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OpenTrials
Completed

NCT Number: NCT03728881

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

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.

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Key information

Conditions

Human Papillomavirus-Related Cervical Carcinoma

Age range

9 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Agencia Costarricense de Investigaciones Biomédicas (ACIB)

Liberia, Guanacaste Province, 50101, Costa Rica

About this study

PRIMARY OBJECTIVE:

I. To demonstrate that the immunogenicity (as determined by enzyme-linked immunosorbent assay [ELISA]) of a single dose of recombinant human papillomavirus bivalent vaccine (Cervarix) in 9-14 year old girls is non-inferior to the immunogenicity of three doses of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (Gardasil), administered at 0, 2, and 6 months, in 18-25 year old women 36 months after initial vaccination, with an interim analysis at 24 months after initial vaccination.

SECONDARY OBJECTIVES:

I. To compare the distribution of HPV -16 and HPV-18 antibodies levels, assessed at 24 and 36 months after initial vaccination, following a single dose of Cervarix in 9-14 year old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women.

II. To compare rates of seroconversion based on HPV-16 and HPV-18 antibody levels, assessed at 24 and 36 months after initial vaccination, following a single dose of Cervarix in 9-14 year old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women.

III. To compare geometric mean titers (GMTs), distributions, and seroconversion rates for HPV-16 and HPV-18 antibodies, assessed at 24 and 36 months after initial vaccination, following a single dose of Cervarix in 9-11 year old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women; to perform a similar comparison restricting to 12-14 year old girls.

IV. To compare GMTs, distributions, and seroconversion rates for HPV-16 and HPV-18 antibodies, assessed at 1-month after vaccination and 1-year after vaccination, following a single dose of Cervarix in 9-10 year old girls and a single dose of Cervarix in 11-14 year old girls.

V. To evaluate whether baseline variables (e.g. geographic district, initial antibody levels, date of vaccination) are associated with GMTs, distributions, and seroconversion rates for HPV16 and HPV-18 antibodies, assessed at 24 and 36 months after initial vaccination.

OUTLINE: Participants are assigned to 1 of 2 groups.

GROUP I: Participants 9-14 years old receive Cervarix intramuscularly (IM) at baseline.

GROUP II: Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity.

After completion of trial vaccine dose(s), participants are followed up at 1, 12, 24, and 36 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

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, including yeast (if Gardasil group)
  • They have received immunoglobulins within 90 days preceding enrollment/vaccination visit
  • 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

Treatment and study plan

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

Biological

Given IM

Other names: Gardasil, Quadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle vaccine, quadrivalent human papillomavirus (types 6, 11, 16, and 18) recombinant vaccine, Recombinant Human Papillomavirus (HPV) Quadrivalent Vaccine, V501

Recombinant Human Papillomavirus Bivalent Vaccine

Biological

Given IM

Other names: Cervarix, GSK-580299, HPV 16/18 L1 VLP/AS04 VAC, HPV-16/18 VLP/AS04 Vaccine, Human Papillomavirus 16/18 L1 Virus-Like Particle/AS04 Vaccine, Human Papillomavirus Bivalent Types 16 and 18 Vaccine, Recombinant, Human Papillomavirus Vaccine L1 16,18, Human Papillomavirus Vaccine, L1 Type 16, 18, Recombinant HPV Bivalent Vaccine

Primary outcomes

  1. Number Seropositive for HPV16 at 36 Months

    Time frame: 36 months following initial HPV vaccination

    Will measure HPV16 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV16 is seropositive if the ELISA concentration is greater than 1.41 IU/mL. Participants whose analysis of the 36-month sample does not generate a valid HPV16 result will be excluded only from the 36-month HPV16 analysis.

  2. Immunogenicity for HPV16 of One Dose of Bivalent HPV Vaccine (Cervarix) in 9-14 Year Old Girls Compared to Three Doses of Quadrivalent HPV Vaccine (Gardasil), Administered at 0,2 and 6 Months, in 18-25 Year Old Women, 36 Months After Initial Vaccination

    Time frame: 36 months following initial vaccination

    Will measure HPV-16 specific serum antibody using the HPV type-specific ELISA on serum. Will estimate the two-sided 99% confidence interval of the GMT ratios for HPV-16 and HPV-18 at 24 months and the two-sided 96% confidence intervals of the GMT ratios for HPV-16 and HPV-18 at 36 months.

  3. Number Seropositive for HPV18 at 36 Months

    Time frame: 36 months following initial vaccination

    Will measure HPV18 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV18 is seropositive if the ELISA concentration is greater than 1.05 IU/mL. Participants whose analysis of the 36-month sample does not generate a valid HPV18 result will be excluded only from the 36-month HPV18 analysis.

  4. Immunogenicity for HPV18 of One Dose of Bivalent HPV Vaccine (Cervarix) in 9-14 Year Old Girls Compared to Three Doses of Quadrivalent HPV Vaccine (Gardasil), Administered at 0,2, and 6 Months, in 18-25 Year Old Women, 36 Months After Initial Vaccination

    Time frame: 36 months following initial vaccination

    Will measure HPV-18 specific serum antibody using the HPV type-specific ELISA on serum. Will estimate the two-sided 99% confidence interval of the GMT ratios for HPV-16 and HPV-18 at 24 months and the two-sided 96% confidence intervals of the GMT ratios for HPV-16 and HPV-18 at 36 months.

  5. Number Seropositive for HPV16 at 24 Months

    Time frame: 24 months following initial HPV vaccination

    Will measure HPV16 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV16 is seropositive if the ELISA titer is greater than 1.41 IU/mL. Participants whose analysis of the 24-month sample does not generate a valid HPV16 result will be excluded only from the 24-month HPV16 analysis.

  6. Immunogenicity for HPV16 of One Dose of Bivalent HPV Vaccine (Cervarix) in 9-14 Year Old Girls Compared to Three Doses of Quadrivalent HPV Vaccine (Gardasil), Administered at 0,2, and 6 Months, in 18-25 Year Old Women, 24 Months After Initial Vaccination

    Time frame: 24 months following initial vaccination

    Will measure HPV-16 specific serum antibody using the HPV type-specific enzyme-linked immunoassay (ELISA) on serum. Will estimate the two-sided 99% confidence interval of the geometric mean concentration (GMC) ratio for HPV-16 at 24 months

  7. Number Seropositive for HPV18 at 24 Months

    Time frame: 24 months following initial vaccination

    Will measure HPV18 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV18 is seropositive if the ELISA titer is greater than 1.05 IU/mL. Participants whose analysis of the 24-month sample does not generate a valid HPV18 result will be excluded only from the 24-month HPV18 analysis.

  8. Immunogenicity for HPV18 of One Dose of Bivalent HPV Vaccine (Cervarix) in 9-14 Year Old Girls Compared to Three Doses of Quadrivalent HPV Vaccine (Gardasil), Administered at 0,2, and 6 Months, in 18-25 Year Old Women, 24 Months After Initial Vaccination

    Time frame: 24 months following initial vaccination

    Will measure HPV-18 specific serum antibody using the HPV type-specific ELISA on serum. Will estimate the two-sided 99% confidence interval of the Geometric Mean Concentration (GMC) ratio for HPV-18 at 24 months.

Secondary outcomes

  1. Comparison of Proportions With Seroconversion Based on HPV16 Antibody Levels Assessed at 36 Months

    Time frame: 36 months

    To compare proportions with seroconversion based on HPV16 antibody levels, assessed at 36 months after initial vaccination, following a single dose of Cervarix in 9-14 year old girls and following three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women.

  2. Comparison of Proportions With Seroconversion Based on HPV18 Antibody Levels Assessed at 36 Months

    Time frame: 36 month

    To compare proportions with seroconversion based on HPV18 antibody levels, assessed at 36 months after initial vaccination, following a single dose of Cervarix in 9-14 year old girls and following three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women.

  3. Comparison of Proportions With Seroconversion Based HPV16 Antibody Levels at 24 Months

    Time frame: 24 months

    To compare proportions with seroconversion based on HPV16 antibody levels, assessed at 24 months after initial vaccination, following a single dose of Cervarix in 9-14 year old girls and following three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women.

  4. Comparison of Proportions With Seroconversion Based on HPV18 Antibody Levels Assessed at 24 Months

    Time frame: 24 months

    To compare proportions with seroconversion based on HPV18 antibody levels, assessed at 24 months after initial vaccination, following a single dose of Cervarix in 9-14 year old girls and following three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women.

  5. Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months

    Time frame: 36 months following initial vaccination

    Distribution of HPV16 antibodies levels assessed at 36 months following a single dose of Cervarix in 9-14 year old girls compared to distribution of HPV16 antibodies levels assessed at 36 months following three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. Shown as medians and ranges by deciles.

  6. Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months

    Time frame: 36 months

    Distribution of HPV18 antibodies levels assessed at 36 months following a single dose of Cervarix in 9-14 year old girls compared to distribution of HPV18 antibodies levels assessed at 36 months following three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. Shown in medians and ranges by deciles.

  7. Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months

    Time frame: 24 months

    Distribution of HPV16 antibodies levels assessed at 24 months following a single dose of Cervarix in 9-14 year old girls compared to distribution of HPV16 antibodies levels assessed at 24 months following three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. Shown as medians and ranges by deciles.

  8. Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months

    Time frame: 24 months

    Distribution of HPV18 antibodies levels assessed at 24 months following a single dose of Cervarix in 9-14 year old girls compared to distribution of HPV18 antibodies levels assessed at 24 months following three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. Shown as medians and ranges by deciles.

  9. Number Seropositive for HPV16 at 36 Months, Excluding 9-10 Year Olds

    Time frame: 36 month

    Will measure HPV16 specific serum antibody using the HPV type-specific ELISA on serum. assessed at 36 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. For computing proportions seropositive and proportions seroconverting, HPV16 is seropositive if the ELISA concentration is greater than 1.41 IU/mL. Participants whose analysis of the 36-month sample does not generate a valid HPV16 result will be excluded only from the 36-month HPV16 analysis.

  10. Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, Excluding 9-10-year-old Girls

    Time frame: 36 month

    To compare GMCs for HPV16 antibodies, assessed at 36 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women.

  11. Comparison of Seroconversion Proportions for HPV16 Antibodies Assessed at 36 Months, Excluding 9-10-year-old Girls

    Time frame: 36 month

    To compare seroconversion proportions for HPV16 antibodies, assessed at 36 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women.

  12. Number Seropositive for HPV18 at 36 Months, Excluding 9-10 Year Olds

    Time frame: 36 month

    Will measure HPV18 specific serum antibody using the HPV type-specific ELISA on serum. assessed at 36 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. For computing proportions seropositive and proportions seroconverting, HPV18 is seropositive if the ELISA concentration is greater than 1.05 IU/mL. Participants whose analysis of the 36-month sample does not generate a valid HPV18 result will be excluded only from the 36-month HPV18 analysis.

  13. Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, Excluding 9-10-year-old Girls

    Time frame: 36 month

    To compare GMCs for HPV18 antibodies, assessed at 36 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25-year-old women.

  14. Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 36 Months, Excluding 9-10-year-old Girls

    Time frame: 36 month

    To compare seroconversion proportions for HPV18 antibodies, assessed at 36 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25-year-old women.

  15. Number Seropositive for HPV16 at 24 Months, Excluding 9-10 Year Olds

    Time frame: 24 month

    Will measure HPV16 specific serum antibody using the HPV type-specific ELISA on serum. assessed at 24 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. For computing proportions seropositive and proportions seroconverting, HPV16 is seropositive if the ELISA concentration is greater than 1.41 IU/mL. Participants whose analysis of the 24-month sample does not generate a valid HPV16 result will be excluded only from the 24-month HPV16 analysis.

  16. Comparison of GMCs for HPV16 Assessed at 24 Months, Excluding 9-10-year-old Girls

    Time frame: 24 months

    To compare GMCs for HPV16 antibodies, assessed at 24 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25-year-old women.

  17. Comparison of Seroconversion Proportions for HPV16 Assessed at 24 Months, Excluding 9-10-year-old Girls

    Time frame: 24 months

    To compare seroconversion proportions for HPV16 antibodies, assessed at 24 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25-year-old women.

  18. Number Seropositive for HPV18 at 24 Months, Excluding 9-10 Year Olds

    Time frame: 24 month

    Will measure HPV18 specific serum antibody using the HPV type-specific ELISA on serum. assessed at 24 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. For computing proportions seropositive and proportions seroconverting, HPV18 is seropositive if the ELISA concentration is greater than 1.05 IU/mL. Participants whose analysis of the 24-month sample does not generate a valid HPV18 result will be excluded only from the 24-month HPV18 analysis.

  19. Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, Excluding 9-10-year-old Girls

    Time frame: 24 months

    To compare GMCs for HPV18 antibodies, assessed at 24 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25-year-old women.

  20. Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 24 Months, Excluding 9-10-year-old Girls

    Time frame: 24 months

    To compare seroconversion proportions for HPV18 antibodies, assessed at 24 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25-year-old women.

  21. Number Seropositive for HPV16 Antibodies, Assessed at 1 Month After Vaccination, in Younger and Older Girls

    Time frame: 1 month

    Will measure HPV16 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV16 is seropositive if the ELISA titer is greater than 1.41 IU/mL. Participants whose analysis of the 1-month sample does not generate a valid HPV16 result will be excluded only from the 1-month HPV16 analysis.

  22. Comparison of GMCs for HPV16 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls

    Time frame: 1 month

    To compare GMCs for HPV16 antibodies, assessed at 1 month after vaccination, following a single dose of Cervarix in 9-10-year-old girls and following a single dose of Cervarix in 11-14-year-old girls, in order to compare girls who were in and not in the age range for routine HPV vaccination in Costa Rica.

  23. Comparison of Seroconversion Proportions for HPV16 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls

    Time frame: 1 month

    To compare seroconversion proportions for HPV16 antibodies, assessed at 1 month after vaccination, following a single dose of Cervarix in 9-10-year-old girls and following a single dose of Cervarix in 11-14-year-old girls.

  24. Number Seropositive for HPV18 Antibodies, Assessed at 1 Month After Vaccination, in Younger and Older Girls

    Time frame: 1 month

    Will measure HPV18 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV18 is seropositive if the ELISA titer is greater than 1.05 IU/mL. Participants whose analysis of the 1-month sample does not generate a valid HPV18 result will be excluded only from the 1-month HPV18 analysis.

  25. Comparison of GMCs for HPV18 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls

    Time frame: 1 month

    To compare seroconversion proportions for HPV18 antibodies, assessed at 1 month after vaccination, following a single dose of Cervarix in 9-10-year-old girls and following a single dose of Cervarix in 11-14-year-old girls, in order to compare girls who were in and not in the age range for routine HPV vaccination in Costa Rica.

  26. Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls

    Time frame: 1 month

    To compare seroconversion proportions for HPV18 antibodies, assessed at 1 month after vaccination, following a single dose of Cervarix in 9-10-year-old girls and following a single dose of Cervarix in 11-14-year-old girls, in order to compare girls who were in and not in the age range for routine HPV vaccination in Costa Rica.

  27. Number Seropositive for HPV16 Antibodies, Assessed at 12 Months After Vaccination, in Younger and Older Girls

    Time frame: 12 months

    Will measure HPV16 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV16 is seropositive if the ELISA titer is greater than 1.41 IU/mL. Participants whose analysis of the 12-month sample does not generate a valid HPV16 result will be excluded only from the 12-month HPV16 analysis.

  28. Comparison of GMCs for HPV16 Antibodies, Assessed at 12 Months After Vaccination in Younger and Older Girls

    Time frame: 1 year

    To compare GMCs for HPV16 antibodies, assessed at 12 months after vaccination, following a single dose of Cervarix in 9-10-year-old girls and following a single dose of Cervarix in 11-14-year-old girls, in order to compare girls who were in and not in the age range for routine HPV vaccination in Costa Rica.

  29. Comparison of Seroconversion Proportions for HPV16 Antibodies, Assessed at 12 Months After Vaccination in Younger and Older Girls

    Time frame: 1 year

    To compare seroconversion proportions for HPV16 antibodies, assessed at 12 months after vaccination, following a single dose of Cervarix in 9-10-year-old girls and following a single dose of Cervarix in 11-14-year-old girls.

  30. Number Seropositive for HPV18 Antibodies, Assessed at 12 Months After Vaccination, in Younger and Older Girls

    Time frame: 12 month

    Will measure HPV18 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV18 is seropositive if the ELISA titer is greater than 1.05 IU/mL. Participants whose analysis of the 12-month sample does not generate a valid HPV18 result will be excluded only from the 12-month HPV18 analysis.

  31. Comparison of GMCs for HPV18 Antibodies, Assessed at 12 Months After Vaccination in Younger and Older Girls

    Time frame: 12 months

    To compare GMCs for HPV18 antibodies, assessed at 12 months after vaccination, following a single dose of Cervarix in 9-10-year-old girls and following a single dose of Cervarix in 11-14-year-old girls. in order to compare girls who were in and not in the age range for routine HPV vaccination in Costa Rica.

  32. Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 12 Months After Vaccination, in Younger and Older Girls

    Time frame: 1 year

    To compare seroconversion proportions for HPV18 antibodies, assessed at 1 year after vaccination, following a single dose of Cervarix in 9-10-year-old girls and following a single dose of Cervarix in 11-14-year-old girls, in order to compare girls who were in and not in the age range for routine HPV vaccination in Costa Rica.

  33. Number Seropositive for HPV16 at 36 Months, By Enrollment Age Group

    Time frame: 36 months

    Will measure HPV16 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV16 is seropositive if the ELISA titer is greater than 1.41 IU/mL. Participants whose analysis of the 36-month sample does not generate a valid HPV16 result will be excluded only from the 36-month HPV16 analysis.

  34. Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, by Enrollment Age Group

    Time frame: 36 month

    To evaluate whether age is associated with GMCs for HPV16 antibodies, assessed at 36 months after initial vaccination.

  35. Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment Age Group

    Time frame: 36 month

    To evaluate whether age is associated with seroconversion proportions for HPV-16 antibodies, assessed at 36 months after initial vaccination.

  36. Number Seropositive for HPV18 at 36 Months, By Enrollment Age Group

    Time frame: 36 months

    Will measure HPV18 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV18 is seropositive if the ELISA titer is greater than 1.05 IU/mL. Participants whose analysis of the 36-month sample does not generate a valid HPV18 result will be excluded only from the 36-month HPV18 analysis.

  37. Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment Age Group

    Time frame: 36 month

    To evaluate whether age is associated with GMCs for HPV18 antibodies, assessed at 36 months after initial vaccination.

  38. Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment Age Group

    Time frame: 36 month

    To evaluate whether age is associated with seroconversion proportions for HPV-16 antibodies, assessed at 36 months after initial vaccination.

  39. Number Seropositive for HPV16 at 24 Months, By Enrollment Age Group

    Time frame: 36 months

    Will measure HPV16 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV16 is seropositive if the ELISA titer is greater than 1.41 IU/mL. Participants whose analysis of the 24-month sample does not generate a valid HPV16 result will be excluded only from the 24-month HPV16 analysis.

  40. Comparison of GMCs for HPV16 Antibodies Assessed at 24 Months, by Enrollment Age Group

    Time frame: 24 month

    To evaluate whether age is associated with GMCs for HPV16 antibodies, assessed at 24 months after initial vaccination.

  41. Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment Age Group

    Time frame: 24 month

    To evaluate whether age is associated with seroconversion proportions for HPV-16 antibodies, assessed at 24 months after initial vaccination.

  42. Number Seropositive for HPV18 at 24 Months, By Enrollment Age Group

    Time frame: 24 months

    Will measure HPV18 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV18 is seropositive if the ELISA titer is greater than 1.05 IU/mL. Participants whose analysis of the 24-month sample does not generate a valid HPV18 result will be excluded only from the 24-month HPV18 analysis.

  43. Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, by Enrollment Age Group

    Time frame: 24 month

    To evaluate whether age is associated with GMCs for HPV18 antibodies, assessed at 24 months after initial vaccination.

  44. Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment Age Group

    Time frame: 24 month

    To evaluate whether age is associated with seroconversion proportions for HPV-16 antibodies, assessed at 24 months after initial vaccination.

  45. Number Seropositive for HPV16, Assessed at 36 Months, by Enrollment Month Group

    Time frame: 36 month

    HPV16 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

  46. Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, by Enrollment Month Group

    Time frame: 36 month

    HPV16 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

  47. Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment Month

    Time frame: 36 month

    HPV16 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

  48. Number Seropositive for HPV18, Assessed at 36 Months, by Enrollment Month Group

    Time frame: 36 month

    HPV18 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

  49. Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment Month Group

    Time frame: 36 month

    HPV18 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

  50. Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment Month

    Time frame: 36 month

    HPV18 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

  51. Number Seropositive for HPV16, Assessed at 24 Months, by Enrollment Month

    Time frame: 24 month

    HPV16 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

  52. Comparison of GMCs for HPV16 Antibodies Assessed at 24 Months, by Enrollment Month Group

    Time frame: 24 month

    HPV16 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

  53. Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment Month

    Time frame: 24 month

    HPV16 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

  54. Number Seropositive for HPV18, Assessed at 24 Months, by Enrollment Month Group

    Time frame: 24 month

    HPV18 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

  55. Comparison of GMCs for HPV18 Antibodies Assessed at 24 Months, by Enrollment Month Group

    Time frame: 24 month

    HPV18 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

  56. Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment Month

    Time frame: 24 month

    HPV18 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

  57. Number Seropositive for HPV16, Assessed at 36 Months, by Enrollment District

    Time frame: 36 month

    HPV16 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

  58. Comparison of GMCs for HPV16 Antibodies, Assessed at 36 Months, by Enrollment District

    Time frame: 36 month

    HPV16 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

  59. Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment District

    Time frame: 36 month

    HPV16 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

  60. Number Seropositive for HPV18, Assessed at 36 Months, by Enrollment District

    Time frame: 36 month

    HPV18 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

  61. Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment District

    Time frame: 36 month

    HPV18 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

  62. Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment District

    Time frame: 36 month

    HPV18 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

  63. Number Seropositive for HPV16, Assessed at 24 Months, by Enrollment District

    Time frame: 24 month

    HPV16 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

  64. Comparison of GMCs for HPV16 Antibodies, Assessed at 24 Months, by Enrollment District

    Time frame: 24 month

    HPV16 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

  65. Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment District

    Time frame: 24 month

    HPV16 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

  66. Number Seropositive for HPV18, Assessed at 24 Months, by Enrollment District

    Time frame: 24 month

    HPV18 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

  67. Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, by Enrollment District

    Time frame: 24 month

    HPV18 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

  68. Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment District

    Time frame: 24 month

    HPV18 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Collaborators

  • Bill and Melinda Gates Foundation
  • Cancer Research UK

Registry information

Official study title

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")

Acronym: PRIMAVERA

Important dates

Study start
2019
Primary completion
2022
Study completion
2024
First posted
Nov 2, 2018
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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