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quadrivalent human papillomavirus recombinant vaccine or nonavalent human papillomavirus vaccine · 1 trial · 2 indications
The prevalence of HPV vaccine initiation in cancer survivors ages 9 to 26 years
To demonstrate the non-inferiority of the antibody responses to the HPV vaccine in cancer survivors ages 9 to 26 years when compared to antibody responses of age- and sex-matched historical healthy population.
To demonstrate comparable safety/tolerability of the HPV vaccine in cancer survivors ages 9 to 26 years when compared to age- and sex-matched general population.
| Arm | Type | Description |
|---|---|---|
| Prevention (vaccine therapy) | EXPERIMENTAL | Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) or nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks. |
| Name | Type | Description |
|---|---|---|
| quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58) | BIOLOGICAL | Given IM |
| laboratory biomarker analysis | OTHER | Correlative studies |
| survey administration | OTHER | Ancillary studies |
| medical chart review | OTHER | Ancillary studies |
Inclusion Criteria: * AIM 1 (SURVEY) (AIM 1 is closed to enrollment) * Cancer survivor * Between 12 and 60 months after completion of cancer therapy (chemotherapy, radiation, hematopoietic cell transplant \[HCT\]) * Scheduled for a return clinic visit at one of the participating institutions * Engl...
It is a preventive vaccine developed by Merck & Company, Inc. (MRK) that combines quadrivalent HPV types 6, 11, 16, and 18 or nonavalent HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. It is being studied in cancer survivors to prevent human papillomavirus infection.
It is used to prevent human papillomavirus infection in younger cancer survivors. The Phase 2 trial NCT01492582 evaluated the vaccine in participants aged 9 years and older with a history of cancer, focusing on HPV infection prevention in this population.
Merck & Company, Inc., which trades under the ticker MRK, is the developer of the quadrivalent and nonavalent human papillomavirus recombinant vaccines. The company conducted the Phase 2 trial NCT01492582 in the United States.
The quadrivalent or nonavalent HPV vaccine is in Phase 2 development for cancer survivors. The only listed trial, NCT01492582, is a completed Phase 2 study with 1,499 participants. It is investigational and not approved for this specific use.
The vaccine was studied in NCT01492582, titled "Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors." This completed Phase 2 trial enrolled 1,499 participants in the United States and included cancer survivors and prevention of HPV infection as conditions.
No, they are different formulations. The quadrivalent vaccine covers HPV types 6, 11, 16, and 18, while the nonavalent vaccine covers HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Both are recombinant vaccines developed by Merck & Company, Inc.