Gardasil 9 Dosage/Direction for Use

General: Dosage: HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) should be administered intramuscularly as 3 separate 0.5-mL doses according to the following schedule: First dose: at elected date; Second dose: 2 months after the first dose; Third dose: 6 months after the first dose.
Individuals are encouraged to adhere to the 0, 2, and 6 months vaccination schedule. However, in clinical studies, efficacy has been demonstrated in individuals who have received all 3 doses within a 1-year period. The second dose should be administered at least 1 month after the first dose, and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period.
Alternatively, in individuals 9 through 14 years of age, HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) can be administered according to a 2-dose schedule; the second dose should be administered between 5 and 13 months after the first dose. If the second vaccine dose is administered earlier than 5 months after the first dose, a third dose should always be administered.
The use of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) should be in accordance with official recommendations.
Method of Administration: HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.
HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) must not be injected intravascularly.
Neither subcutaneous nor intradermal administration has been studied. These methods of administration are not recommended.
Administration of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) in Individuals Who Have Been Previously Vaccinated with GARDASIL: It is recommended that individuals who receive a first dose of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) complete the vaccination course with HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9).
Studies using a mixed regimen (interchangeability) of HPV vaccines were not performed for HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9).
If the decision is made to administer HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) after receiving 3 doses of GARDASIL, there should be an interval of at least 12 months between completion of vaccination with GARDASIL and the start of vaccination with HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9).