← Back to Search

Cancer Vaccine

HPV Vaccine Regimens for Human Papillomavirus

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Received 1 dose of 9vHPV vaccine at least 1 year prior to enrollment and did not receive a second dose of any HPV vaccine
Cohort 0 Participants: Received 1 dose of 9vHPV vaccine at least 1 year prior to enrollment and did not receive a second dose of any HPV vaccine
Must not have
Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial (Cohorts 1-5)
Received any immunoglobulin product or blood-derived product within 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks post last vaccination (up to ~month 61)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing the safety and effectiveness of a new HPV vaccine given in two or three doses over six years in boys, girls, and young women.

Who is the study for?
This trial is for boys and girls aged 9-14, and young women aged 16-26 with a history of limited sexual partners. Participants should not be sexually active during the study or plan to become so. Women must have normal Pap tests. Those previously vaccinated with one dose of HPV vaccine can join, but those who are pregnant, immunocompromised, or have severe allergies cannot.
What is being tested?
The study is testing extended two-dose regimens (0,12; 0,24; 0,36; and 0,60 months) of the 9vHPV vaccine in younger participants against the standard three-dose regimen given to young women at intervals of 0,2,and6 months. The aim is to compare safety and immune response over a period of up to eight years.
What are the potential side effects?
While specific side effects are not listed here,the common side effects for HPV vaccines include pain at injection site,tiredness,muscle or joint pain,dizziness,fainting,nasal congestion,and gastrointestinal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I received one HPV vaccine dose over a year ago and no others.
Select...
I received one dose of the 9vHPV vaccine over a year ago and no other HPV vaccines since.
Select...
I am a woman aged 16-26, never had or only had normal Pap tests, and have had up to 4 sexual partners.
Select...
I am between 9 and 15 years old and have not had sex nor plan to during the vaccination period.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have received an HPV vaccine or participated in an HPV vaccine trial.
Select...
I have not received any blood products or immunoglobulin in the last 3 months.
Select...
I am pregnant or plan to donate eggs within the next 7 months.
Select...
I have a bleeding or clotting disorder.
Select...
I have had my spleen removed.
Select...
I have been on immunosuppressive therapy in the past year.
Select...
I have received at least 2 doses of the HPV vaccine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks post last vaccination (up to ~month 61)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks post last vaccination (up to ~month 61) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Geometric Mean Titers of Anti-Human Papilloma Virus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 as Measured by Competitive Luminex Immunoassay
Percentage of Participants With at Least 1 Serious Vaccine-Related Adverse Event
Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event
+1 more
Secondary study objectives
Geometric Mean Titers ( Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52 , and 58
Geometric Mean Titers ( Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Geometric Mean Titers (Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
+1 more

Side effects data

From 2019 Phase 3 trial • 201 Patients • NCT03546842
45%
Injection site pain
6%
Injection site swelling
1%
Subcutaneous abscess
100%
80%
60%
40%
20%
0%
Study treatment Arm
9vHPV Vaccine

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 4: 2 Doses of 9vHPV Vaccine Given 60 Months ApartExperimental Treatment1 Intervention
9 to 10 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 60.
Group II: Cohort 3: 2 Doses of 9vHPV Vaccine Given 36 Months ApartExperimental Treatment1 Intervention
9 to 12 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 36.
Group III: Cohort 2: 2 Doses of 9vHPV Vaccine Given 24 Months ApartExperimental Treatment1 Intervention
9 to 13 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Months 24.
Group IV: Cohort 1: 2 Doses of 9vHPV Vaccine Given 12 Months ApartExperimental Treatment1 Intervention
9 to 14 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 12.
Group V: Cohort 0: 1 Dose of 9vHPV Vaccine (previous 1-dose recipients)Experimental Treatment1 Intervention
10 to 15 year old girls and boys (who previously received 1 dose of 9vHPV vaccine) receive a second dose of 9vHPV vaccine at Day 1.
Group VI: Cohort 5: 3 Doses of 9vHPV Vaccine Given Over a 6-Month PeriodActive Control1 Intervention
16 to 26 year old young women receive 3 dose regimen of 9vHPV vaccine at Day 1, Month 2 and Month 6.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
9vHPV vaccine
2018
Completed Phase 3
~520

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,905 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,032 Previous Clinical Trials
5,189,100 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,905 Previous Clinical Trials
8,090,769 Total Patients Enrolled

Media Library

9vHPV vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04708041 — Phase 3
Human Papillomavirus Research Study Groups: Cohort 0: 1 Dose of 9vHPV Vaccine (previous 1-dose recipients), Cohort 1: 2 Doses of 9vHPV Vaccine Given 12 Months Apart, Cohort 2: 2 Doses of 9vHPV Vaccine Given 24 Months Apart, Cohort 3: 2 Doses of 9vHPV Vaccine Given 36 Months Apart, Cohort 4: 2 Doses of 9vHPV Vaccine Given 60 Months Apart, Cohort 5: 3 Doses of 9vHPV Vaccine Given Over a 6-Month Period
Human Papillomavirus Clinical Trial 2023: 9vHPV vaccine Highlights & Side Effects. Trial Name: NCT04708041 — Phase 3
9vHPV vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04708041 — Phase 3
~375 spots leftby Jun 2029
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top