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.
|
NEWS HIGHLIGHTSMedia Articles Related to Cervarix (Human Papillomavirus Vaccine)
Genital Wart Decline Tracked to HPV Vaccine (CME/CE)
Source: MedPage Today Dermatology [2013.04.18]
(MedPage Today) -- The incidence of genital warts declined by more than 90% in adolescent and teenage girls in the first 4 to 5 years after introduction of the human papillomavirus vaccine in Australia, investigators reported.
Study Explores Providers' Perceptions Of Parental Concerns About HPV Vaccination
Source: Health News from Medical News Today [2013.05.17]
A new Boston University School of Medicine (BUSM) study has found that low-income and minority parents may be more receptive to vaccinating their daughters against Human Papillomavirus (HPV), while white, middle-class parents are more likely to defer the vaccination. The findings appear online in the May issue of the Journal of Health Care for the Poor and Underserved. Cervical cancer incidence and mortality are markedly higher for low-income and minority women due to higher rates of HPV and limited access to screening and treatment...
HPV Vaccination Sends Genital Wart Cases Plummeting: Study
Source: MedicineNet Cervical Cancer Specialty [2013.04.19]
Title: HPV Vaccination Sends Genital Wart Cases Plummeting: Study
Category: Health News
Created: 4/18/2013 8:35:00 PM
Last Editorial Review: 4/19/2013 12:00:00 AM
Parents Who Veto Vaccinations Often Seek Like-Minded Opinions
Source: MedicineNet Chickenpox (Varicella) Specialty [2013.04.15]
Title: Parents Who Veto Vaccinations Often Seek Like-Minded Opinions
Category: Health News
Created: 4/15/2013 10:35:00 AM
Last Editorial Review: 4/15/2013 12:00:00 AM
Teen's Death From Chickenpox Highlights Need for Vaccination, CDC Reports
Source: MedicineNet Chickenpox (Varicella) Specialty [2013.04.12]
Title: Teen's Death From Chickenpox Highlights Need for Vaccination, CDC Reports
Category: Health News
Created: 4/11/2013 12:35:00 PM
Last Editorial Review: 4/12/2013 12:00:00 AM
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.
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.
|
