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Virus Vaccine

9vHPV + COVID-19 Vaccines for HPV and Coronavirus Prevention

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~month 9
Awards & highlights

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.

Who is the study for?
This trial is for boys and girls aged 9 to 11 who haven't started sexual activity and won't during the study. They must be able to use an electronic report card for vaccination feedback. It's not for those with a history of heart inflammation, recent COVID-19 or related syndromes, blood disorders, immunosuppression, prior HPV vaccination, severe allergies or missing spleen.Check my eligibility
What is being tested?
The study tests the safety and immune response when giving two vaccines together: the 9vHPV vaccine against human papillomavirus and mRNA-1273 vaccine against COVID-19. The goal is to see if getting both at once works as well as when they're given separately.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site (like pain or swelling), fever, fatigue, headache, muscle pain from either vaccine; plus rare risks like heart inflammation which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may 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 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 2022 Phase 3 trial • 614 Patients • NCT04313244
73%
Pain
44%
Myalgia
30%
Erythema
23%
Headache
21%
Swelling
20%
Malaise
19%
Asthenia
8%
COVID-19
3%
Fever
1%
Pyrexia
1%
Upper respiratory tract infection
1%
COVID-19 pneumonia
1%
Dermatitis contact
1%
Diarrhoea
1%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
9vHPV+TDV
9vHPV

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
9vHPV Vaccine
2022
Completed Phase 3
~3300
mRNA-1273 Vaccine
2022
Completed Phase 3
~170

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,657 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,381 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,315 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

Who else is applying?

What state do they live in?
South Carolina
Pennsylvania
Ohio
How old are they?
18 - 65
What site did they apply to?
Medical Center for Clinical Research ( Site 0051)
Dayton Clinical Research ( Site 0028)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Safety and Immunogenicity of 9-valent Human Papillomavirus (9vHPV) Vaccine Coadministered With Messenger Ribonucleic Acid (mRNA)-1273 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (COVID-19) Vaccine (V503-076)
2022. "Safety and Immunogenicity of 9-valent Human Papillomavirus (9vHPV) Vaccine Coadministered With Messenger Ribonucleic Acid (mRNA)-1273 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (COVID-19) Vaccine (V503-076)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05119855.
~55 spots leftby Apr 2025
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