Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT05029856
Status:
WITHDRAWN
Last Update Posted:
2022-05-31
First Post:
2021-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety and Immunogenicity of SII Vaccine Constructs Based on the SARS-CoV-2 (COVID-19) Variant in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050986', 'term': 'YY1 Transcription Factor'}], 'ancestors': [{'id': 'D050981', 'term': 'Erythroid-Specific DNA-Binding Factors'}, {'id': 'D004268', 'term': 'DNA-Binding Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014157', 'term': 'Transcription Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study never started', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-02-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-25', 'studyFirstSubmitDate': '2021-08-25', 'studyFirstSubmitQcDate': '2021-08-25', 'lastUpdatePostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as GMT', 'timeFrame': 'Day 14 and Day 35', 'description': '(MN50) geometric mean titers (GMTs) to the SARS-CoV-2 B.1.351 (Beta) variant at Day 14 (one-dose regimen; Groups C and D) and Day 35 (two-dose regimen; Groups A and B);'}, {'measure': 'MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs', 'timeFrame': 'Day 14 and Day 35', 'description': 'Seroconversion rates (SCRs) or seroresponse rates (SRRs) (proportion of participants who achieve ≥ 4-fold increase from baseline) in MN50 titer concentrations to the SARS-CoV-2 B.1.351 (Beta) variant following their last vaccination.'}, {'measure': 'MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as GMT', 'timeFrame': 'Day 14 and Day 35', 'description': 'Neutralizing antibody MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variant at Day 14 (one-dose regimen; Group H) and Day 35 (two-dose regimen; Group G);'}, {'measure': 'MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as SCRs/SRRs', 'timeFrame': 'Day 14 and Day 35', 'description': 'SCRs/SRRs (proportion of participants who achieve ≥ 4-fold increase from baseline) in MN50 titer concentrations to the SARS-CoV-2 Delta variant following their last vaccination.'}, {'measure': 'Incidence, duration, and severity of solicited local and systemic adverse events (AEs)', 'timeFrame': 'Day 0 to Day 7', 'description': 'Incidence, duration, and severity of solicited local and systemic adverse events (AEs) for 7 days following each vaccination'}, {'measure': 'Incidence, duration, severity, and relationship of unsolicited AEs through 28 days', 'timeFrame': 'Day 0 to Day 28', 'description': 'Incidence, duration, severity, and relationship of unsolicited AEs through 28 days after the last vaccination'}, {'measure': 'Incidence and relationship of medically attended adverse events (MAAEs), adverse events of special interest (AESIs) (predefined list), and serious adverse events (SAEs)', 'timeFrame': 'Day 0 to Day 217', 'description': 'Incidence and relationship of medically attended adverse events (MAAEs), adverse events of special interest (AESIs) (predefined list), and serious adverse events (SAEs) throughout the study.'}], 'secondaryOutcomes': [{'measure': 'MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in previously vaccinated patients', 'timeFrame': 'Day 0 to Day 189', 'description': 'MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 14, and 189 in previously vaccinated individuals'}, {'measure': 'MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in participants seronegative at baseline', 'timeFrame': 'Day 0 to Day 217', 'description': 'MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 21, 35, and 217 in participants seronegative at baseline.'}, {'measure': 'MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs in previously vaccinated patients', 'timeFrame': 'Day 0 to Day 189', 'description': 'MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 14, and 189 in previously vaccinated individuals'}, {'measure': 'MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs in participants seronegative at baseline.', 'timeFrame': 'Day 0 to Day 217', 'description': 'MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 21, 35, and 217 in participants seronegative at baseline.'}, {'measure': 'MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) expressed as GMFR in participants seronegative at baseline', 'timeFrame': 'Day 0 to Day 217', 'description': 'MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 21, 35, and 217 in participants seronegative at baseline.'}, {'measure': 'MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) expressed as GMFR in previously vaccinated participants', 'timeFrame': 'Day 0 to Day 189', 'description': 'MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 14, and 189 in previously vaccinated individuals'}, {'measure': 'MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as SCRs/ SRRs in participants seronegative at baseline', 'timeFrame': 'Day 0 to Day 217', 'description': 'MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 21, 35, and 217 in participants seronegative at baseline.'}, {'measure': 'MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as SCRs/ SRRs in previously vaccinated participants', 'timeFrame': 'Day 0 to Day 189', 'description': 'MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 14, and 189 in previously vaccinated individuals'}, {'measure': 'IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in previously vaccinated participants', 'timeFrame': 'Day 0 to Day 189', 'description': 'IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 14, and 189 in previously vaccinated individuals'}, {'measure': 'IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in participants seronegative at baseline', 'timeFrame': 'Day 0 to Day 217', 'description': 'IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 21, 35, and 217 in participants seronegative at baseline.'}, {'measure': 'IgG geometric mean concentrations (GMCs) to the B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein in participants seronegative at baseline', 'timeFrame': 'Day 0 to Day 217', 'description': 'IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 21, 35, and 217 in participants seronegative at baseline.'}, {'measure': 'IgG geometric mean concentrations (GMCs) to the B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein in previously vaccinated participants', 'timeFrame': 'Day 0 to Day 189', 'description': 'IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 14, and 189 in previously vaccinated individuals'}, {'measure': 'Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in previously vaccinated participants', 'timeFrame': 'Day 0 to Day 189', 'description': 'GMTs to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 14, and 189 in previously vaccinated individuals'}, {'measure': 'Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in participants seronegative at baseline', 'timeFrame': 'Day 0 to Day 217', 'description': 'GMTs to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 21, 35, and 217 in participants seronegative at baseline.'}, {'measure': 'Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs in previously vaccinated participants', 'timeFrame': 'Day 0 to Day 189', 'description': 'GMTs to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 14, and 189 in previously vaccinated individuals'}, {'measure': 'Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs in participants seronegative at baseline', 'timeFrame': 'Day 0 to Day 217', 'description': 'GMTs to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 14, and 189 at Days 0, 21, 35, and 217 in participants seronegative at baseline.'}, {'measure': 'Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.617.2 (Delta) expressed as GMFR in participants seronegative at baseline', 'timeFrame': 'Day 0 to Day 217', 'description': 'GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein and at Days 0, 21, 35, and 217 in participants seronegative at baseline.'}, {'measure': 'Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.617.2 (Delta) expressed as GMFR in previously vaccinated participants', 'timeFrame': 'Day 0 to Day 189', 'description': 'GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein and at Days 0, 14, and 189 in previously vaccinated individuals'}, {'measure': 'Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.617.2 (Delta) expressed as SCRs/SRRs in participants seronegative at baseline', 'timeFrame': 'Day 0 to Day 217', 'description': 'GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein and at Days 0, 21, 35, and 217 in participants seronegative at baseline.'}, {'measure': 'Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.617.2 (Delta) expressed as SCRs/SRRs in previously vaccinated participants', 'timeFrame': 'Day 0 to Day 189', 'description': 'GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein and at Days 0, 14, and 189 in previously vaccinated individuals'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'This is a randomized, observer-blinded, Phase 1/2 study with an open-label group to evaluate the safety and immunogenicity of 3 novel SARS-CoV-2 variant vaccine constructs adjuvanted with Matrix-M1 adjuvant. Investigational products will include a monovalent SII SARS-CoV-2 B.1.351 (Beta) variant vaccine (SII B.1.351), a bivalent SII vaccine containing antigen for both the ancestral strain and B.1.351 (Beta) variant of SARS-CoV-2 (SII Bivalent), and a monovalent SII SARS-CoV-2 B.1.617.2 (Delta) variant vaccine (SII B.1.617.2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adults 18 to 64 years of age, inclusive, at screening.\n2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures.\n3. Female participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile \\[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\\] or postmenopausal \\[defined as amenorrhea at least 12 consecutive months\\]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study.\n\n 1. Condoms (male or female) with spermicide (if acceptable in country)\n 2. Diaphragm with spermicide\n 3. Cervical cap with spermicide\n 4. Intrauterine device\n 5. Oral or patch contraceptives\n 6. Norplant®, Depo-Provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy\n 7. Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle\n4. Is medically stable, as determined by the investigator (based on a review of health status, vital signs \\[to include body temperature\\], medical history, and targeted physical examination \\[to include body weight\\]). Vital signs must be within medically acceptable ranges prior to the first vaccination.\n5. Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.\n\n For previously vaccinated Participants (Groups C, D and H):\n6. Documented receipt of 2 doses of the investigational Novavax vaccine with Matrix-M1 adjuvant (NVX-CoV2373) administered approximately 21 days apart or 2 doses of a TGA-authorized/approved COVID-19 vaccine administered at least 60 days prior to first study vaccination.\n\nExclusion Criteria:\n\nIf an individual meets any of the following criteria, he or she is ineligible for this study:\n\n1. History of laboratory-confirmed (by PCR or serology to SARS-CoV-2) COVID-19 infection at any time prior to randomization/enrollment.\n2. Previous receipt of any investigational or authorized/approved vaccine, prophylactic or therapeutic agent for the prevention or treatment of SARS-CoV-2 infection, except for previously vaccinated participants.\n3. Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to first study vaccination.\n4. Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 30 days prior to the first study vaccination.\n5. Any known allergies to products contained in the investigational product.\n6. Any history of anaphylaxis to any prior vaccine.\n7. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.\n8. Chronic administration (defined as \\> 14 continuous days) of immunosuppressants, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to first study vaccination.\n9. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to first study vaccination.\n10. Active cancer (malignancy) on therapy within 3 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator).\n11. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.\n12. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to the first study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance.\n13. Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the study vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting).\n14. Study team member or immediate family member of any study team member (inclusive of Sponsor, CRO, and study site personnel involved in the conduct or planning of the study)."}, 'identificationModule': {'nctId': 'NCT05029856', 'briefTitle': 'Evaluation of the Safety and Immunogenicity of SII Vaccine Constructs Based on the SARS-CoV-2 (COVID-19) Variant in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novavax'}, 'officialTitle': 'A Randomized, Observer-Blinded, Phase 1/2 Study With an Open-Label Group to Evaluate the Safety and Immunogenicity of SII Vaccine Constructs Based on SARS-CoV-2 Variants in Adults', 'orgStudyIdInfo': {'id': '2019nCoV-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A- SII B.1.351 Vaccine / Matrix-M1 Adjuvant', 'description': '2 doses of 3 μg SII B.1.351 Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose each on Days 0 and Day 21.', 'interventionNames': ['Biological: SII B.1.351']}, {'type': 'EXPERIMENTAL', 'label': 'Group B- SII B.1.351 Vaccine / Matrix-M1 Adjuvant', 'description': '2 doses of 5 μg SII B.1.351 Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose each on Days 0 and Day 21.', 'interventionNames': ['Biological: SII B.1.351']}, {'type': 'EXPERIMENTAL', 'label': 'Group C- SII B.1.351 Vaccine / Matrix-M1 Adjuvant', 'description': '1 dose of 3 μg SII B.1.351 Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) .1 dose on Day 0.', 'interventionNames': ['Biological: SII B.1.351']}, {'type': 'EXPERIMENTAL', 'label': 'Group D - SII B.1.351 Vaccine / Matrix-M1 Adjuvant', 'description': '1 dose of 5 μg SII B.1.351 Vaccine + 50 μg Matrix-M1 adjuvant (co-formulated) .1 dose on Day 0.', 'interventionNames': ['Biological: SII B.1.351']}, {'type': 'EXPERIMENTAL', 'label': 'Group E -SII Bivalent Vaccine / Matrix-M1 Adjuvant', 'description': '2 doses of 6 μg SII Bivalent Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose each on Days 0 and Day 21.', 'interventionNames': ['Biological: SII Bivalent']}, {'type': 'EXPERIMENTAL', 'label': 'Group F- SII Bivalent Vaccine / Matrix-M1 Adjuvant', 'description': '2 doses of 10 μg SII Bivalent Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose each on Days 0 and Day 21.', 'interventionNames': ['Biological: SII Bivalent']}, {'type': 'EXPERIMENTAL', 'label': 'Group G- SII B.1.617.2 Vaccine / Matrix-M1 Adjuvant', 'description': '2 doses of 5 μg SII B.1.617.2 Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose each on Days 0 and Day 21.', 'interventionNames': ['Biological: SII B.1.617.2']}, {'type': 'EXPERIMENTAL', 'label': 'Group H- SII B.1.617.2 Vaccine / Matrix-M1 Adjuvant', 'description': '1 doses of 5 μg SII B.1.617.2 Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose on Days 0.', 'interventionNames': ['Biological: SII B.1.617.2']}], 'interventions': [{'name': 'SII B.1.351', 'type': 'BIOLOGICAL', 'otherNames': ['(Monovalent B.1.351 [Beta] variant strain vaccine)'], 'description': 'Intramuscular (deltoid) injections of 3 μg SII B.1.351 and 50 μg Matrix-M1 Adjuvant,\n\n1 or 2 doses:1 on Day 0 and ± 1 on Day 21.', 'armGroupLabels': ['Group A- SII B.1.351 Vaccine / Matrix-M1 Adjuvant', 'Group C- SII B.1.351 Vaccine / Matrix-M1 Adjuvant']}, {'name': 'SII B.1.351', 'type': 'BIOLOGICAL', 'otherNames': ['(Monovalent B.1.351 [Beta] variant strain vaccine)'], 'description': 'Intramuscular (deltoid) injections of 5 μg SII B.1.351 and 50 μg Matrix-M1 Adjuvant,\n\n1 or 2 doses:1 on Day 0 and ± 1 on Day 21.', 'armGroupLabels': ['Group B- SII B.1.351 Vaccine / Matrix-M1 Adjuvant', 'Group D - SII B.1.351 Vaccine / Matrix-M1 Adjuvant']}, {'name': 'SII Bivalent', 'type': 'BIOLOGICAL', 'otherNames': ['(Bivalent ancestral and B.1.351 [Beta] variant strain vaccine)'], 'description': 'Intramuscular (deltoid) injections of 6 μg SII Bivalent and 50 μg Matrix-M1 Adjuvant, 2 doses: 1 on Day 0 and 1 on Day 21.', 'armGroupLabels': ['Group E -SII Bivalent Vaccine / Matrix-M1 Adjuvant']}, {'name': 'SII Bivalent', 'type': 'BIOLOGICAL', 'otherNames': ['(Bivalent ancestral and B.1.351 [Beta] variant strain vaccine)'], 'description': 'Intramuscular (deltoid) injections of 10 μg SII Bivalent and 50 μg Matrix-M1 Adjuvant, 2 doses: 1 on Day 0 and 1 on Day 21.', 'armGroupLabels': ['Group F- SII Bivalent Vaccine / Matrix-M1 Adjuvant']}, {'name': 'SII B.1.617.2', 'type': 'BIOLOGICAL', 'otherNames': ['(Monovalent B.1.617.2 [Delta] variant strain vaccine)'], 'description': 'Intramuscular (deltoid) injections of 5 μg SII B.1.617.2 and 50 μg Matrix-M1 Adjuvant,\n\n1 or 2 doses:1 on Day 0 and ± 1 on Day 21.', 'armGroupLabels': ['Group G- SII B.1.617.2 Vaccine / Matrix-M1 Adjuvant', 'Group H- SII B.1.617.2 Vaccine / Matrix-M1 Adjuvant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2035', 'city': 'Maroubra', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Australian Clinical Research Network (ACRN)', 'geoPoint': {'lat': -33.95, 'lon': 151.23333}}, {'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Holdsworth House Medical Practice - Sydney', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '3320', 'city': 'Geelong', 'state': 'Victoria', 'country': 'Australia', 'facility': 'University Hospital Geelong-Barwon Health', 'geoPoint': {'lat': -38.14711, 'lon': 144.36069}}, {'zip': '3124', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Emeritus Research', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Clinical Development', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novavax'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novavax', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}