Studies Demonstrate Gardasil® Has Long Duration of Protection From HPV Disease

Studies Demonstrate Gardasil® Has Long Duration of Protection From HPV Disease

  PR Newswire

  LYON, France, December 6, 2012

LYON, France, December 6, 2012 /PRNewswire/ --

      Data represents the largest follow-up available for an HPV vaccine

Data from two large, long term follow-up studies continue to show that
vaccination with Gardasil offers a long duration of protection from human
papillomavirus (HPV) diseases related to HPV types 6, 11, 16 and 18.
HPV-related diseases include cervical cancer and genital warts. 

The interim data, presented at the 28 ^th International Papillomavirus
Conference (IPV) in Puerto Rico, showed that young women ^[ ^1 ^] and
adolescent girls and boys ^[ ^2 ^] vaccinated with Gardasil were protected
from HPV-related diseases for up to eight years following vaccination.
Furthermore, data on immunogenicity ^[ ^3 ^] (the degree to which an immune
response is induced) showed that immune levels remained high for nine years
following vaccination.

" These latest data show an encouraging trend of continued protection with
Gardasil against HPV-related cervical, vaginal and vulvar disease in women
through eight years ," said Professor Susanne Krüger Kjær, Danish Cancer
Society.  " These studies provide further evidence for the ongoing efficacy,
immunogenicity, and safety of Gardasil. "

The European studies were conducted in Sweden, Denmark, Norway and Iceland.
One study followed young women aged between 16-23 years and the second study
followed adolescent boys and girls between 9-15 years. The studies will
continue tracking the study participants for at least 14 years. 

Benoit Soubeyrand, Executive Director, Medical Affairs for Sanofi Pasteur MSD,
stated: " T h ese  data  tell  us  that Gardasil can in effect help
protect people from HPV diseases during the entire period when they are most
at risk  -  from adolescence into early adulthood.  That ' s nearly a
decade of protection that  could  save  many  lives over time. "

More than 100 million doses of Gardasil® have been distributed worldwide since
2006.

Notes to Editors

About the studies

The Scandinavian study ^[ ^1 ^] among young women is an extension of the
pivotal Phase III FUTURE II clinical trial of Gardasil. The study is being
conducted through the national health registry systems in four Nordic
countries: Denmark, Iceland, Norway and Sweden. Because of the extensive
nationwide registers in these countries, it is possible to conduct follow-up
studies that can track the health of the study participants well into the
future, beyond the original study's timeframe. The Long Term Follow-Up (LTFU)
study evaluated effectiveness against the early stages of cervical cancer,
vulvar cancer and vaginal cancer related to HPV types 6/11/16/18. Data from
this Scandinavian study showed a trend of continued protection, with no
breakthrough cases of disease, through eight years. Analysis and observation
of the study participants will be followed for 10 years, for a total of 14
years post vaccination. 

The study among adolescent girls and boys ^[ ^2 ^] aged 10-15 years followed a
randomized, double-blind trial of 1,781 participants. Safety, immunogenicity
and effectiveness of Gardasil were assessed following vaccination in this
population as they got older and as some became sexually active. Results also
showed persistence of high immune response to HPV types 6, 11, 16 or 18 over 8
years in study participants. In this follow up period there were no cases of
disease related to vaccine HPV types 6, 11, 16 or 18 through 8 years. This
study will continue to follow participants through at least 10 years of
post-vaccination follow-up.

References:

1.Krüger Kjær S  et al . Long-term effectiveness of Gardasil™ in the Nordic
    countries. Poster and abstract presented at the 28 ^th International
    Papillomavirus Conference, Puerto Rico, Nov 30- Dec 6 2012.
2.Saah A  et al . Long-term extension study of Gardasil in adolescents;
    results through month 96. Poster and abstract presented at the 28 ^th
    International Papillomavirus Conference, Puerto Rico, Nov 30- Dec 6 2012.
3.Nygård M  et al . A long term follow-up study of the immunogenicity of
    the quadrivalent HPV (qHPV) vaccine in Scandinavia and Iceland. Poster and
    abstract presented at the 28 ^th International Papillomavirus Conference,
    Puerto Rico, Nov 30- Dec 6 2012.

About Sanofi Pasteur MSD

Sanofi Pasteur MSD is a joint venture between Sanofi Pasteur, the vaccine
division of Sanofi, and Merck, known as MSD outside the USA and Canada.
Combining innovation and expertise, Sanofi Pasteur MSD is the only company in
Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw
on the research expertise of Sanofi Pasteur and Merck to focus on the
development of new vaccines for Europe to improve the acceptability, efficacy
and tolerability of vaccination.

For further information please contact:

Caroline ASHE Senior Director External Communications Europe Sanofi Pasteur
MSD Tel : +33-4-37-28-4040 Mob : +33-6-33-46-1365 CAshe@spmsd.com