Table 2.

Efficacy of the vaccine in the prevention of gastroenteritis in the per protocol population

Endpoints	n		VE	95% CI	P value
	Vaccine N=4354	Placebo N= 2187
Severe RVGE
Overall*	71	76	53·6	35·0–66·9	<0·001
At 1 year of age	56	64	56·4	36·6–70·1	<0·001
Severe RVGE requiring hospitalisation or supervised rehydration therapy
Overall*	71	76	53·6	35·0–66·9	<0·001
At 1 year of age	56	64	56·4	36·6–70	<0·001
Very severe RVGE
Overall*	10	11	54·4	−18·3–82·6	0·11
At 1 year of age	9	9	49·8	−42·6–82·4	0·22
RVGE of any severity
Overall*	287	216	34·6	21·6–45·3	<0·001
At 1 year of age	226	171	34·6	19·7–46·6	<0·001
RVGE of any severity requiring hospitalisation or supervised rehydration therapy
Overall*	277	201	32·0	18·0–43·5	<0·001
At 1 year of age	218	161	32·9	17·2–45·5	<0·001
Severe gastroenteritis of any aetiology
Overall*	308	188	18·6	1·9–32·3	0·03
At 1 year of age	221	145	24·1	5·8–38·7	0·01

^*Median age was 17·2 months at the time of analyses

Severe gastroenteritis: episodes with a Vesikari score ≥11

Severe RVGE: episodes with Vesikari score ≥11 and presence of rotavirus (Rotaclone positive and VP6 or VP4 and VP7 positive by RT-PCR) strains. Includes all RVGE except where G9P[11] was isolated

Very severe gastroenteritis: episodes with Vesikari score ≥16

Hospitalisation: inpatient admission for at least 6 hours in a treatment facility or hospital

Supervised rehydration therapy: administration of oral rehydration salts solution or intravenous fluids