Drug intelligence / Profile preview

human papillomavirus vaccine + hepatitis A vaccine

Development stage
Unknown
Lead developer
GSK
Modality
Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

Cervarix + Havrix refers to the clinical trial context in which the hepatitis A vaccine Havrix was utilized as an active control for the evaluation of the human papillomavirus (HPV) vaccine Cervarix. Both products are developed and manufactured by GSK. Cervarix is a bivalent vaccine containing recombinant L1 virus-like particles (VLPs) of HPV types 16 and 18, formulated with the AS04 adjuvant system (comprising aluminum hydroxide and 3-O-desacyl-4'-monophosphoryl lipid A). It is indicated for the prevention of cervical cancer and associated precancerous lesions. Havrix is a sterile suspension of inactivated hepatitis A virus (HM175 strain) used for active immunization against hepatitis A. In large-scale Phase 3 trials, such as the PATRICIA study (Study 008), Havrix was administered to the control group to ensure that participants received a tangible health benefit while maintaining the blinded nature of the study. These two vaccines are separate products and are not administered as a single fixed-dose combination.

Other names
Cervarix + HavrixHPV 16/18 vaccine + HepA vaccine
02

Targets

Hepatitis A virus capsid proteinHPV16 (Human papillomavirus type 16)HPV18 L1

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