Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. Currently, there are no licensed preventions available against COVID-19 and accelerated vaccine development is urgently needed. A safe and effective vaccine for COVID 19 prevention would have significant global public health impact.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I | Active Comparator | Cohort C will include healthy participants aged 18 to 55 years. Cohort D will include healthy elderly participants aged ≥ 56 years. In Cohort D, the elderly population is further divided into 2 different age subgroups; aged 56 to 69 years (Subcohort D1) and aged ≥ 70 years (Subcohort D2). At least 30% of participants in Cohort D will be secured for participants with age ≥ 70 years. |
|
| Part II | Placebo Comparator | Cohort C will include healthy participants aged 18 to 55 years. Cohort D will include healthy elderly participants aged ≥ 56 years. In Cohort D, the elderly population is further divided into 2 different age subgroups; aged 56 to 69 years (Subcohort D1) and aged ≥ 70 years (Subcohort D2). At least 30% of participants in Cohort D will be secured for participants with age ≥ 70 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1222 | Drug | For subjects in part 1 will have that route of Administration as Intramuscular, 5 × 1010 vp (nominal, ± 1.5 × 1010 vp) on V2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Seroresponse to the Spike (S) Antigen of AZD1222 as Measured by Meso Scale Discovery (MSD) Serology Assay | Seroresponse is a binary outcome where a success is when the fold rise in titers compared with baseline is >= 4. The fold rise in titers was calculated as the ratio of the post-vaccination titer level to the baseline titer level. The percentage of participants with a post-vaccination seroresponse (>= 4-fold rise in titers from Day 1 baseline value to Day 57) to the S antigen of AZD1222 as measured by MSD serology assay is reported. | Baseline (Day 1) and Day 57 |
| Number of Participants With Local Solicited Adverse Events (AE) | Solicited AEs are local or systemic predefined AEs for reactogenicity assessment. Participants were given an axillary thermometer, tape measure, and access to app for the solicited AE eDiary, with instructions on use, along with the emergency 24-hour telephone number to contact the on-call study physician if needed. Participants were instructed to record for 7 days following administration of each dose of AZD1222, the timing and severity of local and systemic solicited AEs, if applicable, and whether medication was taken to relieve the symptoms. | From Day 1 up to 7 days post each dose of study vaccination, approximately 14 days |
| Number of Participants With Systemic Solicited AEs | Solicited AEs are local or systemic predefined AEs for reactogenicity assessment. Participants were given an axillary thermometer, tape measure, and access to app for the solicited AE eDiary, with instructions on use, along with the emergency 24-hour telephone number to contact the on-call study physician if needed. Participants were instructed to record for 7 days following administration of each dose of AZD1222, the timing and severity of local and systemic solicited AEs, if applicable, and whether medication was taken to relieve the symptoms. | From Day 1 up to 7 days post each dose of study vaccination, approximately 14 days |
| Number of Participants With AEs, Serious AEs (SAE) and Adverse Event of Special Interest (AESI) Occurring Post Each Dose of Study Vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Seroresponse to the Receptor-Binding Domain (RBD) Antigen of AZD1222 as Measured by MSD Serology Assay | Seroresponse is a binary outcome where a success is when the fold rise in titers compared with baseline is >= 4. The fold rise in titers was calculated as the ratio of the post-vaccination titer level to the baseline titer level. The percentage of participants with a post-vaccination seroresponse (>= 4-fold rise in titers from Day 1 baseline value to Day 57) to the RBD antigen of AZD1222 as measured by MSD serology assay is reported. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fukuoka | 810-0021 | Japan | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37271703 | Derived | Ishikawa K, Nascimento MC, Asano M, Hirata H, Itoh Y, Kelly EJ, Matsui A, Olsson U, Shoemaker K, Green J. One year safety and immunogenicity of AZD1222 (ChAdOx1 nCoV-19): Final analysis of a randomized, placebo-controlled phase 1/2 trial in Japan. Vaccine. 2023 Jun 29;41(29):4199-4205. doi: 10.1016/j.vaccine.2023.05.015. Epub 2023 Jun 2. | |
| 34688944 |
| Label | URL |
|---|---|
| Redacted SAP | View source |
Not provided
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
The study had a screening period (14 days), followed by vaccination and follow-up period (up to 365 days). The study consists of 2 cohorts (Cohort C and Cohort D) with different age populations. The Cohort C included participants aged 18 to 55 years and Cohort D included participants aged >= 56 years. A total of 256 participants were randomized in a 3:1 ratio to receive AZD1222 or placebo.
This Phase I/II study was conducted in healthy, severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) naïve participants at 5 study centers in Japan. First participant was randomized on 23 August 2020 and final data cut-off (DCO) date was 17 January 2022.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort C: AZD1222 | Participants were randomized to receive 2 intramuscular (IM) doses of either 5*10^10 viral particles (vp) (nominal, ± 1.5*10^10 vp) AZD1222 on Days 1 and 29. |
| FG001 | Cohort C: Placebo | Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29. |
| FG002 | Cohort D: AZD1222 | Participants were randomized to receive 2 IM doses of either 5*10^10 vp (nominal, ± 1.5*10^10 vp) AZD1222 on Days 1 and 29. |
| FG003 | Cohort D: Placebo | Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Total vaccinated analysis set (TVS) included all participants who received at least 1 dose of study vaccination.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort C: AZD1222 | Participants were randomized to receive 2 IM doses of either 5*10^10 vp (nominal, ± 1.5*10^10 vp) AZD1222 on Days 1 and 29. |
| BG001 | Cohort C: Placebo | Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Seroresponse to the Spike (S) Antigen of AZD1222 as Measured by Meso Scale Discovery (MSD) Serology Assay | Seroresponse is a binary outcome where a success is when the fold rise in titers compared with baseline is >= 4. The fold rise in titers was calculated as the ratio of the post-vaccination titer level to the baseline titer level. The percentage of participants with a post-vaccination seroresponse (>= 4-fold rise in titers from Day 1 baseline value to Day 57) to the S antigen of AZD1222 as measured by MSD serology assay is reported. | The Fully vaccinated analysis set (FVS) for immunogenicity included all participants in the TVS who received 2 study vaccinations and had no important protocol deviations judged to have the potential to interfere with the generation or interpretation of immune responses. Only participants evaluated for seroresponse at Day 57 are reported. Participants with seroresponse to nucleocapsid antibodies by MSD serology assay at post-baseline up to Day 57 were excluded from this analysis set. | Posted | Number | percentage of participants | Baseline (Day 1) and Day 57 |
|
AEs are reported from first administration of study vaccination up to final DCO of 17 January 2022, up to a maximum of 365 days
The TVS included all participants who received at least 1 dose of study vaccination.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohorts C + D: AZD1222 | Participants were randomized to receive 2 IM doses of either 5*10^10 vp (nominal, ± 1.5*10^10 vp) AZD1222 on Days 1 and 29. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus node dysfunction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tenderness | General disorders | MedDRA 23.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 18, 2021 | Aug 4, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 9, 2021 | Aug 4, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000090985 | ChAdOx1 nCoV-19 |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D019444 | Vaccines, DNA |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D014612 | Vaccines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 0.9% (w/v) saline | Drug | For subjects in placebo will have that route of Administration as Intramuscular 0.9% (w/v) saline on V2 and V6. |
|
An AE is the development of any untoward medical occurrence in a clinical study participant administered medicinal product and which does not necessarily have a causal relationship with this medicinal product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is an AE occurring during any study phase that fulfils one or more of the following criteria: death; immediately life-threatening; in-participant hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital abnormality or birth defect; an important medical event. The AESIs were events of scientific and medical interest specific to the further understanding of the study vaccination safety profile and required close monitoring and rapid communication by the investigators to the sponsor. |
| From Day 1 up to 28 days post each dose of study vaccination, approximately 57 days |
| Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Clinical laboratory values were evaluated for each laboratory parameter as applicable including hematology and clinical chemistry. The baseline was defined as the last non-missing measurement taken prior to the first dose of study vaccination (including unscheduled measurements, if any). | From Day 1 up to 28 days post each dose of study vaccination, approximately 57 days |
| Baseline (Day 1) and Day 57 |
| Geometric Mean Titers (GMTs) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay | The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titer/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titer, where 'n' is the number of participants with titer information. | Baseline (Day 1) and Days 15, 29, 43, 57, 183, and 365 |
| Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay | The fold rise was calculated as the ratio of the post-vaccination titer level to the baseline titer level, where baseline was defined as the last measurement taken before the first dose of study vaccination. The GMFR was calculated as anti-logarithm of Σ (log base 2 transformed (post-vaccination titer/ pre-vaccination titer)/n). Where 'n' is the number of participants with titer information. | Baseline (Day 1) and Days 15, 29, 43, 57, 183, and 365 |
| Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies (nAb) of AZD1222 as Measured by Pseudo-Neutralization Assay | Seroresponse is a binary outcome where a success is when the fold rise in titers compared with baseline is >= 4. The fold rise in titers was calculated as the ratio of the post-vaccination titer level to the baseline titer level. The percentage of participants with a post-vaccination seroresponse (>= 4-fold rise in titers from Day 1 baseline value to Day 57) to SARS-CoV-2 nAb of AZD1222 as measured by pseudo-neutralization assay is reported. | Baseline (Day 1) and Day 57 |
| GMTs for SARS-CoV-2 nAb as Measured by Pseudo-Neutralization Assay | The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titer/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titer, where 'n' is the number of participants with titer information. | Baseline (Day 1) and Days 29, 57, 183, and 365 |
| GMFR for SARS-CoV-2 nAb as Measured by Pseudo-Neutralization Assay | The fold rise was calculated as the ratio of the post-vaccination titer level to the baseline titer level, where baseline was defined as the last measurement taken before the first dose of study vaccination. The GMFR was calculated as anti-logarithm of Σ (log base 2 transformed (post-vaccination titer/ pre-vaccination titer)/n). Where 'n' is the number of participants with titer information. | Baseline (Day 1) and Days 29, 57, 183, and 365 |
| Number of Participants With SAEs and AESIs Occurring Throughout the Study | An SAE is an AE occurring during any study phase that fulfils one or more of the following criteria: death; immediately life-threatening; in-participant hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital abnormality or birth defect; an important medical event. The AESIs were events of scientific and medical interest specific to the further understanding of the study vaccination safety profile and required close monitoring and rapid communication by the investigators to the sponsor. | From Day 1 up to final DCO of 17 January 2022, up to a maximum of 365 days |
| Hachioji-shi |
| 192-0046 |
| Japan |
| Research Site | Minatoku | 108-0075 | Japan |
| Research Site | Sumida-ku | 130-0004 | Japan |
| Research Site | Toshima-ku | 171-0021 | Japan |
| Asano M, Okada H, Itoh Y, Hirata H, Ishikawa K, Yoshida E, Matsui A, Kelly EJ, Shoemaker K, Olsson U, Vekemans J. Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in Japan: a double-blind, randomized controlled phase 1/2 trial. Int J Infect Dis. 2022 Jan;114:165-174. doi: 10.1016/j.ijid.2021.10.030. Epub 2021 Oct 22. |
| Redacted CSP | View source |
| CSR Synopsis | View source |
| Physician Decision |
|
| Withdrawal by Subject |
|
| BG002 | Cohort D: AZD1222 | Participants were randomized to receive 2 IM doses of either 5*10^10 vp (nominal, ± 1.5*10^10 vp) AZD1222 on Days 1 and 29. |
| BG003 | Cohort D: Placebo | Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Cohort C: AZD1222 | Participants were randomized to receive 2 IM doses of either 5*10^10 vp (nominal, ± 1.5*10^10 vp) AZD1222 on Days 1 and 29. |
| OG001 | Cohort C: Placebo | Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29. |
| OG002 | Cohort D: AZD1222 | Participants were randomized to receive 2 IM doses of either 5*10^10 vp (nominal, ± 1.5*10^10 vp) AZD1222 on Days 1 and 29. |
| OG003 | Cohort D: Placebo | Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29. |
|
|
|
| Primary | Number of Participants With Local Solicited Adverse Events (AE) | Solicited AEs are local or systemic predefined AEs for reactogenicity assessment. Participants were given an axillary thermometer, tape measure, and access to app for the solicited AE eDiary, with instructions on use, along with the emergency 24-hour telephone number to contact the on-call study physician if needed. Participants were instructed to record for 7 days following administration of each dose of AZD1222, the timing and severity of local and systemic solicited AEs, if applicable, and whether medication was taken to relieve the symptoms. | The TVS included all participants who received at least 1 dose of study vaccination. | Posted | Count of Participants | Participants | From Day 1 up to 7 days post each dose of study vaccination, approximately 14 days |
|
|
|
| Primary | Number of Participants With Systemic Solicited AEs | Solicited AEs are local or systemic predefined AEs for reactogenicity assessment. Participants were given an axillary thermometer, tape measure, and access to app for the solicited AE eDiary, with instructions on use, along with the emergency 24-hour telephone number to contact the on-call study physician if needed. Participants were instructed to record for 7 days following administration of each dose of AZD1222, the timing and severity of local and systemic solicited AEs, if applicable, and whether medication was taken to relieve the symptoms. | The TVS included all participants who received at least 1 dose of study vaccination. | Posted | Count of Participants | Participants | From Day 1 up to 7 days post each dose of study vaccination, approximately 14 days |
|
|
|
| Primary | Number of Participants With AEs, Serious AEs (SAE) and Adverse Event of Special Interest (AESI) Occurring Post Each Dose of Study Vaccination | An AE is the development of any untoward medical occurrence in a clinical study participant administered medicinal product and which does not necessarily have a causal relationship with this medicinal product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is an AE occurring during any study phase that fulfils one or more of the following criteria: death; immediately life-threatening; in-participant hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital abnormality or birth defect; an important medical event. The AESIs were events of scientific and medical interest specific to the further understanding of the study vaccination safety profile and required close monitoring and rapid communication by the investigators to the sponsor. | The TVS included all participants who received at least 1 dose of study vaccination. Unsolicited AEs that started after the inoculation of non-study coronavirus disease 2019 vaccine were not included in this analysis. | Posted | Count of Participants | Participants | From Day 1 up to 28 days post each dose of study vaccination, approximately 57 days |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Clinical laboratory values were evaluated for each laboratory parameter as applicable including hematology and clinical chemistry. The baseline was defined as the last non-missing measurement taken prior to the first dose of study vaccination (including unscheduled measurements, if any). | The TVS included all participants who received at least 1 dose of study vaccination. | Posted | Count of Participants | Participants | From Day 1 up to 28 days post each dose of study vaccination, approximately 57 days |
|
|
|
| Secondary | Percentage of Participants With Seroresponse to the Receptor-Binding Domain (RBD) Antigen of AZD1222 as Measured by MSD Serology Assay | Seroresponse is a binary outcome where a success is when the fold rise in titers compared with baseline is >= 4. The fold rise in titers was calculated as the ratio of the post-vaccination titer level to the baseline titer level. The percentage of participants with a post-vaccination seroresponse (>= 4-fold rise in titers from Day 1 baseline value to Day 57) to the RBD antigen of AZD1222 as measured by MSD serology assay is reported. | The FVS for immunogenicity included all participants in the TVS who received 2 study vaccinations and had no important protocol deviations judged to have the potential to interfere with the generation or interpretation of immune responses. Only participants evaluated for seroresponse at Day 57 are reported. Participants with seroresponse to nucleocapsid antibodies by MSD serology assay at post-baseline up to Day 57 were excluded from this analysis set. | Posted | Number | percentage of participants | Baseline (Day 1) and Day 57 |
|
|
|
|
| Secondary | Geometric Mean Titers (GMTs) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay | The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titer/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titer, where 'n' is the number of participants with titer information. | The FVS for immunogenicity included all participants in the TVS who received 2 study vaccinations and had no important protocol deviations judged to have the potential to interfere with the generation or interpretation of immune responses. Participants with seroresponse to nucleocapsid antibodies by MSD serology assay at post-baseline up to Day 57 were excluded from this analysis set. | Posted | Geometric Mean | 95% Confidence Interval | arbitrary units per milliliter (AU/mL) | Baseline (Day 1) and Days 15, 29, 43, 57, 183, and 365 |
|
|
|
| Secondary | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay | The fold rise was calculated as the ratio of the post-vaccination titer level to the baseline titer level, where baseline was defined as the last measurement taken before the first dose of study vaccination. The GMFR was calculated as anti-logarithm of Σ (log base 2 transformed (post-vaccination titer/ pre-vaccination titer)/n). Where 'n' is the number of participants with titer information. | The FVS for immunogenicity included all participants in the TVS who received 2 study vaccinations and had no important protocol deviations judged to have the potential to interfere with the generation or interpretation of immune responses. Participants with seroresponse to nucleocapsid antibodies by MSD serology assay at post-baseline up to Day 57 were excluded from this analysis set. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Baseline (Day 1) and Days 15, 29, 43, 57, 183, and 365 |
|
|
|
| Secondary | Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies (nAb) of AZD1222 as Measured by Pseudo-Neutralization Assay | Seroresponse is a binary outcome where a success is when the fold rise in titers compared with baseline is >= 4. The fold rise in titers was calculated as the ratio of the post-vaccination titer level to the baseline titer level. The percentage of participants with a post-vaccination seroresponse (>= 4-fold rise in titers from Day 1 baseline value to Day 57) to SARS-CoV-2 nAb of AZD1222 as measured by pseudo-neutralization assay is reported. | The FVS for immunogenicity included all participants in the TVS who received 2 study vaccinations and had no important protocol deviations judged to have the potential to interfere with the generation or interpretation of immune responses. Only participants evaluated for seroresponse at Day 57 are reported. Participants with seroresponse to nucleocapsid antibodies by MSD serology assay at post-baseline up to Day 57 were excluded from this analysis set. | Posted | Number | percentage of participants | Baseline (Day 1) and Day 57 |
|
|
|
|
| Secondary | GMTs for SARS-CoV-2 nAb as Measured by Pseudo-Neutralization Assay | The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titer/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titer, where 'n' is the number of participants with titer information. | The FVS for immunogenicity included all participants in the TVS who received 2 study vaccinations and had no important protocol deviations judged to have the potential to interfere with the generation or interpretation of immune responses. Participants with seroresponse to nucleocapsid antibodies by MSD serology assay at post-baseline up to Day 57 were excluded from this analysis set. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | Baseline (Day 1) and Days 29, 57, 183, and 365 |
|
|
|
| Secondary | GMFR for SARS-CoV-2 nAb as Measured by Pseudo-Neutralization Assay | The fold rise was calculated as the ratio of the post-vaccination titer level to the baseline titer level, where baseline was defined as the last measurement taken before the first dose of study vaccination. The GMFR was calculated as anti-logarithm of Σ (log base 2 transformed (post-vaccination titer/ pre-vaccination titer)/n). Where 'n' is the number of participants with titer information. | The FVS for immunogenicity included all participants in the TVS who received 2 study vaccinations and had no important protocol deviations judged to have the potential to interfere with the generation or interpretation of immune responses. Participants with seroresponse to nucleocapsid antibodies by MSD serology assay at post-baseline up to Day 57 were excluded from this analysis set. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Baseline (Day 1) and Days 29, 57, 183, and 365 |
|
|
|
| Secondary | Number of Participants With SAEs and AESIs Occurring Throughout the Study | An SAE is an AE occurring during any study phase that fulfils one or more of the following criteria: death; immediately life-threatening; in-participant hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital abnormality or birth defect; an important medical event. The AESIs were events of scientific and medical interest specific to the further understanding of the study vaccination safety profile and required close monitoring and rapid communication by the investigators to the sponsor. | The TVS included all participants who received at least 1 dose of study vaccination. | Posted | Count of Participants | Participants | From Day 1 up to final DCO of 17 January 2022, up to a maximum of 365 days |
|
|
|
| 0 |
| 192 |
| 3 |
| 192 |
| 11 |
| 192 |
| EG001 | Cohorts C + D: Placebo | Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29. | 0 | 64 | 3 | 64 | 0 | 64 |
| Bile duct stone | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Small intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
|
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
|
| After second vaccination |
|
|
| After any vaccination |
|
|
|
| After second vaccination |
|
|
| After any vaccination |
|
|
| SAEs |
|
| AESIs |
|
| Superiority |
|
| S Antibody Titer: Day 15 |
|
|
| S Antibody Titer: Day 29 |
|
|
| S Antibody Titer: Day 43 |
|
|
| S Antibody Titer: Day 57 |
|
|
| S Antibody Titer: Day 183 |
|
|
| S Antibody Titer: Day 365 |
|
|
| RBD Antibody Titer: Baseline (Day 1) |
|
|
| RBD Antibody Titer: Day 15 |
|
|
| RBD Antibody Titer: Day 29 |
|
|
| RBD Antibody Titer: Day 43 |
|
|
| RBD Antibody Titer: Day 57 |
|
|
| RBD Antibody Titer: Day 183 |
|
|
| RBD Antibody Titer: Day 365 |
|
|
|
| S Antibody Titer: Day 29 |
|
|
| S Antibody Titer: Day 43 |
|
|
| S Antibody Titer: Day 57 |
|
|
| S Antibody Titer: Day 183 |
|
|
| S Antibody Titer: Day 365 |
|
|
| RBD Antibody Titer: Day 15 |
|
|
| RBD Antibody Titer: Day 29 |
|
|
| RBD Antibody Titer: Day 43 |
|
|
| RBD Antibody Titer: Day 57 |
|
|
| RBD Antibody Titer: Day 183 |
|
|
| RBD Antibody Titer: Day 365 |
|
|
| Superiority |
|
| Day 29 |
|
|
| Day 57 |
|
|
| Day 183 |
|
|
| Day 365 |
|
|
|
| Day 57 |
|
|
| Day 183 |
|
|
| Day 365 |
|
|
| AESIs |
|