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Also known as GARDASIL®9, GARDASIL®9 (G9), Gardasil
GARDASIL9 · 1 trial · 1 indication
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Solicited systemic AEs include headache, fatigue, nausea, dizziness, muscle aches, joint pain.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An unsolicited AE is an AE that was not solicited using a vaccine report card (VRC) and that is communicated by a participant (or their legally acceptable representative, if applicable). Unsolicited AEs include serious and nonserious AEs.
Serious adverse events (SAEs) include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect.
AEs in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Routine visits are not considered medically-attended adverse events (MAAEs). Examples of routine visits include physical examination, wellness visits, or vaccinations.
Events of clinical interest (ECIs) are defined as an overdose of Sponsor's product, drug-induced liver injury events, or potential immune-mediated diseases (pIMDs).
| Arm | Type | Description |
|---|---|---|
| GARDASIL®9 (G9) | ACTIVE_COMPARATOR | Participants will receive vaccinations with G9. |
| V540B | EXPERIMENTAL | Participants will receive vaccinations with V540B. |
| Name | Type | Description |
|---|---|---|
| GARDASIL®9 (G9) | BIOLOGICAL | Suspension administered via intramuscular (IM) injection |
| V540B | BIOLOGICAL | Experimental vaccine and adjuvant administered via IM injection |
Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Is in good health based on medical history, physical examination, vital sign (VS) measurements and electrocardiograms (ECGs) performed before randomization. Exclusion Criteria: The key exclusion criter...
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.