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")
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,240
- 试验地点
- 1
- 主要终点
- Number Seropositive for HPV16 at 36 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Girls (1D Cervarix®)
Participants 9-14 years old receive Cervarix IM at baseline.
干预措施: Recombinant Human Papillomavirus Bivalent Vaccine (Biological)
Women (3D Gardasil-4®)
Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity.
干预措施: Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine (Biological)
结局指标
主要结局
Number Seropositive for HPV16 at 36 Months
时间窗: 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.
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
时间窗: 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.
Number Seropositive for HPV18 at 36 Months
时间窗: 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.
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
时间窗: 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.
Number Seropositive for HPV16 at 24 Months
时间窗: 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.
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
时间窗: 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
Number Seropositive for HPV18 at 24 Months
时间窗: 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.
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
时间窗: 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.
次要结局
- Comparison of Proportions With Seroconversion Based on HPV16 Antibody Levels Assessed at 36 Months(36 months)
- Comparison of Proportions With Seroconversion Based on HPV18 Antibody Levels Assessed at 36 Months(36 month)
- Comparison of Proportions With Seroconversion Based HPV16 Antibody Levels at 24 Months(24 months)
- Comparison of Proportions With Seroconversion Based on HPV18 Antibody Levels Assessed at 24 Months(24 months)
- Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months(36 months following initial vaccination)
- Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months(36 months)
- Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months(24 months)
- Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months(24 months)
- Number Seropositive for HPV16 at 36 Months, Excluding 9-10 Year Olds(36 month)
- Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, Excluding 9-10-year-old Girls(36 month)
- Comparison of Seroconversion Proportions for HPV16 Antibodies Assessed at 36 Months, Excluding 9-10-year-old Girls(36 month)
- Number Seropositive for HPV18 at 36 Months, Excluding 9-10 Year Olds(36 month)
- Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, Excluding 9-10-year-old Girls(36 month)
- Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 36 Months, Excluding 9-10-year-old Girls(36 month)
- Number Seropositive for HPV16 at 24 Months, Excluding 9-10 Year Olds(24 month)
- Comparison of GMCs for HPV16 Assessed at 24 Months, Excluding 9-10-year-old Girls(24 months)
- Comparison of Seroconversion Proportions for HPV16 Assessed at 24 Months, Excluding 9-10-year-old Girls(24 months)
- Number Seropositive for HPV18 at 24 Months, Excluding 9-10 Year Olds(24 month)
- Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, Excluding 9-10-year-old Girls(24 months)
- Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 24 Months, Excluding 9-10-year-old Girls(24 months)
- Number Seropositive for HPV16 Antibodies, Assessed at 1 Month After Vaccination, in Younger and Older Girls(1 month)
- Comparison of GMCs for HPV16 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls(1 month)
- Comparison of Seroconversion Proportions for HPV16 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls(1 month)
- Number Seropositive for HPV18 Antibodies, Assessed at 1 Month After Vaccination, in Younger and Older Girls(1 month)
- Comparison of GMCs for HPV18 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls(1 month)
- Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment Age Group(36 month)
- Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls(1 month)
- Number Seropositive for HPV16 Antibodies, Assessed at 12 Months After Vaccination, in Younger and Older Girls(12 months)
- Comparison of GMCs for HPV16 Antibodies, Assessed at 12 Months After Vaccination in Younger and Older Girls(1 year)
- Comparison of Seroconversion Proportions for HPV16 Antibodies, Assessed at 12 Months After Vaccination in Younger and Older Girls(1 year)
- Number Seropositive for HPV18 Antibodies, Assessed at 12 Months After Vaccination, in Younger and Older Girls(12 month)
- Comparison of GMCs for HPV18 Antibodies, Assessed at 12 Months After Vaccination in Younger and Older Girls(12 months)
- Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 12 Months After Vaccination, in Younger and Older Girls(1 year)
- Number Seropositive for HPV16 at 36 Months, By Enrollment Age Group(36 months)
- Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, by Enrollment Age Group(36 month)
- Number Seropositive for HPV18 at 36 Months, By Enrollment Age Group(36 months)
- Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment Age Group(36 month)
- Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment Age Group(36 month)
- Number Seropositive for HPV16 at 24 Months, By Enrollment Age Group(36 months)
- Comparison of GMCs for HPV16 Antibodies Assessed at 24 Months, by Enrollment Age Group(24 month)
- Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment Age Group(24 month)
- Number Seropositive for HPV18 at 24 Months, By Enrollment Age Group(24 months)
- Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, by Enrollment Age Group(24 month)
- Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment Age Group(24 month)
- Number Seropositive for HPV16, Assessed at 36 Months, by Enrollment Month Group(36 month)
- Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, by Enrollment Month Group(36 month)
- Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment Month(36 month)
- Number Seropositive for HPV18, Assessed at 36 Months, by Enrollment Month Group(36 month)
- Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment Month Group(36 month)
- Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment Month(36 month)
- Number Seropositive for HPV16, Assessed at 24 Months, by Enrollment Month(24 month)
- Comparison of GMCs for HPV16 Antibodies Assessed at 24 Months, by Enrollment Month Group(24 month)
- Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment Month(24 month)
- Number Seropositive for HPV18, Assessed at 24 Months, by Enrollment Month Group(24 month)
- Comparison of GMCs for HPV18 Antibodies Assessed at 24 Months, by Enrollment Month Group(24 month)
- Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment Month(24 month)
- Number Seropositive for HPV16, Assessed at 36 Months, by Enrollment District(36 month)
- Comparison of GMCs for HPV16 Antibodies, Assessed at 36 Months, by Enrollment District(36 month)
- Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment District(36 month)
- Number Seropositive for HPV18, Assessed at 36 Months, by Enrollment District(36 month)
- Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment District(36 month)
- Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment District(36 month)
- Number Seropositive for HPV16, Assessed at 24 Months, by Enrollment District(24 month)
- Comparison of GMCs for HPV16 Antibodies, Assessed at 24 Months, by Enrollment District(24 month)
- Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment District(24 month)
- Number Seropositive for HPV18, Assessed at 24 Months, by Enrollment District(24 month)
- Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, by Enrollment District(24 month)
- Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment District(24 month)