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.
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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. 
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(Â®) and
Gardasil(Â®) Human Papillomavirus vaccines in 12-15 year old girls. 
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 18-26Â years. 
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 18-26Â 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
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
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.
Clinical Trials Related to Cervarix (Human Papillomavirus Vaccine)
Immunogenicity of Gardasil and Twinrix and the Effect of a Dose of Gardasil or Cervarix Given 42 Months Later. [Enrolling by invitation]
Two human papillomavirus vaccines are now commercially available.
No clinical data exist regarding:
- The immunogenicity and safety of Gardasil and Twinrix when co-administered.
- The immunogenicity and safety of Cervarix when administered to subjects previously
vaccinated with Gardasil.
The main objective of the first phase of this clinical trial was:
â€¢ To assess and compare the immunogenicity of Gardasil and Twinrix Junior when
co-administered or administered at one month interval according to a 0, 6 month schedule to
9-10 year-old girls.
The main objective of the seconde phase of this clinical trial is:
â€¢ To determine the effect of a booster dose of Gardasil or Cervarix on HPV antibodies when
given 42 months post-vaccination of 9-10 year-old girls with two doses of Gardasil.
Study Design & Duration:
Experimental Design: Blind for the third HPV vaccine dose, randomized, single centre study
with two treatment groups.
Duration of the study:
Participants will be followed for the duration of 10 years post-primary vaccination.
Number of Centres:
Cervarix Long-term Safety Surveillance [Completed]
This study aims to assess whether the use of Cervarix® is associated with a modified risk of
central demyelination, type 1 diabetes (DT1), Cutaneous Lupus, inflammatory arthritis,
idiopathic thrombocytopenic purpura (ITP), Lupus erythematosus, myositis and
dermatomyositis, Guillain-Barre syndrome and/or Autoimmune thyroiditis and Graves disease by
using the PGRx information system.
Study of the Molecular Mechanisms Underlying the Cross-neutralizing Capacity of AS04-adjuvanted HPV Vaccine (Cervarixï¿½) in Comparison With the Aluminiumhydroxyphosphate Sulphate Adjuvanted HPV Vaccine (Gardasilï¿½) [Recruiting]
Six identical female twins aged 9-13 years will participate. One sib of each twin pair will
be given Cervarix according to the 0, 1, 6 month vaccination scheme, while the other sib
will be given Gardasil according to the 0, 2, 6 month vaccination scheme. Three blood
samples will be taken (the first prior to vaccine administration, the second and third 7
days after dose 2 and 3, respectively). The blood samples will be used to determine: 1) the
magnitude the anti-HPV 16 and anti-HPV-18 antibody responses, 2) as well as the
cross-reactive pattern of these responses towards related, non-vaccine HPV strains (HPV-31
and - 33, and HPV-45). 3) plasmablast isolated from blood taken 7 days after the 3rd dose in
the first place (and eventually after the 2nd dose also) will be examined for for the usage
of VDJ and VJ segments in the immunoglobulin heavy (VH) and light (VL) heavy and light
chains. Gene useg in B cells induced by Cervarix and Gardasil will be compared. Finally the
cross-reactive potential of monoclonal antibodies obtained by eukaryotic expression of a
series of heavy (VH) and light (VL) chains from single ASC isolated after the 3rd dose of a
three-dose schedule of either Cervarix or Gardasil will be examined.
The duration of the study is approximately 187 days. Five study visits will take place, over
a time period of 6. 5 months, followed by a telephone call after 12 months.
The purpose of the study is to learn more about the molecular mechanisms underlying the
cross-neutralizing capacity of AS04-adjuvanted HPV vaccine (CervarixÂ®) in comparison with
the aluminiumhydroxyphosphate sulphate adjuvanted HPV vaccine (GardasilÂ®).
Study Assessing Risk of Autoimmune Diseases in Females (9 - 25 Years) Exposed to Cervarix® in United Kingdom [Completed]
This is an observational cohort study to assess the risk of autoimmune disease(s) within 12
months of receiving the first dose of Cervarix® in the exposed cohort and over a comparable
period in the unexposed cohorts.
This is an alternative study by GSK using the CPRD database in the UK to fulfil the US FDA
safety commitment. The UK has had sufficient Cervarix® vaccination coverage during the
period mid-September 2008 to 2011 to allow suitable data to be collected.
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine With or Without Co-administration of Cervarix and Boostrix in Female Adolescents and Young Adults [Completed]
The purpose of this study is to evaluate safety and immunogenicity of GSK Biologicals'
meningococcal vaccine GSK134612 (MenACWY-TT) co-administered with Cervarix as compared to
MenACWY-TT and Cervarix administered alone and the co-administration of MenACWY-TT with
Cervarix and Boostrix as compared to MenACWY-TT administered alone and Cervarix
co-administered with Boostrix.