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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04206813




Registration number
NCT04206813
Ethics application status
Date submitted
15/12/2019
Date registered
20/12/2019

Titles & IDs
Public title
An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen
Scientific title
An Open-Label Clinical Trial Evaluating the Immunogenicity of the 9vHPV Vaccination Regimen Over 6 Months Among Women Aged 16 to 45 Years Old, An Exploratory Immunogenicity Study
Secondary ID [1] 0 0
H-39051
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HPV Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Gardasil 9 2 dose regimen
Treatment: Drugs - Gardasil 9 3 dose regimen
Treatment: Drugs - Gardasil 9 rescue dose

Experimental: Intervention group - 240 eligible women will receive a 2-dose regimen of Gardasil 9 at (0 and 6 months, followed by a rescue 3rd dose at month 12)

Active comparator: Control group - 120 eligible women will receive the standard 3-dose regimen of Gardasil 9 at (0, 2, 6 months)


Treatment: Drugs: Gardasil 9 2 dose regimen
a 2-dose regimen of Gardasil 9 at 0 and 6 months

Treatment: Drugs: Gardasil 9 3 dose regimen
standard 3-dose regimen of Gardasil 9 at 0, 2, 6 months

Treatment: Drugs: Gardasil 9 rescue dose
A rescue dose of Gardasil 9 will be given at 12 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in immunogenicity of Gardasil 9
Timepoint [1] 0 0
baseline and 7 months
Primary outcome [2] 0 0
Change in geometric mean titers ratios
Timepoint [2] 0 0
baseline and 7 months
Secondary outcome [1] 0 0
Number of participants with HPV seropositivity at day 1
Timepoint [1] 0 0
day 1
Secondary outcome [2] 0 0
Number of participants with HPV seropositivity at month 7
Timepoint [2] 0 0
month 7

Eligibility
Key inclusion criteria
* Women receiving care at Boston Medical Center
Minimum age
16 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Currently pregnant
* Prior HPV vaccination
* A history of severe allergic reaction, including known allergy to any vaccine component, specially severe allergic to yeast
* Immunocompromised/previous immunosuppressive therapy
* Thrombocytopenia or other coagulation disorder
* Currently breastfeeding

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts

Funding & Sponsors
Primary sponsor type
Other
Name
Boston Medical Center
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Natalie Joseph, MD MPH
Address 0 0
Boston Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Natalie Joseph, MD MPH
Address 0 0
Country 0 0
Phone 0 0
617-414-4524
Fax 0 0
Email 0 0
natalie.pierre-joseph@bmc.org
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04206813