Errata: FDA Briefing Document February 27, 2007
Meeting Topic 1: Safety & Immunogenicity of H5N1 Influenza Virus Vaccine, A/Vietnam/1203/2004
(clade 1), 90µg/mL, Manufactured by Sanofi Pasteur – Page 16
Table 8: Frequency of Local and Systemic Reactogenicity Events in Study FUG01
|
|
Placebo N=48 n (%) |
7.5µg N=101 n (%) |
15 µg N=101 n (%) |
45 µg N=98 n (%) |
90 µg N=103 n (%) |
|
Subj ects with > 1 Injection Site AE(s) |
22 (45.8) |
60 (59.4) |
69 (68.3) |
77 (78.6) |
87 (84.5) |
|
Subjects
with Moderate (Gr 2) Injection Site AEs |
0 (0) |
3 (3.0) |
5 (5.0) |
7 (7.1) |
14 (15.5) |
|
Subjects
with Severe (Gr 3) Injection Site AEs |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
|
# of Injection Site AEs |
89 |
237 |
266 |
424 |
537 |
|
Pain |
20 (22.5) |
52 (21.9) |
89 (33.5) |
149 (35.1) |
194 (36.1) |
|
Tenderness |
19 (21.3) |
69 (29.1) |
91 (34.2) |
150 (35.4) |
189 (35.2) |
|
Erythema/Redness |
31 (34.8) |
85 (35.9) |
62 (23.3) |
95 (22.4) |
98 (18.2) |
|
Induration/Swelling |
19 (21.3) |
31 (13.1) |
24 (9.0) |
30 (7.1) |
56 (10.4) |
|
Subjects with > 1 Systemic AE(s) |
28 (58.3) |
40 (39.6) |
48 (47.5) |
35 (35.7) |
49 (47.6) |
|
Subjects with Moderate (Gr 2) Systemic AEs |
10 (20.8) |
15 (14.9) |
21 (20.8) |
6 (6.1) |
12 (11.7) |
|
Subject with Severe (Gr 3) Systemic AEs |
0 |
1 (1.0) |
2 (2.0) |
0 |
1 (1.0) |
|
# of Systemic AEs |
125 |
207 |
349 |
109 |
171 |
|
Headache |
45 (36) |
70 (33.8) |
107 (30.7) |
44 (40.4) |
65 (38.0) |
|
Malaise |
43 (34.4) |
57 (27.5) |
98 (28.0) |
31 (28.4) |
51 (29.8) |
|
Body aches |
28 (22.4) |
44 (21.3) |
82 (23.5) |
21 (19.3) |
29 (17.0) |
|
Nausea |
4 (3.2) |
20 (9.7) |
42 (12.0) |
7 (6.4) |
15 (8.8) |
|
Feverishness |
5 (4.0) |
16 (7.7) |
20 (5.7) |
6 (5.5) |
11 (6.4) |
Source: LOCAL0 and SYSTEM0 CRTs
Other Adverse Events
The most
frequently reported AEs, regardless of causality,
were in the system organ class (SOC) infections and infestations (21.5%)
followed by, respiratory, thoracic and mediastinal
disorders (14%) and gastrointestinal disorders (10%). Adverse event frequency was similar or
slightly higher in the placebo arm as compared to the vaccine arms except in
the Respiratory, thoracic and mediastinal disorders
SOC where the AE rates in the vaccine arms (10.9%, 13.9%, 7.1% and 9.7% in the
7.5 µg, 15 µg, 45 µg, 90 µg arms respectively)were slightly higher than
the placebo arm (6.25%). The most
commonly reported preferred terms in this SOC were pharyngolaryngeal
pain (namely. sore throat), 33.3%; cough, 22.2%; nasal congestion, 20.0% and
sinus congestion, 11.1%.