Imojev

Imojev Adverse Reactions

vaccine, japanese encephalitis

Manufacturer:

Sanofi

Distributor:

Zuellig
/
Four Star
Full Prescribing Info
Adverse Reactions
Clinical Trials Experience: Data in adult populations: The safety of IMOJEV has been assessed in 8 randomised clinical trials in individuals over 18 years of age. During the development in the adult population, approximately 2,500 individuals received an injection of IMOJEV.
Safety evaluation was performed for all individuals 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 vaccine were headache, fatigue, malaise and myalgia. All these reactions were as frequently reported as after the administration of the inactivated Japanese Encephalitis (JE) comparator vaccine or a placebo.
The most frequently reported reaction at the injection site after the administration of IMOJEV vaccine was injection site pain. All the injection site reactions were less frequently reported than after the administration of the inactivated JE 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 <1/1,000); 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, dyspnoea, rhinorrhoea, cough, wheezing, nasal congestion.
Skin and subcutaneous tissue disorders: Common: Rash.
Infections and infestations: Rare: Viral infections.
Table 13 as follows summarises the possibly related Adverse Events (frequency ≥1.0%) that were reported during clinical trials within 30 days after the administration of a single dose of IMOJEV, of the two first doses and the third dose of the inactivated JE comparator vaccine and of the placebo doses. (See Table 13.)

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Data in paediatric populations: The safety of IMOJEV in paediatric populations has been assessed in Phase II and Phase III clinical trials. Overall, approximately 2,200 children received at least one injection of IMOJEV in these studies.
In addition, 10,000 individuals between 9 months and 5 years of age received IMOJEV either primary or booster vaccination in a large scale Phase IV safety trial aimed at identifying serious, rare adverse reactions (see Adverse Reactions from Post-Marketing Surveillance section).
Results from 5 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 2,200 individuals between 9 months and 5 years of age received an injection of IMOJEV (approximately 50 infants from 9 to 12 months old and 2,050 toddlers from 12 months not previously immunised with a JE vaccine, as well as 100 children previously immunised with a two-dose regime of a JE vaccine).
Safety evaluation was performed for all individuals 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); and irritability, appetite loss, crying and fever in infants and toddlers (9 to 24 months).
The most frequently reported reactions at the in jection site after the administration of IMOJEV vaccine 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.
Table 14 as follows summarises the solicited reactions that were reported during clinical trials after the administration of a single dose of IMOJEV or of a control vaccine. (See Table 14.)

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Table 15 as follows summarises the non-serious adverse reactions that were reported during clinical trials within 28 days after the administration of a single dose of IMOJEV or of a control vaccine. (See Table 15.)

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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: Inconsolable crying.
No serious adverse events within 28 days of administration of IMOJEV were related to vaccination.
During the paediatric clinical trials, 29 cases of convulsions have been reported, including 28 cases of febrile convulsion and 1 case of convulsion without fever. All cases were assessed as not related to vaccination and were reported to be associated with concurrent infectious diseases (or common cold). In 9 cases, convulsions started within 30 days after IMOJEV vaccination.
In the following studies, the safety of IMOJEV presented no clinically relevant difference with the above-described safety profile: In a Phase III trial in 390 individuals 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 a Phase III trial in 119 children between 18 and 36 months of age who received a second dose (booster dose) of IMOJEV.
Adverse Reactions from Post-Marketing Surveillance: 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, as well as from spontaneous reporting in post-marketing surveillance.
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