Cervical Intraepithelial Neoplasia, Papillomavirus Type 16/18 Infection
Conditions
Keywords
Non-inferiority, Immunogenicity, HPV Vaccine Consistency
Brief summary
The study will be extended for subjects who received all three doses of vaccine in Finland, Denmark and Estonia to determine long-term safety and immunogenicity of the HPV-16/18 vaccine. Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of GlaxoSmithKline Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start.
Detailed description
Approximately 750 study subjects received different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALCervarix™
Three doses of vaccine according to a 0, 1, 6 month schedule (during the primary study)
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* A female who enrolled in the HPV-012 (NCT00337818) study in Denmark, Estonia and Finland, received three doses of vaccine and completed Visit 4 (Month 7). * Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative (LAR) and, in addition, the subject must sign and personally date a written informed assent).
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling. * Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | At months 18*, 24, 36 and 48 | Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). \*Data for Month 18 outcome variables were incorporated into the Month 24 analyses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples | At months 24, 36, and 48 | Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL. |
| Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples | At Months 24, 36 and 48 | Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL. |
| Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | Throughout the study period (up to Month 48) | NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSCs assessed include adverse events prompting emergency room or physician visits that are not related to common diseases or serious adverse events (SAEs) that are not related to common diseases. |
| Number of Subjects Reporting SAEs | Throughout the study period (up to Month 48) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. |
Countries
Estonia
Participant flow
Pre-assignment details
Only 8 subjects came to Month 18 whereas most of the subjects came to Month 24. Therefore, no separate analysis at Month 18 was prepared; data for Month 18 outcome variables were incorporated into Month 24 analyses.
Participants by arm
| Arm | Count |
|---|---|
| Cervarix New Process Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process. | 458 |
| Cervarix Old Process Group Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the old manufacturing process. | 154 |
| Cervarix Young Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process. | 158 |
| Total | 770 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 289 | 91 | 107 |
Baseline characteristics
| Characteristic | Cervarix New Process | Cervarix Old Process Group | Cervarix Young | Total |
|---|---|---|---|---|
| Age, Continuous | 20.2 years STANDARD_DEVIATION 2.96 | 20.3 years STANDARD_DEVIATION 2.99 | 12.4 years STANDARD_DEVIATION 1.37 | 18.6 years STANDARD_DEVIATION 4.2 |
| Sex: Female, Male Female | 458 Participants | 154 Participants | 158 Participants | 770 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 11 / 186 | 3 / 65 | 3 / 57 |
Outcome results
Primary
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). \*Data for Month 18 outcome variables were incorporated into the Month 24 analyses.
Time frame: At months 18*, 24, 36 and 48
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix New Process | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 (Month 24) (n=160, 51, 55) | 1440.4 EL.U/mL |
| Cervarix New Process | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 (Month 36) (n=150, 46, 52) | 1397.5 EL.U/mL |
| Cervarix New Process | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 (Month 48) (n=141, 49, 49) | 1140.9 EL.U/mL |
| Cervarix New Process | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 (Month 24) (n=160, 50, 54) | 649.8 EL.U/mL |
| Cervarix New Process | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 (Month 36) (n=151, 45, 51) | 574.7 EL.U/mL |
| Cervarix New Process | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 (Month 48) (n=141, 48, 48) | 462.4 EL.U/mL |
| Cervarix Old Process Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 (Month 48) (n=141, 48, 48) | 519.9 EL.U/mL |
| Cervarix Old Process Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 (Month 24) (n=160, 51, 55) | 1903.7 EL.U/mL |
| Cervarix Old Process Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 (Month 24) (n=160, 50, 54) | 778.8 EL.U/mL |
| Cervarix Old Process Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 (Month 36) (n=151, 45, 51) | 649.6 EL.U/mL |
| Cervarix Old Process Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 (Month 36) (n=150, 46, 52) | 1679.3 EL.U/mL |
| Cervarix Old Process Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 (Month 48) (n=141, 49, 49) | 1427.3 EL.U/mL |
| Cervarix Young | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 (Month 36) (n=150, 46, 52) | 3353.0 EL.U/mL |
| Cervarix Young | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 (Month 48) (n=141, 49, 49) | 2862.2 EL.U/mL |
| Cervarix Young | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 (Month 48) (n=141, 48, 48) | 935.6 EL.U/mL |
| Cervarix Young | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 (Month 24) (n=160, 50, 54) | 1341.8 EL.U/mL |
| Cervarix Young | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 (Month 24) (n=160, 51, 55) | 3861.7 EL.U/mL |
| Cervarix Young | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 (Month 36) (n=151, 45, 51) | 1111.0 EL.U/mL |
Secondary
Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)
NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSCs assessed include adverse events prompting emergency room or physician visits that are not related to common diseases or serious adverse events (SAEs) that are not related to common diseases.
Time frame: Throughout the study period (up to Month 48)
Population: Analysis was performed on the Total vaccinated cohort for Month 24, Month 36 and Month 48, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix New Process | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | MSCs from Month 12 to Month 24 (n= 186, 64, 57) | 12 Subjects |
| Cervarix New Process | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | Pregnancies from Month 36 to Month 48(n=169,63,51) | 15 Subjects |
| Cervarix New Process | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | MSCs from Month 36 to Month 48 (n= 169, 63, 51) | 19 Subjects |
| Cervarix New Process | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | MSCs from Month 24 to Month 36 (n= 184, 65, 53) | 35 Subjects |
| Cervarix New Process | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | NOCDs from Month 12 to Month 24 (n= 186, 64, 57) | 1 Subjects |
| Cervarix New Process | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | Pregnancies from Month 24 to Month 36(n=184,65,53) | 20 Subjects |
| Cervarix New Process | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | NOCDs from Month 36 to Month 48 (n= 169, 63, 51) | 0 Subjects |
| Cervarix New Process | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | NOCDs from Month 24 to Month 36 (n= 184, 65, 53) | 3 Subjects |
| Cervarix New Process | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | Pregnancies from Month 12 to Month 24(n=186,64,57) | 4 Subjects |
| Cervarix Old Process Group | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | MSCs from Month 24 to Month 36 (n= 184, 65, 53) | 10 Subjects |
| Cervarix Old Process Group | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | NOCDs from Month 12 to Month 24 (n= 186, 64, 57) | 0 Subjects |
| Cervarix Old Process Group | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | NOCDs from Month 24 to Month 36 (n= 184, 65, 53) | 0 Subjects |
| Cervarix Old Process Group | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | NOCDs from Month 36 to Month 48 (n= 169, 63, 51) | 1 Subjects |
| Cervarix Old Process Group | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | MSCs from Month 12 to Month 24 (n= 186, 64, 57) | 4 Subjects |
| Cervarix Old Process Group | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | MSCs from Month 36 to Month 48 (n= 169, 63, 51) | 5 Subjects |
| Cervarix Old Process Group | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | Pregnancies from Month 12 to Month 24(n=186,64,57) | 2 Subjects |
| Cervarix Old Process Group | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | Pregnancies from Month 24 to Month 36(n=184,65,53) | 7 Subjects |
| Cervarix Old Process Group | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | Pregnancies from Month 36 to Month 48(n=169,63,51) | 6 Subjects |
| Cervarix Young | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | NOCDs from Month 36 to Month 48 (n= 169, 63, 51) | 1 Subjects |
| Cervarix Young | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | NOCDs from Month 12 to Month 24 (n= 186, 64, 57) | 1 Subjects |
| Cervarix Young | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | Pregnancies from Month 12 to Month 24(n=186,64,57) | 0 Subjects |
| Cervarix Young | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | NOCDs from Month 24 to Month 36 (n= 184, 65, 53) | 1 Subjects |
| Cervarix Young | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | Pregnancies from Month 36 to Month 48(n=169,63,51) | 1 Subjects |
| Cervarix Young | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | MSCs from Month 24 to Month 36 (n= 184, 65, 53) | 6 Subjects |
| Cervarix Young | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | MSCs from Month 12 to Month 24 (n= 186, 64, 57) | 2 Subjects |
| Cervarix Young | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | Pregnancies from Month 24 to Month 36(n=184,65,53) | 0 Subjects |
| Cervarix Young | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | MSCs from Month 36 to Month 48 (n= 169, 63, 51) | 1 Subjects |
Secondary
Number of Subjects Reporting SAEs
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: Throughout the study period (up to Month 48)
Population: Analysis was performed on the Total vaccinated cohort of each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix New Process | Number of Subjects Reporting SAEs | From Month 24 to 36 (n=184,65,53) | 7 Subjects |
| Cervarix New Process | Number of Subjects Reporting SAEs | From Month 12 to 24 (n=186,64,57) | 2 Subjects |
| Cervarix New Process | Number of Subjects Reporting SAEs | From Month 36 to 48 (n=169,63,51) | 5 Subjects |
| Cervarix Old Process Group | Number of Subjects Reporting SAEs | From Month 24 to 36 (n=184,65,53) | 0 Subjects |
| Cervarix Old Process Group | Number of Subjects Reporting SAEs | From Month 12 to 24 (n=186,64,57) | 1 Subjects |
| Cervarix Old Process Group | Number of Subjects Reporting SAEs | From Month 36 to 48 (n=169,63,51) | 2 Subjects |
| Cervarix Young | Number of Subjects Reporting SAEs | From Month 12 to 24 (n=186,64,57) | 0 Subjects |
| Cervarix Young | Number of Subjects Reporting SAEs | From Month 36 to 48 (n=169,63,51) | 0 Subjects |
| Cervarix Young | Number of Subjects Reporting SAEs | From Month 24 to 36 (n=184,65,53) | 3 Subjects |
Secondary
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Time frame: At Months 24, 36 and 48
Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with cervicovaginal secretion sample results available and with cervicovaginal secretion samples having less than 200 erythrocytes per milliliter and with results available for the defined timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix New Process | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples | Anti-HPV-16 [Month 24] (n=74;24;3) | 1403.1 EL.U/mL |
| Cervarix New Process | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples | Anti-HPV-18 [Month 24] (n=74;24;3) | 584.5 EL.U/mL |
| Cervarix New Process | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples | Anti-HPV-16 [Month 48] (n=69;19;4) | 1047.3 EL.U/mL |
| Cervarix New Process | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples | Anti-HPV-18 [Month 48] (n=66;19;4) | 478.4 EL.U/mL |
| Cervarix New Process | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples | Anti-HPV-18 [Month 36] (n=78;27;3) | 555.4 EL.U/mL |
| Cervarix New Process | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples | Anti-HPV-16 [Month 36] (n=78;27;3) | 1291.8 EL.U/mL |
| Cervarix Old Process Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples | Anti-HPV-16 [Month 48] (n=69;19;4) | 1950.5 EL.U/mL |
| Cervarix Old Process Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples | Anti-HPV-16 [Month 24] (n=74;24;3) | 1490.5 EL.U/mL |
| Cervarix Old Process Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples | Anti-HPV-16 [Month 36] (n=78;27;3) | 1435.0 EL.U/mL |
| Cervarix Old Process Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples | Anti-HPV-18 [Month 48] (n=66;19;4) | 805.4 EL.U/mL |
| Cervarix Old Process Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples | Anti-HPV-18 [Month 24] (n=74;24;3) | 648.6 EL.U/mL |
| Cervarix Old Process Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples | Anti-HPV-18 [Month 36] (n=78;27;3) | 542.1 EL.U/mL |
| Cervarix Young | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples | Anti-HPV-18 [Month 36] (n=78;27;3) | 1163.6 EL.U/mL |
| Cervarix Young | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples | Anti-HPV-18 [Month 24] (n=74;24;3) | 1814.6 EL.U/mL |
| Cervarix Young | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples | Anti-HPV-16 [Month 24] (n=74;24;3) | 5399.5 EL.U/mL |
| Cervarix Young | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples | Anti-HPV-18 [Month 48] (n=66;19;4) | 1048.9 EL.U/mL |
| Cervarix Young | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples | Anti-HPV-16 [Month 48] (n=69;19;4) | 3332.7 EL.U/mL |
| Cervarix Young | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples | Anti-HPV-16 [Month 36] (n=78;27;3) | 3733.3 EL.U/mL |
Secondary
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Time frame: At months 24, 36, and 48
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, in post-menarcheal subjects who volunteered for cervicovaginal sampling collection and with cervicovaginal secretion samples having less than 80 erythrocytes per milliliter and with results available for the defined timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix New Process | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples | HPV-16 (Month 24) (n= 55, 13, 1) | 85.4 EL.U/mL |
| Cervarix New Process | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples | HPV-16 (Month 36) (n= 78, 27, 3) | 68.2 EL.U/mL |
| Cervarix New Process | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples | HPV-16 (Month 48) (n=69, 19, 4) | 56.2 EL.U/mL |
| Cervarix New Process | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples | HPV-18 (Month 24) (n= 55, 13, 1) | 45.9 EL.U/mL |
| Cervarix New Process | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples | HPV-18 (Month 36) (n= 78, 27, 3) | 38.9 EL.U/mL |
| Cervarix New Process | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples | HPV-18 (Month 48) (n= 66, 19, 4) | 33.9 EL.U/mL |
| Cervarix Old Process Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples | HPV-18 (Month 48) (n= 66, 19, 4) | 48.8 EL.U/mL |
| Cervarix Old Process Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples | HPV-16 (Month 24) (n= 55, 13, 1) | 107.5 EL.U/mL |
| Cervarix Old Process Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples | HPV-18 (Month 24) (n= 55, 13, 1) | 31.9 EL.U/mL |
| Cervarix Old Process Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples | HPV-18 (Month 36) (n= 78, 27, 3) | 29.6 EL.U/mL |
| Cervarix Old Process Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples | HPV-16 (Month 36) (n= 78, 27, 3) | 62.1 EL.U/mL |
| Cervarix Old Process Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples | HPV-16 (Month 48) (n=69, 19, 4) | 94.5 EL.U/mL |
| Cervarix Young | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples | HPV-16 (Month 36) (n= 78, 27, 3) | 63.4 EL.U/mL |
| Cervarix Young | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples | HPV-16 (Month 48) (n=69, 19, 4) | 129.2 EL.U/mL |
| Cervarix Young | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples | HPV-18 (Month 48) (n= 66, 19, 4) | 97.5 EL.U/mL |
| Cervarix Young | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples | HPV-18 (Month 24) (n= 55, 13, 1) | 107.9 EL.U/mL |
| Cervarix Young | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples | HPV-16 (Month 24) (n= 55, 13, 1) | 198.8 EL.U/mL |
| Cervarix Young | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples | HPV-18 (Month 36) (n= 78, 27, 3) | 19.9 EL.U/mL |