NCT03728881CompletedPhase 3
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")
Source: ClinicalTrials.gov · Last updated 3 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1240 (actual)
- First submitted
- 1 Nov 2018
- Start date
- 1 Apr 2019
- Primary completion date
- 30 Sept 2022
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Cervical cancer, Childhood cancers
- NCT number
- NCT03728881
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 1240
- From 1 Apr 2019 to the primary completion date, 30 Sept 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- They have received immunoglobulins within 90 days preceding enrollment/vaccination visit
Other illness
- 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)
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 9 years to 25 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Agencia Costarricense de Investigaciones Biomédicas (ACIB) Coordinator of this site? Confirm its status | Liberia | Costa Rica | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.