Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:05 PM
Study NCT ID:
NCT07421050
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-19
First Post:
2025-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Subunit Influenza Vaccine (Adjuvant) in Chinese Population Aged 65 Years and Older
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000277', 'term': 'Adjuvants, Pharmaceutic'}, {'id': 'C089950', 'term': 'MF59 oil emulsion'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D010592', 'term': 'Pharmaceutic Aids'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events (AEs) or reactions (ARs) within 30 minutes post-vaccination', 'timeFrame': 'Within 30 minutes post-vaccination'}, {'measure': 'Incidence of adverse events (AEs) or reactions (ARs) within 0-7 days post-vaccination', 'timeFrame': 'Within 0-7 days post-vaccination'}, {'measure': 'Incidence of adverse events (AEs) or reactions (ARs) within 0-28 days post-vaccination', 'timeFrame': 'Within 0-28 days post-vaccination'}, {'measure': 'The incidence of laboratory abnormalities (including blood biochemistry, blood routine and urine routine ) on Day 3 post-vaccination.', 'timeFrame': 'On Day 3 post-vaccination'}, {'measure': 'The incidence of serious adverse events (SAEs) and Adverse Events of Special Interest (AESI) within 12 months post-vaccination.', 'timeFrame': 'Within 12 months post-vaccination.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza', 'Influenza Vaccine']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to evaluate the safety of subunit influenza vaccine (adjuvant) in people aged 65 years and older.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at enrollment is ≥65 years (including the 65th birthday).\n* The participant voluntarily agrees to take part in the trial and has signed the informed consent form.\n* The participant is able to comply with the trial follow-up schedule as required by the protocol (i.e., no plans for long-term absence or relocation from the study site).\n* Medically stable: The participant may have underlying chronic conditions such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, but symptoms/signs must be controlled. If the participant is on any medication, the dosage must have remained stable for at least three weeks prior to vaccination.\n\nExclusion Criteria:\n\n* Axillary temperature \\>37.0°C.\n* Confirmed influenza virus infection by laboratory test or self-test kit positive within the past 12 months.\n* Received any influenza vaccine (licensed or investigational) within the past 12 months or plans to receive any influenza vaccine during the study.\n* Known or suspected allergic to any component of the investigational vaccine.\n* A history of severe allergic reactions to any vaccines or medications (for example, but not limited to: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotic reaction (Arthus reaction)).\n* Congenital malformations or developmental disorders, and genetic defects or severe malnutrition.\n* History of convulsions or seizures, epilepsy, psychiatric disorders, or relevant family history.\n* Severe liver and kidney diseases, malignant tumors, various acute diseases, or being in the acute exacerbation stage of a chronic disease.\n* Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other immune-mediated/autoimmune diseases.\n* A history of asthma, unstable within the past two years requiring emergency treatment, hospitalization, intubation, or oral/intravenous corticosteroids.\n* Individuals who have received immunostimulant or immunosuppressant therapy within the past 6 months (continuously administered orally or via drip infusion for more than 14 days).\n* Suffering from severe cardiovascular diseases (e.g., heart disease, cor pulmonale, pulmonary edema).\n* Blood pressure ≥150/100 mmHg despite medication control.\n* History of live attenuated vaccine within 28 days prior to vaccination, or any other vaccine within 14 days prior to vaccination.\n* Diagnosed with progressive neurological diseases, or a history of Guillain-Barré syndrome.\n* Asplenia or functional asplenia, including splenectomy due to any reason, or resection/partial removal of other vital organs.\n* Received blood or blood-derived products within the past 6 months.\n* A diagnosed history of coagulation disorders (e.g., coagulation factor deficiencies, coagulopathies, platelet disorders).\n* Currently undergoing anti-tuberculosis treatment.\n* Clinically significant abnormalities in laboratory tests (blood biochemistry, blood routine and urine routine) as determined by the investigator.\n* Any condition that, in the opinion of the investigator, makes the participant unsuitable for this clinical trial.'}, 'identificationModule': {'nctId': 'NCT07421050', 'briefTitle': 'Clinical Trial of Subunit Influenza Vaccine (Adjuvant) in Chinese Population Aged 65 Years and Older', 'organization': {'class': 'OTHER', 'fullName': 'Ab&B Bio-tech Co., Ltd.JS'}, 'officialTitle': 'A Randomized, Blinded, Controlled Phase I Clinical Trial to Evaluate the Safety of a Subunit Influenza Vaccine (Adjuvant) in Adults Aged 65 Years and Older', 'orgStudyIdInfo': {'id': 'aTIV-ZHSW-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-dose experimental vaccine', 'interventionNames': ['Biological: Subunit Influenza Vaccine (Adjuvant)']}, {'type': 'EXPERIMENTAL', 'label': 'High-dose experimental vaccine', 'interventionNames': ['Biological: Subunit Influenza Vaccine (Adjuvant)']}, {'type': 'OTHER', 'label': 'Adjuvant', 'interventionNames': ['Biological: MF59']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Biological: 0.9% sodium chloride injection (normal saline)']}], 'interventions': [{'name': 'Subunit Influenza Vaccine (Adjuvant)', 'type': 'BIOLOGICAL', 'description': 'A single 0.25 mL dose is administered intramuscularly into the deltoid muscle of the upper arm on Day 0.', 'armGroupLabels': ['Low-dose experimental vaccine']}, {'name': 'Subunit Influenza Vaccine (Adjuvant)', 'type': 'BIOLOGICAL', 'description': 'A single 0.5 mL dose is administered intramuscularly into the deltoid muscle of the upper arm on Day 0.', 'armGroupLabels': ['High-dose experimental vaccine']}, {'name': 'MF59', 'type': 'BIOLOGICAL', 'description': 'A single 0.5 mL dose is administered intramuscularly into the deltoid muscle of the upper arm on Day 0', 'armGroupLabels': ['Adjuvant']}, {'name': '0.9% sodium chloride injection (normal saline)', 'type': 'BIOLOGICAL', 'description': 'A single 0.5 mL dose is administered intramuscularly into the deltoid muscle of the upper arm on Day 0.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Xiangyang', 'state': 'Hubei', 'country': 'China', 'facility': 'Gucheng County Center for Disease Control and Prevention', 'geoPoint': {'lat': 32.0422, 'lon': 112.14479}}], 'overallOfficials': [{'name': 'Yeqing Tong, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hubei Provincial Center for Disease Control and Prevention'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ab&B Bio-tech Co., Ltd.JS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yither Biotech Co., Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}