DENGVAXIA(Dengue Tetravalent Vaccine, Live)Suspension for Subcutaneous Injection(四)
linical trials. In these studies, a total of 19,102subjects 9 through 16 years of age received at least one dose of DENGVAXIA and 9,484received placebo (0.9% sodium chloride).
Overall, 50.9% of trial participants who receivedDENGVAXIA or placebo were female. Racial groups were reported as 18.9% Asian, 13%American Indian or Alaska native, 6.4% caucasian, 2.6% black, and 59.1% as other.
In thelargest study (Study 1, NCT01374516; N = 20,869) conducted in four Latin American countriesand Puerto Rico, most subjects (99.9%) reported Hispanic ethnicity. All studies enrolled subjectsirrespective of evidence of previous dengue infection.
Solicited Adverse Reactions
In a multi-center, observer-blind, randomized (2:1), placebo-controlled trial conducted in fourLatin American countries and Puerto Rico (Study 1, NCT01374516), 2,000 subjects (out of atotal of 20,869 subjects) were recruited during the first 2 months of enrollment for inclusion inthe reactogenicity subset. Solicited adverse reactions were recorded daily for 14 days followingeach vaccination.
Table 1 presents the frequency and severity of solicited injection site reactions reported within 7days and systemic adverse reactions reported within 14 days following receipt of DENGVAXIAor placebo.
Table 1: Percentages of Subjects with Solicited Injection Site Reactions within 7 Days andSystemic Adverse Reactions within 14 Days Following Receipt of Each Dose of
DENGVAXIA or Placebo in Children and Adolescents 9 through 16 Years of Age inStudy 1
Dose 1 Dose 2 Dose 3
DENGVAXIA
%
N = 1,264-
1,326
Placebo
%
N =
635-657
DENGVAXIA
%
N = 1,228-
1,298
Placebo
%
N =
594-639
DENGVAXIA
%
N = 1,215-
1,279
Placebo
%
N =
597 -631
Injection Site Reactions
Pain* Any
Grade 3
32.4
0.8
26.3
0.9
25.6
0.5
16.4
0.0
22.5
0.9
16.5
0.3
Erythema† Any
Grade 3
4.1
0.0
4.7
0.2
1.9
<0.1
1.7
0.0
1.5
0.0
1.6
0.0
Swelling† Any
Grade 3
3.5
0.0
2.7
0.2
1.9
0.0
0.9
0.0
1.6
0.0
1.3
0.0
Systemic Adverse Reactions
Asthenia‡ Any
Grade 3
24.6
2.7
22.5
2.6
17.8
1.8
16.4
1.1
16.3
1.3
17.4
1.3
Fever§ Any
Grade 3
6.8
1.7
6.6
1.1
5.9
0.8
7.1
1.2
7.3
1.1
8.7
0.8
Headache‡ Any
Grade 3
39.9
5.1
41.6
4.1
29.8
2.1
28.5
2.3
29.6
2.6
25.0
1.9
Malaise‡ Any
Grade 3
24.5
2.4
25.9
2.3
20.8
1.3
16.6
1.3
19.3
1.4
15.2
1.1
Myalgia‡ Any
Grade 3
29.2
2.2
27.4
1.5
21.0
1.6
15.8
0.8
20.0
1.5
18.4
0.8
N: range number of subjects with available data for the specified endpoints
Study 1, NCT01374516
Placebo: 0.9% sodium chloride
For subjects 9 through 11 years of age–Grade 3: Incapacitating, unable to perform usual activities. For subjects 12 through 16years of age–Grade 3: Significant; prevents daily activity.
For subjects 9 through 11 years of age–Grade 3:≥50 mm. For subjects 12 through 16 years of age – Grade 3: >100 mm.
For all subjects – Grade 3: Significant; prevents daily activity.
For all subjects – Any Fever: ≥38.0C. Grade 3: ≥39.0C.
Unsolicited Non-Serious Adverse Rea |
