Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 17 May 2018
• For intramuscular use only. (2)
• Three-dose schedule: Administer a dose (0.5 mL) at 0, 1-2, and 6 months. (2.1)
• Two-dose schedule: Administer a dose (0.5 mL) at 0 and 6 months.
If the second dose is administered earlier than 6 months after the first dose, a third dose should be administered at least 4 months after the second dose. (2.1)
• Pediatric Use: Safety and effectiveness have not been established in children <10 years of age. In a clinical study, 90% of infants <12 months of age who were vaccinated with a reduced dosage formulation had fever. (8.4)
|Date First Approved||05-11-2014|
|Marketing authorisation holder||Wyeth Pharmaceuticals, Inc.|