Trial Outcomes & Findings for Phase II/III Study of AZD2816, for the Prevention of COVID-19 in Adults (NCT NCT04973449)
NCT ID: NCT04973449
Last Updated: 2024-09-19
Results Overview
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. Solicited AEs are local or systemic predefined events for assessment of reactogenicity. An e-diary was used to collect information on the timing and severity of the solicited AEs. Local AEs included pain, redness/erythema, tenderness, induration/swelling at the site of the injection. Systemic AEs included fever (\> 100 °F/37.8 °C), chills, muscle pains, fatigue, headache, malaise, nausea, and vomiting.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
2843 participants
Primary outcome timeframe
During the 7-day follow-up period after vaccination (vaccines administered on Days 1 and 29 [only for primary vaccination cohort])
Results posted on
2024-09-19
Participant Flow
A total of 2843 participants were randomized in this study of which 2834 participants were treated (9 participants were randomized but not treated). Results are presented for 2834 treated participants only.
Participant milestones
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
Previously unvaccinated participants received intramuscular (IM) AZD1222 5\*10\^10 viral particles (vp) on Days 1 and 29 (4-week dosing interval).
|
Primary Vaccination Cohort:- AZD2816 (4)
Previously unvaccinated participants received IM AZD2816 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)
Previously unvaccinated participants received IM AZD1222 5\*10\^10 vp on Day 1 and IM AZD2816 5\*10\^10 vp on Day 29 (4-week dosing interval).
|
Primary Vaccination Cohort:- AZD2816 (12)
Previously unvaccinated participants received IM AZD2816 5\*10\^10 vp on Days 1 and 85 (12-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
Participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
409
|
413
|
411
|
208
|
373
|
377
|
322
|
321
|
|
Overall Study
COMPLETED
|
389
|
393
|
391
|
189
|
359
|
366
|
303
|
308
|
|
Overall Study
NOT COMPLETED
|
20
|
20
|
20
|
19
|
14
|
11
|
19
|
13
|
Reasons for withdrawal
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
Previously unvaccinated participants received intramuscular (IM) AZD1222 5\*10\^10 viral particles (vp) on Days 1 and 29 (4-week dosing interval).
|
Primary Vaccination Cohort:- AZD2816 (4)
Previously unvaccinated participants received IM AZD2816 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)
Previously unvaccinated participants received IM AZD1222 5\*10\^10 vp on Day 1 and IM AZD2816 5\*10\^10 vp on Day 29 (4-week dosing interval).
|
Primary Vaccination Cohort:- AZD2816 (12)
Previously unvaccinated participants received IM AZD2816 5\*10\^10 vp on Days 1 and 85 (12-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
Participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
2
|
5
|
5
|
4
|
7
|
5
|
|
Overall Study
Lost to Follow-up
|
15
|
16
|
16
|
13
|
5
|
6
|
10
|
6
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Other
|
1
|
1
|
2
|
1
|
4
|
0
|
2
|
2
|
Baseline Characteristics
Phase II/III Study of AZD2816, for the Prevention of COVID-19 in Adults
Baseline characteristics by cohort
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=409 Participants
Previously unvaccinated participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Primary Vaccination Cohort:- AZD2816 (4)
n=413 Participants
Previously unvaccinated participants received IM AZD2816 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)
n=411 Participants
Previously unvaccinated participants received IM AZD1222 5\*10\^10 vp on Day 1 and IM AZD2816 5\*10\^10 vp on Day 29 (4-week dosing interval).
|
Primary Vaccination Cohort:- AZD2816 (12)
n=208 Participants
Previously unvaccinated participants received IM AZD2816 5\*10\^10 vp on Days 1 and 85 (12-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=373 Participants
Participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
n=377 Participants
Participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
n=322 Participants
Participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
n=321 Participants
Participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Total
n=2834 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.1 Years
STANDARD_DEVIATION 12.48 • n=99 Participants
|
29.7 Years
STANDARD_DEVIATION 12.95 • n=107 Participants
|
28.0 Years
STANDARD_DEVIATION 12.23 • n=206 Participants
|
28.8 Years
STANDARD_DEVIATION 12.98 • n=7 Participants
|
59.7 Years
STANDARD_DEVIATION 13.72 • n=31 Participants
|
60.4 Years
STANDARD_DEVIATION 13.30 • n=30 Participants
|
55.3 Years
STANDARD_DEVIATION 13.19 • n=3 Participants
|
55.9 Years
STANDARD_DEVIATION 13.73 • n=6 Participants
|
43.2 Years
STANDARD_DEVIATION 19.6 • n=114 Participants
|
|
Sex: Female, Male
Female
|
171 Participants
n=99 Participants
|
169 Participants
n=107 Participants
|
166 Participants
n=206 Participants
|
85 Participants
n=7 Participants
|
172 Participants
n=31 Participants
|
172 Participants
n=30 Participants
|
197 Participants
n=3 Participants
|
192 Participants
n=6 Participants
|
1324 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
238 Participants
n=99 Participants
|
244 Participants
n=107 Participants
|
245 Participants
n=206 Participants
|
123 Participants
n=7 Participants
|
201 Participants
n=31 Participants
|
205 Participants
n=30 Participants
|
125 Participants
n=3 Participants
|
129 Participants
n=6 Participants
|
1510 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
239 Participants
n=99 Participants
|
246 Participants
n=107 Participants
|
257 Participants
n=206 Participants
|
131 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
901 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
143 Participants
n=99 Participants
|
148 Participants
n=107 Participants
|
137 Participants
n=206 Participants
|
70 Participants
n=7 Participants
|
322 Participants
n=31 Participants
|
331 Participants
n=30 Participants
|
291 Participants
n=3 Participants
|
292 Participants
n=6 Participants
|
1734 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
27 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
43 Participants
n=31 Participants
|
36 Participants
n=30 Participants
|
27 Participants
n=3 Participants
|
23 Participants
n=6 Participants
|
199 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
8 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
14 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
13 Participants
n=6 Participants
|
57 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
202 Participants
n=99 Participants
|
192 Participants
n=107 Participants
|
214 Participants
n=206 Participants
|
98 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
714 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
161 Participants
n=99 Participants
|
166 Participants
n=107 Participants
|
151 Participants
n=206 Participants
|
86 Participants
n=7 Participants
|
325 Participants
n=31 Participants
|
328 Participants
n=30 Participants
|
290 Participants
n=3 Participants
|
288 Participants
n=6 Participants
|
1795 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
53 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=31 Participants
|
33 Participants
n=30 Participants
|
19 Participants
n=3 Participants
|
18 Participants
n=6 Participants
|
207 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: During the 7-day follow-up period after vaccination (vaccines administered on Days 1 and 29 [only for primary vaccination cohort])Population: Seronegative safety analysis set included all participants who received at least 1 dose of study treatment, were analysed according to treatment actually received, and were seronegative at baseline. Here, number of participants analyzed denotes those participants who were evaluated for solicited symptoms.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. Solicited AEs are local or systemic predefined events for assessment of reactogenicity. An e-diary was used to collect information on the timing and severity of the solicited AEs. Local AEs included pain, redness/erythema, tenderness, induration/swelling at the site of the injection. Systemic AEs included fever (\> 100 °F/37.8 °C), chills, muscle pains, fatigue, headache, malaise, nausea, and vomiting.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=343 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=375 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
n=299 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Local and Systemic Solicited Treatment Emergent Adverse Events (TEAEs) in Primary Vaccination Cohort (PVC):- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816, and mRNA:AZD2816
Any solicited AEs
|
275 Participants
|
319 Participants
|
277 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Local and Systemic Solicited Treatment Emergent Adverse Events (TEAEs) in Primary Vaccination Cohort (PVC):- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816, and mRNA:AZD2816
Any local solicited AEs
|
225 Participants
|
278 Participants
|
236 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Local and Systemic Solicited Treatment Emergent Adverse Events (TEAEs) in Primary Vaccination Cohort (PVC):- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816, and mRNA:AZD2816
Any systemic solicited AEs
|
211 Participants
|
289 Participants
|
253 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During the 28-day follow-up period after vaccination (vaccines administered on Days 1 and 29 [only for primary vaccination cohort])Population: Seronegative safety analysis set included all participants who received at least 1 dose of study treatment, were analysed according to treatment actually received, and were seronegative at baseline.
The AEs other than solicited AEs are reported as unsolicited AEs and were collected by "open question" at study visits. AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. TEAEs: events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience; persistent or significant disability/incapacity; congenital anomaly. MAAE: an AE leading to a non-routine/unscheduled medically-attended visit, to or from medical doctor for any reason. AESI: an event of scientific and medical interest specific to further understanding of study drug safety profile and require close monitoring and rapid communication by investigators to Sponsor.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=348 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=379 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
n=302 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited TEAEs, Treatment-emergent Serious AEs (TESAEs), Medically Attended AEs (MAAEs), and Adverse Events of Special Interest (AESIs) in PVC:- AZD2816 (4), Booster Cohorts:- AZD1222:AZD2816, and mRNA:AZD2816
Any unsolicited TEAEs
|
70 Participants
|
96 Participants
|
79 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Unsolicited TEAEs, Treatment-emergent Serious AEs (TESAEs), Medically Attended AEs (MAAEs), and Adverse Events of Special Interest (AESIs) in PVC:- AZD2816 (4), Booster Cohorts:- AZD1222:AZD2816, and mRNA:AZD2816
Any TESAEs
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Unsolicited TEAEs, Treatment-emergent Serious AEs (TESAEs), Medically Attended AEs (MAAEs), and Adverse Events of Special Interest (AESIs) in PVC:- AZD2816 (4), Booster Cohorts:- AZD1222:AZD2816, and mRNA:AZD2816
Any MAAEs
|
26 Participants
|
31 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Unsolicited TEAEs, Treatment-emergent Serious AEs (TESAEs), Medically Attended AEs (MAAEs), and Adverse Events of Special Interest (AESIs) in PVC:- AZD2816 (4), Booster Cohorts:- AZD1222:AZD2816, and mRNA:AZD2816
Any AESIs
|
1 Participants
|
10 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During the 28-day follow-up period after vaccination (vaccines administered on Days 1 and 29 [only for primary vaccination cohort])Population: Seronegative safety analysis set included all participants who received at least 1 dose of study treatment, were analysed according to treatment actually received, and were seronegative at baseline.
Number of participants with abnormal laboratory parameters reported as TEAEs are reported. Laboratory tests included haematology and clinical chemistry.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=348 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=379 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
n=302 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816
Anaemia
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816
Eosinophilia
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816
Iron deficiency anaemia
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816
Hypercholesterolaemia
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816
Alanine aminotransferase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816
Fibrin D dimer increased
|
2 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816
Haematocrit decreased
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816
Haemoglobin decreased
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816
Transaminases increased
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816
Lymphopenia
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816
Normochromic normocytic anaemia
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816
Thrombocytopenia
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816
Hyponatraemia
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816
Blood creatine increased
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816
White blood cell count increased
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816
Aspartate aminotransferase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816
Blood alkaline phosphatase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816
Blood fibrinogen increased
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816
Vitamin D decreased
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=348 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=342 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titre (GMT) of SARS-CoV-2 Neutralizing Antibodies (nAb) Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)
|
661.29 1/dilution
Interval 617.16 to 708.57
|
790.96 1/dilution
Interval 735.29 to 850.85
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD1222 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=508 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=329 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD1222 and AZD1222 in Historical Control
|
242.80 1/dilution
Interval 224.82 to 262.23
|
246.45 1/dilution
Interval 227.39 to 267.12
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=344 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=342 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)
|
87.79 Percentage of participants
Interval 83.86 to 91.06
|
89.47 Percentage of participants
Interval 85.73 to 92.52
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD1222 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=508 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=280 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD1222 and AZD1222 in Historical Control
|
242.80 1/dilution
Interval 224.82 to 262.23
|
841.96 1/dilution
Interval 790.34 to 896.96
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])Population: Seronegative safety analysis set included all participants who received at least 1 dose of study treatment, were analysed according to treatment actually received, and were seronegative at baseline. Here, number of participants analyzed denotes those participants who were evaluated for solicited symptoms.
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. Solicited AEs are local or systemic predefined events for assessment of reactogenicity. An e-diary was used to collect information on the timing and severity of the solicited AEs. Local AEs included pain, redness/erythema, tenderness, induration/swelling at the site of the injection. Systemic AEs included fever (\> 100 °F/37.8 °C), chills, muscle pains, fatigue, headache, malaise, nausea, and vomiting.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=188 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=373 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
n=340 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
n=299 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Local and Systemic Solicited TEAEs
Any systemic solicited AEs
|
153 Participants
|
296 Participants
|
206 Participants
|
238 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Local and Systemic Solicited TEAEs
Any solicited AEs
|
168 Participants
|
322 Participants
|
266 Participants
|
269 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Local and Systemic Solicited TEAEs
Any local solicited AEs
|
146 Participants
|
285 Participants
|
209 Participants
|
228 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 28-day follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])Population: Seronegative safety analysis set included all participants who received at least 1 dose of study treatment, were analysed according to treatment actually received, and were seronegative at baseline.
The AEs other than solicited AEs are reported as unsolicited AEs and were collected by "open question" at study visits. AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. TEAEs: events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience; persistent or significant disability/incapacity; congenital anomaly. MAAE: an AE leading to a non-routine/unscheduled medically-attended visit, to or from medical doctor for any reason. AESI: an event of scientific and medical interest specific to further understanding of study drug safety profile and require close monitoring and rapid communication by investigators to Sponsor.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=191 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=380 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
n=349 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
n=300 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited TEAEs, TESAEs, MAAEs, and AESIs
Any unsolicited TEAEs
|
67 Participants
|
93 Participants
|
81 Participants
|
73 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Unsolicited TEAEs, TESAEs, MAAEs, and AESIs
Any TESAEs
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Unsolicited TEAEs, TESAEs, MAAEs, and AESIs
Any MAAEs
|
25 Participants
|
37 Participants
|
34 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Unsolicited TEAEs, TESAEs, MAAEs, and AESIs
Any AESIs
|
7 Participants
|
9 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=348 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=342 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)
|
269.89 1/dilution
Interval 260.72 to 279.37
|
865.48 1/dilution
Interval 837.85 to 894.02
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=348 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=334 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)
|
800.92 1/dilution
Interval 745.59 to 860.36
|
405.20 1/dilution
Interval 373.64 to 439.43
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against the original Wuhan-Hu-1 strain.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=348 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=342 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)
|
719.37 1/dilution
Interval 654.68 to 790.46
|
222.75 1/dilution
Interval 201.6 to 246.12
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD2816 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=508 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=322 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control
|
242.80 1/dilution
Interval 224.82 to 262.23
|
341.96 1/dilution
Interval 315.48 to 370.66
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after booster dose (Day 29)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD2816 is the comparator group and Booster Cohort:- AZD1222:AZD1222 is the reference group, both compared for response against B.1.351 variant.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=329 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=322 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222
|
185.70 1/dilution
Interval 169.32 to 203.66
|
341.96 1/dilution
Interval 315.48 to 370.66
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD2816 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=508 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=322 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and AZD1222 in Historical Control
|
242.80 1/dilution
Interval 224.82 to 262.23
|
213.26 1/dilution
Interval 197.45 to 230.34
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after booster dose (Day 29)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD2816 is the comparator group and Booster Cohort:- AZD1222:AZD1222 is the reference group, both compared for response against the original Wuhan-Hu-1 strain.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=329 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=322 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222
|
246.45 1/dilution
Interval 227.39 to 267.12
|
213.26 1/dilution
Interval 197.45 to 230.34
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD2816 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=348 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=322 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)
|
360.43 1/dilution
Interval 324.9 to 399.84
|
341.96 1/dilution
Interval 315.48 to 370.66
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD2816 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=508 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=280 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control
|
242.80 1/dilution
Interval 224.82 to 262.23
|
1587.58 1/dilution
Interval 1463.98 to 1721.61
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after booster dose (Day 29)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD2816 is the comparator group and Booster Cohort:- mRNA:AZD1222 is the reference group, both compared for response against B.1.351 variant.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=280 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=280 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222
|
718.90 1/dilution
Interval 670.46 to 770.84
|
1587.58 1/dilution
Interval 1463.98 to 1721.61
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD2816 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=508 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=280 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and AZD1222 in Historical Control
|
242.80 1/dilution
Interval 224.82 to 262.23
|
1052.73 1/dilution
Interval 974.55 to 1137.19
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after booster dose (Day 29)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD2816 is the comparator group and Booster Cohort:- mRNA:AZD1222 is the reference group, both compared for response against the original Wuhan-Hu-1 strain.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=280 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=280 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222
|
841.96 1/dilution
Interval 790.34 to 896.96
|
1052.73 1/dilution
Interval 974.55 to 1137.19
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD2816 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=348 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=280 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)
|
360.43 1/dilution
Interval 324.9 to 399.84
|
1587.58 1/dilution
Interval 1463.98 to 1721.61
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD2816 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=508 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=320 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control
|
84.06 Percentage of participants
Interval 80.58 to 87.13
|
82.81 Percentage of participants
Interval 78.22 to 86.78
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after booster dose (Day 29)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD2816 is the comparator group and Booster Cohort:- AZD1222:AZD1222 is the reference group, both compared for response against B.1.351 variant.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=329 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=320 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222
|
65.96 Percentage of participants
Interval 60.56 to 71.07
|
82.81 Percentage of participants
Interval 78.22 to 86.78
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD2816 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=508 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=320 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and AZD1222 in Historical Control
|
84.06 Percentage of participants
Interval 80.58 to 87.13
|
65.94 Percentage of participants
Interval 60.46 to 71.12
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after booster dose (Day 29)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD2816 is the comparator group and Booster Cohort:- AZD1222:AZD1222 is the reference group, both compared for response against the original Wuhan-Hu-1 strain.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=329 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=320 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222
|
65.96 Percentage of participants
Interval 60.56 to 71.07
|
65.94 Percentage of participants
Interval 60.46 to 71.12
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD2816 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=344 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=320 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)
|
51.45 Percentage of participants
Interval 46.03 to 56.85
|
82.81 Percentage of participants
Interval 78.22 to 86.78
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD2816 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=508 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=277 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control
|
84.06 Percentage of participants
Interval 80.58 to 87.13
|
80.51 Percentage of participants
Interval 75.34 to 85.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after booster dose (Day 29)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD2816 is the comparator group and Booster Cohort:- mRNA:AZD1222 is the reference group, both compared for response against B.1.351 variant.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=280 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=277 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222
|
57.50 Percentage of participants
Interval 51.48 to 63.36
|
80.51 Percentage of participants
Interval 75.34 to 85.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD2816 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=508 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=277 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and AZD1222 in Historical Control
|
84.06 Percentage of participants
Interval 80.58 to 87.13
|
49.82 Percentage of participants
Interval 43.78 to 55.86
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after booster dose (Day 29)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD2816 is the comparator group and Booster Cohort:- mRNA:AZD1222 is the reference group, both compared for response against the original Wuhan-Hu-1 strain.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=280 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=277 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222
|
42.86 Percentage of participants
Interval 36.99 to 48.88
|
49.82 Percentage of participants
Interval 43.78 to 55.86
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD2816 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=344 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=277 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)
|
51.45 Percentage of participants
Interval 46.03 to 56.85
|
80.51 Percentage of participants
Interval 75.34 to 85.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])Population: Seronegative safety analysis set included all participants who received at least 1 dose of study treatment, were analysed according to treatment actually received, and were seronegative at baseline.
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. The MAAEs are defined as AEs leading to medically-attended visits that were not routine visits, or an otherwise unscheduled visit to or from medical doctor for any reason. The AESIs are events of scientific and medical interest specific to the further understanding of study drug safety profile and require close monitoring and rapid communication by the investigators to the Sponsor.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=380 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=379 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
n=191 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
n=349 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
n=348 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
n=300 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
n=302 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TESAEs, MAAEs, and AESIs From Day 1 Through 6 Months Post Last Dose
Any TESAEs
|
5 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
—
|
|
Number of Participants With TESAEs, MAAEs, and AESIs From Day 1 Through 6 Months Post Last Dose
Any MAAEs
|
82 Participants
|
69 Participants
|
50 Participants
|
72 Participants
|
65 Participants
|
47 Participants
|
58 Participants
|
—
|
|
Number of Participants With TESAEs, MAAEs, and AESIs From Day 1 Through 6 Months Post Last Dose
Any AESIs
|
51 Participants
|
48 Participants
|
32 Participants
|
41 Participants
|
42 Participants
|
31 Participants
|
33 Participants
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=348 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=334 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)
|
329.46 1/dilution
Interval 319.47 to 339.76
|
446.63 1/dilution
Interval 432.91 to 460.78
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against the Original Wuhan-Hu-1 Strain.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=348 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=334 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)
|
769.03 1/dilution
Interval 731.95 to 808.0
|
581.78 1/dilution
Interval 553.12 to 611.92
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD2816 (4) with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=342 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=342 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4)
|
185.70 1/dilution
Interval 168.16 to 205.07
|
718.10 1/dilution
Interval 662.58 to 778.27
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=334 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=334 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)
|
586.00 1/dilution
Interval 566.15 to 606.54
|
392.13 1/dilution
Interval 380.34 to 404.28
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=344 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=342 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)
|
99.42 Percentage of participants
Interval 97.92 to 99.93
|
100 Percentage of participants
Interval 98.73 to
Upper limit of 95% confidence interval was not evaluable as all participants had seroresponse.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against the original Wuhan-Hu-1 strain.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=344 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=342 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)
|
84.59 Percentage of participants
Interval 80.34 to 88.24
|
49.42 Percentage of participants
Interval 44.0 to 54.85
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=344 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=334 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and the Original Wuhan Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)
|
87.50 Percentage of participants
Interval 83.53 to 90.8
|
62.57 Percentage of participants
Interval 57.14 to 67.78
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=344 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=334 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)
|
99.42 Percentage of participants
Interval 97.92 to 99.93
|
99.40 Percentage of participants
Interval 97.85 to 99.93
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against the original Wuhan-Hu-1 strain.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=344 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=334 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)
|
99.42 Percentage of participants
Interval 97.92 to 99.93
|
80.24 Percentage of participants
Interval 75.56 to 84.38
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD2816 (4) with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=342 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=342 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4)
|
49.42 Percentage of participants
Interval 44.0 to 54.85
|
88.60 Percentage of participants
Interval 84.74 to 91.76
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=334 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=334 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)
|
99.40 Percentage of participants
Interval 97.85 to 99.93
|
99.40 Percentage of participants
Interval 97.85 to 99.93
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD1222 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=348 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=329 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)
|
360.43 1/dilution
Interval 324.9 to 399.84
|
185.70 1/dilution
Interval 169.32 to 203.66
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD1222 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=508 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=329 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control
|
242.80 1/dilution
Interval 224.82 to 262.23
|
185.70 1/dilution
Interval 169.32 to 203.66
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD2816 with response against B.1.351 variant is the comparator group and Booster Cohort:- AZD1222:AZD2816 with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=322 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=322 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- AZD1222:AZD2816
|
213.26 1/dilution
Interval 197.45 to 230.34
|
341.96 1/dilution
Interval 315.48 to 370.66
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information.Booster Cohort:- AZD1222:AZD1222 with response against B.1.351 variant is the comparator group and Booster Cohort:- AZD1222:AZD1222 with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=329 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=329 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- AZD1222:AZD1222
|
246.45 1/dilution
Interval 227.39 to 267.12
|
185.70 1/dilution
Interval 169.32 to 203.66
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD1222 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=508 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=329 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD1222 and AZD1222 in Historical Control
|
84.06 Percentage of participants
Interval 80.58 to 87.13
|
65.96 Percentage of participants
Interval 60.56 to 71.07
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD1222 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 Variant.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=344 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=329 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)
|
51.45 Percentage of participants
Interval 46.03 to 56.85
|
65.96 Percentage of participants
Interval 60.56 to 71.07
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD1222 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=508 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=329 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control
|
84.06 Percentage of participants
Interval 80.58 to 87.13
|
65.96 Percentage of participants
Interval 60.56 to 71.07
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD2816 with response against B.1.351 variant is the comparator group and Booster Cohort:- AZD1222:AZD2816 with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=320 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=320 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816
|
65.94 Percentage of participants
Interval 60.46 to 71.12
|
82.81 Percentage of participants
Interval 78.22 to 86.78
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD1222 with response against B.1.351 variant is the comparator group and Booster Cohort:- AZD1222:AZD1222 with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=329 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=329 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD1222
|
65.96 Percentage of participants
Interval 60.56 to 71.07
|
65.96 Percentage of participants
Interval 60.56 to 71.07
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD1222 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=348 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=280 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)
|
360.43 1/dilution
Interval 324.9 to 399.84
|
718.90 1/dilution
Interval 670.46 to 770.84
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD1222 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=508 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=280 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control
|
242.80 1/dilution
Interval 224.82 to 262.23
|
718.90 1/dilution
Interval 670.46 to 770.84
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD2816 with response against B.1.351 variant is the comparator group and Booster Cohort:- mRNA:AZD2816 with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=280 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=280 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- mRNA:AZD2816
|
1052.73 1/dilution
Interval 974.55 to 1137.19
|
1587.58 1/dilution
Interval 1463.98 to 1721.61
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD1222 with response against B.1.351 variant is the comparator group and Booster Cohort:- mRNA:AZD1222 with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=280 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=280 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- mRNA:AZD1222
|
841.96 1/dilution
Interval 790.34 to 896.96
|
718.90 1/dilution
Interval 670.46 to 770.84
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD1222 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=508 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=280 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD1222 and AZD1222 in Historical Control
|
84.06 Percentage of participants
Interval 80.58 to 87.13
|
42.86 Percentage of participants
Interval 36.99 to 48.88
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD1222 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 Variant.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=344 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=280 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)
|
51.45 Percentage of participants
Interval 46.03 to 56.85
|
57.50 Percentage of participants
Interval 51.48 to 63.36
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD1222 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=508 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=280 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control
|
84.06 Percentage of participants
Interval 80.58 to 87.13
|
57.50 Percentage of participants
Interval 51.48 to 63.36
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD2816 with response against B.1.351 variant is the comparator group and Booster Cohort:- mRNA:AZD2816 with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=277 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=277 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816
|
49.82 Percentage of participants
Interval 43.78 to 55.86
|
80.51 Percentage of participants
Interval 75.34 to 85.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after second dose (Day 57)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD1222 with response against B.1.351 variant is the comparator group and Booster Cohort:- mRNA:AZD1222 with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=280 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=280 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD1222
|
42.86 Percentage of participants
Interval 36.99 to 48.88
|
57.50 Percentage of participants
Interval 51.48 to 63.36
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after first dose (Day 29)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=361 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=357 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4) on Day 29
|
433.42 1/dilution
Interval 398.43 to 471.48
|
364.20 1/dilution
Interval 330.75 to 401.04
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after first dose (Day 29)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=361 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=357 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4) on Day 29
|
233.65 1/dilution
Interval 226.02 to 241.54
|
398.60 1/dilution
Interval 381.99 to 415.95
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after first dose (Day 29)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) with response against the original Wuhan-Hu-1 strain is the reference group.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=361 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=357 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4) on Day 29
|
525.20 1/dilution
Interval 481.75 to 572.58
|
261.55 1/dilution
Interval 240.05 to 284.97
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after first dose (Day 29)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against the original Wuhan-Hu-1 strain.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=361 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=357 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4) on Day 29
|
471.69 1/dilution
Interval 420.91 to 528.59
|
177.02 1/dilution
Interval 160.25 to 195.53
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohorts: 28 days after booster dose (Day 29) and Primary Vaccination Cohorts: 28 days after the second dose (Day 57 for 4-week dosing interval cohorts and Day 113 for 12-week dosing interval cohort)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Chimpanzee adenovirus Ox1 (ChAdOx1) vector nAb were measured by neutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=225 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=232 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
n=217 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
n=7 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
n=320 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
n=277 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of ChAdOx1 nAb in Primary Vaccination Cohorts and Following a Booster Dose of AZD2816
|
1640.99 1/dilution
Interval 1510.43 to 1782.83
|
2369.38 1/dilution
Interval 2165.69 to 2592.23
|
1656.53 1/dilution
Interval 1529.8 to 1793.75
|
2082.82 1/dilution
Interval 787.88 to 5506.1
|
3830.85 1/dilution
Interval 3574.28 to 4105.83
|
811.44 1/dilution
Interval 721.11 to 913.08
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohorts: 28 days after booster dose (Day 29) and Primary Vaccination Cohorts: 28 days after the second dose (Day 57 for 4-week dosing interval cohorts and Day 113 for 12-week dosing interval cohort)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Chimpanzee adenovirus Ox1 vector nAb were measured by neutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=224 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=227 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
n=209 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
n=7 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
n=319 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
n=275 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of ChAdOx1 nAb in Primary Vaccination Cohorts and Following a Booster Dose of AZD2816
|
93.30 Percentage of participants
Interval 89.2 to 96.2
|
89.43 Percentage of participants
Interval 84.68 to 93.11
|
91.39 Percentage of participants
Interval 86.73 to 94.82
|
85.71 Percentage of participants
Interval 42.13 to 99.64
|
62.07 Percentage of participants
Interval 56.5 to 67.42
|
87.64 Percentage of participants
Interval 83.15 to 91.28
|
—
|
—
|
SECONDARY outcome
Timeframe: Booster Cohorts: 28 days after booster dose (Day 29) and Primary Vaccination Cohorts: 28 days after the second dose (Day 57 for 4-week dosing interval cohorts and Day 113 for 12-week dosing interval cohort)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 spike protein binding antibodies were measured by multiplexed immunoassay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=341 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=347 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
n=333 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
n=157 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
n=329 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
n=320 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
n=279 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
n=279 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of SARS-CoV-2 Spike Protein Binding Antibodies in Primary Vaccination Cohorts and Booster Cohorts
B.1.351
|
29325.20 1/dilution
Interval 26677.38 to 32235.81
|
28618.30 1/dilution
Interval 25758.25 to 31795.92
|
23119.62 1/dilution
Interval 20524.01 to 26043.5
|
43047.62 1/dilution
Interval 37018.88 to 50058.17
|
14382.37 1/dilution
Interval 13365.31 to 15476.82
|
16561.93 1/dilution
Interval 15630.53 to 17548.83
|
45587.11 1/dilution
Interval 42653.03 to 48723.02
|
65705.69 1/dilution
Interval 62446.19 to 69135.33
|
|
GMT of SARS-CoV-2 Spike Protein Binding Antibodies in Primary Vaccination Cohorts and Booster Cohorts
Wuhan-Hu-1
|
21570.78 1/dilution
Interval 19701.94 to 23616.89
|
59332.38 1/dilution
Interval 53222.73 to 66143.39
|
38145.52 1/dilution
Interval 33713.61 to 43160.03
|
25672.89 1/dilution
Interval 21953.82 to 30021.99
|
34214.45 1/dilution
Interval 31691.34 to 36938.43
|
29254.7 1/dilution
Interval 27650.2 to 30952.3
|
106061.18 1/dilution
Interval 98649.55 to 114029.66
|
113358.29 1/dilution
Interval 107769.93 to 119236.43
|
SECONDARY outcome
Timeframe: Booster Cohorts: 28 days after booster dose (Day 29) and Primary Vaccination Cohorts: 28 days after the second dose (Day 57 for 4-week dosing interval cohorts and Day 113 for 12-week dosing interval cohort)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 spike protein binding antibodies were measured by multiplexed immunoassay. Seroresponse was defined as \>= 4-fold increase in the GMT of spike protein binding antibodies from baseline.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=341 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=345 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
n=333 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
n=156 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
n=329 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
n=320 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
n=279 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
n=278 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 Spike Protein Binding Antibodies in Primary Vaccination Cohorts and Booster Cohorts
Wuhan-Hu-1
|
95.01 Percentage of participants
Interval 92.14 to 97.07
|
97.68 Percentage of participants
Interval 95.48 to 98.99
|
94.29 Percentage of participants
Interval 91.23 to 96.53
|
96.15 Percentage of participants
Interval 91.82 to 98.58
|
67.78 Percentage of participants
Interval 62.44 to 72.8
|
64.69 Percentage of participants
Interval 59.18 to 69.92
|
36.56 Percentage of participants
Interval 30.9 to 42.51
|
41.01 Percentage of participants
Interval 35.17 to 47.04
|
|
Percentage of Participants With Seroresponse of SARS-CoV-2 Spike Protein Binding Antibodies in Primary Vaccination Cohorts and Booster Cohorts
B.1.351
|
97.36 Percentage of participants
Interval 95.05 to 98.79
|
97.10 Percentage of participants
Interval 94.73 to 98.6
|
93.99 Percentage of participants
Interval 90.88 to 96.29
|
98.08 Percentage of participants
Interval 94.48 to 99.6
|
70.82 Percentage of participants
Interval 65.58 to 75.68
|
75.94 Percentage of participants
Interval 70.87 to 80.52
|
30.47 Percentage of participants
Interval 25.12 to 36.23
|
51.08 Percentage of participants
Interval 45.04 to 57.1
|
SECONDARY outcome
Timeframe: Booster Cohorts: 28 days after booster dose (Day 29) and Primary Vaccination Cohorts: 28 days after the second dose (Day 57 for 4-week dosing interval cohorts and Day 113 for 12-week dosing interval cohort)Population: Seronegative immunogenicity analysis set: all participants who received at least 1 dose of study treatment, had baseline and post-dose antibody measurements, at least 1 post-dose quantifiable serum titre, and no protocol deviations judged to have potential to interfere with the antibody response, were analysed according to treatment actually received, and were seronegative at baseline. The number of participants analyzed denotes those participants who were evaluable at the specified time frame.
Severe acute respiratory syndrome-coronavirus-2 nAb and ChAdOx1 vector nAb were measured by pseudoneutralisation assay. Correlations were based on log2 titre values and assessed by using Spearman rank correlation for all cohorts except Primary Vaccination Cohort:- AZD2816 (12) for which Pearson correlation was used. The correlation coefficient is reported in values from +1 to -1 (+1= perfect association, 0 = no association, and -1= perfect negative association). The closer the correlation coefficient is to zero, weaker the association.
Outcome measures
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=225 Participants
Previously unvaccinated seronegative participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=232 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
n=217 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
n=7 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
n=327 Participants
Seronegative participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
n=320 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
n=275 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
n=277 Participants
Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Correlation Between ChAdOx1 nAb and SARS-CoV-2 nAb Titres
B.1.351
|
-0.0536 Correlation coefficient
Interval -0.18 to 0.08
|
-0.1656 Correlation coefficient
Interval -0.29 to -0.04
|
-0.0783 Correlation coefficient
Interval -0.21 to 0.06
|
0.0253 Correlation coefficient
Interval -0.74 to 0.76
|
0.2061 Correlation coefficient
Interval 0.1 to 0.31
|
0.2297 Correlation coefficient
Interval 0.12 to 33.0
|
0.0225 Correlation coefficient
Interval -0.1 to 0.14
|
-0.0591 Correlation coefficient
Interval -0.18 to 0.06
|
|
Correlation Between ChAdOx1 nAb and SARS-CoV-2 nAb Titres
Wuhan-Hu-1
|
0.0006 Correlation coefficient
Interval -0.13 to 0.13
|
-0.1263 Correlation coefficient
Interval -0.25 to 0.0
|
-0.0162 Correlation coefficient
Interval -0.15 to 0.12
|
-0.1460 Correlation coefficient
Interval -0.81 to 0.69
|
0.1288 Correlation coefficient
Interval 0.02 to 0.23
|
0.1583 Correlation coefficient
Interval 0.05 to 0.26
|
0.0005 Correlation coefficient
Interval -0.12 to 0.12
|
-0.0534 Correlation coefficient
Interval -0.17 to 0.06
|
Adverse Events
Primary Vaccination Cohort:- AZD1222 (4)
Serious events: 3 serious events
Other events: 32 other events
Deaths: 1 deaths
Primary Vaccination Cohort:- AZD2816 (4)
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)
Serious events: 5 serious events
Other events: 42 other events
Deaths: 0 deaths
Primary Vaccination Cohort:- AZD2816 (12)
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Booster Cohort:- AZD1222:AZD1222
Serious events: 6 serious events
Other events: 39 other events
Deaths: 0 deaths
Booster Cohort:- AZD1222:AZD2816
Serious events: 8 serious events
Other events: 37 other events
Deaths: 1 deaths
Booster Cohort:- mRNA:AZD1222
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Booster Cohort:- mRNA:AZD2816
Serious events: 5 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=409 participants at risk
Previously unvaccinated participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Primary Vaccination Cohort:- AZD2816 (4)
n=413 participants at risk
Previously unvaccinated participants received IM AZD2816 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)
n=411 participants at risk
Previously unvaccinated participants received IM AZD1222 5\*10\^10 vp on Day 1 and IM AZD2816 5\*10\^10 vp on Day 29 (4-week dosing interval).
|
Primary Vaccination Cohort:- AZD2816 (12)
n=208 participants at risk
Previously unvaccinated participants received IM AZD2816 5\*10\^10 vp on Days 1 and 85 (12-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=373 participants at risk
Participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
n=375 participants at risk
Participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
n=322 participants at risk
Participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
n=323 participants at risk
Participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.31%
1/323 • Number of events 2 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.31%
1/322 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.27%
1/375 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.24%
1/413 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.27%
1/373 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.24%
1/409 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.24%
1/413 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.24%
1/411 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.31%
1/322 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.27%
1/375 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.27%
1/375 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.31%
1/322 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.27%
1/373 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.27%
1/373 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.24%
1/409 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.27%
1/375 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.27%
1/373 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Nervous system disorders
Hypoglossal nerve paralysis
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.27%
1/373 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Nervous system disorders
Seizure
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.24%
1/411 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.24%
1/411 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.24%
1/413 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.31%
1/323 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.27%
1/375 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.31%
1/323 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.31%
1/323 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.31%
1/323 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Infections and infestations
Abscess
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.24%
1/411 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.24%
1/411 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.27%
1/373 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.27%
1/375 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.24%
1/413 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.31%
1/323 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Infections and infestations
Lymph node tuberculosis
|
0.24%
1/409 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.48%
1/208 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.27%
1/375 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.48%
1/208 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.24%
1/413 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.27%
1/373 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/375 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/409 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/413 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/411 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/208 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/373 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.27%
1/375 • Number of events 1 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/322 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
0.00%
0/323 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
Other adverse events
| Measure |
Primary Vaccination Cohort:- AZD1222 (4)
n=409 participants at risk
Previously unvaccinated participants received IM AZD1222 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Primary Vaccination Cohort:- AZD2816 (4)
n=413 participants at risk
Previously unvaccinated participants received IM AZD2816 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).
|
Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)
n=411 participants at risk
Previously unvaccinated participants received IM AZD1222 5\*10\^10 vp on Day 1 and IM AZD2816 5\*10\^10 vp on Day 29 (4-week dosing interval).
|
Primary Vaccination Cohort:- AZD2816 (12)
n=208 participants at risk
Previously unvaccinated participants received IM AZD2816 5\*10\^10 vp on Days 1 and 85 (12-week dosing interval).
|
Booster Cohort:- AZD1222:AZD1222
n=373 participants at risk
Participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- AZD1222:AZD2816
n=375 participants at risk
Participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD1222
n=322 participants at risk
Participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.
|
Booster Cohort:- mRNA:AZD2816
n=323 participants at risk
Participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
7.8%
32/409 • Number of events 32 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
10.2%
42/413 • Number of events 42 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
10.2%
42/411 • Number of events 42 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
14.4%
30/208 • Number of events 30 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
10.5%
39/373 • Number of events 39 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
9.9%
37/375 • Number of events 37 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
7.8%
25/322 • Number of events 26 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
8.4%
27/323 • Number of events 27 • During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Safety analysis set included all participants who received at least 1 dose of study treatment and were analyzed according to the treatment actually received.
|
Additional Information
Global Clinical Lead
AstraZeneca Clinical study Information Center
Phone: +1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER