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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00485732 | A Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine/Cervarix TM Vaccine in Healthy Females Aged 15-25 Years | PHASE3 | COMPLETED | 225 | — | — | Jun 11, 2007 | Mar 30, 2008 | Jul 20, 2018 | 6 | South Korea |
| NCT00345878 | Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years | PHASE3 | COMPLETED | 271 | — | — | Sep 25, 2006 | Dec 21, 2007 | Jul 20, 2018 | 2 | Malaysia |
| NCT00344032 | Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine in Healthy Indian Women | PHASE3 | COMPLETED | 354 | — | — | Jul 28, 2006 | Dec 4, 2007 | Jul 20, 2018 | 4 | India |
| NCT00306241 | A Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years | PHASE3 | COMPLETED | 300 | — | — | Mar 1, 2006 | Jun 1, 2007 | Nov 4, 2016 | 1 | Hong Kong |
| NCT00290277 | Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV Vaccine in Female Subjects Aged 10-14 Years | PHASE3 | COMPLETED | 300 | — | — | Nov 1, 2005 | Aug 1, 2006 | Sep 28, 2016 | 8 | South Korea |
| NCT00169494 | Human Papilloma Virus Vaccine Consistency and Non-inferiority Trial in Young Adult Women With GSK Bio HPV-16/18 | PHASE3 | COMPLETED | 770 | — | — | Sep 1, 2004 | Jul 1, 2005 | Sep 12, 2016 | 17 | Denmark, Estonia +4 |
| NCT00196924 | Human Papilloma Virus Vaccine Safety and Immunogenicity Trial in Young Adolescent Women With GSK Bio HPV-16/18. | PHASE3 | COMPLETED | 2,067 | — | — | Jun 1, 2004 | Mar 1, 2006 | Mar 23, 2017 | 61 | Australia, Colombia +10 |
| NCT00316693 | Human Papillomavirus (HPV) Vaccine (Cervarix TM) Efficacy, Immunogenicity & Safety Trial in Adult Japanese Women With GSK Biologicals HPV-16/18 Vaccine | PHASE2 | COMPLETED | 1,046 | — | — | Apr 26, 2006 | Feb 10, 2009 | Sep 4, 2018 | 4 | Japan, |
| NCT00231413 | Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine. | PHASE2 | COMPLETED | 383 | — | — | Mar 4, 2005 | Mar 27, 2006 | Dec 12, 2019 | 11 | United States, Belgium |
| NCT00120848 | Follow-up Study of GSK Biologicals' Human Papilloma Virus (HPV) Vaccine to Prevent Cervical Infection in Young Adults | PHASE2 | COMPLETED | 776 | — | — | Nov 1, 2003 | Jul 1, 2007 | Nov 4, 2016 | 27 | United States, Brazil +1 |
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.
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subjects seronegative before vaccination. 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.
Persistent HPV-16 or HPV-18 infection is defined as at least 2 positive Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (\> 150 days) \[as assessed in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6\].
Seroconversion was defined as the appearance of anti-HPV-16 antibodies \[i.e. antibody titer greater than or equal to (≥) the cut-off value\] in the serum of subjects seronegative before vaccination. The cut-off value was 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL.
Anti-HPV-16 antibody titers were presented as Geometric Mean Titers (GMT) and expressed in EL.U/mL.
Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
| Arm | Type | Description |
|---|---|---|
| Cervarix Group | EXPERIMENTAL | - |
| Placebo Group | PLACEBO_COMPARATOR | - |
| Cervarix | EXPERIMENTAL | Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months). |
| Placebo | PLACEBO_COMPARATOR | Subjects who received 3 doses of Placebo (at 0, 1, 6 months). |
| Aimmugen Group | ACTIVE_COMPARATOR | Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule. |
| HPV-16/18 Group | ACTIVE_COMPARATOR | Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| HPV-TETRA A Group | EXPERIMENTAL | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| HPV-TETRA B Group | EXPERIMENTAL | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| HPV-TETRA C Group | EXPERIMENTAL | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| HPV-TETRA D Group | EXPERIMENTAL | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| HPV-TETRA E Group | EXPERIMENTAL | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| HPV-TETRA F Group | EXPERIMENTAL | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| Name | Type | Description |
|---|---|---|
| HPV-16/18 VLP/AS04 vaccine (Cervarix TM) | BIOLOGICAL | Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule. |
| Placebo | BIOLOGICAL | Three doses of placebo administered intramuscularly according to a 0, 1, 6-month schedule. |
| HPV-16/18 L1 VLP AS04 (Cervarix TM) | BIOLOGICAL | Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule. |
| HPV-16/18 L1 VLP AS04 | BIOLOGICAL | - |
| HPV-16/18 L1/AS04 | BIOLOGICAL | - |
| HPV-16/18 vaccine (Cervarix™) | BIOLOGICAL | Intramuscular injection, 3 doses |
| Aimmugen™ | BIOLOGICAL | Intramuscular injection, 3 doses |
| HPV 16/18 L1 AS04 | BIOLOGICAL | 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6. |
| HPV-16/18/31/45 L1 AS04 Formulation 1 | BIOLOGICAL | 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6. |
| HPV-16/18/31/45 L1 AS04 Formulation 2 | BIOLOGICAL | 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6. |
| HPV-16/18/31/45 L1 AS04 Formulation 3 | BIOLOGICAL | 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6. |
| HPV-16/18/31/45 L1 AS04 Formulation 4 | BIOLOGICAL | 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6. |
| HPV-16/18/31/45 L1 AS04 Formulation 5 | BIOLOGICAL | 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6. |
| HPV-16/18/31/45 L1 AS04 Formulation 6 | BIOLOGICAL | 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6. |
| HPV 16/18 VLP AS04 | BIOLOGICAL | - |
Inclusion Criteria: * Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * A female between, and including, 15 and 25 years of age at the time of the first vaccination. * Written info...