Errata: FDA Briefing Document February 27, 2007 Meeting Topic 1: Safety & Immunogenicity of H5N1 Influenza Virus Vaccine, A/Vietnam/1203/2004 (clade 1), 90g/mL, Manufactured by Sanofi Pasteur Page 16

 

Table 8: Frequency of Local and Systemic Reactogenicity Events in Study FUG01

 

 

Placebo

N=48

n (%)

7.5g

N=101

n (%)

15 g

N=101

n (%)

45 g

N=98

n (%)

90 g

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 g, 15 g, 45 g, 90 g 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%.