Table 7.

Unsolicited adverse event by primary system organ class and preferred term – (Total-vaccinated cohort).

Adult Cohort
System Organ Class Preferred Term	HSRV Vaccine (N = 26) n (%) E	Placebo (N = 24) n (%) E
Gastrointestinal Disorders	3 (11.5) 3	1 (4.2) 1
Diarrhoea	2 (7.7) 2	1 (4.2) 1
Vomiting	1 (3.8) 1	0
Infant Cohort
System Organ Class Preferred Term	HSRV Vaccine (N = 25) n (%) E	RotaTeq® (N = 25) n (%) E
Gastrointestinal Disorders	5 (20.0) 5	3 (12.0) 3
Diarrhea	1 (4.0) 1	1 (4.0) 1
Retching	3 (12.0) 3	1 (4.0) 1
Vomiting	1 (4.0) 1	1 (4.0) 1
General Disorders and Administration Site Conditions	1 (4.0) 1	3 (12.0) 3
Pyrexia	1 (4.0) 1	3 (12.0) 3
Infections and Infestations	3 (12.0) 4	1 (4.0) 1
Fungal Infection	2 (8.0) 2	0
Nasopharyngitis	1 (4.0) 1	0
Rhinitis	1 (4.0) 1	1 (4.0) 1
Respiratory, Thoracic and Mediastinal Disorders	3 (12.0) 10	4 (16.0) 7
Cough	3 (12.0) 5	4 (16.0) 4
Nasal Congestion	0	1 (4.0) 1
Rhinorrhea	3 (12.0) 5	2 (8.0) 2

Abbreviations: N: Number of participants dosed in the treatment arm; n: Number of participants with that type of AE; E: Number of occurrences of an adverse event; %: Percentage, calculated using the number of participants dosed in the treatment arm as the denominator (n/N*100); All adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA) version 18.1.