Comparing One or Two Doses of the Human Papillomavirus Vaccine for the Prevention of Human Papillomavirus Infection, ESCUDDO Study (ESCUDDO)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03180034 |
Recruitment Status :
Active, not recruiting
First Posted : June 8, 2017
Last Update Posted : April 25, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Human Papillomavirus Infection Human Papillomavirus-Related Cervical Carcinoma | Biological: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed Other: Questionnaire Administration Biological: Recombinant Human Papillomavirus Bivalent Vaccine Biological: Recombinant Human Papillomavirus Nonavalent Vaccine | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | A Scientific Evaluation of One or Two Doses of Vaccine Against Human Papillomavirus: the ESCUDDO Study ("Estudio de Comparacion de Una y Dos Dosis de Vacunas Contra el Virus de Papiloma Humano (VPH)") |
Actual Study Start Date : | November 29, 2017 |
Estimated Primary Completion Date : | August 1, 2024 |
Estimated Study Completion Date : | August 1, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm I (Gardasil, DTaP)
Participants receive Gardasil IM at month 0 and DTaP IM at month 6.
|
Biological: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed
Given IM
Other Names:
Other: Questionnaire Administration Ancillary studies Biological: Recombinant Human Papillomavirus Nonavalent Vaccine Given IM
Other Names:
|
Experimental: Arm II (Cervarix, DTaP)
Participants receive Cervarix IM at month 0 and DTaP IM at month 6.
|
Biological: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed
Given IM
Other Names:
Other: Questionnaire Administration Ancillary studies Biological: Recombinant Human Papillomavirus Bivalent Vaccine Given IM
Other Names:
|
Active Comparator: Arm III (Gardasil)
Participants receive Gardasil IM at month 0 and 6.
|
Other: Questionnaire Administration
Ancillary studies Biological: Recombinant Human Papillomavirus Nonavalent Vaccine Given IM
Other Names:
|
Active Comparator: Arm IV (Cervarix)
Participants receive Cervarix IM at month 0 and 6.
|
Other: Questionnaire Administration
Ancillary studies Biological: Recombinant Human Papillomavirus Bivalent Vaccine Given IM
Other Names:
|
No Intervention: Arm V (epidemiologic survey)
A concurrent epidemiologic survey for HPV status among unvaccinated women. Survey participants are followed for two study visits six months apart to determine their HPV DNA status, with no further follow-up. These women will be offered HPV vaccination (Cervarix) at the two study visits.
|
- Incidence of persistent human papillomavirus (HPV)-16 and/or HPV-18 cervical infections [ Time Frame: Months 42 and 48 ]To be considered incident and persistent, an HPV-16 and/or HPV-18 infection must fulfill the following criteria: Two same-type HPV positive (by polymerase chain reaction [PCR]) test results 3+ months apart at consecutive study visits reported after the 6-month visit (i.e. 12-month visit or later); type-specific HPV negative (by urine or, if available, PCR) test results from baseline and 6 month visits.
- Incidence of persistent HPV-16 and/or HPV-18 cervical infections [ Time Frame: Baseline, 6 months ]To be considered incident and persistent, an HPV-16 and/or HPV-18 infection must fulfill the following criteria: Two same-type HPV positive (by PCR) test results 3+ months apart at consecutive study visits reported after the 6-month visit (i.e. 12-month visit or later); type-specific HPV negative (by urine or, if available, PCR) test results from baseline and 6 month visits.
- Immunogenicity of one or two doses of Cervarix [ Time Frame: Up to 4 years ]Will be compared between girls who received one or two doses of recombinant human papillomavirus bivalent vaccine (Cervarix). Measured via measurement of serum antibodies.
- Immunogenicity of one or two doses of Gardasil 9 [ Time Frame: Up to 4 years ]Will be compared between girls who received one or two doses of recombinant human papillomavirus nonavalent vaccine (Gardasil 9). Measured via measurement of serum antibodies.
- Incidence of any new HPV infection (after Gardasil 9) [ Time Frame: Up to 4 years ]Demonstrate non-inferiority of one versus two doses of Gardasil 9 in the prevention of any new vaccine type HPV infection.
- Incidence of any new carcinogenic HPV cervical infection (after Cervarix) [ Time Frame: Up to 4 years ]Demonstrate non-inferiority of one versus two doses of Cervarix in the prevention of any new carcinogenic HPV cervical infection.
- Cost and cost-effectiveness evaluation of HPV vaccination in Costa Rica [ Time Frame: Up to 4 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years to 20 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Living in the study area without plans to move outside the country in the next six months
- Able to communicate with study personnel
- Willing to participate in the study and sign the informed assent
- Supported in study participation by at least one of their parents (or guardians), who is willing to sign the informed consent document
- In good health as determined by a medical history (physical exam will be conducted if necessary per the doctor's criterion)
Exclusion Criteria:
- 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, yeast, or latex
- The clinician determining the eligibility in agreement with principal investigator considers that there is a reason that precludes participation
- They have been vaccinated against HPV
- The girl or her parent/legal guardian does not have an identification document

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180034
Costa Rica | |
Agencia Costarricense de Investigaciones Biomédicas (ACIB) | |
Liberia, Guanacaste, Costa Rica, 50101 |
Principal Investigator: | Aimee R Kreimer | National Cancer Institute (NCI) |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT03180034 |
Other Study ID Numbers: |
NCI-2020-08550 NCI-2020-08550 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 999917108 17-C-N108 ( Other Identifier: National Cancer Institute ) |
First Posted: | June 8, 2017 Key Record Dates |
Last Update Posted: | April 25, 2022 |
Last Verified: | December 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Infections Papillomavirus Infections DNA Virus Infections Virus Diseases |
Tumor Virus Infections Vaccines Immunologic Factors Physiological Effects of Drugs |