Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01418937 | Safety Evaluation of a Human Papillomavirus (HPV) Vaccine in Healthy Female Control Subjects From the GSK HPV 023 Study | PHASE3 | COMPLETED | 164 | — | — | May 29, 2012 | Jan 9, 2015 | Jul 12, 2018 | 5 | Brazil |
| NCT00996125 | Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus 580299 Vaccine in Healthy Female Subjects | PHASE3 | COMPLETED | 750 | — | — | Oct 24, 2009 | Dec 8, 2010 | Aug 17, 2018 | 1 | China |
| NCT00552279 | Immunogenicity and Safety of GlaxoSmithKline Biologicals' Huma Papillomavirus (HPV) Vaccine 580299 in Healthy Females 15 - 25 Years of Age | PHASE3 | COMPLETED | 805 | — | — | Nov 12, 2007 | Jul 20, 2009 | Jun 25, 2018 | 16 | Italy, Romania +1 |
| NCT00456807 | Complementary Testing to Evaluate Immunogenicity of Human Papillomavirus (HPV) Vaccine (580299) in Healthy Female Subjects Aged >/= 26 Years | PHASE3 | COMPLETED | 100 | — | — | Apr 1, 2007 | Jan 1, 2008 | Dec 16, 2016 | 2 | Netherlands |
| NCT00359619 | Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine | PHASE2 | COMPLETED | 383 | — | — | Sep 12, 2006 | Jan 30, 2007 | Jan 2, 2020 | 10 | United States, Belgium |
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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.
The pregnancy outcomes were based on reports from pregnant subjects in the study population. Pregnancy outcomes are pregnancies resulting in live births.
Titers were given as geometric mean titers and were measured by Enzyme-linked Immunosorbent Assay (ELISA) and expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies.
Titer given as geometric mean titer (GMT).
The geometric mean and 95% confidence interval of the number of Human Papilloma Virus type 16 (HPV-16) and HPV-18 specific CD4 and CD8 cells producing at least 2 different cytokines is reported per million of CD4 or CD8 T-cells, respectively.
The geometric mean and 95% confidence interval of the number of HPV-16 and HPV-18 specific memory B-cells is reported per million of B-cells. An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification.
Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL)for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Titers are presented as Geometric Mean Titers (GMTs).
Titers given as Geometric Mean Titers (GMTs). An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification.
Pearson coefficients of correlation between serum and CVS for anti-HPV-16 and anti-HPV-18 titers standardized for total IgG were calculated.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL).
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 7 EL.U/mL.
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 7 EL.U/mL.
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 7 EL.U/mL.
| Arm | Type | Description |
|---|---|---|
| HPV Group | EXPERIMENTAL | - |
| Cervarix Group | EXPERIMENTAL | Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule. |
| Placebo Group | EXPERIMENTAL | Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule. |
| Cervarix-12 Group | EXPERIMENTAL | Women received 3 doses of Cervarix TM (human papillomavirus (HPV) vaccine) administered according to a 0, 1, 12-month schedule |
| Cervarix-6 Group | ACTIVE_COMPARATOR | Women received 3 doses of Cervarix TM (HPV vaccine) administered according to a 0, 1, 6-month schedule. |
| Cervarix 1 Group | EXPERIMENTAL | Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| Cervarix 2 Group | EXPERIMENTAL | Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| Cervarix 3 Group | EXPERIMENTAL | Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| Cervarix 4 Group | EXPERIMENTAL | Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| Cervarix 5 Group | EXPERIMENTAL | Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| Cervarix 6 Group | EXPERIMENTAL | Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| Name | Type | Description |
|---|---|---|
| CervarixTM (GSK580299) | BIOLOGICAL | Three intramuscular injections |
| CervarixTM | BIOLOGICAL | Subjects will receive three doses of the Cervarix vaccine intramuscularly according to a 0, 1, 6-month schedule. |
| Control | OTHER | Subjects will receive three doses of control intramuscularly according to a 0, 1, 6-month schedule. |
| Cervarix TM | BIOLOGICAL | Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 12-month schedule. |
| Placebo | BIOLOGICAL | Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule. |
| HPV investigational vaccine GSK568893A, different formulations | BIOLOGICAL | Subjects were administered three doses of HPV investigational vaccine |
Inclusion Criteria: * Subjects who the investigator believes can and will comply with the requirements of the protocol. * A subject previously enrolled in Study HPV-023 (NCT00518336), who received placebo in Study HPV-001 (NCT00689741), and who is 26 years of age or older. * Written informed consen...