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Cervarix (Human Papillomavirus Vaccine) - Summary

 
 



CERVARIX SUMMARY

CERVARIX [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant] is a non-infectious recombinant, AS04-adjuvanted vaccine that contains recombinant L1 protein, the major antigenic protein of the capsid, of oncogenic HPV types 16 and 18.

CERVARIX® is indicated for the following:

CERVARIX® is indicated for the prevention of the following diseases caused by oncogenic human papillomavirus (HPV) types 16 and 18 [see Clinical Studies] :

  • cervical cancer,
  • cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ, and
  • cervical intraepithelial neoplasia (CIN) grade 1.

CERVARIX is approved for use in females 10 through 25 years of age.

Limitations of Use and Effectiveness

CERVARIX does not provide protection against disease due to all HPV types [see Clinical Studies].

CERVARIX has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity [see Clinical Studies].

Females should continue to adhere to recommended cervical cancer screening procedures [see Patient Counseling Information].

Vaccination with CERVARIX may not result in protection in all vaccine recipients.


See all Cervarix indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Cervarix (Human Papillomavirus Vaccine)

Tdap Vaccination During Pregnancy Remains Low
Source: Medscape Public Health & Prevention Headlines [2015.05.22]
Just more than half of women reported Tdap vaccination before, during, or after pregnancy, which falls far short of current recommendations for vaccination during pregnancy.
Medscape Medical News

E-Reminders May Boost HPV Vaccination Rates
Source: MedicineNet Cervical Cancer Specialty [2015.05.20]
Title: E-Reminders May Boost HPV Vaccination Rates
Category: Health News
Created: 5/19/2015 12:00:00 AM
Last Editorial Review: 5/20/2015 12:00:00 AM

UCSF-led study explains how early childhood vaccination reduces leukemia risk
Source: Immune System / Vaccines News From Medical News Today [2015.05.19]
Chronic infections push 'pre-leukemia' cells, common in newborns, into malignancyA team led by UCSF researchers has discovered how a commonly administered vaccine protects against acute...

HPV vaccination may benefit boys as well as girls
Source: Sexual Health / STDs News From Medical News Today [2015.05.13]
A new study partly supports vaccinating all boys against HPV and adds evidence of wider cancer benefit for both sexes, if girls have a higher uptake of injections.

HPV Vaccination for Girls May Help Prevent Cancers in Males
Source: MedicineNet Cancer Prevention Specialty [2015.05.13]
Title: HPV Vaccination for Girls May Help Prevent Cancers in Males
Category: Health News
Created: 5/12/2015 12:00:00 AM
Last Editorial Review: 5/13/2015 12:00:00 AM

more news >>

Published Studies Related to Cervarix (Human Papillomavirus Vaccine)

Impact of malaria and helminth infections on immunogenicity of the human papillomavirus-16/18 AS04-adjuvanted vaccine in Tanzania. [2014]
infections on the immunogenicity of the bivalent HPV-16/18 vaccine... CONCLUSIONS: The data show high HPV immunogenicity regardless of the presence of

A randomized, observer-blinded immunogenicity trial of Cervarix(®) and Gardasil(®) Human Papillomavirus vaccines in 12-15 year old girls. [2013]
CONCLUSIONS: These data demonstrate for the first time that cross-neutralizing

Efficacy of quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine (GARDASIL) in Japanese women aged 18-26 years. [2013]
A randomized double-blind placebo-controlled phase II trial was conducted to evaluate the efficacy of a prophylactic quadrivalent vaccine targeting the human papillomavirus (HPV) types most frequently associated with cervical cancer (types 16/18) and genital warts (types 6/11) in Japanese women aged 18-26 years...

Safety and immunogenicity of human papillomavirus-16/18 AS04-adjuvanted vaccine: a randomized trial in 10-25-year-old HIV-Seronegative African girls and young women. [2013]
have an important public health impact... CONCLUSIONS: The HPV-16/18 AS04-adjuvanted vaccine was highly immunogenic and had

Mother-infant transfer of anti-human papillomavirus (HPV) antibodies following vaccination with the quadrivalent HPV (type 6/11/16/18) virus-like particle vaccine. [2012]
The exploratory immunogenicity objective of this analysis was to characterize the titer of vaccine human papillomavirus (HPV)-type immunoglobulins in both peripartum maternal blood and the cord blood of infants born to women who received blinded therapy.

more studies >>

Clinical Trials Related to Cervarix (Human Papillomavirus Vaccine)

Drug Use Investigation of Cervarix® [Not yet recruiting]

Post-marketing Study to Assess the Safety of CERVARIX When Used in the United States and in Canada [Recruiting]
This study will assess the risk of spontaneous abortion during weeks 1-19 of gestation, and other pregnancy outcomes, in an Exposed vaccinated cohort, i. e. women with last menstrual period between 30 days before and 90 days after any dose of CERVARIX, when compared to a Non-exposed vaccinated cohort, i. e. women with last menstrual period between 120 days and 18 months after the last CERVARIX or GARDASIL dose.

Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls [Recruiting]
This is a phase IV study to evaluate the body's immune response of participants to the Cervarix and Gardasil vaccines against the Human Papilloma Virus (HPV) types associated with increased risk of cervical cancer.

Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination [Recruiting]
The purpose of this post-marketing study is to evaluate the incidence of autoimmune diseases (AIDs) following females who have received at the least the first dose of Cervarix® as part of their routine health care.

Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females [Not yet recruiting]
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IV, observer-blind study is designed to evaluate the safety and immunogenicity of Cervarix™ in HIV infected females aged 15 to 25 years as compared to Merck's HPV vaccine (Gardasil®). For comparative purposes, a group of HIV negative females will also be evaluated. All subjects will receive the HPV vaccine (either Cervarix™ or Gardasil®) according to a three-dose schedule (Day 0, Week 6, Month 6).

The protocol posting has been updated following Protocol update in April 2010. The section impacted is eligibility criteria.

more trials >>


Page last updated: 2015-05-22

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