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

Human Papillomavirus Vaccines Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03431246
• Other study ID #: CÉ: 2017-3036-21
• Status: Completed
• Phase: Phase 3
• First received: January 26, 2018
• Last updated: February 6, 2018
• Start date: October 1, 2016
• Est. completion date: December 5, 2016

Study information

• Verified date: February 2018
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 5, 2016
• Est. primary completion date: November 5, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 18 Years

Eligibility

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

Exclusion Criteria: Immunossupressed or blood coagulation problems

Related Conditions & MeSH terms

• Human Papillomavirus Vaccines

Intervention

Biological:
• Gardasil and Gardasil-9
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.

Locations

Country	Name	City	State
Canada	Laval University Research Hospital Center	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HPV seropositivity	Seropositivity to 9 HPV types included in Gardasil-9 vaccine will be assessed.	One month post vaccine administration.
Secondary	HPV antibody titers	Geometrical mean titers of antibodies to 9 HPV types included in Gardasil-9 vaccine will be assessed	One month post vaccine administration