Adjuvants Systems (AS) containing immunostimulant combinations are used in @entity1 vaccines. Safety pharmacology studies evaluated the cardiorespiratory effects of AS in conscious telemetered @entity235 and in anaesthetised @entity35 . Sixteen telemetered @entity235 (4/group) received intramuscular injections of saline at Day 0, and one clinical dose of AS01, AS03, AS04 or AS15 at Day 7 (7  the equivalent @entity1 dose on a bodyweight basis). Bodyweights were measured through Day 14 and cardiorespiratory parameters and body temperature through 72 h post-treatment. Anaesthetised @entity35 (4/group) received one intravenous injection of AS01, AS03 or AS15 at 1 mL/kg bodyweight (140  the equivalent @entity1 dosages), or saline. Cardiorespiratory parameters were measured for 120 min post-dose. In @entity235 , food consumption and mean bodyweight decreased with AS03, and mean body temperature slightly increased with AS01, AS03 and AS15, but were not considered to be adverse. Cardiovascular effects (a slight, reversible increase in mean heart rate and shortened mean RR/PR/QT-intervals) were observed with AS15. No relevant clinical effects or effects on QRS-complex/QTc-interval durations, arterial pressure or respiratory parameters were observed. In @entity35 , there were no consistent treatment-related effects. Collectively, this suggests that AS01, AS03, AS04 and AS15 are not associated with potentially deleterious effects on ventricular repolarisation, atrio/intra-ventricular conductivities or respiratory functions.

Effects of Adjuvant Systems on the cardiovascular and respiratory functions in telemetered conscious XXXX and anaesthetised @entity35 .

@entity1 :: ('9606', 'Species') :: ['human'] @entity35 :: ('10116', 'Species') :: ['rats'] @entity235 :: ('9615', 'Species') :: ['dogs', 'beagle dogs']
@entity235 :: (9615,Species) :: ['dogs']
