Status:

COMPLETED

Study of the Molecular Mechanisms Underlying the Cross-neutralizing Capacity of AS04-adjuvanted HPV Vaccine (Cervarix®) in Comparison With the Aluminiumhydroxyphosphate Sulphate Adjuvanted HPV Vaccine (Gardasil®)

Lead Sponsor:

University Hospital, Ghent

Conditions:

Infection With Human Papillomavirus

Eligibility:

FEMALE

9-13 years

Phase:

PHASE4

Brief Summary

Six identical female twins aged 9-13 years will participate. One sib of each twin pair will be given Cervarix according to the 0, 1, 6 month vaccination scheme, while the other sib will be given Garda...

Eligibility Criteria

Inclusion

  • Six homozygous twins in good health, without preceding sexual activity (virgin). Subjects have a negative pregnancy test on the day of vaccination and have agreed to continue abstinence during the entire study period and for two months after completion of the vaccination series.

Exclusion

  • Subjects are not participating in any other clinical trials and have not been vaccinated previously against HPV and have not had an administration of MPL or AS04 in the past.

Key Trial Info

Start Date :

June 25 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 23 2015

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT01914367

Start Date

June 25 2013

End Date

September 23 2015

Last Update

December 9 2022

Active Locations (1)

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1

Ghent University Hospital

Ghent, Oost-Vlaanderen, Belgium, 9000

Study of the Molecular Mechanisms Underlying the Cross-neutralizing Capacity of AS04-adjuvanted HPV Vaccine (Cervarix®) in Comparison With the Aluminiumhydroxyphosphate Sulphate Adjuvanted HPV Vaccine (Gardasil®) | DecenTrialz