Qdenga Adverse Reactions

Summary of the safety profile: In clinical studies, the most frequently reported reactions in subjects 4 to 60 years of age were injection site pain (50%), headache (35%), myalgia (31%), injection site erythema (27%), malaise (24%), asthenia (20%) and fever (11%).
These adverse reactions usually occurred within 2 days after the injection, were mild to moderate in severity, had a short duration (1 to 3 days) and were less frequent after the second injection of Qdenga than after the first injection.
Vaccine viremia: In clinical study DEN-205, transient vaccine viremia was observed after vaccination with Qdenga in 49% of study participants who had not been infected with dengue before and in 16% of study participants who had been infected with dengue before. Vaccine viremia usually started in the second week after the first injection and had a mean duration of 4 days. Vaccine viremia was associated with transient, mild to moderate symptoms, such as headache, arthralgia, myalgia and rash in some subjects. Vaccine viremia was rarely detected after the second dose.
Tabulated list of adverse reactions: Adverse reactions associated with Qdenga obtained from clinical studies are tabulated as follows (Table 8).
The safety profile presented as follows is based on a pooled analysis including 14,627 study participants aged 4 to 60 years (13,839 children and 788 adults) who have been vaccinated with Qdenga. This included a reactogenicity subset of 3,830 participants (3,042 children and 788 adults).
Adverse reactions are listed according to the following frequency categories: 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. (See Table 8.)

Click on icon to see table/diagram/image

Paediatric population: Paediatric data in subjects 4 to 17 years of age: Pooled safety data from clinical trials are available for 13839 children (9210 aged 4 to 11 years and 4629 aged 12 to 17 years). This includes reactogenicity data collected in 3042 children (1865 aged 4 to 11 years and 1177 aged 12 to 17 years).
Frequency, type and severity of adverse reactions in children were largely consistent with those in adults. Adverse reactions reported more commonly in children than in adults were fever (11% versus 3%), upper respiratory tract infection (11% versus 3%), nasopharyngitis (6% versus 0.6%), pharyngotonsillitis (2% versus 0.3%), and influenza-like illness (1% versus 0.1%). Adverse reactions reported less commonly in children than adults were injection site erythema (2% versus 27%), nausea (0.03% versus 0.8%) and arthralgia (0.03% versus 1%).
The following reactions were collected in 357 children below 6 years of age vaccinated with Qdenga: decreased appetite (17%), somnolence (13%) and irritability (12%).
Paediatric data in subjects below 4 years of age, i.e. outside the age indication: Reactogenicity in subjects below 4 years of age was assessed in 78 subjects who received at least one dose of Qdenga of which 13 subjects received the indicated 2-dose regimen. Reactions reported with very common frequency were irritability (25%), fever (17%), injection site pain (17%) and loss of appetite (15%). Somnolence (8%) and injection site erythema (3%) were reported with common frequency. Injection site swelling was not observed in subjects below 4 years of age.