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HPV 16/18 VLP AS04 · 10 trials · 1 indication
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...
HPV 16/18 VLP AS04 is an investigational vaccine being studied for the prevention of infections caused by human papillomavirus types 16 and 18. It is being developed for use in healthy females, with clinical trials conducted in young adult women and adolescents.
HPV 16/18 VLP AS04 is being developed by GSK plc, which trades under the ticker GSK. The company has conducted multiple clinical trials of this vaccine candidate across various countries, including the United States, Japan, and several European nations.
HPV 16/18 VLP AS04 is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 3 trial was a consistency and non-inferiority study in young adult women.
HPV 16/18 VLP AS04 has been studied in 10 completed clinical trials with a total enrollment of 6,492 participants. Key trials include NCT00120848, a follow-up study in young adults; NCT00169494, a Phase 3 consistency and non-inferiority trial; NCT00231413, an immunogenicity and safety trial; and NCT00316693, an efficacy trial in Japanese women.
HPV 16/18 VLP AS04 is a virus-like particle vaccine designed to target human papillomavirus types 16 and 18. It contains the AS04 adjuvant system to enhance the immune response. The vaccine is intended to prevent cervical infections caused by these HPV types.
HPV 16/18 VLP AS04 is the vaccine candidate studied in trials that reference Cervarix, such as NCT00316693, which is titled 'Human Papillomavirus (HPV) Vaccine (Cervarix TM) Efficacy, Immunogenicity & Safety Trial.' The vaccine is being developed by GSK plc.