NCT03728881Befejeződött3. fázis
Single Dose of Cervarix Vaccine in Girls or Three Doses of Gardasil Vaccine in Women for the Prevention of Human Papillomavirus Infection, the PRIMAVERA-ESCUDDO Trial
Non-Inferiority Trial Comparing Immunogenicity From 1-Dose of Bivalent HPV Vaccine in Girls to 3-Doses of Quadrivalent Vaccine in Women: The PRIMAVERA-ESCUDDO Trial ("Puente de Respuesta Inmunológica Para Mejorar el Acceso a Vacunas y Erradicar el Cancer")
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. aug. 3.
Rövid összefoglaló (regiszter, angolul)
This phase IIIb trial compares a single dose of the Cervarix vaccine in girls to 3 doses of the Gardasil vaccine in young women for the prevention of human papillomavirus (HPV) infection. Cervarix is a vaccine used to prevent cervical cancer caused by HPV types 16 and 18. Gardasil is vaccine used to prevent cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18 and genital warts caused by HPV types 6 and 11. Giving only one dose of the Cervarix vaccine in girls may work the same as 3 doses of the Gardasil vaccine in young women in preventing HPV infection and ultimately, cervical and other HPV-related cancers. Currently, many women around the world cannot get HPV vaccines because they are too expensive. If this trial can show one dose given to young girls is enough to prevent cancer, more girls might be able to get the vaccine.
- Állapot (regiszter)
- Befejeződött
- Fázis (regiszter)
- 3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 1240 (tényleges)
- Első benyújtás
- 2018. nov. 1.
- Kezdés
- 2019. ápr. 1.
- Elsődleges befejezés
- 2022. szept. 30.
- Fő szponzor
- National Cancer Institute (NCI)
- Betegségek
- Méhnyakrák, Gyermekkori daganatok
- NCT-szám
- NCT03728881
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 3. fázis
- Bevont résztvevők: 1240
- 2019. ápr. 1. és az elsődleges befejezés (2022. szept. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- They have received immunoglobulins within 90 days preceding enrollment/vaccination visit
Más betegség
- They have a diagnosis of an autoimmune, degenerative, or neurological disease without treatment or adequate control; a progressive or severe neurological disease; a genetic immunodeficiency; or any other serious chronic disease without treatment and / or adequate control that, according to the principal investigator or designee, for which vaccination is contraindicated (NOTE: Potential participants with these conditions can be included after consultation with the external medical advisor of the study or with an appropriate specialist)
- They are allergic to one of the vaccine components, including yeast (if Gardasil group)
Egyéb
- They are unwilling to provide a blood sample
- Unwilling to permit export of blood samples to the United States
- They have a positive urine pregnancy test result
- They are pregnant
- They are planning to become pregnant
- The clinician determining eligibility in agreement with the principal investigator considers that there is a reason that precludes participation
- They have been vaccinated against HPV
- The participant or her parent/legal guardian, as applicable, does not have an identification document
Kiket keres a vizsgálat
- Aged between:
- 9 and 14 years inclusive for Cervarix group
- 18 and 25 years inclusive for Gardasil group
- Living in the study area without plans to move outside the country in the next six months
- Able to communicate with study personnel
- Able and willing to provide a blood sample
- Willing to permit export of blood samples to the United States
- Willing to participate in the study and:
- If Cervarix group and less than 12 years old, receive study information and be supported in study participation by at least one of parent (or guardian), who is willing to sign the informed consent document
- If Cervarix group and 12 years old or older, sign the informed assent and be supported in study participation by at least one parent (or guardian), who is willing to sign the informed consent document
- If Gardasil group, sign the informed consent
- In good health as determined by a medical history (physical exam will be conducted if necessary per the doctor's criterion)
Életkor a regiszterben: 9 év – 25 év · Nem: csak nők · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Agencia Costarricense de Investigaciones Biomédicas (ACIB) | Liberia | Costa Rica | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.