Imojev Adverse Reactions

Data from clinical trials: Data in adult population: The safety of IMOJEV has been assessed in 8 randomised clinical trials in subjects over 18 years of age. During the development in the adult population, approximately 2,500 subjects received an injection of IMOJEV.
Safety evaluation was performed for all subjects during the first 4 weeks following vaccination and serious adverse reactions were collected during at least six months of follow-up after a single dose of IMOJEV.
The most frequently reported systemic reactions after the administration of IMOJEV were headache, fatigue, malaise and myalgia. All these reactions were as frequently reported as after the administration of the inactivated Japanese encephalitis comparator vaccine or a placebo.
The most frequently reported reaction at the injection site after the administration of IMOJEV was injection site pain. All the injection site reactions were less frequently reported than after the administration of the inactivated Japanese encephalitis comparator vaccine and as frequently reported as after the administration of a placebo.
Local and systemic reactions are ranked within each system organ class, under headings of frequency, using the following convention [Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000), including isolated reports].
The following possibly related Adverse Events were reported during clinical trials within 30 days after vaccination: General disorders and administration site conditions: Very common: Fatigue, malaise, injection site pain.
Common: Feeling hot, chills, injection site erythema, injection site pruritus, injection site swelling, injection site bruising.
Uncommon: Pyrexia.
Nervous system disorders: Very common: Headache.
Common: Dizziness.
Musculoskeletal and connective tissue disorders: Very common: Myalgia.
Common: Arthralgia.
Gastrointestinal disorders: Common: Diarrhoea, nausea, abdominal pain, vomiting.
Respiratory, thoracic and mediastinal disorders: Common: Pharyngolaryngeal pain, dyspnea, rhinorrhoea, cough, wheezing, nasal congestion.
Skin and subcutaneous tissue disorders: Common: Rash.
Infections and infestations: Rare: Viral infections such as influenza-like illness.
Data in paediatric populations: Results from five Phase II and Phase III clinical trials with similar methodology for recording safety data were included in an integrated analysis of safety. During these clinical trials approximately 2200 individuals between 9 months and 5 years of age (approximately 100 children from 2 years of age, 2050 toddlers from 12 months of age and 50 infants from 9 to 12 months of age) received an injection of IMOJEV.
Safety evaluation was performed for all subjects during the first 4 weeks following vaccination and serious adverse reactions were collected during at least six months of follow-up after a single dose of IMOJEV.
The most frequently reported systemic reactions were malaise, myalgia, fever and headache in children (2 to 5 years) previously immunized with a two-dose primary vaccination with an inactivated Japanese encephalitis vaccine; and irritability, appetite loss, crying and fever in infants and toddlers (9 to 24 months) not previously immunized with a Japanese encephalitis vaccine.
The most frequently reported reactions at the injection site after the administration of IMOJEV was injection site pain/tenderness and injection site erythema.
These adverse events observed during paediatric clinical trials were generally of mild intensity and of short duration. The onset of systemic reactions was generally seen within 3 days after immunisation.
Local and systemic reactions are ranked within each system organ class, under headings of frequency, using the following convention [Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), including isolated reports].
The following related Adverse Events were reported during clinical trials within 28 days after vaccination: General disorders and administration site conditions: Very common: Pyrexia, malaise, irritability, injection site pain/ tenderness, injection site erythema.
Common: Injection site swelling.
Uncommon: Injection site reactions (induration, bruising, haematoma, haemorrhage).
Rare: Injection site pruritus.
Nervous system disorders: Very common: Headache, somnolence.
Musculoskeletal and connective tissue disorders: Very common: Myalgia.
Gastrointestinal disorders: Very common: Vomiting.
Metabolism and nutrition disorders: Very common: Appetite loss.
Infections and infestations: Uncommon: Upper respiratory tract infection.
Rare: Viral infection.
Skin and subcutaneous tissue disorders: Uncommon: Urticaria.
Rare: Rash, maculo-papular rash, post inflammatory pigmentation change.
Psychiatric disorders: Very common: Crying.
Infections and infestations: Rare: Upper respiratory tract infection, viral infections.
The safety of IMOJEV presented no clinically relevant difference with the previously described safety profile in the following phase III trials.
In 390 subjects between 36 and 42 months of age (45 out of the 390 received a single dose of IMOJEV, and 345 out of the 390 received a second dose (booster dose) of IMOJEV 2 years after the first dose).
In 119 children between 18 and 36 months of age who received a second dose (booster dose) of IMOJEV.
No additional adverse reactions were identified from the phase IV safety trial conducted in 10,000 individuals between 9 months and 5 years of age.
Data from post-marketing experience: No additional adverse reaction has been identified during post-marketing experience at this time.