AzTrials
AzTrials

Human Papillomavirus-Related Cervical CarcinomaPhase 3PRIMAVERANCT03728881

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

A Phase 3 study testing Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine and Recombinant Human Papillomavirus Bivalent Vaccine in people with Human Papillomavirus-Related Cervical Carcinoma, run by National Cancer Institute (NCI) at 1 site in Costa Rica.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 9 to 25 years, women onlyHealthy volunteers can take part
What is being tested?
Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine and Recombinant Human Papillomavirus Bivalent Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,240 participants
Where
1 siteCosta Rica
Study dates
1 Apr 2019to 23 Apr 2024
Phase
Phase 3

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 25 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Costa Rica1 site

  • Agencia Costarricense de Investigaciones Biomédicas (ACIB)

    Liberia, Guanacaste Province, 50101

Other trials in Costa Rica

About this study

Official 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")

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

  1. 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.

Being tested
Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine, Recombinant Human Papillomavirus Bivalent Vaccine
Keywords
HPV vaccine, Single dose HPV vaccination

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant VaccineBiological

    Also called 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

    Given IM

  • Recombinant Human Papillomavirus Bivalent VaccineBiological

    Also called Cervarix, GSK-580299, HPV 16/18 L1 VLP/AS04 VAC, HPV-16/18 VLP/AS04 Vaccine

    Given IM

Study groups in NCT03728881
Study groupRoleWhat they receive
Girls (1D Cervarix®)ExperimentalParticipants 9-14 years old receive Cervarix IM at baseline.
Receives: Biological: Recombinant Human Papillomavirus Bivalent Vaccine
Women (3D Gardasil-4®)Active comparatorParticipants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity.
Receives: Biological: Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number Seropositive for HPV16 at 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 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.

    Measured: 36 months following initial HPV vaccination

  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

    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.

    Measured: 36 months following initial vaccination

  3. Number Seropositive for HPV18 at 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 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.

    Measured: 36 months following initial vaccination

  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

    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.

    Measured: 36 months following initial vaccination

  5. Number Seropositive for HPV16 at 24 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.

    Measured: 24 months following initial HPV vaccination

  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

    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

    Measured: 24 months following initial vaccination

  7. Number Seropositive for HPV18 at 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.

    Measured: 24 months following initial vaccination

  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

    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.

    Measured: 24 months following initial vaccination

Secondary outcomes (68)

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

    Measured: 36 months

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

    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.

    Measured: 36 month

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

    Measured: 24 months

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

    Measured: 24 months

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

    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.

    Measured: 36 months following initial vaccination

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

    Measured: 36 months

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

    Measured: 24 months

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

    Measured: 24 months

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

    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.

    Measured: 36 month

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

    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.

    Measured: 36 month

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

    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.

    Measured: 36 month

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

    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.

    Measured: 36 month

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

    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.

    Measured: 36 month

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

    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.

    Measured: 36 month

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

    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.

    Measured: 24 month

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

    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.

    Measured: 24 months

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

    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.

    Measured: 24 months

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

    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.

    Measured: 24 month

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

    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.

    Measured: 24 months

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

    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.

    Measured: 24 months

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

    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.

    Measured: 1 month

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

    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.

    Measured: 1 month

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

    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.

    Measured: 1 month

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

    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.

    Measured: 1 month

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

    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.

    Measured: 1 month

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

    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.

    Measured: 1 month

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

    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.

    Measured: 12 months

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

    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.

    Measured: 1 year

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

    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.

    Measured: 1 year

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

    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.

    Measured: 12 month

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

    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.

    Measured: 12 months

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

    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.

    Measured: 1 year

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

    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.

    Measured: 36 months

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

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

    Measured: 36 month

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

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

    Measured: 36 month

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

    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.

    Measured: 36 months

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

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

    Measured: 36 month

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

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

    Measured: 36 month

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

    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.

    Measured: 36 months

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

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

    Measured: 24 month

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

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

    Measured: 24 month

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

    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.

    Measured: 24 months

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

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

    Measured: 24 month

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

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

    Measured: 24 month

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

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

    Measured: 36 month

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

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

    Measured: 36 month

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

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

    Measured: 36 month

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

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

    Measured: 36 month

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

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

    Measured: 36 month

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

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

    Measured: 36 month

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

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

    Measured: 24 month

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

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

    Measured: 24 month

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

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

    Measured: 24 month

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

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

    Measured: 24 month

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

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

    Measured: 24 month

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

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

    Measured: 24 month

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

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

    Measured: 36 month

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

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

    Measured: 36 month

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

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

    Measured: 36 month

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

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

    Measured: 36 month

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

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

    Measured: 36 month

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

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

    Measured: 36 month

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

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

    Measured: 24 month

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

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

    Measured: 24 month

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

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

    Measured: 24 month

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

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

    Measured: 24 month

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

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

    Measured: 24 month

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

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

    Measured: 24 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2018
  2. Study start1 Apr 2019
  3. Primary completion30 Sep 2022
  4. Study completion23 Apr 2024

Resources

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 3
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03728881
Sponsor's protocol ID
NCI-2020-07432
Other IDs
NCI-2020-07432, 19-C-N009
Acronym
PRIMAVERA
Status last verified
Jul 2025
First submitted
1 Nov 2018
Last updated
3 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: There is a plan to make IPD and related data dictionaries available.

Publications

  • Cortes B, Ocampo R, Porras C, Liu D, Gail MH, Sierra MS, Herrero R, Lowy DR, Carvajal LJ, Kemp TJ, Fantin R, Schussler J, Hildesheim A, Sampson JN, Pinto LA, Schiller JT, Kreimer AR. Human papillomavirus (HPV) type 16 and type 18 antibody concentrations after a single dose of bivalent HPV vaccine in girls aged 9-14 years compared with three doses of quadrivalent HPV vaccine in women aged 18-25 years in Costa Rica (PRIMAVERA): a non-randomised, open-label, immunobridging, non-inferiority trial. Lancet Infect Dis. 2025 Dec;25(12):1314-1324. doi: 10.1016/S1473-3099(25)00284-1. Epub 2025 Jul 16.

    PubMed 40683285

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