HealthyPhase 4NCT01717118
Evaluation of Immunogenicity Levels in Women With HPV Vaccine in Mexico
A Phase 4 study testing Bivalent Vaccines and Tetravalent Vaccine in people with Healthy, run by Instituto Nacional de Salud Publica, Mexico at 1 site in Mexico.
Trial summary
In September 2009 the National Vaccination Council approved the policy for anti-HPV vaccination in 9-year-old girls with an extended scheme of 0, 6, and 60 months, under the following justification: Antibody induction due to the vaccine is greater than that produced by natural exposure to the virus Immune response in… Read more about this study
- Who is it for?
- Ages 9 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Bivalent Vaccines and Tetravalent Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2009to Aug 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- • Women 18 to 24 years of age who agree to participate by signing an informed consent form prior to recruitment.
- Girls 9 and 10 years of age whose father/mother/guardian signs the informed consent form to participate in the study.
Who cannot join
- • Prior administration of an anti-HPV vaccine
- Pregnant women or women planning to get pregnant in the next 8 months.
- Auto-immune diseases
- Women with a history of Guillain Barré syndrome.
- Prior administration of immunoglobulins and/or any blood product in the past 6 months before the study's first vaccine dose.
Trial locations and contacts
1 site in 1 country.
About this study
In September 2009 the National Vaccination Council approved the policy for anti-HPV vaccination in 9-year-old girls with an extended scheme of 0, 6, and 60 months, under the following justification:
- Antibody induction due to the vaccine is greater than that produced by natural exposure to the virus
- Immune response in girls 9 to 11 years of age is similar to the response obtained after three doses in women 16 to 26 years of age
- The third dose will be administered at the time when maximum protection is required, near the onset of sexual activity Thus the National Institute of Public Health was commissioned to monitor anti-HPV antibody levels in women who received the anti-HPV vaccine to determine non-inferiority of the extended scheme in 9-year-old girls compared with the traditional scheme of 3 doses in women 18 to 24 years of age. To this end, a sentinel cohort will be formed to evaluate immunogenicity levels in 3 age groups, and stratified by vaccine type. The hypothesis is that in 9-year-old girls who are administered the amplified HPV vaccination scheme (0-6-60) show immunogenicity levels that are not lower than those of adult women who have been administered the traditional scheme (0-1/2-6).
Read more
The main objectives are to monitor the levels of immunity induced by vaccination against HPV with two vaccination schemes with the quadrivalent vaccine: Traditional Extended (0-6-60 months) and traditional (0-2-6); Monitoring levels of immunity induced by vaccination against HPV with three vaccine schemes with bivalent vaccine: Extended (0-6-60 months), traditional (0-1-6) and two doses (0- 6); as well as evaluating the interchangeability of the bivalent and quadrivalent vaccines in the third dose of extended scheme. The study design is to create a sentinel cohort of women vaccinated against HPV in the following comparison groups:
- Women of nine years with extended vaccination scheme with three doses of quadrivalent vaccine (0-6-60)
- Women of nine years with extended vaccination scheme with two doses of the quadrivalent vaccine and the third dose with bivalent (0-6-60)
- Women of nine years with traditional vaccination scheme with the quadrivalent HPV vaccine (0-2-6)
- Women between 18 and 24 years with traditional vaccination scheme with the quadrivalent HPV vaccine (0-2-6)
- Women of nine years with extended vaccination scheme with three doses of bivalent vaccine (0-6-60)
- Women of nine years with extended vaccination scheme with two doses of bivalent vaccine and the third tetravalent dose
- Women of nine years with two vaccine doses scheme with the bivalent HPV vaccine (0-6)
- Women of nine years with traditional vaccination scheme with bivalent HPV vaccine (0-1-6)
- Women between 18 and 24 years with traditional vaccination scheme with bivalent HPV vaccine (0-1-6)
- To monitoring HPV infections, at month 61 of follow-up, a group of 400 women aged 14-15 years, who have not been vaccinated against HPV, will be invited , in order to make the monitoring of occurrence of HPV infections in urine per month 61, 72, 96 and 120 post dose 0 in vaccinated groups
Read the detailed description
Hypothesis Girls 9 and 10 years of age who are administered the amplified anti/HPV vaccination scheme (0-6-60), show immunogenicity levels against HPV antibodies that are not lower than those of 9-year-old girls and adult women who have been administered the traditional scheme (0-1/2-6).
The vaccination schemes for HPV traditional (0-1 / 2-6) and extended (0-6-60), are equivalent from the immunologically perspective and therefore the number of memory B and T lymphocytes as well as the structure of repertoire will be not different between schemes.
Objectives The main objectives are to monitor the levels of immunity induced by vaccination against HPV with two vaccination schemes with the quadrivalent vaccine: Traditional Extended (0-6-60 months) and traditional (0-2-6); Monitoring levels of immunity induced by vaccination against HPV with three vaccine schemes with bivalent vaccine: Extended (0-6-60 months), traditional (0-1-6) and two doses (0- 6); as well as evaluating the interchangeability of the bivalent and quadrivalent vaccines in the third dose of extended scheme. The study design is to create a sentinel cohort of women vaccinated against HPV in the following comparison groups:
- Women of nine years with extended vaccination scheme with three doses of quadrivalent vaccine (0-6-60)
- Women of nine years with extended vaccination scheme with two doses of the quadrivalent vaccine and the third dose with bivalent (0-6-60)
- Women of nine years with traditional vaccination scheme with the quadrivalent HPV vaccine (0-2-6)
- Women between 18 and 24 years with traditional vaccination scheme with the quadrivalent HPV vaccine (0-2-6)
- Women of nine years with extended vaccination scheme with three doses of bivalent vaccine (0-6-60)
- Women of nine years with extended vaccination scheme with two doses of bivalent vaccine and the third tetravalent dose
- Women of nine years with two vaccine doses scheme with the bivalent HPV vaccine (0-6)
- Women of nine years with traditional vaccination scheme with bivalent HPV vaccine (0-1-6)
- Women between 18 and 24 years with traditional vaccination scheme with bivalent HPV vaccine (0-1-6)
- To monitoring HPV infections, at month 61 of follow-up, a group of 400 women aged 14-15 years, who have not been vaccinated against HPV, will be invited , in order to make the monitoring of occurrence of HPV infections in urine per month 61, 72, 96 and 120 post dose 0 in vaccinated groups
Methodology
Study design:
Creating a sentinel cohort of women vaccinated against HPV in three comparison groups:
- Women of nine years with extended vaccination scheme with three doses of quadrivalent vaccine (0-6-60)
- Women of nine years with extended vaccination scheme with two doses of the quadrivalent vaccine and the third dose with bivalent (0-6-60)
- Women of nine years with traditional vaccination scheme with the quadrivalent HPV vaccine (0-2-6)
- Women between 18 and 24 years with traditional vaccination scheme with the quadrivalent HPV vaccine (0-2-6)
- Women of nine years with extended vaccination scheme with three doses of bivalent vaccine (0-6-60)
- Women of nine years with extended vaccination scheme with two doses of bivalent vaccine and the third tetravalent dose
- Women of nine years with two vaccine doses scheme with the bivalent HPV vaccine (0-6)
- Women of nine years with traditional vaccination scheme with bivalent HPV vaccine (0-1-6)
- Women between 18 and 24 years with traditional vaccination scheme with bivalent HPV vaccine (0-1-6) Selecting the study population.
A fraction of the population of females will be invited to participate in the study proportionately, combining strategies in schools and the community.
A total of 2450 women will be recruited. For the study purposes, they will be classified by vaccine type administered, (tetravalent and bivalent), as well as by age group and vaccination scheme.
Forming groups for evaluation.
Two groups of participants will be formed. Participants will be classified by vaccine type received:
- Bivalent Vaccine. This group will consist of a total of 2000 women. Two thirds of them will be 9 to 10 years of age, and 500 will be 18 to 24 years of age. In the first age group, 1000 of them will be administered the vaccine in the amplified scheme of 0, 6, 60 months. Five hundred females from this age group will be administered the vaccine according to the traditional scheme of 0, 1, 6 months. All females from the 18 to 24 age group will be administered the traditional scheme of 0, 1, 6 months.
- Tetravalent Vaccine:
A total of 450 females will participate. The 9 to 10 year age group will include 300 women, and the 18 to 24 year age group will include 150 females.
The vaccination scheme will be conformed as follows: In the group of 9- to 10-year-olds, 150 of them will be administered the vaccine in the amplified scheme of 0, 6, 60 months, and the remaining 150 will receive the vaccine under the traditional scheme of 0, 2, 6 months. The group of 18- to 24-year-old women will be conducted under the traditional scheme of 0, 2 and 6 months.
The vaccination scheme will be assigned according to number in the record and/or geographical location.
For quantification of immunological memory of B and T lymphocytes and characterizing lymphocytes B repertoire in women vaccinated against HPV, 60 participants for group, recruited for medical evaluation at month 60.
To evaluate the interchangeability of quadrivalent and bivalent vaccines a randomization will be performed in the group of girls aged 14-15 years who have been assigned at the beginning of the project with extended vaccination scheme (0-6-60) with the bivalent vaccine, so that one third of this group will receive the bivalent vaccine, another third will receive the quadrivalent vaccine and the remaining third will no longer receive additional doses.
- Conditions
- Healthy
- Being tested
- Bivalent Vaccines, Tetravalent Vaccine
- Keywords
- Evaluation, Immunogenicity, Levels, Women, HPV, Vaccine, Mexico
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bivalent VaccinesBiological
Also called CERVARIX
Tetravalent VaccineBiological
Also called Gardasil
| Study group | Role | What they receive |
|---|---|---|
| Tetravalent Vaccine | Active comparator | * Month 2 visit: May be scheduled on the appropriate month +/- 3 weeks.
* Month 6, 21, 60 and 61 visit (vaccination scheme 0, 2, 6): May be programmed on the appropriate month +/- 4 weeks.
* Month 7 and 61 visit (vaccination scheme 0, 6, 60): The time interval between the month 6/60 visit and the month 7/61 visit must be at least 3 weeks and maximum 7 weeks from the previous vaccination Receives: Biological: Tetravalent Vaccine |
| Bivalent Vaccine | Active comparator | * Month 1 visit: May be scheduled 21 to 62 days after the Day 0 visit.
* Month 6 visit: May be scheduled 161 to 216 days after the Day 0 visit.
* Month 6 visit: The time interval between the month 6 visit and the month 7 visit must be at least 3 weeks and maximum 7 weeks from the previous vaccination.
* Month 21, 60 and 61 visit (vaccination scheme 0, 1, 6): May be scheduled on the appropriate month +/- 4 weeks.
* Month 61 (vaccination scheme 0, 6, 60) The time interval between the month 60 visit and the month 61 visit must be at least 3 weeks and maximum 7 weeks from the previous vaccination Receives: Biological: Bivalent Vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
To monitor immunogenicity levels induced by anti/HPV vaccine in traditional squeme
Bivalent Vaccine: Five hundred females from this age group will be administered the vaccine according to the traditional scheme of 0, 1, 6 months. All females from the 18 to 24 age group will be administered the traditional scheme of 0, 1, 6 months.
Tetravalent Vaccine:
150 will receive the vaccine under the traditional scheme of 0, 2, 6 months. The group of 18- to 24-year-old women will be conducted under the traditional scheme of 0, 2 and 6 months.
Measured: 6 months
Secondary outcomes (1)
To monitor immunogenicity levels induced by anti/HPV vaccine in extended squeme
BIVALENT VACCINE: This group will consist of a total of 2000 women. Two thirds of them will be 9 to 10 years of age, and 500 will be 18 to 24 years of age. In the first age group, 1000 of them will be administered the vaccine in the amplified scheme of 0, 6, 60 months.
TETRAVALENT VACCINE: the group of 9- to 10-year-olds, 150 of them will be administered the vaccine in the amplified scheme of 0, 6, 60 months
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startNov 2009
- Primary completionFeb 2015
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Salud Publica, Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Secretaria de Salud, Mexico
- Responsible party
- Principal investigator, Eduardo Cesar Lazcano Ponce, Instituto Nacional de Salud Publica, Mexico
- Investigators
- Eduardo C Lazcano, Phd, MD, Principal investigator, National Institute of Public Health MexicoAurelio Cruz, Valdez, Study director, National Institute of Public Health MexicoJanet L. Pacheco, Study chair, National Institute of public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717118
- Sponsor's protocol ID
- 883
- Status last verified
- Aug 2018
- First submitted
- 26 Oct 2012
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
PubMed 41276263Lazcano-Ponce E, Torres-Ibarra L, Cruz-Valdez A, Salmeron J, Barrientos-Gutierrez T, Prado-Galbarro J, Stanley M, Munoz N, Herrero R, Hernandez-Avila M. Persistence of Immunity When Using Different Human Papillomavirus Vaccination Schedules and Booster-Dose Effects 5 Years After Primary Vaccination. J Infect Dis. 2019 Jan 1;219(1):41-49. doi: 10.1093/infdis/jiy465.
PubMed 30085139Lazcano-Ponce E, Stanley M, Munoz N, Torres L, Cruz-Valdez A, Salmeron J, Rojas R, Herrero R, Hernandez-Avila M. Overcoming barriers to HPV vaccination: non-inferiority of antibody response to human papillomavirus 16/18 vaccine in adolescents vaccinated with a two-dose vs. a three-dose schedule at 21 months. Vaccine. 2014 Feb 3;32(6):725-32. doi: 10.1016/j.vaccine.2013.11.059. Epub 2013 Dec 16.
PubMed 24355090
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunogenicity Levels in Women With HPV Vaccine in Mexico
- ClinicalTrials.gov ID
- NCT01717118
- Acronym / sponsor ID
- 883
- Conditions
- Healthy
- Keywords
- Evaluation, Immunogenicity, Levels, Women, HPV, Vaccine, Mexico
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Instituto Nacional de Salud Publica, MexicoUniversity, hospital or other
- Collaborators
- Secretaria de Salud, Mexico
- Study start
- Nov 2009
- Primary completion
- Feb 2015 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In September 2009 the National Vaccination Council approved the policy for anti-HPV vaccination in 9-year-old girls with an extended scheme of 0, 6, and 60 months, under the following justification:
- Antibody induction due to the vaccine is greater than that produced by natural exposure to the virus
- Immune response in girls 9 to 11 years of age is similar to the response obtained after three doses in women 16 to 26 years of age
- The third dose will be administered at the time when maximum protection is required, near the onset of sexual activity Thus the National Institute of Public Health was commissioned to monitor anti-HPV antibody levels in women who received the anti-HPV vaccine to determine non-inferiority of the extended scheme in 9-year-old girls compared with the traditional scheme of 3 doses in women 18 to 24 years of age. To this end, a sentinel cohort will be formed to evaluate immunogenicity levels in 3 age groups, and stratified by vaccine type. The hypothesis is that in 9-year-old girls who are administered the amplified HPV vaccination scheme (0-6-60) show immunogenicity levels that are not lower than those of adult women who have been administered the traditional scheme (0-1/2-6).
The main objectives are to monitor the levels of immunity induced by vaccination against HPV with two vaccination schemes with the quadrivalent vaccine: Traditional Extended (0-6-60 months) and traditional (0-2-6); Monitoring levels of immunity induced by vaccination against HPV with three vaccine schemes with bivalent vaccine: Extended (0-6-60 months), traditional (0-1-6) and two doses (0- 6); as well as evaluating the interchangeability of the bivalent and quadrivalent vaccines in the third dose of extended scheme. The study design is to create a sentinel cohort of women vaccinated against HPV in the following comparison groups:
- Women of nine years with extended vaccination scheme with three doses of quadrivalent vaccine (0-6-60)
- Women of nine years with extended vaccination scheme with two doses of the quadrivalent vaccine and the third dose with bivalent (0-6-60)
- Women of nine years with traditional vaccination scheme with the quadrivalent HPV vaccine (0-2-6)
- Women between 18 and 24 years with traditional vaccination scheme with the quadrivalent HPV vaccine (0-2-6)
- Women of nine years with extended vaccination scheme with three doses of bivalent vaccine (0-6-60)
- Women of nine years with extended vaccination scheme with two doses of bivalent vaccine and the third tetravalent dose
- Women of nine years with two vaccine doses scheme with the bivalent HPV vaccine (0-6)
- Women of nine years with traditional vaccination scheme with bivalent HPV vaccine (0-1-6)
- Women between 18 and 24 years with traditional vaccination scheme with bivalent HPV vaccine (0-1-6)
- To monitoring HPV infections, at month 61 of follow-up, a group of 400 women aged 14-15 years, who have not been vaccinated against HPV, will be invited , in order to make the monitoring of occurrence of HPV infections in urine per month 61, 72, 96 and 120 post dose 0 in vaccinated groups
Detailed description
Hypothesis Girls 9 and 10 years of age who are administered the amplified anti/HPV vaccination scheme (0-6-60), show immunogenicity levels against HPV antibodies that are not lower than those of 9-year-old girls and adult women who have been administered the traditional scheme (0-1/2-6).
The vaccination schemes for HPV traditional (0-1 / 2-6) and extended (0-6-60), are equivalent from the immunologically perspective and therefore the number of memory B and T lymphocytes as well as the structure of repertoire will be not different between schemes.
Objectives The main objectives are to monitor the levels of immunity induced by vaccination against HPV with two vaccination schemes with the quadrivalent vaccine: Traditional Extended (0-6-60 months) and traditional (0-2-6); Monitoring levels of immunity induced by vaccination against HPV with three vaccine schemes with bivalent vaccine: Extended (0-6-60 months), traditional (0-1-6) and two doses (0- 6); as well as evaluating the interchangeability of the bivalent and quadrivalent vaccines in the third dose of extended scheme. The study design is to create a sentinel cohort of women vaccinated against HPV in the following comparison groups:
- Women of nine years with extended vaccination scheme with three doses of quadrivalent vaccine (0-6-60)
- Women of nine years with extended vaccination scheme with two doses of the quadrivalent vaccine and the third dose with bivalent (0-6-60)
- Women of nine years with traditional vaccination scheme with the quadrivalent HPV vaccine (0-2-6)
- Women between 18 and 24 years with traditional vaccination scheme with the quadrivalent HPV vaccine (0-2-6)
- Women of nine years with extended vaccination scheme with three doses of bivalent vaccine (0-6-60)
- Women of nine years with extended vaccination scheme with two doses of bivalent vaccine and the third tetravalent dose
- Women of nine years with two vaccine doses scheme with the bivalent HPV vaccine (0-6)
- Women of nine years with traditional vaccination scheme with bivalent HPV vaccine (0-1-6)
- Women between 18 and 24 years with traditional vaccination scheme with bivalent HPV vaccine (0-1-6)
- To monitoring HPV infections, at month 61 of follow-up, a group of 400 women aged 14-15 years, who have not been vaccinated against HPV, will be invited , in order to make the monitoring of occurrence of HPV infections in urine per month 61, 72, 96 and 120 post dose 0 in vaccinated groups
Methodology
Study design:
Creating a sentinel cohort of women vaccinated against HPV in three comparison groups:
- Women of nine years with extended vaccination scheme with three doses of quadrivalent vaccine (0-6-60)
- Women of nine years with extended vaccination scheme with two doses of the quadrivalent vaccine and the third dose with bivalent (0-6-60)
- Women of nine years with traditional vaccination scheme with the quadrivalent HPV vaccine (0-2-6)
- Women between 18 and 24 years with traditional vaccination scheme with the quadrivalent HPV vaccine (0-2-6)
- Women of nine years with extended vaccination scheme with three doses of bivalent vaccine (0-6-60)
- Women of nine years with extended vaccination scheme with two doses of bivalent vaccine and the third tetravalent dose
- Women of nine years with two vaccine doses scheme with the bivalent HPV vaccine (0-6)
- Women of nine years with traditional vaccination scheme with bivalent HPV vaccine (0-1-6)
- Women between 18 and 24 years with traditional vaccination scheme with bivalent HPV vaccine (0-1-6) Selecting the study population.
A fraction of the population of females will be invited to participate in the study proportionately, combining strategies in schools and the community.
A total of 2450 women will be recruited. For the study purposes, they will be classified by vaccine type administered, (tetravalent and bivalent), as well as by age group and vaccination scheme.
Forming groups for evaluation.
Two groups of participants will be formed. Participants will be classified by vaccine type received:
- Bivalent Vaccine. This group will consist of a total of 2000 women. Two thirds of them will be 9 to 10 years of age, and 500 will be 18 to 24 years of age. In the first age group, 1000 of them will be administered the vaccine in the amplified scheme of 0, 6, 60 months. Five hundred females from this age group will be administered the vaccine according to the traditional scheme of 0, 1, 6 months. All females from the 18 to 24 age group will be administered the traditional scheme of 0, 1, 6 months.
- Tetravalent Vaccine:
A total of 450 females will participate. The 9 to 10 year age group will include 300 women, and the 18 to 24 year age group will include 150 females.
The vaccination scheme will be conformed as follows: In the group of 9- to 10-year-olds, 150 of them will be administered the vaccine in the amplified scheme of 0, 6, 60 months, and the remaining 150 will receive the vaccine under the traditional scheme of 0, 2, 6 months. The group of 18- to 24-year-old women will be conducted under the traditional scheme of 0, 2 and 6 months.
The vaccination scheme will be assigned according to number in the record and/or geographical location.
For quantification of immunological memory of B and T lymphocytes and characterizing lymphocytes B repertoire in women vaccinated against HPV, 60 participants for group, recruited for medical evaluation at month 60.
To evaluate the interchangeability of quadrivalent and bivalent vaccines a randomization will be performed in the group of girls aged 14-15 years who have been assigned at the beginning of the project with extended vaccination scheme (0-6-60) with the bivalent vaccine, so that one third of this group will receive the bivalent vaccine, another third will receive the quadrivalent vaccine and the remaining third will no longer receive additional doses.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tetravalent Vaccine | Active comparator | Biological: Tetravalent Vaccine* Month 2 visit: May be scheduled on the appropriate month +/- 3 weeks. * Month 6, 21, 60 and 61 visit (vaccination scheme 0, 2, 6): May be programmed on the appropriate month +/- 4 weeks. * Month 7 and 61 visit (vaccination scheme 0, 6, 60): The time interval between the month 6/60 visit and the month 7/61 visit must be at least 3 weeks and maximum 7 weeks from the previous vaccination |
| Bivalent Vaccine | Active comparator | Biological: Bivalent Vaccines* Month 1 visit: May be scheduled 21 to 62 days after the Day 0 visit. * Month 6 visit: May be scheduled 161 to 216 days after the Day 0 visit. * Month 6 visit: The time interval between the month 6 visit and the month 7 visit must be at least 3 weeks and maximum 7 weeks from the previous vaccination. * Month 21, 60 and 61 visit (vaccination scheme 0, 1, 6): May be scheduled on the appropriate month +/- 4 weeks. * Month 61 (vaccination scheme 0, 6, 60) The time interval between the month 60 visit and the month 61 visit must be at least 3 weeks and maximum 7 weeks from the previous vaccination |
Who may qualify
- Ages
- 9 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- • Women 18 to 24 years of age who agree to participate by signing an informed consent form prior to recruitment.
Key exclusion criteria (5 listed)
- • Prior administration of an anti-HPV vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bivalent VaccinesAlso: CERVARIX | Biological | Bivalent Vaccine |
| Tetravalent VaccineAlso: Gardasil | Biological | Tetravalent Vaccine |
Primary outcome
To monitor immunogenicity levels induced by anti/HPV vaccine in traditional squeme
Time frame: 6 months
Bivalent Vaccine: Five hundred females from this age group will be administered the vaccine according to the traditional scheme of 0, 1, 6 months. All females from the 18 to 24 age group will be administered the traditional scheme of 0, 1, 6 months. Tetravalent Vaccine: 150 will receive the vaccine under the traditional scheme of 0, 2, 6 months. The group of 18- to 24-year-old women will be conducted under the traditional scheme of 0, 2 and 6 months.
1 secondary outcome
To monitor immunogenicity levels induced by anti/HPV vaccine in extended squeme
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Derived from this study: PubMed 41276263Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
- Derived from this study: PubMed 30085139Lazcano-Ponce E, Torres-Ibarra L, Cruz-Valdez A, Salmeron J, Barrientos-Gutierrez T, Prado-Galbarro J, Stanley M, Munoz N, Herrero R, Hernandez-Avila M. Persistence of Immunity When Using Different Human Papillomavirus Vaccination Schedules and Booster-Dose Effects 5 Years After Primary Vaccination. J Infect Dis. 2019 Jan 1;219(1):41-49. doi: 10.1093/infdis/jiy465.
- Derived from this study: PubMed 24355090Lazcano-Ponce E, Stanley M, Munoz N, Torres L, Cruz-Valdez A, Salmeron J, Rojas R, Herrero R, Hernandez-Avila M. Overcoming barriers to HPV vaccination: non-inferiority of antibody response to human papillomavirus 16/18 vaccine in adolescents vaccinated with a two-dose vs. a three-dose schedule at 21 months. Vaccine. 2014 Feb 3;32(6):725-32. doi: 10.1016/j.vaccine.2013.11.059. Epub 2013 Dec 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo C Lazcano, Phd, MD principal investigator
National Institute of Public Health Mexico
Aurelio Cruz, Valdez study director
National Institute of Public Health Mexico
Janet L. Pacheco study chair
National Institute of public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bivalent Vaccines and Tetravalent Vaccine in people with Healthy, run by Instituto Nacional de Salud Publica, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To monitor immunogenicity levels induced by anti/HPV vaccine in traditional squeme (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01717118, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.