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Completed

NCT Number: NCT03431246

Immunogenicity of One Dose of Gardasil and One Dose of Gardasil-9

This study will assess the immunogenicity of one dose of Gardasil and one dose of Gardasil-9

Completed

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Key information

Conditions

Human Papillomavirus Vaccines

Age range

12 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Laval University Research Hospital Center

Québec, G1E7G9, Canada

About this study

This is a one group exploratory study.

The main objective of this study is to assess the persistance of anti-HPV after a single dose Gardasil and the effect of one dose of Gardasil-9 when administered 3-8 years later.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Have received a single dose of Gardasil 3-8 years before recruitement.

-

Exclusion criteria

Immunossupressed or blood coagulation problems

-

Treatment and study plan

Gardasil and Gardasil-9

Biological

All subjects will receive one dose of Gardasil-9. Blodd samples for serological testing will be collected just before and one month post Gardasil-9 administration.

Primary outcomes

  1. Anti-HPV seropositivity

    Time frame: One month post vaccine administration.

    Seropositivity to 9 HPV types included in Gardasil-9 vaccine will be assessed.

Secondary outcomes

  1. HPV antibody titers

    Time frame: One month post vaccine administration

    Geometrical mean titers of antibodies to 9 HPV types included in Gardasil-9 vaccine will be assessed

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

Persistance of Anti-HPV After a Single Dose of Gardasil and the Effect of a Dose of Gardasil-9 When Administered 3-8 Years Later

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 13, 2018
Registry last updated
Feb 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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