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Pharmacotherapeutic group: Yellow Fever Vaccine (Live). ATC code: J07B L1.
Pharmacology: Pharmacodynamics: STAMARIL PASTEUR is a live attenuated yellow fever virus vaccine. As with other live attenuated viral vaccines, there is a sub-clinical infections in healthy recipients that results in the production of specific B and T cells and the appearance of specific circulating antibody.
Protective immunity appears from about 10 days after vaccination, is expected to be 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 PASTEUR seroconversion rates of 93% and 100% were obtained.
Paediatric population: In a clinical study involving 377 toddlers aged 12 to 13 months the yellow fever seropositivity rates 28 days post injection of STAMARIL PASTEUR were 99.7% (98.5; 100.0) and the Geometric Mean Titres were 423 (375; 478). In phase I clinical study involving approximately 30 children and adolescents aged 2 to 17 years a seroconversion rate of 90 to 100% was observed.
Pharmacokinetics: No pharmacokinetic studies have been performed.
Toxicology: Preclinical safety data: Pre-clinical date reveals no special hazard for humans.
