Pharmacotherapeutic Group: Yellow Fever Vaccine (Live). ATC Code: J07B-L01.
Pharmacology: Pharmacodynamics: 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 titre 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.
Paediatric Population: 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 Titres 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.
Pharmacokinetics: No pharmacokinetic studies have been performed.
Toxicology: Preclinical Safety Data: No non-clinical studies have been performed.