A Phase 3, Multicenter, Open-Label Study to Evaluate the Safety and Immunogenicity of 2-dose Regimens of 9vHPV and mRNA-1273 SARS-CoV-2 Vaccines Where the First Dose of Each Vaccine Are Given Concomitantly in Boys and Girls 9 to 11 Years of Age

  • STATUS
    Recruiting
  • End date
    Nov 9, 2023
  • participants needed
    400
  • sponsor
    Merck Sharp & Dohme LLC
Updated on 14 September 2022
Accepts healthy volunteers

Summary

The primary hypothesis is that concomitant administration of the first doses of a 2-dose regimen of 9vHPV vaccine and 2-dose regimen of mRNA-1273 vaccine induces noninferior geometric mean titers (GMTs) of antibodies to each of the 9vHPV vaccine types at 4 weeks postdose 2 of 9vHPV vaccine AND noninferior geometric mean concentrations (GMCs) of SARS-CoV-2 spike protein-specific binding antibody at 4 weeks Postdose 2 of mRNA-1273 vaccine, compared with the corresponding postdose 2 GMTs/GMCs induced by a 2-dose regimen of 9vHPV vaccine and mRNA-1273 vaccine, where the first doses of each are administered nonconcomitantly.

Details
Condition Papillomavirus Infections, Coronavirus Disease (COVID-19)
Treatment 9vHPV Vaccine, mRNA-1273 vaccine
Clinical Study IdentifierNCT05119855
SponsorMerck Sharp & Dohme LLC
Last Modified on14 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Has not yet had coitarche and does not plan on becoming sexually active during the vaccination period
Participant or participant's legally acceptable representative can read, understand, and complete the electronic vaccination report card (eVRC)

Exclusion Criteria

Known allergy to any vaccine component
History of severe allergic reaction that required medical intervention
Thrombocytopenia or any coagulation disorder
Has a history of myocarditis or pericarditis
Has a history of a clinical or microbiological diagnosis of COVID-19 ≤90 days prior to Day 1 visit or history of multisystem inflammatory syndrome in children (MIS-C) at any time prior to Day 1 visit
Females only: participant is pregnant
Currently immunocompromised, or been diagnosed with immunodeficiency
Had a splenectomy
Receiving or has received immunosuppressive therapies within the last year
Received any immunoglobulin product or blood-derived product within 3 months
Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note