← Back to Search

Cancer Vaccine

Gardasil9 Vaccine for Human Papillomavirus

Phase < 1
Recruiting
Led By Natalie Pierre-Joseph, MD
Research Sponsored by Boston Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children aged 4-8 years old
Naïve to HPV Vaccine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights

Study Summary

This trial will explore whether a two-dose regimen of the 9-valent HPV vaccine is effective in providing immunity against the virus. The trial will last for four years, with participants receiving the vaccine doses at months 0 and 12.

Who is the study for?
This trial is for children aged 4-8 who get care at Boston Medical Center or its community health centers and have never had an HPV vaccine. It's not for kids with blood clotting issues, severe allergies (especially to yeast), or weakened immune systems.Check my eligibility
What is being tested?
The study tests the effectiveness of a two-dose regimen of Gardasil9, an HPV vaccine, given over one year to prevent warts and human papillomavirus in young children.See study design
What are the potential side effects?
Gardasil9 may cause pain at the injection site, fever, headache, nausea, dizziness. Rarely it can trigger allergic reactions. Side effects are usually mild.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child is between 4 and 8 years old.
Select...
I have never received the HPV vaccine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
HPV11 antibodies at 13 months
HPV11 antibodies at 60 months
HPV16 antibodies at 13 months
+15 more
Secondary outcome measures
Injection site redness after first injection
Injection site redness after second injection
Injection site swelling after first injection
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
HPV 9-valent human papillomavirus vaccine (Gardasil 9) - 0.5mL intramuscular dose - 2 doses (Month 0, 12)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gardasil9
2019
Completed Phase 4
~420

Find a Location

Who is running the clinical trial?

Boston Medical CenterLead Sponsor
382 Previous Clinical Trials
869,309 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,868 Previous Clinical Trials
5,051,838 Total Patients Enrolled
Natalie Pierre-Joseph, MDPrincipal InvestigatorBoston Medical Center

Media Library

Gardasil9 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05329961 — Phase < 1
Human Papillomavirus Research Study Groups: Single Arm
Human Papillomavirus Clinical Trial 2023: Gardasil9 Highlights & Side Effects. Trial Name: NCT05329961 — Phase < 1
Gardasil9 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05329961 — Phase < 1

Frequently Asked Questions

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

Is there an open enrollment period for this experiment?

"Yes, there is evidence on clinicaltrials.gov that this medical research study, which was originally listed on September 26th 2022, is actively enrolling participants. 150 volunteers need to be procured from 1 participating institution."

Answered by AI

Does this clinical trial enroll adults above the age of 45?

"Participants must be between 4 and 8 years of age to meet the enrollment criterion. In addition, there are 19 trials for patients below majority and 54 studies involving individuals older than 65."

Answered by AI

What goal is this experiment attempting to reach?

"According to Merck Sharp & Dohme LLC, the main evaluation criterion of this trial will be HPV31 antibodies at 13 months. This metric will be monitored and assessed over a 60 month time period. Also, secondary outcomes such as injection site swelling severity and redness after both initial and second injections shall also be tracked on a scale from 0-4 (0 being no symptoms while 4 is severe)."

Answered by AI

What is the current enrollment count for this trial?

"Affirmatively, the information hosted on clinicaltrials.gov confirms that this medical study is actively enrolling patients; it was initially announced on September 26th 2022 and has been amended as recently as October 1st of the same year. The team needs to recruit 150 individuals from a single site."

Answered by AI

What criteria must potential participants meet to join this research initiative?

"This research project is accepting 150 young patients aged 4-8 years old, who have been diagnosed with human papillomavirus. For entry into this study, enrollees must also meet the criteria of having a medical record at Boston Medical Centre or one of its affiliated Community Health Centers and not previously receiving HPV Vaccination."

Answered by AI
~100 spots leftby Apr 2028