VAXELIS

STN: 125563
Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine
Tradename: VAXELIS
Manufacturer: MSP Vaccine Company
Indication:

• VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. VAXELIS is approved for use as a 3-dose series in children from 6 weeks through 4 years of age (prior to the 5th birthday).

Product Information

• Package Insert - VAXELIS
• Patient Information - VAXELIS

Supporting Documents

• March 12, 2026 Approval Letter - VAXELIS
• April 12, 2023 Approval Letter - VAXELIS
• October 27, 2020 Approval Letter - VAXELIS
• September 25, 2020 Approval Letter - VAXELIS
• May 5, 2020 Approval Letter - VAXELIS
• March 23, 2020 Approval Letter - VAXELIS
• December 21, 2018 Approval Letter - VAXELIS
• December 18, 2018 Summary Basis for Regulatory Action - VAXELIS
• Approval History, Letters, Reviews, and Related Documents - VAXELIS
• Clinical Review - VAXELIS
• May 4, 2015 Statistical Review - VAXELIS