Immunological non-inferiority and safety of a quadrivalent inactivated influenza vaccine versus two trivalent inactivated influenza vaccines in China: Results from two studies

Figures & data

Table 1. Baseline characteristics of the participants by vaccine received (Phase III study; safety analysis set).

	Shz QIV 0.25 mL (N = 1152)	Shz QIV 0.5 mL (N = 2991)	Shz TIVs Pooled (N = 2945)	All (N = 7088)
Sex: n (%)
Male	618 (53.6)	1394 (46.6)	1432 (48.6)	3444 (48.6)
Female	534 (46.4)	1597 (53.4)	1513 (51.4)	3644 (51.4)
Missing	0	0	0	0
Sex ratio: Male/Female	1.16	0.87	0.95	0.95
Age (year)
M	1152	2991	2945	7088
Mean (SD)	1.6 (0.44)	19.3 (24.64)	19.5 (24.72)	16.5 (23.52)
Min; Max	0.5; 2.0	0.5; 84.0	0.5; 89.0	0.5; 89.0
Median	1.8	6.0	6.0	3.0
Q1; Q3	1.3; 2.0	2.0; 35.0	2.0; 36.0	1.9; 15.0
Age group: n(%)
6–35 months	1152 (100)	1192 (39.9)	1151 (39.1)	3495 (49.3)
6–23 months	626 (54.3)	631 (21.1)	611 (20.7)	1868 (26.4)
24–35 months	526 (45.7)	561 (18.8)	540 (18.3)	1627 (23.0)
≥3 years	0	1799 (60.1)	1794 (60.9)	3593 (50.7)
3–8 years	0	449 (15.0)	446 (15.1)	895 (12.6)
9–17 years	0	480 (16.0)	481 (16.3)	961 (13.6)
9–11 years	0	298 (10.0)	301 (10.2)	599 (8.5)
12–17 years	0	182 (6.1)	180 (6.1)	362 (5.1)
18–60 years	0	450 (15.0)	447 (15.2)	897 (12.7)
>60 years	0	420 (14.0)	420 (14.3)	840 (11.9)
≥65 years	0	335 (11.2)	340 (11.5)	675 (9.5)

n:number of participants fulfilling the item listed; M: number of participants with available data for the relevant endpoint; Q1; Q3: first quartile; third quartile.

Table 2. Non-inferiority of Shz QIV to Shz TIV using GMTs in participants aged 6–35 months after last dose (Phase III study; per protocol set).

		Shz QIV 0.25 mL/Shz TIVs*						Shz QIV 0.5 mL/Shz TIVs*
	Antigen/strain	M	GMT	(95% CI)	GMT ratio	(95% CI)	Non-inferiority§	M	GMT	(95% CI)	GMT ratio	(95% CI)	Non-inferiority§
QIV	A/H1N1	1010	170	(160; 181)	–	–	–	1042	187	(176; 198)	–	–	–
	A/H3N2	1010	158	(147; 169)	–	–	–	1042	171	(160; 182)	–	–	–
	B/Victoria	1010	64.0	(60.7; 67.4)	–	–	–	1042	78.9	(74.8; 83.4)	–	–	–
	B/Yamagata	1010	96.6	(91.1; 102)	–	–	–	1042	120	(113; 127)	–	–	–
TIV1	A/H1N1	495	180	(166; 195)	0.946	(0.854; 1.049)	–	495	180	(166; 195)	1.039	(0.940; 1.149)	–
	A/H3N2	495	174	(158; 191)	0.906	(0.806; 1.019)	–	495	174	(158; 191)	0.980	(0.874; 1.100)	–
	B/Victoria	495	91.3	(84.9; 98.0)	0.701	(0.641; 0.767)	No	495	91.3	(84.9; 98.0)	0.865	(0.788; 0.950)	Yes
TIV2	A/H1N1	505	179	(164; 196)	0.949	(0.853; 1.055)	–	505	179	(164; 196)	1.041	(0.938; 1.155)	–
	A/H3N2	505	160	(146; 176)	0.986	(0.878; 1.107)	–	505	160	(146; 176)	1.066	(0.951; 1.195)	–
	B/Yamagata	505	106	(97.0; 115)	0.914	(0.825; 1.013)	Yes	505	106	(97.0; 115)	1.136	(1.025; 1.258)	Yes
TIVs Pooled	A/H1N1	1000	180	(169; 191)	0.947	(0.870; 1.032)	Yes	1000	180	(169; 191)	1.040	(0.956; 1.131)	Yes
	A/H3N2	1000	167	(156; 178)	0.946	(0.860; 1.040)	Yes	1000	167	(156; 178)	1.023	(0.931; 1.123)	Yes

M: number of participants with available data for the relevant endpoint.

*Shz TIVs means any one of the Shz TIV1, Shz TIV2 or Shz TIVs pooled group.

§Non-inferiority on GMTs is concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is >0.667 for each of the comparisons applicable in this column.

Table 3. Non-inferiority of Shz QIV to Shz TIV using seroconversion rate in participants aged 6–35 months after last dose (Phase III study; per protocol set).

		Shz QIV 0.25 mL minus Shz TIVs*						Shz QIV 0.5 mL minus Shz TIVs*
	Antigen/strain	n/M	%	(95% CI)	Difference (%)	(95% CI)	Non-inferiority§	n/M	%	(95% CI)	Difference (%)	(95% CI)	Non-inferiority§
QIV	A/H1N1	941/1009	93.3	(91.5; 94.7)	–	–	–	964/1042	92.5	(90.7; 94.0)	–	–	–
	A/H3N2	962/1009	95.3	(93.9; 96.6)	–	–	–	999/1042	95.9	(94.5; 97.0)	–	–	–
	B/Victoria	843/1009	83.5	(81.1; 85.8)	–	–	–	931/1042	89.3	(87.3; 91.2)	–	–	–
	B/Yamagata	913/1009	90.5	(88.5; 92.2)	–	–	–	979/1042	94.0	(92.3; 95.3)	–	–	–
TIV1	A/H1N1	465/495	93.9	(91.5; 95.9)	−0.68	(−3.15; 2.15)	–	465/495	93.9	(91.5; 95.9)	−1.42	(−3.93; 1.43)	–
	A/H3N2	474/495	95.8	(93.6; 97.4)	−0.42	(−2.49; 2.02)	–	474/495	95.8	(93.6; 97.4)	0.12	(−1.89; 2.51)	–
	B/Victoria	461/495	93.1	(90.5; 95.2)	−9.58	(−12.66; −6.22)	No	461/495	93.1	(90.5; 95.2)	−3.78	(−6.57; −0.68)	Yes
TIV2	A/H1N1	463/505	91.7	(88.9; 93.9)	1.58	(−1.14; 4.64)	–	463/505	91.7	(88.9; 93.9)	0.83	(−1.91; 3.92)	–
	A/H3N2	482/505	95.4	(93.2; 97.1)	−0.10	(−2.21; 2.36)	–	482/505	95.4	(93.2; 97.1)	0.43	(−1.61; 2.85)	–
	B/Yamagata	452/505	89.5	(86.5; 92.0)	0.98	(−2.11; 4.39)	Yes	452/505	89.5	(86.5; 92.0)	4.45	(1.57; 7.70)	Yes
TIVs Pooled	A/H1N1	928/1000	92.8	(91.0; 94.3)	0.46	(−1.78; 2.71)	Yes	928/1000	92.8	(91.0; 94.3)	−0.29	(−2.56; 2.00)	Yes
	A/H3N2	956/1000	95.6	(94.1; 96.8)	−0.26	(−2.11; 1.59)	Yes	956/1000	95.6	(94.1; 96.8)	0.27	(−1.50; 2.07)	Yes

n: number of participants experiencing the endpoint listed in the first two columns.

M: number of participants with available data for the relevant endpoint.

*Shz TIVs means any one of the Shz TIV1, Shz TIV2 or Shz TIVs pooled group.

§Non-inferiority in seroconversion is concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is > −10% for each applicable comparison.

Table 4. Superiority of Shz QIV to Shz TIV using GMT (a) and seroconversion rates (b) against the B strains (after last dose in those aged 6–35 months) (Phase III study; Full Analysis Set).

a)
Antigen/strain	Shz QIV				Shz TIV1		Shz TIV2			Shz QIV/Shz TIVs*
	M	GMT	(95% CI)	M	GMT	(95% CI)	M	GMT	(95% CI)	GMT ratio	(95% CI)	Superiority§
6–35 months (QIV 0.5 mL)
B/Victoria	1113	77.9	(73.9; 82.1)	–	–	–	541	27.3	(24.6; 30.2)	2.856	(2.576; 3.166)	Yes
B/Yamagata	1113	120	(113; 127)	546	23.3	(21.0; 25.9)	–	–	–	5.145	(4.615; 5.737)	Yes
≥3 years
B/Victoria	1760	79.4	(75.2; 83.9)	–	–	–	870	29.3	(27.2; 31.6)	2.711	(2.475; 2.970)	Yes
B/Yamagata	1760	190	(179; 201)	881	73.1	(67.2; 79.5)	–	–	–	2.591	(2.352; 2.855)	Yes
b)
Antigen/strain	Shz QIV			Shz TIV1			Shz TIV2			Shz QIV minus Shz TIVs*
	n/M	%	(95% CI)	n/M	%	(95% CI)	n/M	%	(95% CI)	Difference (%)	(95% CI)	Superiority§
6–35 months (QIV 0.5 mL)
B/Victoria	992/1112	89.2	(87.2 ; 91.0)	–	–	–	272/541	50.3	(46.0 ; 54.6)	38.93	(34.30 ; 43.46)	Yes
B/Yamagata	1043/1112	93.8	(92.2 ; 95.1)	226/546	41.4	(37.2 ; 45.7)	–	–	–	52.40	(47.94 ; 56.66)	Yes
≥3 years
B/Victoria	1239/1760	70.4	(68.2; 72.5)	–	–	–	293/870	33.7	(30.5; 36.9)	36.72	(32.85; 40.43)	Yes
B/Yamagata	1370/1760	77.8	(75.8; 79.8)	370/881	42.0	(38.7; 45.3)	–	–	–	35.84	(32.00; 39.57)	Yes

M: number of participants with available data for the relevant endpoint.

*Shz TIVs means either Shz TIV1 or Shz TIV2 group displayed in the column names.

For B/Victoria strain, the immunogenicity of Shz QIV compared to Shz TIV2 group which does not contain B/Victoria strain.

For B/Yamagata strain, the immunogenicity of Shz QIV compared to Shz TIV1 group which does not contain B/Yamagata strain.

§Superiority in GMTs is observed if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is > 1 for each of the comparisons applicable in this column; superiority in seroconversion is observed if the lower limit of the 2-sided 95% CI of the difference of seroconversion rates between groups is >10% for each applicable comparison.

Table 5. Non-inferiority of Shz QIV to Shz TIV using GMTs and seroconversion rates in participants aged ≥3 years (Phase III study; per-protocol set).

		Shz QIV/Shz TIVs*						Shz QIV minus Shz TIVs*
	Antigen/strain	M	GMT	(95% CI)	GMT ratio	(95% CI)	Non-inferiority§	n/M	%	(95% CI)	Difference (%)	(95% CI)	Non-inferiority§
QIV	A/H1N1	1312	232	(218; 247)	–	–	–	898/1312	68.4	(65.9; 71.0)	–	–	–
	A/H3N2	1312	283	(264; 303)	–	–	–	1027/1312	78.3	(75.9; 80.5)	–	–	–
	B/Victoria	1312	88.6	(83.1; 94.5)	–	–	–	962/1312	73.3	(70.8; 75.7)	–	–	–
	B/Yamagata	1312	208	(194; 222)	–	–	–	1045/1312	79.6	(77.4; 81.8)	–	–	–
TIV1	A/H1N1	656	237	(216; 261)	0.978	(0.876; 1.092)	–	443/656	67.5	(63.8; 71.1)	0.91	(−3.40; 5.34)	–
	A/H3N2	656	264	(239; 292)	1.073	(0.956; 1.205)	–	521/656	79.4	(76.1; 82.5)	−1.14	(−4.87; 2.76)	–
	B/Victoria	656	87.8	(80.3; 96.0)	1.006	(0.904; 1.119)	Yes	506/656	77.1	(73.7; 80.3)	−3.81	(−7.73; 0.28)	Yes
TIV2	A/H1N1	648	267	(242; 293)	0.871	(0.779; 0.974)	–	467/648	72.1	(68.4; 75.5)	−3.62	(−7.82; 0.72)	–
	A/H3N2	648	299	(270; 332)	0.947	(0.842; 1.065)	–	521/648	80.4	(77.1; 83.4)	−2.12	(−5.81; 1.76)	–
	B/Yamagata	648	191	(173; 211)	1.091	(0.974; 1.223)	Yes	493/648	76.1	(72.6; 79.3)	3.57	(−0.29; 7.59)	Yes
TIVs Pooled	A/H1N1	1304	251	(235; 269)	0.923	(0.843; 1.011)	Yes	910/1304	69.8	(67.2; 72.3)	−1.34	(−4.87; 2.20)	Yes
	A/H3N2	1304	281	(262; 302)	1.009	(0.916; 1.110)	Yes	1042/1304	79.9	(77.6; 82.1)	−1.63	(−4.74; 1.49)	Yes

n: number of participants experiencing the endpoint listed in the first two columns.

M: number of participants with available data for the relevant endpoint.

*Shz TIVs means any one of the Shz TIV1, Shz TIV2 or Shz TIVs pooled group.

§Non-inferiority on GMTs is concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is >0.667 for each of the comparisons applicable in this column, or if the differences of seroconversion rates between groups is > −10% for each applicable comparison.

Table 6. Safety overview after any injection (Phase III study; safety analysis set).

	6–35 months									≥ 3 years
	Shz QIV 0.25 mL (N=1152)			Shz QIV 0.5 mL (N=1192)			Shz TIVs Pooled (N=1151)		Shz QIV (N=1799)			Shz TIVs Pooled (N=1794)
Participants experiencing at least one:	n/M	%	(95% CI)	n/M	%	(95% CI)	n/M	%	(95% CI)	n/M	%	(95% CI)	n/M	%	(95% CI)
Within 30 minutes after any injection
Immediate unsolicited AE	2/1152	0.2	(0.0; 0.6)	2/1192	0.2	(0.0; 0.6)	2/1151	0.2	(0.0; 0.6)	1/1799	<0.1	(0.0; 0.3)	1/1794	<0.1	(0.0; 0.3)
Immediate unsolicited AR	2/1152	0.2	(0.0; 0.6)	2/1192	0.2	(0.0; 0.6)	0/1151	0	(0; 0.3)	1/1799	<0.1	(0.0; 0.3)	0/1794	0	(0; 0.2)
Within solicited period after any injection
Solicited reaction	403/1148	35.1	(32.3; 37.9)	470/1190	39.5	(36.7; 42.3)	401/1147	35.0	(32.2; 37.8)	335/1790	18.7	(16.9; 20.6)	261/1786	14.6	(13.0; 16.3)
Solicited injection site reaction	166/1148	14.5	(12.5; 16.6)	193/1190	16.2	(14.2; 18.4)	165/1147	14.4	(12.4; 16.6)	178/1790	9.9	(8.6; 11.4)	143/1786	8.0	(6.8; 9.4)
Tenderness/pain	121/1148	10.5	(8.8; 12.5)	124/1190	10.4	(8.7; 12.3)	104/1147	9.1	(7.5; 10.9)	158/1790	8.8	(7.6; 10.2)	129/1786	7.2	(6.1; 8.5)
Erythema	55/1148	4.8	(3.6; 6.2)	74/1190	6.2	(4.9; 7.7)	64/1146	5.6	(4.3; 7.1)	32/1790	1.8	(1.2; 2.5)	19/1786	1.1	(0.6; 1.7)
Swelling	9/1148	0.8	(0.4; 1.5)	16/1190	1.3	(0.8; 2.2)	8/1146	0.7	(0.3; 1.4)	14/1790	0.8	(0.4; 1.3)	7/1786	0.4	(0.2; 0.8)
Induration	3/1148	0.3	(0.1; 0.8)	5/1190	0.4	(0.1; 1.0)	4/1146	0.3	(0.1; 0.9)	4/1790	0.2	(0.1; 0.6)	3/1786	0.2	(0.0; 0.5)
Ecchymosis	6/1148	0.5	(0.2; 1.1)	5/1190	0.4	(0.1; 1.0)	1/1146	<0.1	(0.0; 0.5)	3/1790	0.2	(0.0; 0.5)	1/1786	<0.1	(0.0; 0.3)
Solicited systemic reaction	317/1148	27.6	(25.0; 30.3)	362/1190	30.4	(27.8; 33.1)	318/1147	27.7	(25.2; 30.4)	213/1790	11.9	(10.4; 13.5)	164/1786	9.2	(7.9; 10.6)
Fever	226/1148	19.7	(17.4; 22.1)	290/1190	24.4	(22.0; 26.9)	253/1147	22.1	(19.7; 24.6)	154/1790	8.6	(7.3; 10.0)	115/1786	6.4	(5.3; 7.7)
Vomiting*	27/625	4.3	(2.9; 6.2)	24/629	3.8	(2.5; 5.6)	21/608	3.5	(2.2; 5.2)
Crying abnormal*	53/625	8.5	(6.4; 10.9)	52/629	8.3	(6.2; 10.7)	54/608	8.9	(6.7; 11.4)
Drowsiness*	27/625	4.3	(2.9; 6.2)	24/629	3.8	(2.5; 5.6)	24/608	3.9	(2.5; 5.8)
Appetite lost*	59/625	9.4	(7.3; 12.0)	58/629	9.2	(7.1; 11.8)	58/608	9.5	(7.3; 12.2)
Irritability*	64/625	10.2	(8.0; 12.9)	50/629	7.9	(6.0; 10.3)	49/608	8.1	(6.0; 10.5)
Headache†	5/523	1.0	(0.3; 2.2)	7/561	1.2	(0.5; 2.6)	5/538	0.9	(0.3; 2.2)	39/1790	2.2	(1.6; 3.0)	25/1786	1.4	(0.9; 2.1)
Malaise†	17/523	3.3	(1.9; 5.2)	11/561	2.0	(1.0; 3.5)	18/538	3.3	(2.0; 5.2)	30/1790	1.7	(1.1; 2.4)	22/1786	1.2	(0.8; 1.9)
Myalgia†	2/523	0.4	(0.0; 1.4)	5/561	0.9	(0.3; 2.1)	3/538	0.6	(0.1; 1.6)	34/1790	1.9	(1.3; 2.6)	34/1786	1.9	(1.3; 2.7)
Shivering†	0/523	0	(0; 0.7)	3/561	0.5	(0.1; 1.6)	3/538	0.6	(0.1; 1.6)	8/1789	0.4	(0.2; 0.9)	5/1786	0.3	(0.1; 0.7)
Within 28 days after any injection
Unsolicited AE	223/1152	19.4	(17.1; 21.8)	224/1192	18.8	(16.6; 21.1)	238/1151	20.7	(18.4; 23.1)	82/1799	4.6	(3.6; 5.6)	74/1794	4.1	(3.3; 5.2)
Unsolicited AR	30/1152	2.6	(1.8; 3.7)	30/1192	2.5	(1.7; 3.6)	34/1151	3.0	(2.1; 4.1)	10/1799	0.6	(0.3; 1.0)	6/1794	0.3	(0.1; 0.7)
AE leading to discontinuation	3/1152	0.3	(0.1; 0.8)	2/1192	0.2	(0.0; 0.6)	2/1151	0.2	(0.0; 0.6)	0/1799	0	(0; 0.2)	0/1794	0	(0; 0.2)
SAE	13/1152	1.1	(0.6; 1.9)	8/1192	0.7	(0.3; 1.3)	18/1151	1.6	(0.9; 2.5)	7/1799	0.4	(0.2; 0.8)	8/1794	0.4	(0.2; 0.9)
Death	1/1152	<0.1	(0.0; 0.5)	0/1192	0	(0; 0.3)	1/1151	<0.1	(0.0; 0.5)	0/1799	0	(0; 0.2)	0/1794	0	(0; 0.2)
AESI	1/1152	<0.1	(0.0; 0.5)	0/1192	0	(0; 0.3)	0/1151	0	(0; 0.3)	0/1799	0	(0; 0.2)	0/1794	0	(0; 0.2)
During 6-month follow-up period
SAE	13/1152	1.1	(0.6; 1.9)	16/1192	1.3	(0.8; 2.2)	21/1151	1.8	(1.1; 2.8)	21/1799	1.2	(0.7; 1.8)	22/1794	1.2	(0.8; 1.9)
Death	0/1152	0	(0; 0.3)	0/1192	0	(0; 0.3)	0/1151	0	(0; 0.3)	0/1799	0	(0; 0.2)	1/1794	<0.1	(0.0; 0.3)
AESI	2/1152	0.2	(0.0; 0.6)	2/1192	0.2	(0.0; 0.6)	2/1151	0.2	(0.0; 0.6)	1/1799	<0.1	(0.0; 0.3)	1/1794	<0.1	(0.0; 0.3)
During the study
SAE	26/1152	2.3	(1.5; 3.3)	24/1192	2.0	(1.3; 3.0)	39/1151	3.4	(2.4; 4.6)	26/1799	1.4	(0.9; 2.1)	30/1794	1.7	(1.1; 2.4)
Death	1/1152	<0.1	(0.0; 0.5)	0/1192	0	(0; 0.3)	1/1151	<0.1	(0.0; 0.5)	0/1799	0	(0; 0.2)	1/1794	<0.1	(0.0; 0.3)
AESI	3/1152	0.3	(0.1; 0.8)	2/1192	0.2	(0.0; 0.6)	2/1151	0.2	(0.0; 0.6)	1/1799	<0.1	(0.0; 0.3)	1/1794	<0.1	(0.0; 0.3)

n: number of participants experiencing the endpoint listed in the first column.

M: number of participants with available data for the relevant endpoint.

Intensity scales based on the Chinese NMPA scale classification.

*Assessed infants aged ≤ 23 months

^†Assess in those aged ≥ 2 years

Table 7. Summary of solicited ARs within 7 days after any injection (Phase III study; safety analysis set).

	6–35 months									≥ 3 years
Participants experiencing at least one:	Shz QIV 0.25 mL (n=1152)			Shz QIV 0.5 mL (N=1192)			Shz TIVs Pooled (N=1151)			Shz QIV (N=1799)			Shz TIVs Pooled (N=1794)
	n/M	%	95% CI	n/M	%	95% CI	n/M	%	95% CI	n/M	%	95% CI	n/M	%	95% CI
Solicited reaction	403/1148	35.1	(32.3; 37.9)	470/1190	39.5	(36.7; 42.3)	401/1147	35.0	(32.2; 37.8)	335/1790	18.7	(16.9; 20.6)	261/1786	14.6	(13.0; 16.3)
Grade 3 solicited reaction	7/1148	0.6	(0.2; 1.3)	12/1190	1.0	(0.5; 1.8)	11/1147	1.0	(0.5; 1.7)	7/1790	0.4	(0.2; 0.8)	2/1786	0.1	(0.0; 0.4)
Solicited injection site reaction	166/1148	14.5	(12.5; 16.6)	193/1190	16.2	(14.2; 18.4)	165/1147	14.4	(12.4; 16.6)	178/1790	9.9	(8.6; 11.4)	143/1786	8.0	(6.8; 9.4)
Grade 3 injection site reaction	1/1148	<0.1	(0.0; 0.5)	0/1190	0	(0; 0.3)	0/1147	0	(0; 0.3)	4/1790	0.2	(0.1; 0.6)	1/1786	<0.1	(0.0; 0.3)
Solicited systemic reaction	317/1148	27.6	(25.0; 30.3)	362/1190	30.4	(27.8; 33.1)	318/1147	27.7	(25.2; 30.4)	213/1790	11.9	(10.4; 13.5)	164/1786	9.2	(7.9; 10.6)
Grade 3 systemic reaction	7/1148	0.6	(0.2; 1.3)	12/1190	1.0	(0.5; 1.8)	11/1147	1.0	(0.5; 1.7)	3/1790	0.2	(0.0; 0.5)	1/1786	<0.1	(0.0; 0.3)

n: number of participants experiencing the endpoint listed in the first column.

M: number of participants with available data for the relevant endpoint.

Intensity scales based on the Chinese NMPA scale classification.

Data availability statement

Qualified researchers may request access to patient-level data and related documents [including, e.g., the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications]. Patient-level data will be anonymized, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi’s data sharing criteria, eligible studies, and process for requesting access can be found at https://vivli.org/.