NIMENRIX™ - GlaxoSmithKline

TOXICOLOGY
Non-clinical data reveal no special hazard for humans based on local tolerance, acute
toxicity, repeated dose toxicity, developmental/reproductive toxicity and fertility studies.
Table 10
Nonclinical toxicology studies
Study type
and species
Local tolerance
and acute toxicity
New Zealand
White rabbit
Repeated dose
toxicity
New Zealand
White rabbit
Reproductive and
developmental
toxicity
Wistar rat
Route and dosage
regimen
One intramuscular
injection; full human dose
Five repeated
intramuscular injections
two weeks apart; full
human dose per injection
Intramuscular injection
42 and 28 days before
mating and on gestation
days 6, 8, 11 and 15; 2/5
of the full human dose
per injection (200 μl)
Results
No distinct treatment-related changes in general and local
clinical signs and body weight. No macroscopic abnormalities
seen at injection site. A slight mononuclear type inflammation
was observed microscopically at the injection sites of both the
saline control and MenACWY-TT groups.
No treatment-related changes observed in general and in local
clinical signs, ophthalmoscopy, rectal body temperature,
haematology, clinical chemistry or organ weights.
Very slight to slight inflammation in the injected muscles
which diminished distinctly over time with a clear recovery
process observed 28-days after the last dose. No adverse
vaccine formulation-related histopathological changes were
observed any other tissues or organs.
No treatment-related effects on maternal toxicity, prenatal
development (including external, visceral and skeletal
abnormalities), or postnatal development
October 22, 2014
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