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.
Media Articles Related to Cervarix (Human Papillomavirus Vaccine)
Influenza Vaccination Rates Up; Goal Not Met in Asthmatics
Source: Medscape Medical News Headlines [2013.12.06]
From 2010 to 2011, 50% of people with asthma received the influenza vaccine, which is an increase from 36% just 5 years earlier but still below the goal of 80% in children and 90% in adults.
Medscape Medical News
Chickenpox vaccination not linked to increased shingles incidence
Source: Immune System / Vaccines News From Medical News Today [2013.12.03]
A new study claims to have ruled out a link between childhood vaccination against varicella (chickenpox) and the increased incidence of herpes zoster (shingles) in adults, according to an article published in the Annals of Internal Medicine.Chickenpox and shingles are both caused by the same virus - the varicella zoster virus (VZV).
FDA study helps provide an understanding of rising rates of whooping cough and response to vaccination
Source: Immune System / Vaccines News From Medical News Today [2013.11.29]
A new study is helping to provide a better understanding of vaccines for whooping cough, the common name for the disease pertussis. Based on an animal model, the study conducted by the U.S.
Vaccinations: One more weapon in the fight against antibiotic resistance
Source: Immune System / Vaccines News From Medical News Today [2013.11.26]
Doctors, pharmacists and nurses are being asked to encourage their patients to keep up with the vaccinations recommended in the National Immunisation Program (NIP) schedule, as immunisation can help reduce the rates of vaccine-preventable diseases that may have required antibiotics to treat them or their complications.
Study examines barriers to human papillomavirus vaccination among teens
Source: Sexual Health / STDs News From Medical News Today [2013.11.26]
Barriers to human papillomavirus (HPV) vaccination among adolescents in the U.S. range from financial concerns and parental attitudes to social influences and concerns about the vaccination's effect on sexual behavior, according to a review of the available medical literature published by JAMA Pediatrics, a JAMA Network publication.
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
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. 
The quadrivalent HPV types 6, 11, 16, 18 vaccine (GardasilÂ®) 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. 
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
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 CervarixÂ® [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 CervarixÂ® 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 CervarixÂ® 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 Cervarixâ„˘ in HIV infected females aged 15 to 25 years as compared to
Merck's HPV vaccine (GardasilÂ®). For comparative purposes, a group of HIV negative females
will also be evaluated. All subjects will receive the HPV vaccine (either Cervarixâ„˘ or
GardasilÂ®) 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.