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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)

Clinical trial evaluates heterologous prime/boost regimens in preventative HIV vaccination
Source: HIV / AIDS News From Medical News Today [2014.10.05]
Almost 40 million people worldwide live with HIV/AIDS, with an estimated 2.5 million new cases per year.

Researchers unlock vital new information to improve vaccinations against pneumococcus infection
Source: Respiratory / Asthma News From Medical News Today [2014.10.02]
Every ten seconds a human being dies from Streptococcus pneumoniae infection, also known as pneumococcus, making it a leading global killer.

Health officials urge flu vaccination for all, including healthy adults
Source: Flu / Cold / SARS News From Medical News Today [2014.09.23]
Influenza vaccination coverage estimates show an encouraging upward trend overall, but coverage among healthy 18 to 64 year-olds has yet to top 40 percent, according to new data announced at a news...

Moffitt Cancer Center study finds few physicians are recommending HPV vaccination for boys
Source: Sexual Health / STDs News From Medical News Today [2014.09.19]
Research from Moffitt Cancer Center shows family physicians and pediatricians are not always recommending vaccination against human papillomavirus (HPV) for young male patients.

Flu vaccination rates among health care workers climb with mandatory policy
Source: Flu / Cold / SARS News From Medical News Today [2014.09.09]
Hospitals can greatly improve their flu vaccination rate among health care workers by using a mandatory employee vaccination policy, according to a Henry Ford Health System study.

more news >>

Published Studies Related to Cervarix (Human Papillomavirus Vaccine)

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.

Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted vaccine administered according to an alternative dosing schedule compared with the standard dosing schedule in healthy women aged 15 to 25 years: results from a randomized study. [2011.03]
BACKGROUND: The human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine is immunogenic, has a clinically acceptable safety profile, and prevents incident and persistent HPV-16/18 infection and cervical precancerous lesions. This study (NCT00552279) evaluated the vaccine when administered according to an alternative dosing schedule (0-1-12 months) compared with the standard dosing schedule (0-1-6 months)... CONCLUSIONS: The third dose of the HPV-16/18 vaccine can be administered any time between 6 and 12 months after the first dose, with adequate immunogenicity and a clinically acceptable safety profile.

Quadrivalent human papillomavirus (HPV) types 6, 11, 16, 18 vaccine: for the prevention of genital warts in males. [2011]
The quadrivalent HPV types 6, 11, 16, 18 vaccine (Gardasil®) is a recombinant vaccine comprising purified virus-like particles derived from the L1 capsid proteins of HPV types 6, 11, 16 and 18. The vaccine was highly immunogenic... The most common adverse events reported were injection-site related, and most of these were of mild to moderate severity.

Prevalence and type distribution of human papillomavirus in healthy Japanese women aged 20 to 25 years old enrolled in a clinical study. [2011]
Efficacy, immunogenicity and tolerability of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine were evaluated in Japanese women aged 20-25 years, for which results have been reported previously. We analyzed the baseline data from that study and report the prevalence rates of HPV infection in young healthy Japanese women...

Vaccination with a human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in Korean girls aged 10-14 years. [2010.08]
The human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine has been demonstrated to be highly efficacious and immunogenic with a favorable safety profile... In conclusion, the HPV-16/18 AS04-adjuvanted vaccine is shown to be highly immunogenic and generally well-tolerated in Korean girls aged 10-14 yr.

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: 2014-10-05

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