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Also known as GARDASIL®9, GARDASIL9, GARDASIL®9 (G9)
Gardasil · 2 trials · 2 indications
Vaccine-induced anti-HPV 6 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 6 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.
Vaccine-induced anti-HPV 11 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 11 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 16 mMU/mL.
Vaccine-induced anti-HPV 16 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 16 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.
Vaccine-induced anti-HPV 18 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 18 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 24 mMU/mL.
Frequency of participants with Vaccine site reactions, Frequency of participants with Non Vaccine Adverse Events,
the number of non vaccine adverse events
| Arm | Type | Description |
|---|---|---|
| Gardasil™ | EXPERIMENTAL | Gardasil™ 3 dose regimen |
| Placebo | PLACEBO_COMPARATOR | Gardasil™ matching placebo 3 dose regimen |
| Gardasil | EXPERIMENTAL | 0.5 ml single dose Gardasil vaccine given at three separate visits |
| Name | Type | Description |
|---|---|---|
| Gardasil™ | BIOLOGICAL | Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6) |
| Placebo | BIOLOGICAL | Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6) |
| Gardasil | DRUG | 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6 |
Inclusion Criteria: * Girls ages 9 to 15 years (must not yet have had coitarche) * Healthy females ages 16 to 23 years (individuals with a lifetime history of 0 to 3 male or female sexual partners) Exclusion Criteria: All Subjects: * History of known prior vaccination with an HPV vaccine. Women...
GARDASIL is a vaccine used to prevent human papillomavirus (HPV) infections and related conditions, including cervical cancer, vulvar cancer, vaginal cancer, and genital warts. It is also studied in healthy individuals for safety and immunogenicity. The vaccine is developed by Merck & Company, Inc. and is in Phase 3 clinical development.
GARDASIL is a vaccine that targets human papillomavirus (HPV) types to prevent infections and associated cancers. It is designed to elicit an immune response against HPV, thereby reducing the risk of cervical cancer, vulvar cancer, vaginal cancer, and genital warts. The vaccine is being studied in clinical trials for its efficacy and safety.
GARDASIL is developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The vaccine is being studied in clinical trials for the prevention of HPV infections and related cancers.
GARDASIL is in Phase 3 clinical development. It is being studied in a Phase 3 trial (NCT00157950) for papillomavirus infections and a Phase 3 trial (NCT00543543) for cervical cancer and other HPV-related conditions. The vaccine is investigational and not yet approved.
GARDASIL is being studied in several clinical trials, including NCT00157950 (Phase 3, completed) for papillomavirus infections, NCT00260039 (Phase 2, completed) for HPV and cervical cancer, NCT00543543 (Phase 3, completed) for cervical cancer and genital warts, and NCT06623409 (Phase 1, active) for safety in healthy adults.
GARDASIL is also known as GARDASIL 9, GARDASIL9, and GARDASIL 9 (G9). These names refer to the same vaccine product developed by Merck & Company, Inc. for the prevention of HPV infections and related cancers.