Dengue vaccine group                                                                                     Control group
Age cohort 2–5 yrs 6–11 yrs 12–17 yrs 18–45 yrs All 2–5 yrs 6–11 yrs 12–17 yrs 18–45 yrs All
N=40 N=40 N=20 N=20 N=120 N=20 N=20 N=10 N=10 N=60
Subjects experiencing at least one / n, %
Injection site reactions
Pain Any 5, 13% 12, 30% 10, 50% 7, 35% 34, 29% 13, 65% 19, 95% 9, 90% 7, 70% 48, 80%
Erythema Any 1, 3% 5, 13% 2, 10% 0 8, 7% 3, 15% 4, 20% 3, 30% 3, 30% 13, 22%
  Grade 3             1, 5%     1, 2%
Swelling Any 0 2, 5% 1, 5% 2, 10% 5, 4% 4, 20% 4, 20% 0 1, 10% 9, 15%
  Grade 3             1, 5%     1, 2%
Systemic reaction
Fever Any 12, 30% 10, 25% 9, 45% 2, 10% 33, 28% 6, 30% 5, 25% 2, 20% 3, 30% 16, 27%
  Grade 3 1, 3%       1, 1% 2, 10%       2, 3%
Headache Any 11, 28% 12, 31%* 10, 50% 9, 45% 42, 35% 5, 25% 7, 35% 5, 50% 1, 10% 18, 30%
  Grade 3       1, 5% 1, 1%          
Malaise Any 7, 18% 9, 23%* 11, 55% 8, 40% 35, 29% 2, 10% 4, 20% 3, 30% 5, 50% 14, 23%
Myalgia Any 3, 8% 8, 21%* 8, 40% 5, 25% 24, 20% 3, 15% 3, 15% 5, 50% 3, 30% 14, 23%
Asthenia Any 3, 8% 6, 15%* 5, 25% 2, 10% 16, 13% 2, 10% 0 0 1, 10% 3, 5%
  Grade 3   1, 3%   1, 5% 2, 2%          
*N=39 due to missing data for one participant. Grade 3 injection site pain: Incapacitating, unable to perform usual activities, Grade 3 erythema or swelling: adults/ adolescents: >10 cm; children: >5 cm, Grade 3 fever > 39.0°C, Grade 3: headache, malaise, myalgia, or asthenia: Daily activity prevented
Table 3: Percentages of individuals (by age and vaccine group) reporting at least 1 injection site and/or systemic reaction after any vaccination (safety analysis set).