| Primary | 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 | 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. | 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. | Posted | | Count of Participants | | Participants | | During the 7-day follow-up period after vaccination (vaccines administered on Days 1 and 29 [only for primary vaccination cohort]) | | | | ID | Title | Description |
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| OG000 | Primary Vaccination Cohort:- AZD2816 (4) | Previously unvaccinated seronegative participants received IM AZD2816 5*10^10 vp on Days 1 and 29 (4-week dosing interval). | | OG001 | 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. | | OG002 | 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. |
| | | Title | Denominators | Categories |
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| Any solicited AEs | | | | Any local solicited AEs | |
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| Primary | 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 | 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. | 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. | Posted | | Count of Participants | | Participants | | During the 28-day follow-up period after vaccination (vaccines administered on Days 1 and 29 [only for primary vaccination cohort]) | | | | ID | Title | Description |
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| OG000 | Primary Vaccination Cohort:- AZD2816 (4) | Previously unvaccinated seronegative participants received IM AZD2816 5*10^10 vp on Days 1 and 29 (4-week dosing interval). |
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| Primary | Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816 | Number of participants with abnormal laboratory parameters reported as TEAEs are reported. Laboratory tests included haematology and clinical chemistry. | 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. | Posted | | Count of Participants | | Participants | | During the 28-day follow-up period after vaccination (vaccines administered on Days 1 and 29 [only for primary vaccination cohort]) | | | | ID | Title | Description |
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| OG000 | Primary Vaccination Cohort:- AZD2816 (4) | Previously unvaccinated seronegative participants received IM AZD2816 5*10^10 vp on Days 1 and 29 (4-week dosing interval). | | OG001 | 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. | | OG002 | Booster Cohort:- mRNA:AZD2816 | |
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| Primary | 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) | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | Primary Vaccination Cohort:- AZD2816 (4) | Previously unvaccinated seronegative participants received IM AZD2816 5*10^10 vp on Days 1 and 29 (4-week dosing interval). | | OG001 |
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| Primary | GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD1222 and AZD1222 in Historical Control | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | Booster Cohort:- AZD1222:AZD1222 | 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. | |
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| Primary | 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) | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | Primary Vaccination Cohort:- AZD2816 (4) | Previously unvaccinated seronegative participants received IM AZD2816 5*10^10 vp on Days 1 and 29 (4-week dosing interval). | | OG001 | Primary Vaccination Cohort:- AZD1222 (4) | |
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| Primary | GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD1222 and AZD1222 in Historical Control | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Participants With Local and Systemic Solicited TEAEs | 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. | 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. | Posted | | Count of Participants | | Participants | | During the 7-day follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts]) | | | | ID | Title | Description |
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| OG000 | Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) | Previously unvaccinated seronegative 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). | | OG001 | Primary Vaccination Cohort:- AZD2816 (12) |
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| Secondary | Number of Participants With Unsolicited TEAEs, TESAEs, MAAEs, and AESIs | 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. | 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. | Posted | | Count of Participants | | Participants | | During the 28-day follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts]) | | | | ID | Title | Description |
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| OG000 | Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) | Previously unvaccinated seronegative 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). |
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| Secondary | GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4) | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | Primary Vaccination Cohort:- AZD2816 (4) | Previously unvaccinated seronegative participants received IM AZD2816 5*10^10 vp on Days 1 and 29 (4-week dosing interval). | | OG001 | Primary Vaccination Cohort:- AZD1222 (4) | |
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| Secondary | 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) | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) | Previously unvaccinated seronegative 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). | | OG001 |
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| Secondary | 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) | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | Primary Vaccination Cohort:- AZD2816 (4) | Previously unvaccinated seronegative participants received IM AZD2816 5*10^10 vp on Days 1 and 29 (4-week dosing interval). | | OG001 | Primary Vaccination Cohort:- AZD1222 (4) |
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| Secondary | 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 | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222 | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 28 days after booster dose (Day 29) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Booster Cohort:- AZD1222:AZD1222 |
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| Secondary | GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and AZD1222 in Historical Control | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222 | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 28 days after booster dose (Day 29) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 |
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| Secondary | GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4) | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | 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 | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222 | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 28 days after booster dose (Day 29) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Booster Cohort:- mRNA:AZD1222 |
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| Secondary | GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and AZD1222 in Historical Control | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222 | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 28 days after booster dose (Day 29) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 |
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| Secondary | GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4) | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | 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 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 |
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| Secondary | 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 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 28 days after booster dose (Day 29) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Booster Cohort:- AZD1222:AZD1222 | |
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| Secondary | 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 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Historical Control |
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| Secondary | 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 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 28 days after booster dose (Day 29) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Booster Cohort:- AZD1222:AZD1222 |
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| Secondary | 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) | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Primary Vaccination Cohort:- AZD1222 (4) |
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| Secondary | 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 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 |
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| Secondary | 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 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 28 days after booster dose (Day 29) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Booster Cohort:- mRNA:AZD1222 | |
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| Secondary | 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 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Historical Control |
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| Secondary | 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 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 28 days after booster dose (Day 29) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Booster Cohort:- mRNA:AZD1222 |
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| Secondary | 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) | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Primary Vaccination Cohort:- AZD1222 (4) |
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| Secondary | Number of Participants With TESAEs, MAAEs, and AESIs From Day 1 Through 6 Months Post Last Dose | 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. | 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. | Posted | | Count of Participants | | Participants | | During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts]) | | | | ID | Title | Description |
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| OG000 | Primary Vaccination Cohort:- AZD2816 (4) | Previously unvaccinated seronegative participants received IM AZD2816 5*10^10 vp on Days 1 and 29 (4-week dosing interval). |
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| Secondary | 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) | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
|---|
| OG000 | Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) | Previously unvaccinated seronegative 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). | | OG001 | Primary Vaccination Cohort:- AZD1222 (4) |
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| Secondary | 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) | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
|---|
| OG000 | Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) | Previously unvaccinated seronegative 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). | | OG001 | Primary Vaccination Cohort:- AZD1222 (4) |
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| Secondary | 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) | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
|---|
| OG000 | Primary Vaccination Cohort:- AZD2816 (4) (Comparator) | Previously unvaccinated seronegative participants received IM AZD2816 5*10^10 vp on Days 1 and 29 (4-week dosing interval). | | OG001 | Primary Vaccination Cohort:- AZD2816 (4) (Reference) |
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| Secondary | 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) | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
|---|
| OG000 | Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) (Comparator) | Previously unvaccinated seronegative 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). | | OG001 |
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| Secondary | 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) | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
|---|
| OG000 | Primary Vaccination Cohort:- AZD2816 (4) | Previously unvaccinated seronegative participants received IM AZD2816 5*10^10 vp on Days 1 and 29 (4-week dosing interval). | | OG001 | Primary Vaccination Cohort:- AZD1222 (4) | Previously unvaccinated seronegative participants received IM AZD1222 5*10^10 vp on Days 1 and 29 (4-week dosing interval). |
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| Secondary | 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) | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
|---|
| OG000 | Primary Vaccination Cohort:- AZD2816 (4) | Previously unvaccinated seronegative participants received IM AZD2816 5*10^10 vp on Days 1 and 29 (4-week dosing interval). | | OG001 | Primary Vaccination Cohort:- AZD1222 (4) | Previously unvaccinated seronegative participants received IM AZD1222 5*10^10 vp on Days 1 and 29 (4-week dosing interval). |
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| Secondary | 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) | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
|---|
| OG000 | Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) | Previously unvaccinated seronegative 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). | | OG001 | Primary Vaccination Cohort:- AZD1222 (4) |
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| Secondary | 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) | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
|---|
| OG000 | Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) | Previously unvaccinated seronegative 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). | | OG001 | Primary Vaccination Cohort:- AZD1222 (4) | |
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| Secondary | 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) | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
|---|
| OG000 | Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) | Previously unvaccinated seronegative 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). | | OG001 | Primary Vaccination Cohort:- AZD1222 (4) | |
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| Secondary | 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) | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
|---|
| OG000 | Primary Vaccination Cohort:- AZD2816 (4) (Comparator) | Previously unvaccinated seronegative participants received IM AZD2816 5*10^10 vp on Days 1 and 29 (4-week dosing interval). | | OG001 | Primary Vaccination Cohort:- AZD2816 (4) (Reference) | Previously unvaccinated seronegative participants received IM AZD2816 5*10^10 vp on Days 1 and 29 (4-week dosing interval). |
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| Secondary | 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) | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
|---|
| OG000 | Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) (Comparator) | Previously unvaccinated seronegative 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). | | OG001 | Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) (Reference) |
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| Secondary | GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4) | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | Booster Cohort:- AZD1222:AZD1222 | 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. |
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| Secondary | 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 | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | Booster Cohort:- AZD1222:AZD1222 | 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. |
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| Secondary | GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- AZD1222:AZD2816 | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | Booster Cohort:- AZD1222:AZD2816 (Comparator) | 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. | | OG001 |
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| Secondary | GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- AZD1222:AZD1222 | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | Booster Cohort:- AZD1222:AZD1222 (Comparator) | 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. | | OG001 |
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| Secondary | 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 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | Booster Cohort:- AZD1222:AZD1222 | 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. | | OG001 | Historical Control |
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| Secondary | 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) | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | Booster Cohort:- AZD1222:AZD1222 | 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. | | OG001 | Primary Vaccination Cohort:- AZD1222 (4) |
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| Secondary | 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 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | Booster Cohort:- AZD1222:AZD1222 | 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. | | OG001 |
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| Secondary | 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 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | Booster Cohort:- AZD1222:AZD2816 (Comparator) | 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. | | OG001 | Booster Cohort:- AZD1222:AZD2816 (Reference) |
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| Secondary | 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 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | Booster Cohort:- AZD1222:AZD1222 (Comparator) | 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. | | OG001 | Booster Cohort:- AZD1222:AZD1222 (Reference) |
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| Secondary | GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4) | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | 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 | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- mRNA:AZD2816 | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
|---|
| OG000 | Booster Cohort:- mRNA:AZD2816 (Comparator) | Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5*10^10 vp on Day 1. | | OG001 |
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| Secondary | GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- mRNA:AZD1222 | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | Booster Cohort:- mRNA:AZD1222 (Comparator) | Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according 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. | | OG001 |
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| Secondary | 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 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Historical Control |
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| Secondary | 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) | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Primary Vaccination Cohort:- AZD1222 (4) |
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| Secondary | 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 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 |
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| Secondary | 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 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | Booster Cohort:- mRNA:AZD2816 (Comparator) | Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5*10^10 vp on Day 1. | | OG001 | Booster Cohort:- mRNA:AZD2816 (Reference) |
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| Secondary | 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 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 28 days after second dose (Day 57) | | | | ID | Title | Description |
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| OG000 | Booster Cohort:- mRNA:AZD1222 (Comparator) | Seronegative participants, who previously received 2 doses of approved mRNA based vaccine according 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. | | OG001 | Booster Cohort:- mRNA:AZD1222 (Reference) |
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| Secondary | 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 | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 28 days after first dose (Day 29) | | | | ID | Title | Description |
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| OG000 | Primary Vaccination Cohort:- AZD2816 (4) | Previously unvaccinated seronegative participants received IM AZD2816 5*10^10 vp on Days 1 and 29 (4-week dosing interval). | | OG001 | Primary Vaccination Cohort:- AZD1222 (4) |
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| Secondary | 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 | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 28 days after first dose (Day 29) | | | | ID | Title | Description |
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| OG000 | Primary Vaccination Cohort:- AZD2816 (4) | Previously unvaccinated seronegative participants received IM AZD2816 5*10^10 vp on Days 1 and 29 (4-week dosing interval). | | OG001 | Primary Vaccination Cohort:- AZD1222 (4) | |
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| Secondary | 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 | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 28 days after first dose (Day 29) | | | | ID | Title | Description |
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| OG000 | Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) | Previously unvaccinated seronegative 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). | | OG001 |
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| Secondary | 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 | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 28 days after first dose (Day 29) | | | | ID | Title | Description |
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| OG000 | Primary Vaccination Cohort:- AZD2816 (4) | Previously unvaccinated seronegative participants received IM AZD2816 5*10^10 vp on Days 1 and 29 (4-week dosing interval). | | OG001 | Primary Vaccination Cohort:- AZD1222 (4) |
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| Secondary | GMT of ChAdOx1 nAb in Primary Vaccination Cohorts and Following a Booster Dose of AZD2816 | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 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) | | | | ID | Title | Description |
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| OG000 | Primary Vaccination Cohort:- AZD1222 (4) | Previously unvaccinated seronegative participants received IM AZD1222 5*10^10 vp on Days 1 and 29. | | OG001 | Primary Vaccination Cohort:- AZD2816 (4) | Previously unvaccinated seronegative participants received IM AZD2816 5*10^10 vp on Days 1 and 29 (4-week dosing interval). |
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| Secondary | Percentage of Participants With Seroresponse of ChAdOx1 nAb in Primary Vaccination Cohorts and Following a Booster Dose of AZD2816 | Chimpanzee adenovirus Ox1 vector nAb were measured by neutralisation assay. Seroresponse was defined as >= 4-fold increase in the GMT of nAb from baseline. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 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) | | | | ID | Title | Description |
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| OG000 | Primary Vaccination Cohort:- AZD1222 (4) | Previously unvaccinated seronegative participants received IM AZD1222 5*10^10 vp on Days 1 and 29. | | OG001 | Primary Vaccination Cohort:- AZD2816 (4) | Previously unvaccinated seronegative participants received IM AZD2816 5*10^10 vp on Days 1 and 29 (4-week dosing interval). |
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| Secondary | GMT of SARS-CoV-2 Spike Protein Binding Antibodies in Primary Vaccination Cohorts and Booster Cohorts | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | 1/dilution | | 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) | | | | ID | Title | Description |
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| OG000 | Primary Vaccination Cohort:- AZD1222 (4) | Previously unvaccinated seronegative participants received IM AZD1222 5*10^10 vp on Days 1 and 29. | | OG001 | Primary Vaccination Cohort:- AZD2816 (4) | Previously unvaccinated seronegative participants received IM AZD2816 5*10^10 vp on Days 1 and 29 (4-week dosing interval). |
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| Secondary | Percentage of Participants With Seroresponse of SARS-CoV-2 Spike Protein Binding Antibodies in Primary Vaccination Cohorts and Booster Cohorts | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 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) | | | | ID | Title | Description |
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| OG000 | Primary Vaccination Cohort:- AZD1222 (4) | Previously unvaccinated seronegative participants received IM AZD1222 5*10^10 vp on Days 1 and 29. | | OG001 | Primary Vaccination Cohort:- AZD2816 (4) | Previously unvaccinated seronegative participants received IM AZD2816 5*10^10 vp on Days 1 and 29 (4-week dosing interval). |
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| Secondary | Correlation Between ChAdOx1 nAb and SARS-CoV-2 nAb Titres | 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. | 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. | Posted | | Number | 95% Confidence Interval | Correlation coefficient | | 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) | | | | ID | Title | Description |
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| OG000 | Primary Vaccination Cohort:- AZD1222 (4) | Previously unvaccinated seronegative participants received IM AZD1222 5*10^10 vp on Days 1 and 29. | | OG001 | Primary Vaccination Cohort:- AZD2816 (4) |
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