Table 2.

Characteristics of Adverse events in the LGG and Placebo Groups and Immune Response to Immunization with Live Attenuated Influenza Vaccine

ADVERSE EVENTS	LGG (n=19)	PLACEBO (n=20)	P value
Serious Adverse Events	0 (0%)	1 (5%) *	1.00
Any Adverse Event %	14 (74%)	17 (85%)	0.45
- Any Adverse Event by Day 14	14 (74%)	17 (85%)	0.45
- Any Adverse Event between Day 14 and 28	8 (42%)	11 (55%)	0.53
- Any Adverse Event between Day 28 and 56	7 (37%)	5 (25%)	0.50
Non-gastrointestinal Adverse Events
- Rhinorrhea	9 (47%)	9 (45%)	1.00
- Headache	6 (32%)	6 (30%)	1.00
- Cough	2 (11%)	6 (30%)	0.24
- Muscle Aches	0 (0%)	6 (30%)	0.02
- Sore Throat	1 (5%)	4 (20%)	0.34
- Weakness	0 (0%)	3 (15%)	0.23
- Chills	0 (0%)	2 (10%)	0.49
- Fever	0 (0%)	0 (0%)	1.00
Gastrointestinal Adverse Events
- Nausea	6 (32%)	2 (10%)	0.13
- Gas	4 (21%)	4 (20%)	1.00
- Rumbling	2 (11)	3 (15% )	1.00
- Decreased appetite	0% (0%)	5 (25%)	0.047
- Diarrhea	1 (5%)	3 (15%)	0.61
- Bloating	1 (5%)	2 (10%)	1.00
- Abdominal pain	1 (5%)	1 (5%)	1.00
- Constipation	1 (5%)	1 (5%)	1.00
Other Adverse Events Volunteered by Subjects	1 (5%) **	4 (20%) **	1.00

^*One study subject in the placebo group had a serious adverse event (hospitalization for a sinus infection on study day 58), considered unrelated to the study protocol.

^**The other adverse event volunteered by subject in the LGG group were symptoms consistent with conjunctivitis, the other 4 events volunteered by subjects in the placebo group were symptoms consistent with conjunctivitis (1) transient rash (1), ear wax build up (1) and pain after being hit by a car door (1). All these events were rated mild and were considered unrelated to the study protocol.