Immunogenicity of Gardasil and Twinrix and the Effect of a Dose of Gardasil or Cervarix Given 42 Months Later.
NCT ID: NCT01456715
Last Updated: 2020-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
418 participants
INTERVENTIONAL
2008-09-30
2018-12-31
Brief Summary
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No clinical data exist regarding:
* The immunogenicity and safety of Gardasil and Twinrix when co-administered.
* The immunogenicity and safety of Cervarix when administered to subjects previously vaccinated with Gardasil.
The main objective of the first phase of this clinical trial was:
• To assess and compare the immunogenicity of Gardasil and Twinrix Junior when co-administered or administered at one month interval according to a 0, 6 month schedule to 9-10 year-old girls.
The main objective of the seconde phase of this clinical trial is:
• To determine the effect of a booster dose of Gardasil or Cervarix on HPV antibodies when given 42 months post-vaccination of 9-10 year-old girls with two doses of Gardasil.
Study Design \& Duration:
Experimental Design: Blind for the third HPV vaccine dose, randomized, single centre study with two treatment groups.
Duration of the study:
Participants will be followed for the duration of 10 years post-primary vaccination.
Number of Centres:
One Center.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Gardasil, Immunogenicity, Booster dose.
Gardasil vaccine, Immunogenicity, Booster dose.
Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Gardasil given 42 months later.
Cervarix, Immunogenicity, Booster dose.
Cervarix Vaccine, Immunogenicity, Booster Dose.
Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Cervarix given 42 months later.
Interventions
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Gardasil vaccine, Immunogenicity, Booster dose.
Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Gardasil given 42 months later.
Cervarix Vaccine, Immunogenicity, Booster Dose.
Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Cervarix given 42 months later.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
12 Years
14 Years
FEMALE
Yes
Sponsors
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Laval University
OTHER
Responsible Party
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Vladimir Gilca
Principal investigator
Principal Investigators
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Vladimir Gilca, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
INSPQ, CHUQ-CHUL, Laval University
Locations
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Laval University Research Hospital Center
Québec, , Canada
Countries
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Other Identifiers
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9427-L1802/1-21C
Identifier Type: OTHER
Identifier Source: secondary_id
122.05.01
Identifier Type: -
Identifier Source: org_study_id
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