BridgeMD
Safety and Immunogenicity of Extended 2-dose Regimens of 9vHPV Vaccine
EU CTIS ID: 2022-500256-37-00
What this study is testing
1. In a population who are seronegative to the relevant HPV type at Day 1, to demonstrate that administration of a 2-dose regimen of 9vHPV vaccine in boys and girls 9 to 14 years of age induces noninferior cLIA GMTs of antibodies to each of the 9vHPV vaccine types compared with young women 16 to 26 years of age receiving a 3-dose regimen of the same vaccine at Day 1, Month 2, and Month 6. 2. In 10- to 15-year-old boys and girls who received a single dose of 9vHPV vaccine at least 1 year prior to enrollment, to characterize the immune response to a second dose of 9vHPV vaccine (as measured by cLIA GMTs of antibodies to each of the 9vHPV vaccine types) at 4 weeks post dose 2 taking into account the time interval between administration of doses 1 and 2 (Cohort 0). 3. To evaluate the safety of administering the 9vHPV vaccine based on the dosing regimens investigated in this study. Four 2-dose cohorts (Cohorts 1-4) are compared to the 3-dose cohort (Cohort 5) in this objective. Cohort 1: 9-14-year-olds receiving 2 doses 12 months apart; Cohort 2: 9-13-year-olds receiving 2 doses 24 months apart; Cohort 3: 9-12-year-olds receiving 2 doses 36 months apart; Cohort 4: 9-10-year-olds receiving 2 doses 60 months apart; and Cohort 5: 16-26-year-old women receiving 3 doses.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Boys and girls 9 to 15 years must not have had coitarche and do not plan on becoming sexually active during the vaccination period
- Women 16 to 26 years who have never had a Papanicolaou (Pap) test or only have had normal Pap test results
- Women 16 to 26 years with a lifetime history of 0 to 4 male and/or female sexual partners
- Cohort 0 participants 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
You likely can't join if
- Known allergy to any vaccine component
- Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial (Cohorts 1-5)
- History of severe allergic reaction that required medical intervention
- Thrombocytopenia or any coagulation disorder
- Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7
- Currently immunocompromised, or been diagnosed with immunodeficiency
See the full eligibility criteria
- Boys and girls 9 to 15 years must not have had coitarche and do not plan on becoming sexually active during the vaccination period
- Women 16 to 26 years who have never had a Papanicolaou (Pap) test or only have had normal Pap test results
- Women 16 to 26 years with a lifetime history of 0 to 4 male and/or female sexual partners
- Cohort 0 participants 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
- Known allergy to any vaccine component
- Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial (Cohorts 1-5)
- History of severe allergic reaction that required medical intervention
- Thrombocytopenia or any coagulation disorder
- Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7
- 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
- Has received more than 1 dose of an HPV vaccine (Cohort 0)
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- South Africa
- Taiwan
- United States
- Colombia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; South Africa; Taiwan; United States; Colombia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.