A Study to Test 2 Doses of the HRV Vaccine in Healthy Infants.

NCT ID: NCT00140673

Last Updated: 2019-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 63227 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-05
• Study Completion Date: 2005-10-20

Brief Summary

The main objectives of this study are: 1) In a subset (N = 20 000), to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age. 2) In all subjects (N = 60 000), to determine the safety of GSK Biologicals' HRV vaccine with respect to definite intussusception (IS) within 31 days (Day 0-Day 30) after each HRV vaccine dose.

Detailed Description

The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-13 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month schedule. Routine EPI vaccinations are given at the discretion of the investigator and according to local National Plans of Immunisation schedule in each participating country. A minimum 2-week interval was to be observed between HRV vaccine and OPV doses. Of the total enrolled cohort of 60 000 subjects, 20 000 subjects were followed for efficacy and safety until one year of age while 40 000 subjects were followed for safety only until 30-90 days after the second HRV/placebo dose. A subset (N = approximately 13 000) of the 20 000 subjects are followed for efficacy and safety until 24 months of age. From the 20 000 subjects followed for efficacy and safety, a subset of 100 subjects per country (center specific, except Finland) provided two blood sample to evaluate immunogenicity.

Conditions

Infections, Rotavirus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Interventions

Rotavirus

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy infants 6-13 weeks of age at the time of the first study vaccination whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits)

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine or placebo, or planned use during the study period
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.)
• Child is unlikely to remain in the study area for the duration of the study
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
• History of allergic disease or reaction likely to be exacerbated by any component of the vaccine
• Administration of immunoglobulins and/or blood products since birth or planned administration during the study period
• 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

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 13 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Villanueva, Mendoza Province, Argentina

GSK Investigational Site

Belém, Pará, Brazil

GSK Investigational Site

Valparaíso, Región de Valparaíso, Chile

GSK Investigational Site

Concepción, Región Del Biobio, Chile

GSK Investigational Site

Cali Colombia, , Colombia

GSK Investigational Site

Santo Domingo, , Dominican Republic

GSK Investigational Site

Tampere, , Finland

GSK Investigational Site

Tegucigalpa, , Honduras

GSK Investigational Site

Cuernavaca, , Mexico

GSK Investigational Site

Durango, , Mexico

GSK Investigational Site

Mexico City, , Mexico

GSK Investigational Site

México, , Mexico

GSK Investigational Site

Tlanepantla, , Mexico

GSK Investigational Site

León, , Nicaragua

GSK Investigational Site

Panama City, , Panama

GSK Investigational Site

Lima, , Peru

GSK Investigational Site

Valencia, Carabobo, Venezuela

Countries

Argentina; Brazil; Chile; Colombia; Dominican Republic; Finland; Honduras; Mexico; Nicaragua; Panama; Peru; Venezuela

References

Costa Clemens SA et al. Operational organization of a large scale phase III clinical trial of rotavirus vaccine in multiple sites and countries in Latin America. Poster presented at ICP, Cancun, Mexico, 15-20 August 2004.

Reference Type: BACKGROUND

De Vos B et al. Rotarix™: an effective way to prevent rotavirus diarrhoea and vomiting. Proc. 9th Congress of the Asian Pan Pacific Society of Paediatric Gastroenterology, Hepatology and Nutrition & 27th Annual Congress of the Malaysian Paediatric Association, Kuala Lumpur, 16-19 June 2005.

Reference Type: BACKGROUND

Macias M et al. The rotavirus vaccine RIX4414 (Rotarix) is not associated with intussusception in one year old infants. Proc. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), Washington DC, USA, 16-19 December 2005.

Reference Type: BACKGROUND

O'Ryan et al. A novel rotavirus vaccine RIX4414 is not associated with intussusception. Proc. 44th ICAAC, Washington DC, USA, October 30-November 2, 2004.

Reference Type: BACKGROUND

Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, Abate H, Breuer T, Clemens SC, Cheuvart B, Espinoza F, Gillard P, Innis BL, Cervantes Y, Linhares AC, Lopez P, Macias-Parra M, Ortega-Barria E, Richardson V, Rivera-Medina DM, Rivera L, Salinas B, Pavia-Ruz N, Salmeron J, Ruttimann R, Tinoco JC, Rubio P, Nunez E, Guerrero ML, Yarzabal JP, Damaso S, Tornieporth N, Saez-Llorens X, Vergara RF, Vesikari T, Bouckenooghe A, Clemens R, De Vos B, O'Ryan M; Human Rotavirus Vaccine Study Group. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006 Jan 5;354(1):11-22. doi: 10.1056/NEJMoa052434.

Reference Type: BACKGROUND

PMID: 16394298 (View on PubMed)

Vesikari et al. High efficacy of two doses of Rotarix™ (RIX4414) against rotavirus disease in Europe, Latin-America and Asia. Presented at ACPID, Cebu, Philippines, 7-10 March 2006.

Reference Type: BACKGROUND

Vesikari T et al. Overcoming the safety hurdle: the rotavirus vaccine RIX4414 is not associated with intussusception. 23rd Annual Meeting of European Society for Paediatric Infectious Diseases, Valencia, Spain, 18-20 May 2005.

Reference Type: BACKGROUND

Vesikari T et al. RIX4414: A new attenuated human rotavirus vaccine. 23rd Annual Meeting of European Society for Paediatric Infectious Diseases, Valencia, Spain, 18-20 May 2005.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 24047799 (View on PubMed)

De Vos B, Han HH, Bouckenooghe A, Debrus S, Gillard P, Ward R, Cheuvart B. Live attenuated human rotavirus vaccine, RIX4414, provides clinical protection in infants against rotavirus strains with and without shared G and P genotypes: integrated analysis of randomized controlled trials. Pediatr Infect Dis J. 2009 Apr;28(4):261-6. doi: 10.1097/INF.0b013e3181907177.

Reference Type: BACKGROUND

PMID: 19289978 (View on PubMed)

Han HH, Karkada N, Jayadeva G, Dubin G. Serologic response to porcine circovirus type 1 (PCV1) in infants vaccinated with the human rotavirus vaccine, Rotarix: A retrospective laboratory analysis. Hum Vaccin Immunother. 2017 Jan 2;13(1):237-244. doi: 10.1080/21645515.2016.1231262.

Reference Type: BACKGROUND

PMID: 27657348 (View on PubMed)

Justino MC, Araujo EC, van Doorn LJ, Oliveira CS, Gabbay YB, Mascarenhas JD, Miranda YS, Guerra Sde F, Silva VB, Linhares AC. Oral live attenuated human rotavirus vaccine (Rotarix) offers sustained high protection against severe G9P[8] rotavirus gastroenteritis during the first two years of life in Brazilian children. Mem Inst Oswaldo Cruz. 2012 Nov;107(7):846-53. doi: 10.1590/s0074-02762012000700002.

Reference Type: BACKGROUND

PMID: 23147138 (View on PubMed)

Linhares AC, Velazquez FR, Perez-Schael I, Saez-Llorens X, Abate H, Espinoza F, Lopez P, Macias-Parra M, Ortega-Barria E, Rivera-Medina DM, Rivera L, Pavia-Ruz N, Nunez E, Damaso S, Ruiz-Palacios GM, De Vos B, O'Ryan M, Gillard P, Bouckenooghe A; Human Rotavirus Vaccine Study Group. Efficacy and safety of an oral live attenuated human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in Latin American infants: a randomised, double-blind, placebo-controlled phase III study. Lancet. 2008 Apr 5;371(9619):1181-9. doi: 10.1016/S0140-6736(08)60524-3.

Reference Type: BACKGROUND

PMID: 18395579 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Document Type: Dataset Specification

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Informed Consent Form

View Document

Document Type: Individual Participant Data Set

View Document

Related Links

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Other Identifiers

444563/023

Identifier Type: -

Identifier Source: org_study_id