to provide the regulatory authorities in Japan with immunogenicity, efficacy, safety and reactogenicity data of GSK Biologicals' Human Rotavirus \[HRV\] vaccine, given as a 2-dose primary vaccination, in healthy Japanese infants aged approximately 2 months at the time of the first dose and previously uninfected with HRV. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Infections, Rotavirus; Rotavirus Vaccines

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains

  Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.

  From 2 weeks after Dose 2 up to 2 years of age

Secondary Outcomes (10)

• Number of Subjects Reporting Severe Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains

  From 2 weeks after Dose 2 up to 2 years of age

• Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of G1 Type

  From 2 weeks after Dose 2 up to 2 years of age

• Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of Non-G1 Types

  From 2 weeks after Dose 2 up to 2 years of age

• Number of Subjects Hospitalized Due to Rotavirus (RV) Gastroenteritis (GE) Caused by the Circulating Wild-type RV Strains

  From 2 weeks after Dose 2 up to 2 years of age

• Number of Subjects Reporting Any Rotavirus (RV) Gatroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains

  From Dose 1 up to 2 years of age

Study Arms (2)

Rotarix Group

EXPERIMENTAL

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

Biological: Rotarix

Placebo Group

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

Rotarix BIOLOGICAL

Two-dose oral vaccination.

Rotarix Group

Placebo BIOLOGICAL

Two-dose oral administration.

Placebo Group

Eligibility Criteria

• Age: 6 Weeks - 14 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy male or female infant between, and including, 6 and 14 weeks (42-104 days) of age at the time of the first vaccination.
• 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
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Written informed consent obtained from the parent or guardian of the subject.
• Born between a gestation period of 36 and 42 weeks inclusive.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period.
• History of use of experimental rotavirus vaccine.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• 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 (pharmaceutical product or device).
• Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for intussusception.
• Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition determined by the investigator.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Previous confirmed occurrence of RV GE.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
• A family history of congenital or hereditary immunodeficiency.
• Acute disease at the time of enrolment.
• Gastroenteritis within 7 days preceding the study vaccine administration.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (20)

GSK Investigational Site

Aichi, 451-0052, Japan

Location

GSK Investigational Site

Chiba, 275-8580, Japan

Location

GSK Investigational Site

Fukuoka, 802-8533, Japan

Location

GSK Investigational Site

Hiroshima, 720-8520, Japan

Location

GSK Investigational Site

Hiroshima, 730-8518, Japan

Location

GSK Investigational Site

Hiroshima, 730-8798, Japan

Location

GSK Investigational Site

Hiroshima, 734-8530, Japan

Location

GSK Investigational Site

Hiroshima, 737-0811, Japan

Location

GSK Investigational Site

Hokkaido, 003-0021, Japan

Location

GSK Investigational Site

Hokkaido, 065-0033, Japan

Location

GSK Investigational Site

Kagawa, 765-8501, Japan

Location

GSK Investigational Site

Kanagawa, 247-8533, Japan

Location

GSK Investigational Site

Miyagi, 981-3203, Japan

Location

GSK Investigational Site

Miyagi, 983-8520, Japan

Location

GSK Investigational Site

Nagano, 386-8610, Japan

Location

GSK Investigational Site

Nagasaki, 856-8562, Japan

Location

GSK Investigational Site

Niigata, 957-8588, Japan

Location

GSK Investigational Site

Okayama, 701-0204, Japan

Location

GSK Investigational Site

Okayama, 701-1192, Japan

Location

GSK Investigational Site

Osaka, 591-8025, Japan

Location

Related Publications (5)

• Kawamura N, Tokoeda Y, Oshima M, Okahata H, Tsutsumi H, Van Doorn LJ, Muto H, Smolenov I, Suryakiran PV, Han HH. Efficacy, safety and immunogenicity of RIX4414 in Japanese infants during the first two years of life. Vaccine. 2011 Aug 26;29(37):6335-41. doi: 10.1016/j.vaccine.2011.05.017. Epub 2011 Jun 2.

  PMID: 21640780 BACKGROUND

• Kawamura N et al. Efficacy of Human Rotavirus (G1P[8] strain) Vaccine (HRV) RIX4414 in Japanese Infants during the Two-year Efficacy Follow-up Period. Abstract presented at the 114th Annual Meeting of Japan Pediatric Society (JPS). Tokyo, Japan, 12-14 August 2011.

  BACKGROUND

• Kawamura N et al. Efficacy of human rotavirus vaccine RIX4414 in Japanese infants from 2 weeks post dose 2 up to data lock point. Abstract presented at the 28th meeting of European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4-8 May 2010.

  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

• Bergman H, Henschke N, Hungerford D, Pitan F, Ndwandwe D, Cunliffe N, Soares-Weiser K. Vaccines for preventing rotavirus diarrhoea: vaccines in use. Cochrane Database Syst Rev. 2021 Nov 17;11(11):CD008521. doi: 10.1002/14651858.CD008521.pub6.

  PMID: 34788488 DERIVED

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

Interventions

RIX4414 vaccine

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

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 3
• 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: May 29, 2007
• First Posted: May 30, 2007
• Study Start: June 19, 2007
• Primary Completion: March 31, 2009
• Study Completion: November 21, 2009
• Last Updated: January 2, 2020
• Results First Posted: November 17, 2010

Record last verified: 2019-12

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

JP (20)