<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01717118</url>
  </required_header>
  <id_info>
    <org_study_id>883</org_study_id>
    <nct_id>NCT01717118</nct_id>
  </id_info>
  <brief_title>Evaluation of Immunogenicity Levels in Women With HPV Vaccine in Mexico</brief_title>
  <official_title>Evaluation of Immunogenicity Levels in Women With HPV Vaccine in Mexico</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Salud Publica, Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Secretaria de Salud, Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto Nacional de Salud Publica, Mexico</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In September 2009 the National Vaccination Council approved the policy for anti-HPV&#xD;
      vaccination in 9-year-old girls with an extended scheme of 0, 6, and 60 months, under the&#xD;
      following justification:&#xD;
&#xD;
        -  Antibody induction due to the vaccine is greater than that produced by natural exposure&#xD;
           to the virus&#xD;
&#xD;
        -  Immune response in girls 9 to 11 years of age is similar to the response obtained after&#xD;
           three doses in women 16 to 26 years of age&#xD;
&#xD;
        -  The third dose will be administered at the time when maximum protection is required,&#xD;
           near the onset of sexual activity Thus the National Institute of Public Health was&#xD;
           commissioned to monitor anti-HPV antibody levels in women who received the anti-HPV&#xD;
           vaccine to determine non-inferiority of the extended scheme in 9-year-old girls compared&#xD;
           with the traditional scheme of 3 doses in women 18 to 24 years of age. To this end, a&#xD;
           sentinel cohort will be formed to evaluate immunogenicity levels in 3 age groups, and&#xD;
           stratified by vaccine type. The hypothesis is that in 9-year-old girls who are&#xD;
           administered the amplified HPV vaccination scheme (0-6-60) show immunogenicity levels&#xD;
           that are not lower than those of adult women who have been administered the traditional&#xD;
           scheme (0-1/2-6).&#xD;
&#xD;
      The main objectives are to monitor the levels of immunity induced by vaccination against HPV&#xD;
      with two vaccination schemes with the quadrivalent vaccine: Traditional Extended (0-6-60&#xD;
      months) and traditional (0-2-6); Monitoring levels of immunity induced by vaccination against&#xD;
      HPV with three vaccine schemes with bivalent vaccine: Extended (0-6-60 months), traditional&#xD;
      (0-1-6) and two doses (0- 6); as well as evaluating the interchangeability of the bivalent&#xD;
      and quadrivalent vaccines in the third dose of extended scheme. The study design is to create&#xD;
      a sentinel cohort of women vaccinated against HPV in the following comparison groups:&#xD;
&#xD;
        -  Women of nine years with extended vaccination scheme with three doses of quadrivalent&#xD;
           vaccine (0-6-60)&#xD;
&#xD;
        -  Women of nine years with extended vaccination scheme with two doses of the quadrivalent&#xD;
           vaccine and the third dose with bivalent (0-6-60)&#xD;
&#xD;
        -  Women of nine years with traditional vaccination scheme with the quadrivalent HPV&#xD;
           vaccine (0-2-6)&#xD;
&#xD;
        -  Women between 18 and 24 years with traditional vaccination scheme with the quadrivalent&#xD;
           HPV vaccine (0-2-6)&#xD;
&#xD;
        -  Women of nine years with extended vaccination scheme with three doses of bivalent&#xD;
           vaccine (0-6-60)&#xD;
&#xD;
        -  Women of nine years with extended vaccination scheme with two doses of bivalent vaccine&#xD;
           and the third tetravalent dose&#xD;
&#xD;
        -  Women of nine years with two vaccine doses scheme with the bivalent HPV vaccine (0-6)&#xD;
&#xD;
        -  Women of nine years with traditional vaccination scheme with bivalent HPV vaccine&#xD;
           (0-1-6)&#xD;
&#xD;
        -  Women between 18 and 24 years with traditional vaccination scheme with bivalent HPV&#xD;
           vaccine (0-1-6)&#xD;
&#xD;
        -  To monitoring HPV infections, at month 61 of follow-up, a group of 400 women aged 14-15&#xD;
           years, who have not been vaccinated against HPV, will be invited , in order to make the&#xD;
           monitoring of occurrence of HPV infections in urine per month 61, 72, 96 and 120 post&#xD;
           dose 0 in vaccinated groups&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis Girls 9 and 10 years of age who are administered the amplified anti/HPV&#xD;
      vaccination scheme (0-6-60), show immunogenicity levels against HPV antibodies that are not&#xD;
      lower than those of 9-year-old girls and adult women who have been administered the&#xD;
      traditional scheme (0-1/2-6).&#xD;
&#xD;
      The vaccination schemes for HPV traditional (0-1 / 2-6) and extended (0-6-60), are equivalent&#xD;
      from the immunologically perspective and therefore the number of memory B and T lymphocytes&#xD;
      as well as the structure of repertoire will be not different between schemes.&#xD;
&#xD;
      Objectives The main objectives are to monitor the levels of immunity induced by vaccination&#xD;
      against HPV with two vaccination schemes with the quadrivalent vaccine: Traditional Extended&#xD;
      (0-6-60 months) and traditional (0-2-6); Monitoring levels of immunity induced by vaccination&#xD;
      against HPV with three vaccine schemes with bivalent vaccine: Extended (0-6-60 months),&#xD;
      traditional (0-1-6) and two doses (0- 6); as well as evaluating the interchangeability of the&#xD;
      bivalent and quadrivalent vaccines in the third dose of extended scheme. The study design is&#xD;
      to create a sentinel cohort of women vaccinated against HPV in the following comparison&#xD;
      groups:&#xD;
&#xD;
        -  Women of nine years with extended vaccination scheme with three doses of quadrivalent&#xD;
           vaccine (0-6-60)&#xD;
&#xD;
        -  Women of nine years with extended vaccination scheme with two doses of the quadrivalent&#xD;
           vaccine and the third dose with bivalent (0-6-60)&#xD;
&#xD;
        -  Women of nine years with traditional vaccination scheme with the quadrivalent HPV&#xD;
           vaccine (0-2-6)&#xD;
&#xD;
        -  Women between 18 and 24 years with traditional vaccination scheme with the quadrivalent&#xD;
           HPV vaccine (0-2-6)&#xD;
&#xD;
        -  Women of nine years with extended vaccination scheme with three doses of bivalent&#xD;
           vaccine (0-6-60)&#xD;
&#xD;
        -  Women of nine years with extended vaccination scheme with two doses of bivalent vaccine&#xD;
           and the third tetravalent dose&#xD;
&#xD;
        -  Women of nine years with two vaccine doses scheme with the bivalent HPV vaccine (0-6)&#xD;
&#xD;
        -  Women of nine years with traditional vaccination scheme with bivalent HPV vaccine&#xD;
           (0-1-6)&#xD;
&#xD;
        -  Women between 18 and 24 years with traditional vaccination scheme with bivalent HPV&#xD;
           vaccine (0-1-6)&#xD;
&#xD;
        -  To monitoring HPV infections, at month 61 of follow-up, a group of 400 women aged 14-15&#xD;
           years, who have not been vaccinated against HPV, will be invited , in order to make the&#xD;
           monitoring of occurrence of HPV infections in urine per month 61, 72, 96 and 120 post&#xD;
           dose 0 in vaccinated groups&#xD;
&#xD;
      Methodology&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      Creating a sentinel cohort of women vaccinated against HPV in three comparison groups:&#xD;
&#xD;
        -  Women of nine years with extended vaccination scheme with three doses of quadrivalent&#xD;
           vaccine (0-6-60)&#xD;
&#xD;
        -  Women of nine years with extended vaccination scheme with two doses of the quadrivalent&#xD;
           vaccine and the third dose with bivalent (0-6-60)&#xD;
&#xD;
        -  Women of nine years with traditional vaccination scheme with the quadrivalent HPV&#xD;
           vaccine (0-2-6)&#xD;
&#xD;
        -  Women between 18 and 24 years with traditional vaccination scheme with the quadrivalent&#xD;
           HPV vaccine (0-2-6)&#xD;
&#xD;
        -  Women of nine years with extended vaccination scheme with three doses of bivalent&#xD;
           vaccine (0-6-60)&#xD;
&#xD;
        -  Women of nine years with extended vaccination scheme with two doses of bivalent vaccine&#xD;
           and the third tetravalent dose&#xD;
&#xD;
        -  Women of nine years with two vaccine doses scheme with the bivalent HPV vaccine (0-6)&#xD;
&#xD;
        -  Women of nine years with traditional vaccination scheme with bivalent HPV vaccine&#xD;
           (0-1-6)&#xD;
&#xD;
        -  Women between 18 and 24 years with traditional vaccination scheme with bivalent HPV&#xD;
           vaccine (0-1-6) Selecting the study population.&#xD;
&#xD;
      A fraction of the population of females will be invited to participate in the study&#xD;
      proportionately, combining strategies in schools and the community.&#xD;
&#xD;
      A total of 2450 women will be recruited. For the study purposes, they will be classified by&#xD;
      vaccine type administered, (tetravalent and bivalent), as well as by age group and&#xD;
      vaccination scheme.&#xD;
&#xD;
      Forming groups for evaluation.&#xD;
&#xD;
      Two groups of participants will be formed. Participants will be classified by vaccine type&#xD;
      received:&#xD;
&#xD;
        1. Bivalent Vaccine. This group will consist of a total of 2000 women. Two thirds of them&#xD;
           will be 9 to 10 years of age, and 500 will be 18 to 24 years of age. In the first age&#xD;
           group, 1000 of them will be administered the vaccine in the amplified scheme of 0, 6, 60&#xD;
           months. Five hundred females from this age group will be administered the vaccine&#xD;
           according to the traditional scheme of 0, 1, 6 months. All females from the 18 to 24 age&#xD;
           group will be administered the traditional scheme of 0, 1, 6 months.&#xD;
&#xD;
        2. Tetravalent Vaccine:&#xD;
&#xD;
      A total of 450 females will participate. The 9 to 10 year age group will include 300 women,&#xD;
      and the 18 to 24 year age group will include 150 females.&#xD;
&#xD;
      The vaccination scheme will be conformed as follows: In the group of 9- to 10-year-olds, 150&#xD;
      of them will be administered the vaccine in the amplified scheme of 0, 6, 60 months, and the&#xD;
      remaining 150 will receive the vaccine under the traditional scheme of 0, 2, 6 months. The&#xD;
      group of 18- to 24-year-old women will be conducted under the traditional scheme of 0, 2 and&#xD;
      6 months.&#xD;
&#xD;
      The vaccination scheme will be assigned according to number in the record and/or geographical&#xD;
      location.&#xD;
&#xD;
      For quantification of immunological memory of B and T lymphocytes and characterizing&#xD;
      lymphocytes B repertoire in women vaccinated against HPV, 60 participants for group,&#xD;
      recruited for medical evaluation at month 60.&#xD;
&#xD;
      To evaluate the interchangeability of quadrivalent and bivalent vaccines a randomization will&#xD;
      be performed in the group of girls aged 14-15 years who have been assigned at the beginning&#xD;
      of the project with extended vaccination scheme (0-6-60) with the bivalent vaccine, so that&#xD;
      one third of this group will receive the bivalent vaccine, another third will receive the&#xD;
      quadrivalent vaccine and the remaining third will no longer receive additional doses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2009</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To monitor immunogenicity levels induced by anti/HPV vaccine in traditional squeme</measure>
    <time_frame>6 months</time_frame>
    <description>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.&#xD;
Tetravalent Vaccine:&#xD;
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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To monitor immunogenicity levels induced by anti/HPV vaccine in extended squeme</measure>
    <time_frame>60 months</time_frame>
    <description>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.&#xD;
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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2000</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Tetravalent Vaccine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Month 2 visit: May be scheduled on the appropriate month +/- 3 weeks.&#xD;
Month 6, 21, 60 and 61 visit (vaccination scheme 0, 2, 6): May be programmed on the appropriate month +/- 4 weeks.&#xD;
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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bivalent Vaccine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Month 1 visit: May be scheduled 21 to 62 days after the Day 0 visit.&#xD;
Month 6 visit: May be scheduled 161 to 216 days after the Day 0 visit.&#xD;
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.&#xD;
Month 21, 60 and 61 visit (vaccination scheme 0, 1, 6): May be scheduled on the appropriate month +/- 4 weeks.&#xD;
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</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Bivalent Vaccines</intervention_name>
    <arm_group_label>Bivalent Vaccine</arm_group_label>
    <other_name>CERVARIX</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Tetravalent Vaccine</intervention_name>
    <arm_group_label>Tetravalent Vaccine</arm_group_label>
    <other_name>Gardasil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Women 18 to 24 years of age who agree to participate by signing an informed consent&#xD;
             form prior to recruitment.&#xD;
&#xD;
               -  Girls 9 and 10 years of age whose father/mother/guardian signs the informed&#xD;
                  consent form to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Prior administration of an anti-HPV vaccine&#xD;
&#xD;
               -  Pregnant women or women planning to get pregnant in the next 8 months.&#xD;
&#xD;
               -  Auto-immune diseases&#xD;
&#xD;
               -  Women with a history of Guillain Barré syndrome.&#xD;
&#xD;
               -  Prior administration of immunoglobulins and/or any blood product in the past 6&#xD;
                  months before the study's first vaccine dose.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eduardo C Lazcano, Phd, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Public Health Mexico</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aurelio Cruz, Valdez</last_name>
    <role>Study Director</role>
    <affiliation>National Institute of Public Health Mexico</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Janet L. Pacheco</last_name>
    <role>Study Chair</role>
    <affiliation>National Institute of public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro Médico Cuauhtemoc</name>
      <address>
        <city>Cuernavaca</city>
        <state>Morelos</state>
        <zip>1299</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>August 23, 2018</last_update_submitted>
  <last_update_submitted_qc>August 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Nacional de Salud Publica, Mexico</investigator_affiliation>
    <investigator_full_name>Eduardo Cesar Lazcano Ponce</investigator_full_name>
    <investigator_title>Executive Director of the Center of Research in population health</investigator_title>
  </responsible_party>
  <keyword>Evaluation</keyword>
  <keyword>Immunogenicity</keyword>
  <keyword>Levels</keyword>
  <keyword>Women</keyword>
  <keyword>HPV</keyword>
  <keyword>Vaccine</keyword>
  <keyword>Mexico</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01717118
org study id: 883
nct id: NCT01717118
lead sponsor: 
collaborator: 
has dmc: No
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
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:

        1. 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.

        2. 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.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: To monitor immunogenicity levels induced by anti/HPV vaccine in traditional squeme
time frame: 6 months
description: 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.
measure: To monitor immunogenicity levels induced by anti/HPV vaccine in extended squeme
time frame: 60 months
description: 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
arm group label: Tetravalent Vaccine
arm group type: Active Comparator
description: 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
arm group label: Bivalent Vaccine
arm group type: Active Comparator
description: 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
intervention type: Biological
intervention name: Bivalent Vaccines
arm group label: Bivalent Vaccine
other name: CERVARIX
intervention type: Biological
intervention name: Tetravalent Vaccine
arm group label: Tetravalent Vaccine
other name: Gardasil
criteria: 
gender: Female
minimum age: 9 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eduardo C Lazcano, Phd, MD
role: Principal Investigator
affiliation: National Institute of Public Health Mexico
last name: Aurelio Cruz, Valdez
role: Study Director
affiliation: National Institute of Public Health Mexico
last name: Janet L. Pacheco
role: Study Chair
affiliation: National Institute of public Health
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Instituto Nacional de Salud Publica, Mexico
investigator full name: Eduardo Cesar Lazcano Ponce
investigator title: Executive Director of the Center of Research in population health
mesh term: Vaccines