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Study on the Safety and Immune Response of 9vHPV Vaccine in Preventing HPV in Boys and Girls Aged 9-14 Compared to Young Women Aged 16-26

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What is this study about?

This clinical trial is focused on studying the prevention of persistent anogenital infection and disease caused by the Human Papillomavirus (HPV). The study involves the use of a vaccine called Gardasil 9, which is designed to protect against nine types of HPV: types 6, 11, 16, 18, 31, 33, 45, 52, and 58. The vaccine is administered as a suspension for injection, which means it is given as a liquid shot into the muscle.

The purpose of the study is to evaluate the safety and immune response of different dosing schedules of the Gardasil 9 vaccine. The study compares a 2-dose regimen given to boys and girls aged 9 to 14 years with a standard 3-dose regimen given to young women aged 16 to 26 years. The study also looks at the immune response in boys and girls aged 10 to 15 years who have already received one dose of the vaccine at least a year before joining the study. Participants will receive the vaccine at different intervals, and their immune response will be measured to see how well the vaccine works over time.

Throughout the study, participants will be monitored for any side effects or adverse reactions to the vaccine. The study aims to ensure that the vaccine is safe and effective in preventing HPV-related diseases. Participants will receive the vaccine through an intramuscular injection, which means the shot is given directly into a muscle. The study will help determine the best dosing schedule for the Gardasil 9 vaccine to provide optimal protection against HPV.

1 initial vaccination

Upon joining the study, participants will receive the first dose of the Gardasil 9 vaccine. This vaccine is administered as an intramuscular injection, which means it is given as a shot into a muscle.

The vaccine is designed to help prevent infections caused by certain types of the human papillomavirus (HPV).

2 second vaccination

Participants aged 9 to 14 will receive a second dose of the Gardasil 9 vaccine after a specified interval, which varies depending on the cohort they are in. The intervals are 12, 24, 36, or 60 months after the first dose.

Participants aged 16 to 26 will receive their second dose 2 months after the first dose.

3 third vaccination (if applicable)

Only participants aged 16 to 26 will receive a third dose of the Gardasil 9 vaccine. This dose is administered 6 months after the first dose.

4 follow-up and monitoring

Participants will be monitored for any side effects or reactions to the vaccine. This includes checking for any injection-site reactions or other symptoms.

Regular follow-up visits will be scheduled to assess the immune response to the vaccine. Blood samples may be taken to measure the levels of antibodies against HPV.

5 final assessment

At the end of the study period, a final assessment will be conducted to evaluate the overall safety and effectiveness of the vaccine regimen.

Participants will be informed about the results of their participation and any relevant findings from the study.

Who Can Join the Study?

  • Boys and girls aged 9 to 15 years must not have started any sexual activity and do not plan on becoming sexually active during the vaccination period.
  • Women aged 16 to 26 years who have never had a Papanicolaou (Pap) test or only have had normal Pap test results. A Pap test is a procedure to test for cervical cancer in women.
  • Women aged 16 to 26 years with a lifetime history of 0 to 4 male and/or female sexual partners.
  • Participants in Cohort 0 must have received 1 dose of the 9-valent HPV (9vHPV) vaccine at least 1 year before joining the study and did not receive a second dose of any HPV vaccine. The 9vHPV vaccine is designed to protect against nine types of human papillomavirus (HPV).

Who Cannot Join the Study?

  • Participants who have a current or past infection with any of the HPV types included in the study. HPV stands for Human Papillomavirus, a virus that can cause certain diseases.
  • Participants who have received any HPV vaccine before, except for those specified in the study.
  • Participants with a known allergy to any component of the HPV vaccine.
  • Participants with a weakened immune system, which means their body has a reduced ability to fight infections and diseases.
  • Participants who are pregnant or planning to become pregnant during the study period.
  • Participants who have any medical condition that, in the opinion of the study doctor, might interfere with the study results or pose a risk to the participant.
  • Participants who are currently participating in another clinical trial or have participated in another trial within a certain time frame before this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland
Jerzy Tadeusz Brzostek Lekarz Debica Poland

Other Sites

Site Name City Country Status
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o. Tarnow Poland
Grlcgty Dvfcxpjxvyi I Lhhiglqr Nvohaqupotza Lodz Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not recruiting
15.07.2022

Trial locations

Investigated drugs:

9vHPV Vaccine is a vaccine designed to protect against nine types of human papillomavirus (HPV). HPV is a common virus that can lead to certain types of cancer and other diseases. The vaccine works by stimulating the body’s immune system to produce antibodies against these virus types, helping to prevent infection. In this clinical trial, the vaccine is being tested in different age groups and dosing schedules to evaluate its safety and how well it triggers an immune response. The study aims to find out if a two-dose schedule in younger participants is as effective as a three-dose schedule in older participants.

Human Papillomavirus Infection – Human Papillomavirus (HPV) infection is caused by a group of viruses that affect the skin and moist membranes lining the body, such as the cervix, anus, mouth, and throat. The virus is transmitted through direct skin-to-skin contact, often during sexual activity. HPV infection can lead to the development of warts in the anogenital region and other areas. Some types of HPV are associated with the development of certain cancers, such as cervical cancer. The infection often progresses without symptoms, making it difficult to detect without screening. Over time, persistent infection with high-risk HPV types can lead to cellular changes and the development of precancerous lesions.

Trial ID:
2022-500256-37-00
Protocol code:
V503-069
NCT ID:
NCT04708041
Trial Phase:
Therapeutic confirmatory (Phase III)

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