Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Sanofi Pasteur Europe, 14 Espace Henry Vallée, 69007 Lyon, FRANCE Distributed in the UK by: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Pharmacotherapeutic group: Yellow Fever Vaccine (Live)
ATC code: J07BL01
STAMARIL is a live attenuated yellow fever virus vaccine. As with other live attenuated viral vaccines, there is a sub-clinical infection in healthy recipients that results in the production of specific B and T cells and the appearance of specific circulating antibody. A neutralizing antibody titer of 1:10 is assumed to correlate with protection.
Protective immunity appears from about 10 days after vaccination, lasts at least 10 years and may be life-long.
In clinical studies in adults it has been shown that 28 days following vaccination with STAMARIL seroconversion rates of 93% and 100% were obtained.
In a clinical study conducted in 337 toddlers aged 12 to 13 months the yellow fever seropositivity rates 28 days post injection of STAMARIL were 99.7% (98.5; 100.0) and the Geometric Mean Titers were 423 (375; 478). In another clinical study conducted in 30 children and adolescents aged 2 to 17 years a seroconversion rate of 90 to 100% was observed confirming results observed in earlier clinical studies.
No pharmacokinetic studies have been performed.
No non-clinical studies have been performed.
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