CompletedNCT03431246Updated Feb 13, 2018

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

A Phase 3 interventional study of Gardasil and Gardasil-9 in Human Papillomavirus Vaccines, sponsored by Laval University. Completed at 1 site in Canada. Open to female participants aged 12 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-13.

Sponsored by Laval University · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 32
Allocation: Not applicable
Ages: 12 Years to 18 Years
Sex: Female

Study summary

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

Read the detailed 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.

Conditions studied

Human Papillomavirus Vaccines

Who can participate

Ages eligible: 12 Years to 18 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Eligibility criteria

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

Exclusion Criteria: Immunossupressed or blood coagulation problems

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 32 participants (actual)

Study arms

Experimental
Gardasil and Gardasil-9
Biological: Gardasil and Gardasil-9

Interventions

BiologicalGardasil 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.

What researchers measure

Primary outcomes

Anti-HPV seropositivity
Seropositivity to 9 HPV types included in Gardasil-9 vaccine will be assessed.
Time frame: One month post vaccine administration.

Secondary outcomes

HPV antibody titers
Geometrical mean titers of antibodies to 9 HPV types included in Gardasil-9 vaccine will be assessed
Time frame: One month post vaccine administration

Study locations

1 site

Laval University Research Hospital Center
Quebec, G1E7G9, Canada

References and documents

Publications

Gilca V, Sauvageau C, Panicker G, De Serres G, Schiller J, Ouakki M, Unger ER. Long intervals between two doses of HPV vaccines and magnitude of the immune response: a post hoc analysis of two clinical trials. Hum Vaccin Immunother. 2019;15(7-8):1980-1985. doi: 10.1080/21645515.2019.1605278. Epub 2019 Jun 3. PubMed 31017850 ↗

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03431246
Lead sponsor: Laval University
Collaborators: Centers for Disease Control and Prevention
Responsible party: Vladimir Gilca (Medical Epidemiologist, Laval University) — Principal investigator
First posted: Feb 13, 2018
Start date: Oct 1, 2016
Primary completion: Nov 5, 2016
Completion: Dec 5, 2016
Last update: Feb 13, 2018

Study contacts

Gaston DeSerres, MD, PhD

study chair · Quebec Public Health Institute

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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