Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine in Healthy Infants

NCT ID: NCT00425737

Last Updated: 2016-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 405 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31
• Study Completion Date: 2001-07-31

Brief Summary

To assess the efficacy, immune response and safety of the oral live attenuated HRV vaccine (Rotarix) in healthy infants approximately 2 months of age and previously uninfected with human rotavirus

Conditions

Infections, Rotavirus

Study Design

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

Interventions

Rotarix

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy infants 6 and 12 weeks of age at the time of the first vaccination.
• Written informed consent obtained from the parents or guardians of the subject.
• Born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria

• Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine or placebo or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.)
• Use of antibiotics during the period starting from 7 days before each dose of vaccine(s) and ending 7 days after.
• Any clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator.
• 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.
• Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
• Household contact with an immunosuppressed individual or pregnant woman.
• Abnormal stool pattern.
• Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
• Previous confirmed occurrence of rotavirus gastroenteritis.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 12 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

References

De Vos B, Vesikari T, Linhares AC, Salinas B, Perez-Schael I, Ruiz-Palacios GM, Guerrero Mde L, Phua KB, Delem A, Hardt K. A rotavirus vaccine for prophylaxis of infants against rotavirus gastroenteritis. Pediatr Infect Dis J. 2004 Oct;23(10 Suppl):S179-82. doi: 10.1097/01.inf.0000142370.16514.4a.

Reference Type: BACKGROUND

PMID: 15502699 (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)

Soriano-Gabarró M et al. (2008) Potential impact of Rotarix according to rotavirus type distribution. Pediatr Infect Dis J. 27(1):28-32.

Reference Type: BACKGROUND

Vesikari T et al. (2003) Efficacy of oral human rotavirus vaccine in infants against acute rotavirus gastroenteritis in the community determined with rotavirus antigen detection by EIA and rotavirus RT-PCR as end points. J Clin Virol. 27(1):8 (Abstract n° 24).

Reference Type: BACKGROUND

Vesikari T, Karvonen A, Puustinen L, Zeng SQ, Szakal ED, Delem A, De Vos B. Efficacy of RIX4414 live attenuated human rotavirus vaccine in Finnish infants. Pediatr Infect Dis J. 2004 Oct;23(10):937-43. doi: 10.1097/01.inf.0000141722.10130.50.

Reference Type: BACKGROUND

PMID: 15602194 (View on PubMed)

Vesikari T, Karvonen A, Puustinen L, Szakal ED, Zeng SQ, Delem A, De Vos B. A short report on highlights of world-wide development of RIX4414: an European experience. Vaccine. 2006 May 1;24(18):3779. doi: 10.1016/j.vaccine.2005.07.028. Epub 2005 Aug 1. No abstract available.

Reference Type: BACKGROUND

PMID: 16581159 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

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

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Document Type: Informed Consent Form

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

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Document Type: Dataset Specification

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

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Document Type: Study Protocol

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

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Document Type: Clinical Study Report

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

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Document Type: Statistical Analysis Plan

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

View Document

Related Links

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Other Identifiers

444563/004

Identifier Type: -

Identifier Source: org_study_id