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NCT00222664

Qidong Hepatitis B Intervention Study

Completed Phase 4 Last updated 13 September 2005
What this trial tests

Phase 4 trial testing Hep-V Vax in Hepatitis B in 80,000 participants. Completed in 1 December 2004.

Timeline
1 September 1983
1 December 2004

Quick facts

Lead sponsorUniversity of Oxford
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment80,000
Start date1 September 1983
Estimated completion1 December 2004
Sites3 locations across China, United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

University of Oxford

Who can join

0 and older, any sex, with Hepatitis B or Liver Neoplasms.

Sponsor's own description

During 1983-1990 in the Jiangsu province of China, 80,000 infants were randomised by area of birth between control, standard Hepatitis B vaccination (at 0, 1 and 6 months of age) and standard vaccination plus a booster dose at about 2 to 3 years of age. The aim is to prevent establishment of chronic HBV infection in early childhood, hence to prevent the morbidity of chronic hepatitis B in young adolescents and the incidence/mortality several decades later from liver cancer and other HBV related chronic liver diseases. Long-term follow-up through central registries will determine the impact of vaccination on liver cancer incidence and mortality.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Efficacy of neonatal HBV vaccination on liver cancer and other liver diseases over 30-year follow-up of the Qidong hepatitis B intervention study: a cluster randomized controlled trial.
    Qu C, Chen T, Fan C, Zhan Q, et al · · 2014 · cited 93× · PMID 25549238 · DOI 10.1371/journal.pmed.1001774

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Other recruiting trials for Hepatitis B

Currently open trials in the same condition.

Other University of Oxford trials

Trials by the same sponsor.

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