Date: 2012-09-11
Type of
information: Publication of results in a medical journal
phase: 2b
Announcement: publication in The Lancet of detailed results of study conducted in Thailand with Sanofi's dengue vaccine candidate
Company: Sanofi Pasteur (France)
Product: tetravalent dengue vaccine candidate
Action
mechanism:
Disease: dengue fever
Therapeutic
area: Infectious diseases
Country: Thailand
Trial
details:
- The study was conducted in 4,002 children aged 4 to 11 years, in partnership with the Mahidol University under the patronage of the Thai Ministry of Public Health in Muang district of the Ratchaburi Province. Sanofi Pasteur\'s dengue vaccine candidate is a live, attenuated vaccine. The vaccination schedule is 3 doses given 6 months apart (at 0, 6 and 12 months).
Latest
news:
- Sanofi Pasteur, the vaccines division of Sanofi has announced the online publication in The Lancet of clinical study results showing the ability of its vaccine candidate to protect against dengue fever caused by three dengue virus types. The results of the world’s first efficacy study confirm the excellent safety profile of Sanofi Pasteur’s dengue vaccine candidate.
The full analysis of vaccine efficacy against each serotype, reflecting real-life conditions (intent to treat analysis) showed vaccine efficacy to be 61.2% against dengue virus type 1, 81.9% against type 3 and 90% against type 4. One of the dengue virus types (serotype 2) eluded the vaccine. First results have been presented and analyses are ongoing to understand the lack of protection for serotype 2 in the particular epidemiological context of Thailand. Large-scale phase III clinical studies of Sanofi Pasteur’s dengue vaccine candidate are underway with 31,000 children and adolescents in 10 countries in Asia and Latin America. These studies will generate important additional data in a broader population and in a variety of epidemiological settings to define the best conditions to set up vaccination programs in order to protect people at risk of dengue.
Is
general: Yes
