Infections, Papillomavirus, Papillomavirus Vaccines
Conditions
Keywords
Vaccines, Cervical cancer, Immunogenicity, Humans, Safety, Viral infections, Human papillomavirus (HPV), Comparative study, Human papillomavirus vaccine, Adults
Brief summary
HPV infection has been established as a necessary cause of cervical cancer. GSK Biologicals has developed an HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in \> 70%, approximately, of all cervical cancers. Recently, Merck's HPV vaccine Gardasil® \[quadrivalent human papillomavirus (HPV-6,11,16,18 L1 VLP) recombinant vaccine\] has been approved by the FDA for prevention of genital tract cancers and pre-cancers and genital warts in females. Although the GSK HPV vaccine and Gardasil® have different compositions and are expected to have different efficacy profiles, each vaccine targets prevention of HPV-16 and 18 genital tract cancers and pre-cancers. Therefore, a comparison of the immunogenicity of the two vaccines is warranted. This Phase 3b study is designed to compare the immunogenicity of the GSK vaccine (HPV-16/18) to Gardasil® in healthy adult females 18-45 years of age. The Protocol Posting has been updated as the study will be extended by 3 additional years.
Detailed description
This Protocol Posting has been updated following Protocol Amendment 25, November 2010
Interventions
Three doses administered intramuscularly at months 0, 1 and 6
Three doses administered intramuscularly at months 0, 2 and 6
One dose administered intramuscularly at month 1 to maintain blinding
Sponsors
Study design
Eligibility
Inclusion criteria
* A woman whom the investigator believes that she or her legally acceptable representative (in the event that the subject is illiterate) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits). * A woman between and including 18 and 45 years of age at the time of the first vaccination. * Written informed consent must be obtained from the subject prior to enrollment. * Subject must be free of obvious health problems as established by medical history and history-directed clinical examination before entering into the study. * Subject must have a negative urine pregnancy test. * Subject must be of non-childbearing potential, or if she is of child bearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series. * Subject must have an intact cervix.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period up to Month 60. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned administration during the study period up to Month 60. * Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. days 0-29) each dose of vaccine. Administration of routine vaccines up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window. * Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study. * A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first eight months of the study (Months 0-8). * Previous administration of components of the investigational vaccine * Previous or planned vaccination against HPV outside of this protocol. * Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination. * History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines. * Hypersensitivity to latex. * Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests. * History of significant medical conditions and currently under treatment. * Received immunoglobulins and/or blood product within 90 days preceding enrolment or planned administration during the study period up to Month 60. Enrollment will be deferred until the subject is outside of specified window. * Acute disease at the time of enrolment. Enrollment will be deferred until condition is resolved. All vaccines can be administered to persons with a minor illness * Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a pelvic exam cannot be performed. Enrollment will be deferred until condition is resolved according to investigator's medical judgement.
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) Neutralizing Antibodies | At Month 7 | Titers are displayed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value | At Month 7 | Other oncogenic HPV types include HPV-31 and HPV-45. The titer value (=serum dilution giving a 50 percent reduction of the signal compared to a control without serum) used as the cut-off for seroconversion was 40 for both other oncogenic types HPV-31 and HPV-45. |
| Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay | At Month 7 | Other Oncogenic Types include HPV-31 and HPV-45. Titers were measured by neutralization assay and are given as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum |
| Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | At Month 6, 7, 12, 18, 24, 36, 48 and 60 | The titer value (=serum dilution giving a 50 percent reduction of the signal compared to a control without serum) used as the cut-off for seroconversion was 40 for both HPV-16 and HPV-18. |
| Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | At Month 6, 7, 12, 18, 24, 36, 48 and 60 | Cut-off values assessed were greater than or equal to 8 ELISA units per milliliter (EL.U/mL) for HPV-16 and greater than or equal to 7 EL.U/mL for HPV-18. |
| Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | At Month 6, 7, 12, 18, 24, 36, 48 and 60 | Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). |
| Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | At Month 6, 7, 12, 18, 24, 36 and 48 | Other oncogenic types include HPV-31 and HPV-45. Cut-off values assessed were greater than or equal 59 EL.U/mL in the sera of subjects seronegative before vaccination. |
| Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | At Month 6, 7, 12, 18, 24, 36 and 48 | Other oncogenic types include HPV-31 and HPV-45. Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). |
| Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | At Month 7, 12, 18, 24, 36 and 48 | Number of cells were expressed as geometric mean, minimum and maximum values of specific CD4 cells producing at least 2 cytokines (CD40 Ligand, Interleukin-2, Tumor Necrosis Factor Alpha or Interferon-gamma) per million of CD4 T-cells. |
| Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | At Month 6, 7, 12, 18, 24, 36, 48 and 60 | Titers are given as Geometric Mean Titers (GMTs). Titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum. Data for Month 7 on subjects aged 18 to 26 years are given in the outcome above as a primary outcome measure. |
| Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | At Month 7, 12, 18, 24, 36 and 48 | HPV-16 and HPV-18 Specific Memory B Cells were measured by Enzyme-linked immunosorbent spot (ELISPOT) assay and expressed as geometric mean, minimum and maximum values of specific B-cells per million of cells. |
| Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | At Month 7, 12, 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). |
| Number of Subjects Completing the 3-dose Vaccination Schedule | Up to Month 7 | — |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms | During the 7-day period (Day 0-6) following vaccination | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. All solicited local symptoms were assessed as related to study vaccination. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | During the 7-day period (Day 0-6) following vaccination | Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During the 30-day period (Day 0-29) following vaccination | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.Grade 3 AE = AE that prevented normal activity. Related AE = AE assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | Up to Month 7 | NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. |
| Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Up to Month 7 | 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. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed. |
| Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | At Month 7, 12 and 18 | Data were expressed as geometric mean, minimum and maximum values of specific CD8 cells producing at least 2 cytokines (CD40 Ligand, Interleukin-2, Tumor Necrosis Factor Alpha or Interferon-gamma) per million of CD8 T-cells. Analyses for further time points were not performed, as there was no response at these time points. |
Countries
United States
Participant flow
Pre-assignment details
Subjects who missed Month 7 visit and/or one or more follow-up visits were permitted to attend the next scheduled follow-up visits.
Participants by arm
| Arm | Count |
|---|---|
| Cervarix Group Subjects received 3 doses of GSK Biologicals human papillomavirus \[HPV\] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm. | 553 |
| Gardasil Group Subjects received 3 doses of Gardasil® (Merck's human papillomavirus \[HPV\] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm. | 553 |
| Total | 1,106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Other | 340 | 345 |
Baseline characteristics
| Characteristic | Cervarix Group | Gardasil Group | Total |
|---|---|---|---|
| Age, Continuous | 30.3 years STANDARD_DEVIATION 8.02 | 30.2 years STANDARD_DEVIATION 7.78 | 30.25 years STANDARD_DEVIATION 7.9 |
| Sex: Female, Male Female | 553 Participants | 553 Participants | 1106 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 500 / 553 | 462 / 553 |
| serious Total, serious adverse events | 44 / 553 | 37 / 553 |
Outcome results
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Titers are displayed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.
Time frame: At Month 7
Population: Analysis was performed on subjects from the According-to-Protocol (ATP) cohort for immunogenicity aged 18 to 26 years and who were seronegative by Pseudovirion (PSV) neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16 | 36791.8 titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18 | 16486.9 titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16 | 10053.1 titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18 | 2257.9 titer |
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-16 and HPV-18 Specific Memory B Cells were measured by Enzyme-linked immunosorbent spot (ELISPOT) assay and expressed as geometric mean, minimum and maximum values of specific B-cells per million of cells.
Time frame: At Month 7, 12, 18, 24, 36 and 48
Population: Results are presented by age group in subjects with detectable B-cells (\>0) at defined time points, who were HPV-16/18 seronegative (by PSV neutralizing assay), DNA negative and HPV-16/18 specific B-cell negative at baseline from a subset of the ATP cohort for immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 36-45-year, Month 36 | 503.9 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 36-45-year, Month 7 | 785.7 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 18-26-year, Month 7 | 700.7 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 18-26-year, Month 12 | 344.1 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 18-26-year, Month 18 | 262.1 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 18-26-year, Month 24 | 233.5 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 18-26-year, Month 36 | 207.7 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 18-26-year, Month 48 | 219.7 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 27-35-year, Month 7 | 898.0 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 27-35-year, Month 12 | 237.6 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 27-35-year, Month 18 | 216.5 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 27-35-year, Month 24 | 279.1 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 27-35-year, Month 36 | 506.5 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 27-35-year, Month 48 | 354.3 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 36-45-year, Month 7 | 1476.0 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 36-45-year, Month 12 | 363.7 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 36-45-year, Month 18 | 301.3 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 36-45-year, Month 24 | 492.1 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 36-45-year, Month 48 | 364.8 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 18-26-year, Month 7 | 313.2 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 18-26-year, Month 12 | 152.5 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 18-26-year, Month 18 | 137.3 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 18-26-year, Month 24 | 255.5 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 18-26-year, Month 36 | 391.0 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 18-26-year, Month 48 | 124.7 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 27-35-year, Month 7 | 433.4 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 27-35-year, Month 12 | 172.4 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 27-35-year, Month 18 | 202.5 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 27-35-year, Month 24 | 151.6 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 27-35-year, Month 36 | 161.9 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 27-35-year, Month 48 | 366.4 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 36-45-year, Month 12 | 459.8 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 36-45-year, Month 18 | 436.9 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 36-45-year, Month 24 | 576.8 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 36-45-year, Month 36 | 376.6 cells per million B-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 36-45-year, Month 48 | 302.4 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 36-45-year, Month 12 | 242.8 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 27-35-year, Month 48 | 134.2 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 36-45-year, Month 48 | 738.0 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 27-35-year, Month 18 | 74.7 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 18-26-year, Month 7 | 358.5 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 18-26-year, Month 7 | 163.9 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 18-26-year, Month 12 | 192.3 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 36-45-year, Month 48 | 91.7 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 18-26-year, Month 18 | 325.2 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 18-26-year, Month 12 | 63.8 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 18-26-year, Month 24 | 440.0 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 27-35-year, Month 24 | 97.0 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 18-26-year, Month 36 | 505.4 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 18-26-year, Month 18 | 76.4 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 18-26-year, Month 48 | 130.0 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 36-45-year, Month 18 | 91.5 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 27-35-year, Month 7 | 253.5 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 18-26-year, Month 24 | 101.0 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 27-35-year, Month 12 | 202.8 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 27-35-year, Month 36 | 224.2 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 27-35-year, Month 18 | 194.3 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 18-26-year, Month 36 | 114.1 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 27-35-year, Month 24 | 141.2 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 36-45-year, Month 36 | 23.0 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 27-35-year, Month 36 | 142.1 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 18-26-year, Month 48 | 118.0 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 27-35-year, Month 48 | 358.0 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 36-45-year, Month 7 | 192.5 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 36-45-year, Month 7 | 539.3 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 27-35-year, Month 7 | 153.7 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 36-45-year, Month 12 | 270.8 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 36-45-year, Month 24 | 106.6 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 36-45-year, Month 18 | 210.2 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-18, 27-35-year, Month 12 | 130.4 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 36-45-year, Month 24 | 338.0 cells per million B-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells | HPV-16, 36-45-year, Month 36 | 192.9 cells per million B-cells |
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
Number of cells were expressed as geometric mean, minimum and maximum values of specific CD4 cells producing at least 2 cytokines (CD40 Ligand, Interleukin-2, Tumor Necrosis Factor Alpha or Interferon-gamma) per million of CD4 T-cells.
Time frame: At Month 7, 12, 18, 24, 36 and 48
Population: Results are presented by age group for subjects HPV-16/18 seronegative (by PSV neutralizing assay), DNA negative and HPV-16/18 specific T-cell negative (i.e., with \< 500 cells/million cells at baseline) from a subset of the ATP cohort for immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 18-26-year, Month 7 | 1285.6 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 18-26-year, Month 12 | 1087.6 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 18-26-year, Month 18 | 1194.4 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 18-26-year, Month 24 | 1195.9 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 18-26-year, Month 36 | 838.3 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 18-26-year, Month 48 | 1272.4 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 27-35-year, Month 12 | 664.1 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 27-35-year, Month 18 | 1134.4 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 27-35-year, Month 24 | 919.8 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 27-35-year, Month 48 | 307.7 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 36-45-year, Month 7 | 979.7 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 36-45-year, Month 12 | 707.7 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 36-45-year, Month 18 | 1116.8 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 36-45-year, Month 24 | 1118.9 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 36-45-year, Month 36 | 710.5 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 36-45-year, Month 48 | 1247.9 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 18-26-year, Month 7 | 998.8 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 18-26-year, Month 12 | 716.4 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 18-26-year, Month 18 | 844.3 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 18-26-year, Month 24 | 793.0 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 18-26-year, Month 36 | 622.6 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 18-26-year, Month 48 | 927.7 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 27-35-year, Month 7 | 924.3 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 27-35-year, Month 12 | 416.5 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 27-35-year, Month 18 | 710.8 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 27-35-year, Month 24 | 575.6 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 27-35-year, Month 48 | 643.7 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 36-45-year, Month 7 | 815.6 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 36-45-year, Month 12 | 384.3 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 36-45-year, Month 18 | 949.0 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 36-45-year, Month 24 | 807.2 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 36-45-year, Month 36 | 337.4 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 36-45-year, Month 48 | 764.0 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 27-35-year, Month 7 | 990.7 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 27-35-year, Month 36 | 431.0 cells per million CD4 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 27-35-year, Month 36 | 265.4 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 18-26-year, Month 48 | 388.6 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 18-26-year, Month 7 | 729.1 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 18-26-year, Month 18 | 264.2 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 18-26-year, Month 12 | 421.3 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 36-45-year, Month 12 | 405.0 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 18-26-year, Month 18 | 309.0 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 27-35-year, Month 24 | 355.8 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 18-26-year, Month 24 | 323.5 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 18-26-year, Month 36 | 211.4 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 18-26-year, Month 36 | 399.9 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 36-45-year, Month 18 | 195.4 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 27-35-year, Month 7 | 637.1 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 18-26-year, Month 48 | 162.1 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 27-35-year, Month 12 | 493.3 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 27-35-year, Month 36 | 206.2 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 27-35-year, Month 18 | 448.0 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 27-35-year, Month 7 | 680.7 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 27-35-year, Month 24 | 373.0 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 36-45-year, Month 24 | 520.5 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 27-35-year, Month 48 | 560.8 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 27-35-year, Month 12 | 471.2 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 36-45-year, Month 7 | 609.8 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 27-35-year, Month 36 | 85.9 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 36-45-year, Month 12 | 431.3 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 27-35-year, Month 18 | 568.4 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 36-45-year, Month 18 | 446.1 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 36-45-year, Month 36 | 392.1 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 36-45-year, Month 24 | 789.3 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 18-26-year, Month 24 | 197.4 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 36-45-year, Month 36 | 494.2 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 27-35-year, Month 48 | 426.7 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-16, 36-45-year, Month 48 | 642.4 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 36-45-year, Month 48 | 612.2 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 18-26-year, Month 7 | 594.9 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 36-45-year, Month 7 | 212.2 cells per million CD4 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells | HPV-18, 18-26-year, Month 12 | 192.3 cells per million CD4 T-cells |
Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells
Data were expressed as geometric mean, minimum and maximum values of specific CD8 cells producing at least 2 cytokines (CD40 Ligand, Interleukin-2, Tumor Necrosis Factor Alpha or Interferon-gamma) per million of CD8 T-cells. Analyses for further time points were not performed, as there was no response at these time points.
Time frame: At Month 7, 12 and 18
Population: Results are presented by age group for subjects HPV-16/18 seronegative (by PSV neutralizing assay), DNA negative and HPV-16/18 specific T-cell negative (i.e., with \< 200 cells/million cells at baseline) from a subset of the ATP cohort for immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-16, 18-26-year, Month 18 | 3.5 cells per million CD8 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-16, 18-26-year, Month 7 | 5.3 cells per million CD8 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-16, 36-45-year, Month 7 | 3.0 cells per million CD8 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-16, 36-45-year, Month 12 | 4.6 cells per million CD8 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-18, 18-26-year, Month 18 | 4.1 cells per million CD8 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-18, 27-35-year, Month 18 | 3.1 cells per million CD8 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-16, 27-35-year, Month 12 | 5.0 cells per million CD8 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-16, 36-45-year, Month 18 | 4.1 cells per million CD8 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-18, 27-35-year, Month 7 | 2.6 cells per million CD8 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-16, 27-35-year, Month 7 | 2.5 cells per million CD8 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-18, 27-35-year, Month 12 | 3.5 cells per million CD8 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-18, 18-26-year, Month 7 | 9.3 cells per million CD8 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-18, 36-45-year, Month 7 | 9.2 cells per million CD8 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-16, 27-35-year, Month 18 | 2.4 cells per million CD8 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-18, 36-45-year, Month 12 | 2.4 cells per million CD8 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-18, 18-26-year, Month 12 | 4.6 cells per million CD8 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-18, 36-45-year, Month 18 | 6.3 cells per million CD8 T-cells |
| Cervarix Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-16, 18-26-year, Month 12 | 4.0 cells per million CD8 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-18, 36-45-year, Month 18 | 4.5 cells per million CD8 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-16, 18-26-year, Month 12 | 2.8 cells per million CD8 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-16, 18-26-year, Month 18 | 4.5 cells per million CD8 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-16, 27-35-year, Month 7 | 5.1 cells per million CD8 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-16, 27-35-year, Month 12 | 3.8 cells per million CD8 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-16, 27-35-year, Month 18 | 8.6 cells per million CD8 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-16, 36-45-year, Month 12 | 4.0 cells per million CD8 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-16, 36-45-year, Month 18 | 8.9 cells per million CD8 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-18, 18-26-year, Month 7 | 3.0 cells per million CD8 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-18, 18-26-year, Month 12 | 3.4 cells per million CD8 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-16, 18-26-year, Month 7 | 3.2 cells per million CD8 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-16, 36-45-year, Month 7 | 6.1 cells per million CD8 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-18, 27-35-year, Month 18 | 7.1 cells per million CD8 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-18, 18-26-year, Month 18 | 4.3 cells per million CD8 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-18, 27-35-year, Month 7 | 3.6 cells per million CD8 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-18, 27-35-year, Month 12 | 4.6 cells per million CD8 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-18, 36-45-year, Month 7 | 3.4 cells per million CD8 T-cells |
| Gardasil Group | Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells | HPV-18, 36-45-year, Month 12 | 6.8 cells per million CD8 T-cells |
Number of Subjects Completing the 3-dose Vaccination Schedule
Time frame: Up to Month 7
Population: The number of subjects completing the 3-dose vaccination schedule was defined as the number of subjects who received the 3 active doses (placebo administrations are not reflected).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects Completing the 3-dose Vaccination Schedule | 468 Participants |
| Gardasil Group | Number of Subjects Completing the 3-dose Vaccination Schedule | 467 Participants |
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day period (Day 0-6) following vaccination
Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 76 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 24 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 10 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 250 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 19 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 114 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 10 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 145 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 25 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 102 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 230 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 26 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 59 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 262 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms | 134 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 13 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 209 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 132 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 30 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 19 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms | 172 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 15 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms | 139 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 103 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 8 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 11 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 81 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 209 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 58 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 220 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 18 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 21 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 3 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 12 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 12 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 20 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 1 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 2 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 74 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 181 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 46 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms | 106 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 187 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 90 Participants |
Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. All solicited local symptoms were assessed as related to study vaccination.
Time frame: During the 7-day period (Day 0-6) following vaccination
Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Pain | 91 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms | Any Swelling | 191 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Redness | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms | Any Redness | 232 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Swelling | 5 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms | Any Pain | 487 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Swelling | 3 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms | Any Pain | 375 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms | Any Swelling | 114 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Pain | 18 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Gardasil Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms | Any Redness | 134 Participants |
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: Up to Month 7
Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | NOCD(s) | 14 Participants |
| Cervarix Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | MSC(s) | 164 Participants |
| Gardasil Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | NOCD(s) | 13 Participants |
| Gardasil Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | MSC(s) | 148 Participants |
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. Note: NOCD and MSC cases were unblinded at the Month 60 analysis.
Time frame: Up to Month 60
Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | Any NOCD(s) | 39 Participants |
| Cervarix Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | Any MSC(s) | 259 Participants |
| Gardasil Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | Any NOCD(s) | 43 Participants |
| Gardasil Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | Any MSC(s) | 226 Participants |
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: Up to Month 48
Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | NOCDs | 33 Participants |
| Cervarix Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | MSCs | 251 Participants |
| Gardasil Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | MSCs | 216 Participants |
| Gardasil Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | NOCDs | 33 Participants |
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: Up To Month 36
Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | NOCD(s) | 27 Participants |
| Cervarix Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | MSC(s) | 239 Participants |
| Gardasil Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | NOCD(s) | 29 Participants |
| Gardasil Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | MSC(s) | 205 Participants |
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: Up To Month 24
Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | NOCD(s) | 20 Participants |
| Cervarix Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | MSC(s) | 221 Participants |
| Gardasil Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | NOCD(s) | 21 Participants |
| Gardasil Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | MSC(s) | 192 Participants |
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: Up To Month 18
Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | NOCD(s) | 20 Participants |
| Cervarix Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | MSC(s) | 210 Participants |
| Gardasil Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | NOCD(s) | 21 Participants |
| Gardasil Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | MSC(s) | 185 Participants |
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: Up To Month 12
Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | MSC(s) | 181 Participants |
| Cervarix Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | NOCD(s) | 14 Participants |
| Gardasil Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | NOCD(s) | 17 Participants |
| Gardasil Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs) | MSC(s) | 168 Participants |
Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value
The titer value (=serum dilution giving a 50 percent reduction of the signal compared to a control without serum) used as the cut-off for seroconversion was 40 for both HPV-16 and HPV-18.
Time frame: At Month 6, 7, 12, 18, 24, 36, 48 and 60
Population: Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 27-35-year, Month 36 | 63 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 18-26-year, Month 7 | 104 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 18-26-year, Month 12 | 101 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 18-26-year, Month 18 | 100 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 18-26-year, Month 36 | 60 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 18-26-year, Month 48 | 54 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 18-26-year, Month 60 | 35 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 27-35-year, Month 6 | 90 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 27-35-year, Month 7 | 90 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 27-35-year, Month 12 | 91 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 27-35-year, Month 18 | 87 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 27-35-year, Month 24 | 84 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 18-26-year, Month 6 | 104 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 27-35-year, Month 48 | 54 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 27-35-year, Month 60 | 43 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 36-45-year, Month 6 | 95 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 36-45-year, Month 18 | 90 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 36-45-year, Month 24 | 87 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 36-45-year, Month 36 | 61 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 36-45-year, Month 48 | 50 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 36-45-year, Month 60 | 46 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 18-26-year, Month 6 | 117 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 18-26-year, Month 7 | 118 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 18-26-year, Month 12 | 112 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 18-26-year, Month 18 | 109 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 18-26-year, Month 24 | 106 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 18-26-year, Month 36 | 64 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 18-26-year, Month 48 | 59 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 18-26-year, Month 60 | 39 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 27-35-year, Month 6 | 99 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 27-35-year, Month 18 | 101 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 27-35-year, Month 24 | 98 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 27-35-year, Month 60 | 53 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 36-45-year, Month 12 | 104 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 36-45-year, Month 36 | 69 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 36-45-year, Month 48 | 59 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 18-26-year, Month 24 | 97 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 36-45-year, Month 7 | 96 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 36-45-year, Month 12 | 89 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 27-35-year, Month 7 | 102 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 27-35-year, Month 12 | 104 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 27-35-year, Month 36 | 75 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 27-35-year, Month 48 | 66 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 36-45-year, Month 6 | 107 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 36-45-year, Month 7 | 110 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 36-45-year, Month 18 | 102 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 36-45-year, Month 24 | 99 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 36-45-year, Month 60 | 55 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 18-26-year, Month 18 | 91 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 18-26-year, Month 6 | 101 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 18-26-year, Month 18 | 106 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 18-26-year, Month 7 | 103 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 36-45-year, Month 24 | 68 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 18-26-year, Month 12 | 99 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 18-26-year, Month 24 | 92 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 18-26-year, Month 24 | 87 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 27-35-year, Month 48 | 34 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 18-26-year, Month 36 | 61 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 18-26-year, Month 36 | 60 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 18-26-year, Month 48 | 56 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 36-45-year, Month 7 | 83 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 18-26-year, Month 60 | 39 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 18-26-year, Month 48 | 57 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 27-35-year, Month 6 | 83 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 36-45-year, Month 18 | 79 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 27-35-year, Month 7 | 85 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 18-26-year, Month 60 | 40 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 27-35-year, Month 12 | 84 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 36-45-year, Month 12 | 83 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 27-35-year, Month 18 | 82 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 27-35-year, Month 6 | 84 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 27-35-year, Month 24 | 77 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 27-35-year, Month 12 | 92 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 27-35-year, Month 36 | 49 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 36-45-year, Month 6 | 78 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 27-35-year, Month 48 | 49 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 27-35-year, Month 18 | 74 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 27-35-year, Month 60 | 28 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 27-35-year, Month 7 | 99 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 36-45-year, Month 6 | 81 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 36-45-year, Month 60 | 38 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 36-45-year, Month 18 | 82 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 27-35-year, Month 60 | 22 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 36-45-year, Month 24 | 80 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 27-35-year, Month 24 | 68 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 36-45-year, Month 36 | 57 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 36-45-year, Month 12 | 90 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 36-45-year, Month 48 | 53 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 36-45-year, Month 7 | 91 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-16, 36-45-year, Month 60 | 45 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 36-45-year, Month 36 | 45 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 18-26-year, Month 6 | 121 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 27-35-year, Month 36 | 43 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 18-26-year, Month 7 | 131 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 36-45-year, Month 48 | 44 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value | Anti-HPV-18, 18-26-year, Month 12 | 122 Participants |
Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value
Other oncogenic HPV types include HPV-31 and HPV-45. The titer value (=serum dilution giving a 50 percent reduction of the signal compared to a control without serum) used as the cut-off for seroconversion was 40 for both other oncogenic types HPV-31 and HPV-45.
Time frame: At Month 7
Population: Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value | Anti-HPV-31, 27-35-year | 59 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value | Anti-HPV-45, 18-26-year | 35 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value | Anti-HPV-45, 27-35-year | 21 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value | Anti-HPV-31, 18-26-year | 90 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value | Anti-HPV-31, 36-45-year | 68 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value | Anti-HPV-45, 36-45-year | 28 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value | Anti-HPV-45, 27-35-year | 7 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value | Anti-HPV-31, 27-35-year | 32 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value | Anti-HPV-31, 36-45-year | 39 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value | Anti-HPV-31, 18-26-year | 60 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value | Anti-HPV-45, 18-26-year | 4 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value | Anti-HPV-45, 36-45-year | 10 Participants |
Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Other oncogenic types include HPV-31 and HPV-45. Cut-off values assessed were greater than or equal 59 EL.U/mL in the sera of subjects seronegative before vaccination.
Time frame: At Month 6, 7, 12, 18, 24, 36 and 48
Population: Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 36 | 30 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 12 | 101 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 6 | 42 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 18 | 90 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 48 | 22 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 24 | 89 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 18 | 80 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 36 | 50 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 6 | 45 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 48 | 37 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 7 | 80 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 6 | 62 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 7 | 76 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 7 | 85 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 36 | 44 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 12 | 81 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 18 | 48 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 18 | 68 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 12 | 72 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 24 | 68 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 12 | 69 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 36 | 45 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 12 | 89 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 48 | 36 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 24 | 49 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 6 | 58 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 18 | 52 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 7 | 83 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 36 | 33 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 12 | 73 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 48 | 37 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 18 | 56 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 48 | 20 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 24 | 51 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 24 | 50 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 36 | 31 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 6 | 95 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 48 | 28 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 24 | 77 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 6 | 75 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 7 | 109 Participants |
| Cervarix Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 7 | 98 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 48 | 34 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 12 | 103 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 18 | 71 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 24 | 62 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 36 | 42 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 48 | 32 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 6 | 76 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 7 | 81 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 12 | 80 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 18 | 53 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 24 | 48 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 36 | 29 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 48 | 23 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 6 | 70 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 7 | 78 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 18 | 56 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 12 | 75 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 24 | 51 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 36 | 38 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 48 | 32 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 6 | 104 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 7 | 109 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 12 | 105 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 18 | 77 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 24 | 68 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 36 | 46 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 7 | 111 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 6 | 83 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 7 | 86 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 12 | 84 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 18 | 64 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 24 | 56 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 36 | 29 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 48 | 21 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 6 | 76 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 7 | 80 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 12 | 80 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 18 | 67 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 24 | 61 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 36 | 41 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 48 | 32 Participants |
| Gardasil Group | Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 6 | 104 Participants |
Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Cut-off values assessed were greater than or equal to 8 ELISA units per milliliter (EL.U/mL) for HPV-16 and greater than or equal to 7 EL.U/mL for HPV-18.
Time frame: At Month 6, 7, 12, 18, 24, 36, 48 and 60
Population: Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 48 | 43 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 24 | 81 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 36 | 50 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 48 | 46 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 60 | 31 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 6 | 57 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 12 | 57 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 18 | 54 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 24 | 52 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 36 | 41 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 60 | 28 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 6 | 64 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 7 | 64 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 12 | 59 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 18 | 61 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 24 | 58 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 48 | 35 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 60 | 31 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 6 | 95 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 36 | 49 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 60 | 31 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 6 | 71 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 12 | 72 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 18 | 69 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 36 | 54 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 48 | 50 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 60 | 39 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 6 | 74 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 12 | 69 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 18 | 69 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 24 | 67 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 36 | 51 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18 36-45-year, Month 60 | 39 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 6 | 91 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 12 | 87 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 18 | 84 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 7 | 57 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 48 | 37 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 36 | 42 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 7 | 95 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 12 | 92 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 18 | 90 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 24 | 87 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 48 | 47 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 7 | 71 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 24 | 68 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 7 | 74 Participants |
| Cervarix Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 7 | 91 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 36 | 41 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 48 | 36 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 24 | 73 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 24 | 50 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 36 | 53 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 60 | 23 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 48 | 47 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 48 | 52 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 60 | 35 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 7 | 68 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 6 | 55 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 6 | 99 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 12 | 57 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 12 | 70 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 18 | 53 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 6 | 66 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 24 | 51 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 18 | 71 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 36 | 35 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 48 | 36 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 7 | 100 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 60 | 20 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 24 | 67 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 6 | 52 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 6 | 67 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 7 | 52 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 48 | 51 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 12 | 53 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 12 | 97 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 18 | 52 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18 36-45-year, Month 60 | 41 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 36 | 36 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 36 | 51 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 48 | 36 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 6 | 85 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 60 | 31 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 7 | 86 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 24 | 82 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 18 | 87 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 12 | 81 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 60 | 38 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 24 | 61 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 7 | 67 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 18 | 76 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 12 | 68 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 36 | 59 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 18 | 64 Participants |
| Gardasil Group | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 7 | 56 Participants |
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (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. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAE(s) was not assessed. Note: SAEs were unblinded at the Month 60 analysis.
Time frame: Up to Month 60
Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Any SAE(s) | 44 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Related SAE(s) | 1 Participants |
| Gardasil Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Any SAE(s) | 37 Participants |
| Gardasil Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Related SAE(s) | 1 Participants |
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (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. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.
Time frame: Up to Month 7
Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Any SAE(s) | 6 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Related SAE(s) | 1 Participants |
| Gardasil Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Any SAE(s) | 7 Participants |
| Gardasil Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Related SAE(s) | 1 Participants |
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (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. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.
Time frame: Up to Month 12
Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Any SAE(s) | 12 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Related SAE(s) | 1 Participants |
| Gardasil Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Any SAE(s) | 20 Participants |
| Gardasil Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Related SAE(s) | 1 Participants |
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (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. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.
Time frame: Up to Month 18
Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Any SAE(s) | 14 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Related SAE(s) | 1 Participants |
| Gardasil Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Any SAE(s) | 20 Participants |
| Gardasil Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Related SAE(s) | 1 Participants |
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (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. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.
Time frame: Up to Month 24
Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Any SAE(s) | 23 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Related SAE(s) | 1 Participants |
| Gardasil Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Any SAE(s) | 22 Participants |
| Gardasil Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Related SAE(s) | 1 Participants |
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (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. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.
Time frame: Up to Month 36
Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Any SAE(s) | 30 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Related SAE(s) | 1 Participants |
| Gardasil Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Any SAE(s) | 28 Participants |
| Gardasil Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Related SAE(s) | 1 Participants |
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (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. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.
Time frame: Up to Month 48
Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Any SAE(s) | 37 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Related SAE(s) | 1 Participants |
| Gardasil Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Any SAE(s) | 34 Participants |
| Gardasil Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Related SAE(s) | 1 Participants |
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.Grade 3 AE = AE that prevented normal activity. Related AE = AE assessed by the investigator as causally related to the study vaccination.
Time frame: During the 30-day period (Day 0-29) following vaccination
Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 235 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 41 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 70 Participants |
| Gardasil Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 202 Participants |
| Gardasil Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 37 Participants |
| Gardasil Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 63 Participants |
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Other oncogenic types include HPV-31 and HPV-45. Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Time frame: At Month 6, 7, 12, 18, 24, 36 and 48
Population: Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 36 | 74.5 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 18 | 231.3 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 24 | 192.9 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 48 | 99.8 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 48 | 64.4 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 48 | 124.7 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 7 | 720.6 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 6 | 88.4 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 12 | 212.1 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 7 | 588.5 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 18 | 135.3 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 7 | 687.5 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 24 | 125.9 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 12 | 357.0 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 36 | 94.3 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 12 | 197.1 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 7 | 634.3 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 12 | 166.5 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 12 | 196.3 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 18 | 109.5 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 18 | 121.7 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 24 | 214.8 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 24 | 114.1 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 48 | 82.8 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 24 | 108.8 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 18 | 106.0 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 6 | 69.1 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 36 | 94.4 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 12 | 348.0 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 7 | 1245.8 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 18 | 216.2 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 48 | 67.4 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 36 | 140.5 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 24 | 99.1 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 6 | 103.3 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 48 | 79.1 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 6 | 155.4 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 6 | 103.0 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 36 | 169.2 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 7 | 1248.1 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 36 | 85.5 EL.U/mL |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 6 | 108.5 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 36 | 94.7 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 6 | 230.0 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 7 | 865.9 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 12 | 265.0 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 18 | 115.1 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 24 | 108.6 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 36 | 94.0 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 7 | 602.7 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 12 | 217.8 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 18 | 95.6 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 24 | 86.7 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 36 | 69.2 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 48 | 59.8 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 6 | 223.8 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 7 | 649.6 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 12 | 243.5 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 18 | 122.9 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 24 | 110.6 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 36 | 92.8 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 36-45-year, Month 48 | 71.8 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 6 | 242.6 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 7 | 1103.5 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 18 | 127.1 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 48 | 75.6 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 6 | 260.7 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 7 | 828.8 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 12 | 242.3 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 18 | 102.0 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 24 | 100.6 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 36 | 73.5 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 7 | 985.1 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 12 | 298.2 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 18 | 141.6 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 48 | 74.3 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 18-26-year, Month 48 | 75.7 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-31, 27-35-year, Month 6 | 235.9 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 12 | 277.8 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 24 | 114.0 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 18-26-year, Month 36 | 95.2 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 27-35-year, Month 48 | 60.2 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 6 | 258.8 EL.U/mL |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-45, 36-45-year, Month 24 | 122.7 EL.U/mL |
Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay
Other Oncogenic Types include HPV-31 and HPV-45. Titers were measured by neutralization assay and are given as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum
Time frame: At Month 7
Population: Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity with titer greater than or equal to 40 ED50 and who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay | Anti-HPV-45, 36-45-year | 157.6 titer |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay | Anti-HPV-31, 27-35-year | 369.6 titer |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay | Anti-HPV-31, 36-45-year | 231.0 titer |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay | Anti-HPV-45, 18-26-year | 129.7 titer |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay | Anti-HPV-45, 27-35-year | 144.1 titer |
| Cervarix Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay | Anti-HPV-31, 18-26-year | 387.3 titer |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay | Anti-HPV-45, 27-35-year | 379.9 titer |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay | Anti-HPV-31, 18-26-year | 143.2 titer |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay | Anti-HPV-45, 18-26-year | 86.5 titer |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay | Anti-HPV-31, 27-35-year | 191.8 titer |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay | Anti-HPV-45, 36-45-year | 79.0 titer |
| Gardasil Group | Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay | Anti-HPV-31, 36-45-year | 198.5 titer |
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Time frame: At Month 6, 7, 12, 18, 24, 36, 48 and 60
Population: Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 18 | 501.2 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 60 | 430.3 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 24 | 390.5 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 48 | 1169.1 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 6 | 538.7 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 60 | 231.8 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 24 | 932.8 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 6 | 331.1 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 7 | 4246.6 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 7 | 2709.6 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 18 | 2266.3 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 12 | 1477.9 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 18 | 454.8 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 6 | 536.2 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 24 | 345.2 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 7 | 5076.9 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 36 | 276.8 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 36 | 582.1 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 48 | 231.2 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 7 | 3789.2 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 60 | 242.2 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 7 | 8864.0 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 48 | 449.7 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 12 | 3332.8 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 36 | 1373.2 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 60 | 1196.8 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 60 | 451.8 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 6 | 414.0 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 12 | 1978.0 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 36 | 746.3 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 6 | 314.6 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 48 | 608.2 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 24 | 1771.9 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 60 | 602.7 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 12 | 1521.7 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 7 | 2726.3 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 18 | 905.0 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 48 | 462.2 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 24 | 713.9 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 36 | 540.0 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 18 | 825.0 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 12 | 892.4 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 24 | 649.2 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 36 | 341.7 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 18 | 1177.3 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 48 | 304.7 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 12 | 838.8 EL.U/mL |
| Cervarix Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 6 | 827.7 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 60 | 41.0 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 6 | 889.3 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 12 | 1137.3 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 18 | 560.1 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 24 | 419.7 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 36 | 297.7 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 6 | 715.8 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 7 | 2203.1 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 12 | 769.2 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 18 | 384.0 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 60 | 155.7 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 6 | 690.4 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 7 | 2064.7 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 24 | 308.4 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 36 | 237.1 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 48 | 225.9 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 60 | 199.0 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 6 | 155.4 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 7 | 756.8 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 12 | 194.0 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 24 | 70.1 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 36 | 61.5 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 48 | 55.1 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 60 | 49.6 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 6 | 128.6 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 7 | 503.4 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 12 | 130.4 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 18 | 55.0 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 24 | 46.4 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 48 | 30.6 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 60 | 30.9 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 6 | 131.3 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 7 | 636.2 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 12 | 185.0 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 18 | 85.8 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 24 | 66.9 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 36 | 53.5 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 36-45-year, Month 48 | 47.8 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 7 | 3248.8 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 48 | 247.1 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 18-26-year, Month 60 | 231.9 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 24 | 300.6 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 36 | 201.9 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 27-35-year, Month 48 | 188.7 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 12 | 722.2 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-16, 36-45-year, Month 18 | 382.7 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 18-26-year, Month 18 | 89.6 EL.U/mL |
| Gardasil Group | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Anti-HPV-18, 27-35-year, Month 36 | 39.2 EL.U/mL |
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Titers are given as Geometric Mean Titers (GMTs). Titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum. Data for Month 7 on subjects aged 18 to 26 years are given in the outcome above as a primary outcome measure.
Time frame: At Month 6, 7, 12, 18, 24, 36, 48 and 60
Population: Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 36-45-year, Month 12 | 3032.4 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 18-26-year, Month 12 | 14524.7 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 18-26-year, Month 18 | 6000.3 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 18-26-year, Month 24 | 5184.2 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 18-26-year, Month 48 | 3900.9 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 18-26-year, Month 60 | 4117.8 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 27-35-year, Month 6 | 1263.1 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 27-35-year, Month 7 | 23907.9 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 27-35-year, Month 18 | 2907.9 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 27-35-year, Month 24 | 2269.2 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 27-35-year, Month 36 | 1897.6 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 27-35-year, Month 48 | 2046.3 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 27-35-year, Month 60 | 1925.3 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 36-45-year, Month 6 | 1729.8 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 36-45-year, Month 12 | 7110.4 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 36-45-year, Month 18 | 2344.0 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 36-45-year, Month 24 | 2058.5 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 18-26-year, Month 6 | 686.2 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 18-26-year, Month 12 | 4472.4 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 18-26-year, Month 18 | 2256.1 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 18-26-year, Month 24 | 1652.0 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 18-26-year, Month 36 | 1593.7 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 18-26-year, Month 48 | 1710.9 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 27-35-year, Month 6 | 429.2 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 27-35-year, Month 7 | 9501.6 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 27-35-year, Month 12 | 2266.3 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 27-35-year, Month 24 | 1028.4 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 27-35-year, Month 36 | 942.8 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 27-35-year, Month 48 | 982.4 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 27-35-year, Month 60 | 967.2 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 36-45-year, Month 6 | 618.8 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 36-45-year, Month 18 | 1426.7 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 36-45-year, Month 24 | 1040.0 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 36-45-year, Month 36 | 903.5 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 36-45-year, Month 48 | 784.5 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 36-45-year, Month 60 | 816.6 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 18-26-year, Month 36 | 3844.7 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 27-35-year, Month 12 | 7419.2 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 36-45-year, Month 7 | 17301.5 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 36-45-year, Month 36 | 1794.2 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 36-45-year, Month 48 | 2081.4 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 36-45-year, Month 60 | 1784.5 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 18-26-year, Month 60 | 1522.9 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 27-35-year, Month 18 | 1302.2 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 36-45-year, Month 7 | 9845.5 Titer |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 18-26-year, Month 6 | 1627.9 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 36-45-year, Month 7 | 1438.8 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 18-26-year, Month 6 | 1592.4 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 27-35-year, Month 6 | 175.8 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 18-26-year, Month 12 | 3265.2 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 36-45-year, Month 48 | 91.5 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 18-26-year, Month 18 | 1182.7 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 27-35-year, Month 7 | 1043.0 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 36-45-year, Month 60 | 764.9 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 18-26-year, Month 48 | 750.4 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 27-35-year, Month 12 | 280.3 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 18-26-year, Month 60 | 529.8 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 27-35-year, Month 18 | 133.3 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 27-35-year, Month 6 | 1014.1 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 36-45-year, Month 60 | 105.3 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 27-35-year, Month 7 | 4958.4 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 27-35-year, Month 24 | 116.2 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 27-35-year, Month 18 | 689.8 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 18-26-year, Month 24 | 893.5 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 27-35-year, Month 36 | 101.9 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 27-35-year, Month 36 | 501.7 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 36-45-year, Month 36 | 823.7 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 27-35-year, Month 48 | 677.6 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 27-35-year, Month 48 | 76.9 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 27-35-year, Month 60 | 346.4 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 18-26-year, Month 36 | 653.2 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 36-45-year, Month 7 | 7634.4 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 27-35-year, Month 60 | 74.4 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 36-45-year, Month 12 | 2678.2 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 36-45-year, Month 6 | 168.7 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 36-45-year, Month 18 | 994.8 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 36-45-year, Month 12 | 433.9 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 36-45-year, Month 24 | 874.7 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 36-45-year, Month 48 | 1018.7 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 27-35-year, Month 12 | 1755.9 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 18-26-year, Month 6 | 234.1 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 36-45-year, Month 18 | 181.5 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 18-26-year, Month 12 | 595.8 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 27-35-year, Month 24 | 618.8 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 18-26-year, Month 18 | 249.3 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 36-45-year, Month 24 | 135.8 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 18-26-year, Month 24 | 175.1 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-16, 36-45-year, Month 6 | 1916.5 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 18-26-year, Month 36 | 127.8 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 36-45-year, Month 36 | 103.2 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 18-26-year, Month 48 | 139.0 Titer |
| Gardasil Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies | Anti-HPV-18, 18-26-year, Month 60 | 126.2 Titer |
Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS)
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Time frame: At Month 7, 12, 18, 24, 36 and 48
Population: Analyses were done on those subjects from the ATP cohort for immunogenicity for whom CVS samples with less than 200 erythrocytes per microliter were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-18, Month 7 | 88.6 EL.U/mL |
| Cervarix Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-16, Month 12 | 129.7 EL.U/mL |
| Cervarix Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-18, Month 12 | 59.0 EL.U/mL |
| Cervarix Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-16, Month 24 | 85.0 EL.U/mL |
| Cervarix Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-18, Month 18 | 33.2 EL.U/mL |
| Cervarix Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-16, Month 7 | 168.9 EL.U/mL |
| Cervarix Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-18, Month 24 | 43.9 EL.U/mL |
| Cervarix Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-16, Month 36 | 57.1 EL.U/mL |
| Cervarix Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-18, Month 36 | 24.3 EL.U/mL |
| Cervarix Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-16, Month 18 | 96.0 EL.U/mL |
| Cervarix Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-18, Month 48 | 16.6 EL.U/mL |
| Cervarix Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-16, Month 48 | 32.7 EL.U/mL |
| Gardasil Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-18, Month 48 | 20.2 EL.U/mL |
| Gardasil Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-16, Month 18 | 52.8 EL.U/mL |
| Gardasil Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-16, Month 48 | 72.2 EL.U/mL |
| Gardasil Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-16, Month 7 | 90.7 EL.U/mL |
| Gardasil Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-16, Month 24 | 45.1 EL.U/mL |
| Gardasil Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-16, Month 36 | 48.8 EL.U/mL |
| Gardasil Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-18, Month 7 | 43.4 EL.U/mL |
| Gardasil Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-18, Month 12 | 29.1 EL.U/mL |
| Gardasil Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-18, Month 18 | 16.4 EL.U/mL |
| Gardasil Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-18, Month 24 | 21.5 EL.U/mL |
| Gardasil Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-18, Month 36 | 23.3 EL.U/mL |
| Gardasil Group | Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS) | Anti-HPV-16, Month 12 | 46.8 EL.U/mL |