Virus Vaccine

9vHPV Vaccine for Human Papillomavirus

Q: How many slots are open for patients in this experiment?

<p>The sponsor, Merck Sharp &#x26; Dohme Corp., needs to enroll 400 eligible patients from different clinical trial sites in order to begin the study. These sites are located in Washington, D.C. and Little Rock, Arkansas.</p>

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

You / your child is between 9 and 11 years old?

Be younger than 18 years old

Must not have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to ~month 9

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Study Summary

This trial is testing whether it is non-inferior to give two doses of the 9vHPV vaccine and two doses of the mRNA-1273 vaccine at the same time or if it is better to spread them out.

Eligible Conditions

Human Papillomavirus
COVID-19

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You or your child must be between 9 and 11 years of age.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~month 9

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~month 9

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~month 9 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Geometric Mean Concentrations of SARS-CoV-2 Spike Protein-Specific Binding Antibodies

Geometric Mean Titers of Anti-Human Papillomavirus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

Percentage of Participants with at Least 1 Serious Adverse Event

+3 more

Secondary outcome measures

Percentage of Participants Who Experience Seroresponse Following Administration of a 2-Dose Regimen of mRNA-1273 Vaccine

Percentage of Participants Who Seroconvert to Each of the 9vHPV Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 Following Administration of a 2-Dose Regimen of 9vHPV Vaccine

Side effects data

From 2014 Phase 3 trial • 2520 Patients • NCT01651949

64%

Injection site pain

21%

Injection site erythema

20%

Injection site swelling

14%

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Heterosexual and MSM Males

Females

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

2Treatment groups

Experimental Treatment

Group I: Non-concomitant GroupExperimental Treatment2 Interventions

Participants will receive the first and second doses of mRNA-1273 vaccine on Day 1 and at Month 1, respectively; participants will then receive the first and second doses of 9vHPV vaccine at Months 2 and 8, respectively.

Group II: Concomitant GroupExperimental Treatment2 Interventions

Participants will receive the first dose of 9vHPV vaccine and first dose of mRNA-1273 vaccine on Day 1; participants will then receive the second dose of mRNA-1273 vaccine at Month 1 and the second dose of 9vHPV vaccine at Month 6.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Human papillomavirus type 11 L1 capsid protein antigen

FDA approved

0 / 1Eligibility criteria met

Find a site

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,577,926 Total Patients Enrolled

Merck Sharp & Dohme LLCLead Sponsor

3,793 Previous Clinical Trials

5,001,796 Total Patients Enrolled

Medical DirectorStudy Director

Merck Sharp & Dohme LLC

2,710 Previous Clinical Trials

7,992,284 Total Patients Enrolled

Media Library

9vHPV Vaccine (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05119855 — Phase 3

Human Papillomavirus Research Study Groups: Non-concomitant Group, Concomitant Group

Human Papillomavirus Clinical Trial 2023: 9vHPV Vaccine Highlights & Side Effects. Trial Name: NCT05119855 — Phase 3

9vHPV Vaccine (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05119855 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there specific requirements for volunteers in this research project?

"Eligible participants for this study must be between 9-11 years old and have a papillomavirus infection. Up to 400 individuals can take part in the clinical trial."

Answered by AI

Has this medical experiment been conducted before?

"As of now, there are 70 active studies regarding the 9vHPV Vaccine in 295 cities across 46 countries. The very first clinical trial was sponsored by Merck Sharp & Dohme Corp. and took place in 2002. 12167 people participated in the Phase 3 drug approval process. In the 18 years since 2002, 128 trials have completed."

Answered by AI

Is there room for new patients in this trial?

"Yes, this is an active recruitment. The clinical trial was posted on 3/28/2022 and was most recently edited on 10/28/2022. They are looking for 400 patients at 31 locations."

Answered by AI

Is this the first time the 9vHPV Vaccine has been used in a clinical setting?

"Currently, there are 70 different 9vHPV Vaccine clinical trials underway with 29 of them in Phase 3. Most of these studies are happening in Miami, Florida, however, there are 878 total locations running trials for 9vHPV Vaccine."

Answered by AI

How many slots are open for patients in this experiment?

"The sponsor, Merck Sharp & Dohme Corp., needs to enroll 400 eligible patients from different clinical trial sites in order to begin the study. These sites are located in Washington, D.C. and Little Rock, Arkansas."

Answered by AI

Will this trial be accepting participants who are under the age of 40?

"According to the inclusion criteria, only patients aged 9 to 11 are eligible for this particular clinical trial. Out of the total 3077 clinical trials, 197 are for patients under 18 and 1080 are for patients over 65."

Answered by AI

Can you tell me how many different research facilities are participating in this project?

"This trial has 31 recruiting sites, some of which are the Emerson Clinical Research Institute (Site 0021) in Washington, Preferred Research Partners Inc. (Site 0092) in Little Rock, and Cognitive Clinical Trials, LLC (Site 0054) in Phoenix."

Answered by AI

Are there any risks associated with receiving the 9vHPV Vaccine?

"The 9vHPV Vaccine received a safety score of 3. This is due to the fact that it is a Phase 3 trial, indicating that there is both data supporting its efficacy and multiple rounds of data affirming its safety."

Answered by AI