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NCT00140673

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

Completed Phase 3 Last updated 30 December 2019
What this trial tests

Phase 3 trial testing Rotavirus in Infections, Rotavirus in 63,227 participants. Completed in 20 October 2005.

Timeline
5 August 2003
20 October 2005

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment63,227
Start date5 August 2003
Estimated completion20 October 2005
Sites17 locations across Panama, Colombia, Finland, Dominican Republic, Peru, Chile, Honduras, Mexico

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 6 Weeks to 13 Weeks, any sex, with Infections, Rotavirus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. 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.
    Linhares AC, Velázquez FR, Pérez-Schael I, Sáez-Llorens X, et al · · 2008 · cited 281× · PMID 18395579 · DOI 10.1016/s0140-6736(08)60524-3
  2. Vaccines for preventing rotavirus diarrhoea: vaccines in use.
    Bergman H, Henschke N, Hungerford D, Pitan F, et al · · 2021 · cited 57× · PMID 34788488 · DOI 10.1002/14651858.cd008521.pub6
  3. Vaccines for preventing rotavirus diarrhoea: vaccines in use.
    Soares-Weiser K, Bergman H, Henschke N, Pitan F, et al · · 2019 · cited 40× · PMID 31684685 · DOI 10.1002/14651858.cd008521.pub5
  4. Vaccines for preventing rotavirus diarrhoea: vaccines in use.
    Soares-Weiser K, Bergman H, Henschke N, Pitan F, et al · · 2019 · cited 40× · PMID 30912133 · DOI 10.1002/14651858.cd008521.pub4
  5. Force of infection: a determinant of vaccine efficacy?
    Kaslow DC. · · 2021 · cited 36× · PMID 33846340 · DOI 10.1038/s41541-021-00316-5
  6. A multi-country study of intussusception in children under 2 years of age in Latin America: analysis of prospective surveillance data.
    Sáez-Llorens X, Velázquez FR, Lopez P, Espinoza F, et al · · 2013 · cited 22× · PMID 23710610 · DOI 10.1186/1471-230x-13-95
  7. Early exposure of infants to natural rotavirus infection: a review of studies with human rotavirus vaccine RIX4414.
    Cunliffe N, Zaman K, Rodrigo C, Debrus S, et al · · 2014 · cited 18× · PMID 25433534 · DOI 10.1186/s12887-014-0295-2
  8. Serologic response to porcine circovirus type 1 (PCV1) in infants vaccinated with the human rotavirus vaccine, Rotarix™: A retrospective laboratory analysis.
    Han HH, Karkada N, Jayadeva G, Dubin G. · · 2017 · cited 5× · PMID 27657348 · DOI 10.1080/21645515.2016.1231262

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00140673.

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