Frequencies are reported as: Very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1000 to <1/100; rare: ≥1/10,000 to <1/1000; very rare: <1/10,000.
In controlled clinical studies, signs and symptoms were actively monitored during a 42-day follow-up period. The vaccinees were also requested to report any clinical events during the study period.
The safety profile presented as follows is based on a total of approximately 12,000 subjects administered with Priorix in clinical trials.
Infections and Infestations: Common: Upper respiratory tract infection. Uncommon: Otitis media.
Blood and Lymphatic System Disorders: Uncommon: Lymphadenopathy.
Immune System Disorders: Rare: Allergic reactions.
Metabolism and Nutrition Disorders: Uncommon: Anorexia.
Psychiatric Disorders: Uncommon: Nervousness, abnormal crying, insomnia.
Nervous System Disorders: Rare: Febrile convulsions.
Eye Disorders: Uncommon: Conjunctivitis.
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Bronchitis, cough.
Gastrointestinal Disorders: Uncommon: Parotid gland enlargement, diarrhoea, vomiting.
Skin and Subcutaneous Tissue Disorders: Common: Rash.
General Disorders and Administration Site Conditions: Very Common: Redness at the injection site, fever ≥38°C (rectal) or ≥37.5°C (axillary/oral). Common: Pain and swelling at the injection site, fever >39.5°C (rectal) or >39°C (axillary/oral).
In general, the frequency category for adverse reactions was similar for the 1st and 2nd vaccine doses. The exception to this was pain at the injection site which was common after the 1st vaccine dose and very common after the 2nd vaccine dose.
During post-marketing surveillance, the following reactions have been reported additionally in temporal association with Priorix vaccination:
Infections and Infestations: Meningitis.
Blood and Lymphatic System Disorders: Thrombocytopenia, thrombocytopenic purpura.
Immune System Disorders: Anaphylactic reactions.
Nervous System Disorders: Transverse myelitis, Guillain-Barre syndrome, peripheral neuritis, encephalitis [encephalitis has been reported with a frequency <1/10 million doses. The risk of encephalitis following administration of the vaccine is far below the risk of encephalitis caused by natural diseases (measles: 1 in 1000-2000 cases; rubella: Approximately 1 in 6000 cases)].
Skin and Subcutaneous Tissue Disorders: Erythema multiforme.
Musculoskeletal and Connective Tissue Disorders: Arthralgia, arthritis.
General Disorders and Administration Site Conditions: Kawasaki syndrome.
In rare cases, a mumps-like condition with an abbreviated incubation period cannot be ruled out. In isolated cases, transient, painful swelling of the testicles has been reported after combined mumps, measles and rubella vaccination.
In rare cases, a measles-like syndrome has been reported following vaccination with Priorix.
Accidental intravascular administration may give rise to severe reactions or even shock. Immediate measures depend on the severity of the reaction (see Precautions).
In comparative studies, a statistically significant lower incidence of local pain, redness and swelling was reported with Priorix compared with the comparator. The incidence of other adverse reactions listed previously was similar in both vaccines.