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| Name | Class |
|---|---|
| Coalition for Epidemic Preparedness Innovations | OTHER |
| The Peter Doherty Institute for Infection and Immunity | OTHER |
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This clinical trial is a single-blind, randomised study to determine the reactogenicity and immunogenicity of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) vaccine (Pfizer-BioNTech) as booster dose in adults, who have previously received either Sinopharm (BBIBP-CorV®), AstraZeneca (ChAdOx1-S, or Vaxzevria®) or Sputnik V (Gam-COVID-Vac®) as their primary doses 6 to 9 months earlier. Both standard and fractional doses will be tested.
Participants are healthy adults aged 18 years or older, with no upper age limit. Procedures will be implemented to ensure participants of all ages (aged 18 and above) are included and that there is an even age distribution (<50 and ≥50 years) in each group. There will be a total of 6 groups (Sinopharm-standard dose Pfizer, Sinopharm-fractional dose Pfizer, AstraZeneca-standard dose Pfizer, AstraZeneca-fractional dose Pfizer, Sputnik - standard dose Pfizer, Sputnik - fractional dose Pfizer), with 200 participants per group for Sinopharm and 100 for AstraZeneca and Sputnik.
As per brief summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Pfizer-BioNTech booster group | Active Comparator | Biological/Vaccine: Tozinameran - Standard Dose Other Names: BNT162b2 Comirnaty Pfizer Covid-19 vaccine Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose. |
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| Fractional Pfizer-BioNTech booster group | Experimental | Biological/Vaccine: Tozinameran - Standard Dose Other Names: BNT162b2 Comirnaty Pfizer Covid-19 vaccine Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.3 ml. Liquid for injection. Single dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tozinameran - Standard Dose | Biological | Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Seroresponse | Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using IgG ELISA. The primary endpoint is the seroresponse rate at the Day-28 visit. The seroresponse rate at the individual level is defined as either a ≥4-fold rise in binding antibodies at the Day-28 visit compared to baseline (pre-vaccination) with a titre of <200 BAU/ml, a ≥2-fold rise among participants with a baseline (pre-vaccination) titre of >200 BAU/ml, or a ≥4-times the lower limit of detection if baseline levels are lower than the limit of detection. | 28-days post booster vaccination |
| Solicited Grade 3 or 4 Local or Systemic Reaction | Questionnaire to document solicited reactions is developed specifically for this study. Data will be reported as the proportion of participants who report grade 3 or 4 reactions by each intervention arm. Solicited reactions such as pain, tenderness, erythema/redness, induration, swelling, fever, nausea, vomiting, headache, fatigue/malaise, myalgia, arthralgia, diarrhea, enlarged lymph nodes will be collected from the participants 7 days post-vaccination. | 7 days post booster vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Seroresponse by Priming Vaccine Strata | Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using IgG ELISA. The primary endpoint is the seroresponse rate at the Day-28 visit. The seroresponse rate at the individual level is defined as either a ≥4-fold rise in binding antibodies at the Day-28 visit compared to baseline (pre-vaccination) with a titre of <200 BAU/ml, a ≥2-fold rise among participants with a baseline (pre-vaccination) titre of >200 BAU/ml, or a ≥4-times the lower limit of detection if baseline levels are lower than the limit of detection. Priming strata (previously COVID vaccination): AstraZeneca (ChAdOx1-S, or Vaxzevria®); Sinopharm (BBIBP-CorV®); Sputnik V (Gam-COVID-Vac®) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tsetsegsaikhan Batmunkh, MD | Ministry of Health, Mongolia | Principal Investigator |
| Kim Mulholland, MD/Prof | Murdoch Childrens Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| District Health Centre | Ulaanbaatar | Mongolia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34863358 | Background | Munro APS, Janani L, Cornelius V, Aley PK, Babbage G, Baxter D, Bula M, Cathie K, Chatterjee K, Dodd K, Enever Y, Gokani K, Goodman AL, Green CA, Harndahl L, Haughney J, Hicks A, van der Klaauw AA, Kwok J, Lambe T, Libri V, Llewelyn MJ, McGregor AC, Minassian AM, Moore P, Mughal M, Mujadidi YF, Murira J, Osanlou O, Osanlou R, Owens DR, Pacurar M, Palfreeman A, Pan D, Rampling T, Regan K, Saich S, Salkeld J, Saralaya D, Sharma S, Sheridan R, Sturdy A, Thomson EC, Todd S, Twelves C, Read RC, Charlton S, Hallis B, Ramsay M, Andrews N, Nguyen-Van-Tam JS, Snape MD, Liu X, Faust SN; COV-BOOST study group. Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial. Lancet. 2021 Dec 18;398(10318):2258-2276. doi: 10.1016/S0140-6736(21)02717-3. Epub 2021 Dec 2. | |
| 41948336 |
| Label | URL |
|---|---|
| Quarter-dose of Moderna COVID vaccine still rouses a big immune response | View source |
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We will share de-identified data to ethically approved studies in cases where participants have indicated on the consent form that they consent to the use of their data and where consistent with terms of collaboration agreements.
Individual participant data (IPD) sharing plans in development
IPD sharing plans in development
There are two study arms (i.e. groups to which participants were randomised), as per "Arms and Interventions" in Protocol Section, corresponding to the primary analysis comparing a full dose to a fractional dose. Stratified randomisation was performed to ensure balanced randomisation according to the primary vaccine received (prior to this study) and age for secondary subgroup analyses. The Participant Flow was edited to reflect the randomisation of participants into two arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard | 30µg Pfizer-BioNTech booster dose |
| FG001 | Fractional | 15µg Pfizer-BioNTech booster dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 20, 2023 | Apr 17, 2024 |
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Study participants who have received two doses of either Sinopharm, AstraZeneca or Sputnik vaccine as their primary vaccine will be randomised into one of two groups. The two groups consist of a standard or fractional dose of Pfizer vaccine.
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The participants and those evaluating reactogenicity will be blinded to the vaccine allocation for the first 28 days following vaccination. After that, both clinical investigators and participants will be aware of their investigational product allocation. Laboratory staff will remain blinded to the investigational product allocation during the immunology testing.
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| Tozinameran - Fractional Dose | Biological | Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose. |
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| 28-days post booster vaccination |
| SARS-CoV-2 Specific IgG Antibodies at Day-28 | Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using IgG ELISA. | 28-days post booster vaccination |
| SARS-CoV-2 Specific IgG Antibodies at Day-28 by Priming Vaccine Strata | Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using IgG ELISA. Priming strata (previously COVID vaccination): AstraZeneca (ChAdOx1-S, or Vaxzevria®); Sinopharm (BBIBP-CorV®); Sputnik V (Gam-COVID-Vac®) | 28-days post booster vaccination |
| SARS-CoV-2 Specific IgG Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination. | Serum samples collected at baseline (pre booster), 28 days, 6 months, 12 months, 18 months, and 24 months post booster vaccination from the study arms will be evaluated for SARS-CoV-2 specific IgG antibodies using the commercial Euroimmun S1 IgG ELISA. Data will be reported as binding antibody units (BAU)/mL and presented as geometric mean concentration (GMC) and 95% confidence intervals (CI). | Baseline (pre booster), 28 days, 6 months, 12 months, 18 months, and 24 months post-booster vaccination. |
| SARS-CoV-2 Specific Neutralising Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination Measured by Surrogate Virus Neutralisation Test (sVNT). | Serum samples collected at baseline (pre booster), 28 days-, 6- and 12-months post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific neutralising antibodies using the GenScript® cPass surrogate virus neutralization test (sVNT) for both wild-type and Omicron variant. Neutralising antibody response will be reported as percentage (%) inhibition of receptor binding domain-angiotensin-converting enzyme 2 (RBD-ACE2) binding relative to a positive control. | Baseline (pre-booster), 28 days, 6 months, 12 months, 18 months, and 24 months post-booster vaccination. |
| SARS-CoV-2 Specific Neutralising Antibodies at Baseline (Pre Booster), 28 Days-, 6- and 12-months Post Booster Vaccination Measured by SARS-CoV-2 Microneutralisation Assay | A subset of samples (20%) from all four timepoints will be assessed using a SARS-CoV-2 microneutralisation assay to both the wild type (vaccine) strain and for two SARS-CoV-2 Variants of concern. Neutralizing antibody will be reported as endpoint titre. | Baseline (pre booster), 28 days-, 6- and 12-months post booster vaccination |
| Interferon Gamma (IFNγ) Concentrations in International Units (IU)/mL | IFN-γ concentrations (IU/mL) as a measure of cellular immunity will be assessed in a subset of participants. IFN-γ production will be stimulated using QuantiFERON Human IFN-γ SARS-CoV-2 (Qiagen) and quantified by ELISA. Results are summarised as geometric mean concentrations (GMCs) with 95% confidence intervals. | Baseline (pre booster), 28 days, 6-, 12 -, 18-, and 24-months post booster vaccination |
| Number of IFNγ Producing Cells/Million PBMCs | Applicable to the subset participants with additional blood collection. IFNγ producing cells as a measurement of cellular immunity will be assessed on a subset of the participants (40%) from each group. IFN-γ Enzyme-Linked ImmunoSpot (Elispot) assay will be performed on isolated peripheral blood mononuclear cells (PBMCs). Data will be reported as number of IFNγ producing cells/million and presented using means and 95% CI. | Baseline (pre-booster), 28 days, 6 and 12 months post booster vaccination |
| Frequency of Cytokine-expressing T Cells | Frequency of wild-type SARS-CoV-2 spike-specific cytokine-expressing T cells will be assessed in a subset of participants (~40%) using intracellular cytokine staining (ICS) by flow cytometry on PBMC samples. Results are reported as the frequency (%) of cytokine-expressing CD4 and CD8 memory T cells, summarised as geometric mean concentrations (GMCs) with 95% confidence intervals. | Baseline (pre-booster), 28 days, 6 and 12 months post-booster vaccination |
| Cellular Immunity: Multiplex Cytokine Assays - Reported as Cytokine Concentrations in pg/ml and Presented as GMC and 95% CI | Wild-type SARS-CoV-2 spike-specific cytokine concentrations following PBMC stimulation will be assessed in a predefined subset of participants (approximately 40%) using multiplex cytokine assays. Cytokine concentrations will be reported in pg/mL and summarised as geometric mean concentrations (GMCs) with 95% confidence intervals. IFN-γ ELISpot, intracellular cytokine staining (flow cytometry), and multiplex cytokine assays will be performed on isolated peripheral blood mononuclear cells (PBMCs). | Baseline (pre booster), 28 days-, 6 and 12 months post booster vaccination |
| Incidence of Unsolicited Adverse Events (AE) | All unsolicited AE will be collected for 28 days post booster vaccination. Data will be presented as proportion of participants who report unsolicited AE. | 28 days-post booster vaccination |
| Incidence of Medically Attended Adverse Events | All participants with medically attended AE will be collected for 3 months post booster vaccination. Data will be presented as number of participants who report unsolicited AE. | 3 months post booster vaccination |
| Incidence of Serious Adverse Events (SAE) | SAE will be collected throughout the follow-up period of 24 months post booster vaccination. Data will be presented as a proportion of participants who report unsolicited SAE. | 24 months post-booster |
| Incidence of PCR Confirmed COVID-19 Infection | Confirmed SARS-CoV-2 infections will be documented throughout the follow-up period, by clinical severity. | Up to 24 months post booster vaccination |
| Number of IFNγ Producing Cells/Million PBMCs | Applicable to the subset participants with additional blood collection. IFNγ producing cells as a measurement of cellular immunity will be assessed on a subset of the participants (40%) from each group. IFN-γ Enzyme-Linked ImmunoSpot (Elispot) assay will be performed on isolated peripheral blood mononuclear cells (PBMCs). Data will be reported as number of IFNγ producing cells/million and presented using means and 95% CI. | At 18 and 24 months post booster vaccination |
| Frequency of Cytokine-expressing T Cells | Frequency of wild-type SARS-CoV-2 spike-specific cytokine-expressing T cells will be assessed in a subset of participants (~40%) using intracellular cytokine staining (ICS) by flow cytometry on PBMC samples. Results are reported as the frequency (%) of cytokine-expressing CD4 and CD8 memory T cells, summarised as geometric mean concentrations (GMCs) with 95% confidence intervals. | 18 and 24 months post-booster vaccination |
| Cellular Immunity: Multiplex Cytokine Assays - Reported as Cytokine Concentrations in pg/ml and Presented as GMC and 95% CI | Wild-type SARS-CoV-2 spike-specific cytokine concentrations following PBMC stimulation will be assessed in a predefined subset of participants (approximately 40%) using multiplex cytokine assays. Cytokine concentrations will be reported in pg/mL and summarised as geometric mean concentrations (GMCs) with 95% confidence intervals. IFN-γ ELISpot, intracellular cytokine staining (flow cytometry), and multiplex cytokine assays will be performed on isolated peripheral blood mononuclear cells (PBMCs). | 18 and 24 months post booster vaccination |
| Derived |
| Batmunkh T, Neal EF, Amraa O, Mazarakis N, Altangerel B, Avaa N, Batbayar L, Batsukh K, Bright K, Burentogtokh T, Do LAH, Dorj G, Hart JD, Jamiyandorj O, Javkhlantugs K, Jigjidsuren S, Justice F, Li S, Mashbaatar K, Moore KA, Namjil N, Nguyen CD, Ochirbat B, Surenjav U, Thomson H, Tsolmon B, Licciardi PV, von Mollendorf C, Mulholland K. Fractional BNT162b2 boosters induce durable immune responses after non-mRNA priming in Mongolia: a randomised controlled trial. Front Immunol. 2026 Mar 23;17:1789248. doi: 10.3389/fimmu.2026.1789248. eCollection 2026. |
| 41072276 | Derived | Batmunkh T, Neal EFG, Amraa O, Mazarakis N, Altangerel B, Avaa N, Batbayar L, Batsukh K, Bright K, Burentogtokh T, Do LAH, Dorj G, Hart JD, Jamiyandorj O, Javkhlantugs K, Jigjidsuren S, Justice F, Li S, Mashbaatar K, Moore KA, Namjil N, Nguyen CD, Ochirbat B, Surenjav U, Thomson H, Tsolmon B, Licciardi PV, von Mollendorf C, Mulholland K. Immunogenicity and safety at twelve months of fractional and standard BNT162b2 booster doses in adults primed with ChAdOx1-S, BBIBP-CorV, or Gam-COVID-Vac in Mongolia: a randomised controlled trial. Vaccine. 2025 Nov 14;66:127840. doi: 10.1016/j.vaccine.2025.127840. Epub 2025 Oct 9. |
| 38357398 | Derived | Batmunkh T, Moore KA, Thomson H, Altangerel B, Amraa O, Avaa N, Batbayar L, Batsukh K, Bright K, Burentogtokh T, Ha Do LA, Dorj G, Hart JD, Javkhlantugs K, Jigjidsuren S, Justice F, Li S, Licciardi PV, Mashbaatar K, Mazarakis N, Neal EFG, Nguyen CD, Ochirbat B, Tsolmon B, Tuya A, Surenjav U, von Mollendorf C, Mulholland K. Immunogenicity, safety, and reactogenicity of a half- versus full-dose BNT162b2 (Pfizer-BioNTech) booster following a two-dose ChAdOx1 nCoV-19, BBIBP-CorV, or Gam-COVID-Vac priming schedule in Mongolia: a randomised, controlled, non-inferiority trial. Lancet Reg Health West Pac. 2023 Nov 21;42:100953. doi: 10.1016/j.lanwpc.2023.100953. eCollection 2024 Jan. |
| US Food and Drug Administration (FDA). Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials 2007 | View source |
| Received allocated d dose |
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| Included in Day 28 immunogenicity analysis |
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| COMPLETED | Included in Month-12 immunogenicity analysis |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AstraZeneca (ChAdOx1-S, or Vaxzevria®) - Standard Pfizer-BioNTech Booster Group | Previously received two doses of AstraZeneca as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose. |
| BG001 | AstraZeneca (ChAdOx1-S, or Vaxzevria®) - Fractional Pfizer-BioNTech Booster Group | Previously received two doses of AstraZeneca as primary COVID-19 vaccine . Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose. |
| BG002 | Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group | Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose. |
| BG003 | Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group | Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose. |
| BG004 | Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group | Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose. |
| BG005 | Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group | Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI | Number | kg/m2 |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Seroresponse | Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using IgG ELISA. The primary endpoint is the seroresponse rate at the Day-28 visit. The seroresponse rate at the individual level is defined as either a ≥4-fold rise in binding antibodies at the Day-28 visit compared to baseline (pre-vaccination) with a titre of <200 BAU/ml, a ≥2-fold rise among participants with a baseline (pre-vaccination) titre of >200 BAU/ml, or a ≥4-times the lower limit of detection if baseline levels are lower than the limit of detection. | The analysis of immunogenicity endpoints included all participants with outcome data. There are two study arms, as per "Arms and Interventions" in Protocol Section, corresponding to the primary analysis comparing a full dose to a fractional dose. Stratified randomisation was performed to ensure balanced randomisation according to the primary vaccine received (prior to this study) and age for secondary subgroup analyses. The primary outcome is unstratified. | Posted | Count of Participants | Participants | 28-days post booster vaccination |
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| Primary | Solicited Grade 3 or 4 Local or Systemic Reaction | Questionnaire to document solicited reactions is developed specifically for this study. Data will be reported as the proportion of participants who report grade 3 or 4 reactions by each intervention arm. Solicited reactions such as pain, tenderness, erythema/redness, induration, swelling, fever, nausea, vomiting, headache, fatigue/malaise, myalgia, arthralgia, diarrhea, enlarged lymph nodes will be collected from the participants 7 days post-vaccination. | The reactogenicity and safety analysis populations included all randomised participants who received a study vaccine, according to the vaccine received. There are two study arms, as per "Arms and Interventions" in Protocol Section. Stratified randomisation was performed to ensure balanced randomisation according to the primary vaccine received (prior to this study) and age for secondary subgroup analyses. The primary outcome is unstratified. | Posted | Count of Participants | Participants | 7 days post booster vaccination |
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| Secondary | Seroresponse by Priming Vaccine Strata | Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using IgG ELISA. The primary endpoint is the seroresponse rate at the Day-28 visit. The seroresponse rate at the individual level is defined as either a ≥4-fold rise in binding antibodies at the Day-28 visit compared to baseline (pre-vaccination) with a titre of <200 BAU/ml, a ≥2-fold rise among participants with a baseline (pre-vaccination) titre of >200 BAU/ml, or a ≥4-times the lower limit of detection if baseline levels are lower than the limit of detection. Priming strata (previously COVID vaccination): AstraZeneca (ChAdOx1-S, or Vaxzevria®); Sinopharm (BBIBP-CorV®); Sputnik V (Gam-COVID-Vac®) | The analysis of immunogenicity endpoints included all participants with outcome data | Posted | Count of Participants | Participants | 28-days post booster vaccination |
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| Secondary | SARS-CoV-2 Specific IgG Antibodies at Day-28 | Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using IgG ELISA. | The analysis of immunogenicity endpoints included all participants with outcome data. | Posted | Geometric Mean | 95% Confidence Interval | BAU/ml | 28-days post booster vaccination |
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| Secondary | SARS-CoV-2 Specific IgG Antibodies at Day-28 by Priming Vaccine Strata | Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using IgG ELISA. Priming strata (previously COVID vaccination): AstraZeneca (ChAdOx1-S, or Vaxzevria®); Sinopharm (BBIBP-CorV®); Sputnik V (Gam-COVID-Vac®) | The analysis of immunogenicity endpoints included all participants with outcome data | Posted | Geometric Mean | 95% Confidence Interval | BAU/ml | 28-days post booster vaccination |
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| Secondary | SARS-CoV-2 Specific IgG Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination. | Serum samples collected at baseline (pre booster), 28 days, 6 months, 12 months, 18 months, and 24 months post booster vaccination from the study arms will be evaluated for SARS-CoV-2 specific IgG antibodies using the commercial Euroimmun S1 IgG ELISA. Data will be reported as binding antibody units (BAU)/mL and presented as geometric mean concentration (GMC) and 95% confidence intervals (CI). | Standard arm: baseline 1 withdrawn; day 28: 6 missed, 1 withdrawn; 6 months: 9 missed, 4 withdrawn, 1 lost to follow up (LTFU); 12 months: 5 missed, 3 withdrawn; 18 months: 8 missed, 17 withdrawn, 1 LTFU; 24 months: 5 withdrawn, 7 LTFU. Fractional arm: baseline 1 withdrawn; day 28: 4 missed, 1 withdrawn; 6 months: 6 missed, 3 withdrawn, 1 sample not taken; 12 months: 3 missed, 5 withdrawn, 1 LTFU; 18 months: 9 missed, 12 withdrawn, 4 LTFU; 24 months: 6 withdrawn, 8 LTFU. | Posted | Geometric Mean | 95% Confidence Interval | binding antibody units (BAU/mL) | Baseline (pre booster), 28 days, 6 months, 12 months, 18 months, and 24 months post-booster vaccination. |
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| Secondary | SARS-CoV-2 Specific Neutralising Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination Measured by Surrogate Virus Neutralisation Test (sVNT). | Serum samples collected at baseline (pre booster), 28 days-, 6- and 12-months post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific neutralising antibodies using the GenScript® cPass surrogate virus neutralization test (sVNT) for both wild-type and Omicron variant. Neutralising antibody response will be reported as percentage (%) inhibition of receptor binding domain-angiotensin-converting enzyme 2 (RBD-ACE2) binding relative to a positive control. | Participant numbers vary because some missed visits or withdrew. One baseline sample was not collected. Follow-up blood collection was 98% at Day 28, 96% at 6 months, 95% at 12 months, 88% at 18 months, and 87% at 24 months. By 24 months, 59 withdrew for relocation, voluntary withdrawal, death, or investigator decision, and 22 were lost to follow-up. | Posted | Median | Inter-Quartile Range | percentage (%) inhibition | Baseline (pre-booster), 28 days, 6 months, 12 months, 18 months, and 24 months post-booster vaccination. |
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| Secondary | SARS-CoV-2 Specific Neutralising Antibodies at Baseline (Pre Booster), 28 Days-, 6- and 12-months Post Booster Vaccination Measured by SARS-CoV-2 Microneutralisation Assay | A subset of samples (20%) from all four timepoints will be assessed using a SARS-CoV-2 microneutralisation assay to both the wild type (vaccine) strain and for two SARS-CoV-2 Variants of concern. Neutralizing antibody will be reported as endpoint titre. | Not Posted | Baseline (pre booster), 28 days-, 6- and 12-months post booster vaccination | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Interferon Gamma (IFNγ) Concentrations in International Units (IU)/mL | IFN-γ concentrations (IU/mL) as a measure of cellular immunity will be assessed in a subset of participants. IFN-γ production will be stimulated using QuantiFERON Human IFN-γ SARS-CoV-2 (Qiagen) and quantified by ELISA. Results are summarised as geometric mean concentrations (GMCs) with 95% confidence intervals. | Participant numbers differ because only 256 enrolled in the CMI substudy, with equal allocation by arm. Evaluable IGRA samples varied by visit due to missed visits or unavailable specimens. Sample completeness ranged from ~93-95% early to ~86% at 24 months. Thus, each row reflects only participants with valid samples at that time point, not the full substudy cohort. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Baseline (pre booster), 28 days, 6-, 12 -, 18-, and 24-months post booster vaccination |
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| Secondary | Number of IFNγ Producing Cells/Million PBMCs | Applicable to the subset participants with additional blood collection. IFNγ producing cells as a measurement of cellular immunity will be assessed on a subset of the participants (40%) from each group. IFN-γ Enzyme-Linked ImmunoSpot (Elispot) assay will be performed on isolated peripheral blood mononuclear cells (PBMCs). Data will be reported as number of IFNγ producing cells/million and presented using means and 95% CI. | ELISpot analyses of wild-type SARS-CoV-2 spike-specific IFN-γ responses were conducted in a predefined subset of participants with additional blood collection. Approximately 40% of participants in each arm were included in this cellular immunity substudy. The numbers analysed at each time point reflect participants with available and valid ELISpot results and therefore differ from the total number of participants randomised to each arm. | Posted | Median | Inter-Quartile Range | IFN-γ SFU per 10⁶ cells | Baseline (pre-booster), 28 days, 6 and 12 months post booster vaccination |
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| Secondary | Frequency of Cytokine-expressing T Cells | Frequency of wild-type SARS-CoV-2 spike-specific cytokine-expressing T cells will be assessed in a subset of participants (~40%) using intracellular cytokine staining (ICS) by flow cytometry on PBMC samples. Results are reported as the frequency (%) of cytokine-expressing CD4 and CD8 memory T cells, summarised as geometric mean concentrations (GMCs) with 95% confidence intervals. | ICS analyses were conducted in a predefined subset of participants (~40%) who provided additional blood samples. The numbers analysed at each time point reflect participants with available and valid ICS results and therefore differ from the total number randomised. | Posted | Geometric Mean | 95% Confidence Interval | % of cytokine-expressing T cells | Baseline (pre-booster), 28 days, 6 and 12 months post-booster vaccination |
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| Secondary | Cellular Immunity: Multiplex Cytokine Assays - Reported as Cytokine Concentrations in pg/ml and Presented as GMC and 95% CI | Wild-type SARS-CoV-2 spike-specific cytokine concentrations following PBMC stimulation will be assessed in a predefined subset of participants (approximately 40%) using multiplex cytokine assays. Cytokine concentrations will be reported in pg/mL and summarised as geometric mean concentrations (GMCs) with 95% confidence intervals. IFN-γ ELISpot, intracellular cytokine staining (flow cytometry), and multiplex cytokine assays will be performed on isolated peripheral blood mononuclear cells (PBMCs). | Multiplex cytokine analyses were conducted in a predefined subset of participants with additional blood collection. Approximately 40% of participants in each arm were included in this cellular immunity substudy. The numbers analysed at each time point reflect participants with available and valid multiplex cytokine assay results and therefore differ from the total number of participants randomised to each arm. | Posted | Geometric Mean | 95% Confidence Interval | pg/mL | Baseline (pre booster), 28 days-, 6 and 12 months post booster vaccination |
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| Secondary | Incidence of Unsolicited Adverse Events (AE) | All unsolicited AE will be collected for 28 days post booster vaccination. Data will be presented as proportion of participants who report unsolicited AE. | The reactogenicity and safety analysis populations included all randomised participants who received a study vaccine, according to the vaccine received | Posted | Count of Participants | Participants | 28 days-post booster vaccination |
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| Secondary | Incidence of Medically Attended Adverse Events | All participants with medically attended AE will be collected for 3 months post booster vaccination. Data will be presented as number of participants who report unsolicited AE. | Posted | Count of Participants | Participants | 3 months post booster vaccination |
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| Secondary | Incidence of Serious Adverse Events (SAE) | SAE will be collected throughout the follow-up period of 24 months post booster vaccination. Data will be presented as a proportion of participants who report unsolicited SAE. | Posted | Count of Participants | Participants | 24 months post-booster |
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| Secondary | Incidence of PCR Confirmed COVID-19 Infection | Confirmed SARS-CoV-2 infections will be documented throughout the follow-up period, by clinical severity. | Posted | Count of Participants | Participants | Up to 24 months post booster vaccination |
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| Secondary | Number of IFNγ Producing Cells/Million PBMCs | Applicable to the subset participants with additional blood collection. IFNγ producing cells as a measurement of cellular immunity will be assessed on a subset of the participants (40%) from each group. IFN-γ Enzyme-Linked ImmunoSpot (Elispot) assay will be performed on isolated peripheral blood mononuclear cells (PBMCs). Data will be reported as number of IFNγ producing cells/million and presented using means and 95% CI. | Not Posted | Sep 2026 | At 18 and 24 months post booster vaccination | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Cytokine-expressing T Cells | Frequency of wild-type SARS-CoV-2 spike-specific cytokine-expressing T cells will be assessed in a subset of participants (~40%) using intracellular cytokine staining (ICS) by flow cytometry on PBMC samples. Results are reported as the frequency (%) of cytokine-expressing CD4 and CD8 memory T cells, summarised as geometric mean concentrations (GMCs) with 95% confidence intervals. | Not Posted | Sep 2026 | 18 and 24 months post-booster vaccination | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cellular Immunity: Multiplex Cytokine Assays - Reported as Cytokine Concentrations in pg/ml and Presented as GMC and 95% CI | Wild-type SARS-CoV-2 spike-specific cytokine concentrations following PBMC stimulation will be assessed in a predefined subset of participants (approximately 40%) using multiplex cytokine assays. Cytokine concentrations will be reported in pg/mL and summarised as geometric mean concentrations (GMCs) with 95% confidence intervals. IFN-γ ELISpot, intracellular cytokine staining (flow cytometry), and multiplex cytokine assays will be performed on isolated peripheral blood mononuclear cells (PBMCs). | Not Posted | Sep 2026 | 18 and 24 months post booster vaccination | Participants |
Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Pfizer-BioNTech Booster Group- AstraZeneca | Previously received two doses of AstraZeneca as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose. | 0 | 65 | 0 | 65 | 5 | 65 |
| EG001 | Fractional Pfizer-BioNTech Booster Group- AstraZeneca | Previously received two doses of AstraZeneca as primary COVID-19 vaccine. Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose. | 0 | 65 | 2 | 65 | 7 | 65 |
| EG002 | Standard Pfizer-BioNTech Booster Group- Sinopharm | Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose. | 0 | 201 | 2 | 201 | 10 | 201 |
| EG003 | Fractional Pfizer-BioNTech Booster Group- Sinopharm | Previously received two doses of Sinopharm as primary COVID-19 vaccine. Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose. | 0 | 200 | 0 | 200 | 7 | 200 |
| EG004 | Standard Pfizer-BioNTech Booster Group- Sputnik | Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose. | 0 | 34 | 1 | 34 | 5 | 34 |
| EG005 | Fractional Pfizer-BioNTech Booster Group- Sputnik | Previously received two doses of Sputnik as primary COVID-19 vaccine. Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose. | 0 | 36 | 0 | 36 | 5 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatobiliary | Hepatobiliary disorders | Non-systematic Assessment |
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| Lower limb fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Gout | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Abdominal cramps | Gastrointestinal disorders | Non-systematic Assessment |
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| Acute respiratory tract infection | Infections and infestations | Non-systematic Assessment |
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| Acute upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
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| Allergy to chemicals | Immune system disorders | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Chest discomfort | General disorders | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Furuncle | Infections and infestations | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Irregular menstruation | Reproductive system and breast disorders | Non-systematic Assessment |
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| Natural menopause | Social circumstances | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | Non-systematic Assessment |
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| Tooth infection | Infections and infestations | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kim Mulholland | Murdoch Children's Research Institute | +61 3 99366656 | kim.mulholland@mcri.edu.au |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 23, 2024 | May 24, 2024 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
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| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
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Previously received two doses of AstraZeneca as primary COVID-19 vaccine . Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose. |
| OG002 | Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group | Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose. |
| OG003 | Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group | Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose. |
| OG004 | Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group | Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose. |
| OG005 | Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group | Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose. |
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| OG002 | Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group | Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose. |
| OG003 | Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group | Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose. |
| OG004 | Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group | Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose. |
| OG005 | Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group | Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose. |
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Biological/Vaccine: Tozinameran - Standard Dose Other Names: BNT162b2 Comirnaty Pfizer Covid-19 vaccine Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.3 ml. Liquid for injection. Single dose. |
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| OG001 | Fractional Pfizer-BioNTech Booster Group | Biological/Vaccine: Tozinameran - Standard Dose Other Names: BNT162b2 Comirnaty Pfizer Covid-19 vaccine Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.3 ml. Liquid for injection. Single dose. |
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| OG002 | Standard Pfizer-BioNTech Booster Group- Sinopharm | Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose. |
| OG003 | Fractional Pfizer-BioNTech Booster Group- Sinopharm | Previously received two doses of Sinopharm as primary COVID-19 vaccine . Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose. |
| OG004 | Standard Pfizer-BioNTech Booster Group-Sputnik | Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose. |
| OG005 | Fractional Pfizer-BioNTech Booster Group- Sputnik | Previously received two doses of Sputnik as primary COVID-19 vaccine . Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose. |
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Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose. |
| OG003 | Fractional Pfizer-BioNTech Booster Group- Sinopharm | Previously received two doses of Sinopharm as primary COVID-19 vaccine. Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose. |
| OG004 | Standard Pfizer-BioNTech Booster Group- Sputnik | Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose. |
| OG005 | Fractional Pfizer-BioNTech Booster Group- Sputnik | Previously received two doses of Sputnik as primary COVID-19 vaccine. Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose. |
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