Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-05 @ 12:18 AM
Study NCT ID:
NCT06850051
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on the Safety and Immunogenicity of Influenza, Respiratory Syncytial Virus, Human Metapneumovirus and Parainfluenza Vaccines in Adults 18 to 49 Years of Age.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}], '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'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-02-11', 'studyFirstSubmitQcDate': '2025-02-23', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination', 'timeFrame': 'Within 30 minutes after each vaccination', 'description': 'Number of participants with unsolicited systemic AEs'}, {'measure': "Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form) occurring through 7 days after vaccination", 'timeFrame': 'Through 7 days after each vaccination', 'description': 'Number of participants with solicited injection site and systemic reactions'}, {'measure': 'Presence of unsolicited AEs reported through 28 days after vaccination', 'timeFrame': 'Through 28 days after each vaccination', 'description': 'Number of participants with unsolicited AEs'}, {'measure': 'Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study', 'timeFrame': 'Throughout study, approximately 6 months', 'description': ': Number of participants with SAEs and AESIs'}, {'measure': 'Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination', 'timeFrame': 'Through 7 days after vaccination', 'description': ': Number of participants with out-of-range biological tests'}, {'measure': 'Hemagglutinin Inhibition Assay (HAI) antibody (Ab) response to each homologous influenza strain at Day 1 and Day 29', 'timeFrame': 'Day 1 and Day 29'}, {'measure': 'RSV A, hMPV A and PIV3 serum neutralizing antibodies (nAb) titers at Day 1 and Day 29', 'timeFrame': 'Day 1 and Day 29'}], 'secondaryOutcomes': [{'measure': 'RSV B and hMPV A nAb titers at Day 1 and Day 29', 'timeFrame': 'Day 1 and Day 29'}, {'measure': 'Neutralization Test (NT) Ab response to each homologous influenza strain at Day 29', 'timeFrame': 'Day 29'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['influenza', 'respiratory syncytial virus', 'parainfluenza', 'human metapneumovirus'], 'conditions': ['Healthy Volunteers', 'Influenza Vaccination', 'Respiratory Syncytial Virus Vaccination', 'Parainfluenza Vaccination', 'Human Metapneumovirus Vaccination']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety and immunogenicity of different vaccines of hemagglutinin formulations of trivalent influenza vaccine or of a combined respiratory syncytial virus / human metapneumovirus / parainfluenza virus type 3 vaccine in healthy participants 18 to 49 years of age. A lipid nanoparticle will be used in this study.\n\nOverall, the study is designed to:\n\n* Assess the safety profile of the candidate formulations\n* Describe the immunogenicity profile of the candidate formulations\n* Eligible participants will be randomized to receive a single intramuscular injection of either one of the vaccine formulations.\n\nParticipants will be provided with a diary to solicit reporting of injection site reactions and systemic reactions, unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest AESIs).\n\nParticipants will also be required to record their daily temperature on the diary.', 'detailedDescription': 'The duration of study participation will be approximately 6 months for each participant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 18 to 49 years on the day of inclusion\n* A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:\n\n * Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile OR\n * Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention administration.\n\nExclusion Criteria:\n\n\\- Any medical condition or circumstance which, in the opinion of the investigator, might interfere with the evaluation of the study objectives\n\nNote: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT06850051', 'briefTitle': 'A Study on the Safety and Immunogenicity of Influenza, Respiratory Syncytial Virus, Human Metapneumovirus and Parainfluenza Vaccines in Adults 18 to 49 Years of Age.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase 1, Parallel, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Different Formulations of Multivalent Influenza and Respiratory Syncytial Virus (RSV)/Human Metapneumovirus (hMPV)/Parainfluenza Virus Type 3 (PIV3) Vaccines in Healthy Participants 18 to 49 Years of Age.', 'orgStudyIdInfo': {'id': 'VAV00030'}, 'secondaryIdInfos': [{'id': 'U1111-1311-1743', 'type': 'OTHER', 'domain': 'WHO ICTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 trivalent influenza vaccine-hemagglutinin (TIV-HA) formulation 1 at high dose', 'description': 'Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.', 'interventionNames': ['Biological: TIV-HA formulation 1 at high dose']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 TIV-HA formulation 2 at high dose', 'description': 'Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.', 'interventionNames': ['Biological: TIV-HA formulation 2 at high dose']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 TIV-HA formulation 1 at low dose', 'description': 'Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.', 'interventionNames': ['Biological: TIV-HA Vaccine formulation 1 at low dose']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4 TIV-HA formulation 2 at low dose', 'description': 'Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.', 'interventionNames': ['Biological: TIV-HA formulation 2 at low dose']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5 RSV/hMPV/PIV3 formulation 1 at high dose', 'description': 'Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.', 'interventionNames': ['Biological: RSV/hMPV/PIV3 formulation 1 at high dose']}, {'type': 'EXPERIMENTAL', 'label': 'Group 6 RSV/hMPV/PIV3 formulation 2 at high dose', 'description': 'Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.', 'interventionNames': ['Biological: RSV/hMPV/PIV3 formulation 2 at high dose']}, {'type': 'EXPERIMENTAL', 'label': 'Group 7 RSV/hMPV/PIV3 formulation 1 at low dose', 'description': 'Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.', 'interventionNames': ['Biological: RSV/hMPV/PIV3 formulation 1 at low dose']}, {'type': 'EXPERIMENTAL', 'label': 'Group 8 RSV/hMPV/PIV3 formulation 2 at low dose', 'description': 'Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.', 'interventionNames': ['Biological: RSV/hMPV/PIV3 formulation 2 at low dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 9 recombinant influenza vaccine quadrivalent (RIV4)', 'description': 'Participants will receive a single IM (Intramuscular) injection on day 1 of the RIV4 vaccine according to their randomization schedule.', 'interventionNames': ['Biological: RIV4 (Supemtek®)']}], 'interventions': [{'name': 'TIV-HA Vaccine formulation 1 at low dose', 'type': 'BIOLOGICAL', 'description': 'Suspension for injection in a vial. Route of administration: IM injection', 'armGroupLabels': ['Group 3 TIV-HA formulation 1 at low dose']}, {'name': 'TIV-HA formulation 1 at high dose', 'type': 'BIOLOGICAL', 'description': 'Suspension for injection in a vial. Route of administration: IM injection', 'armGroupLabels': ['Group 1 trivalent influenza vaccine-hemagglutinin (TIV-HA) formulation 1 at high dose']}, {'name': 'TIV-HA formulation 2 at low dose', 'type': 'BIOLOGICAL', 'description': 'Suspension for injection in a vial. Route of administration: IM injection', 'armGroupLabels': ['Group 4 TIV-HA formulation 2 at low dose']}, {'name': 'TIV-HA formulation 2 at high dose', 'type': 'BIOLOGICAL', 'description': 'Suspension for injection in a vial. Route of administration: IM injection', 'armGroupLabels': ['Group 2 TIV-HA formulation 2 at high dose']}, {'name': 'RSV/hMPV/PIV3 formulation 2 at low dose', 'type': 'BIOLOGICAL', 'description': 'Suspension for injection in a vial. Route of administration: IM injection', 'armGroupLabels': ['Group 8 RSV/hMPV/PIV3 formulation 2 at low dose']}, {'name': 'RSV/hMPV/PIV3 formulation 1 at high dose', 'type': 'BIOLOGICAL', 'description': 'Suspension for injection in a vial. Route of administration: IM injection', 'armGroupLabels': ['Group 5 RSV/hMPV/PIV3 formulation 1 at high dose']}, {'name': 'RSV/hMPV/PIV3 formulation 2 at high dose', 'type': 'BIOLOGICAL', 'description': 'Suspension for injection in a vial. Route of administration: IM injection', 'armGroupLabels': ['Group 6 RSV/hMPV/PIV3 formulation 2 at high dose']}, {'name': 'RSV/hMPV/PIV3 formulation 1 at low dose', 'type': 'BIOLOGICAL', 'description': 'Suspension for injection in a vial. Route of administration: IM injection', 'armGroupLabels': ['Group 7 RSV/hMPV/PIV3 formulation 1 at low dose']}, {'name': 'RIV4 (Supemtek®)', 'type': 'BIOLOGICAL', 'description': 'Solution for injection in a prefilled syringe. Route of administration: IM injection', 'armGroupLabels': ['Group 9 recombinant influenza vaccine quadrivalent (RIV4)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2148', 'city': 'Blacktown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Paratus Clinical', 'geoPoint': {'lat': -33.76667, 'lon': 150.91667}}, {'zip': '4006', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Paratus Clinical', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '4506', 'city': 'Morayfield', 'state': 'Queensland', 'country': 'Australia', 'facility': 'University of Sunshine Coast Clinical Trials', 'geoPoint': {'lat': -27.10876, 'lon': 152.94907}}, {'zip': '4101', 'city': 'South Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'University of Sunshine Coast Clinical Trials', 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'zip': '4215', 'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Griffith University', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '3124', 'city': 'Camberwell', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Emeritus Research', 'geoPoint': {'lat': -37.84205, 'lon': 145.0694}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}