CTRI/2026/01/101592 [Registered on: 19/01/2026] Trial Registered Prospectively
Last Modified On:
08/06/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Vaccine
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A Phase 1 Trial to Evaluate the Safety and Tolerability of a New Adjuvanted Influenza Vaccine in Adults 18–50 Years.
Scientific Title of Study
A randomized, phase 1, single-centre, observer-blind, active-controlled, 3-arm study to evaluate the safety, tolerability, and immunogenicity of a single administration of TETRALITE, a novel adjuvanted influenza vaccine, in healthy participants aged 18 to 50 years.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Ganesan Karthikeyan
Designation
Executive Director, THSTI
Affiliation
BRIC - Translational Health Science and Technology Institute (THSTI)
Address
Translational Health Science and Technology Institute, NCR Biotech Science Cluster, 3rd milestone, Faridabad Gurugram Expressway, Post Box #04
Faridabad
Faridabad HARYANA 121001 India
Phone
01292876400
Fax
Email
ed@thsti.res.in
Details of Contact Person Scientific Query
Name
Dr Nitya Wadhwa
Designation
Senior Professor, THSTI and Faculty in charge, CDSA
Affiliation
BRIC-Translational Health Science and Technology Institute (THSTI)
Address
Maternal and Child Health Department, Translational Health Science and Technology Institute, NCR Biotech Science Cluster, 3rd milestone, Faridabad Gurugram Expressway, Post Box #04
Faridabad
Faridabad HARYANA 121001 India
Phone
01292876342
Fax
Email
nitya.wadhwa@thsti.res.in
Details of Contact Person Public Query
Name
Dr Nitya Wadhwa
Designation
Senior Professor, THSTI and Faculty in charge, CDSA
Affiliation
BRIC-Translational Health Science and Technology Institute (THSTI)
Address
Maternal and Child Health Department, Translational Health Science and Technology Institute, NCR Biotech Science Cluster, 3rd milestone, Faridabad Gurugram Expressway, Post Box #04
Faridabad
Faridabad HARYANA 121001 India
Phone
01292876342
Fax
Email
nitya.wadhwa@thsti.res.in
Source of Monetary or Material Support
Department of Biotechnology, Ministry of Science & Technology, Government of India
Primary Sponsor
Name
BRIC - Translational Health Science and Technology Institute (THSTI)
Department of Pulmonary Medicine
Christian Medical College Vellore (Ranipet Campus)
Kilminnal Village, Ranipet District
Tamil Nadu, Pin code - 632 517
Vellore TAMIL NADU
Composition: 3 microgram VaxiFlu-4™ + 1 mg LVA,
Dose: 0.5 ml,
Route: Intramuscular (IM),
Frequency: on Day 1 (Single administration)
Comparator Agent
VaxiFlu-4™ (Full dose (15 microgram) of VaxiFlu-4™)
Composition: 15 microgram VaxiFlu-4™,
Dose: 0.5 ml,
Route: Intramuscular (IM),
Frequency: on Day 1 (Single administration)
Inclusion Criteria
Age From
18.00 Year(s)
Age To
50.00 Year(s)
Gender
Both
Details
1.Written and signed informed consent obtained before any study-related activities.
2.Aged 18 to 50 years (inclusive), at the time of signing the Informed Consent Form (ICF)
3.Participants who are considered to be in good general health as determined by a medical evaluation including medical history, Physical Examination (PE), and laboratory tests within 21 days prior to enrolment.
4.Participants with a Body Mass Index (BMI) within the range of 18.5 to 35 kg/m2 inclusive at screening.
5.No serologic markers of past or ongoing Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human Immunodeficiency Virus (HIV) infection.
6.Women who are not pregnant or breastfeeding, and one of the following conditions applies:
• Women of non-childbearing potential (WONCBP): Non-childbearing potential is defined as surgically sterilized (e.g. hysterectomy, bilateral oophorectomy, or tubal ligation/salpingectomy) or postmenopausal (defined as having no menstrual bleeding for at least 12 months) without an alternative medical cause prior to study. (OR)
• Women of Childbearing Potential (WOCBP) and using a highly effective contraceptive method (with a failure rate of less than 1 % per year),from at least one month prior to study vaccination and for 3 months post vaccination. The investigator should evaluate the potential for contraceptive method failure (e.g. noncompliance, recently initiated) in relation to study vaccination. Highly effective contraception is defined as stabilized on oral birth control for at least one month before study participation, intrauterine device/system, implant, injection, transdermal patch, vasectomized partner, or sexual abstinence (excluding periodic abstinence). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant. The participant should commit her abstinence for at least one month prior to study vaccination and for 3 months’ post vaccination. If the participant will not maintain abstinence and changes her status, the participant must first commit to another highly effective method of contraception, which should be discussed with the investigator prior to terminating sexual abstinence as a contraceptive method.
7.WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test before vaccination on day of randomization (Day 1). The investigator is responsible for reviewing medical history and menstrual history to decrease the risk of inclusion of a woman with early undetected pregnancy.
8.Participants who are willing and able to comply with the study procedures and are in the view of the investigator capable of completing the study.
ExclusionCriteria
Details
1.History of lab-confirmed influenza infection, excluding COVID-19, 12 months prior to the day of study vaccination.
2.Past history or current immune-mediated and/or autoimmune diseases as indicated by the investigator.
3.History of serious reactions to vaccines as determined by the investigator.
4.Clinical conditions which are a contraindication for IM administration, as judged by the investigator.
5.History of confirmed hypersensitivity, allergy, and/or anaphylaxis to eggs, squalene-based adjuvants, or other components of the study vaccine (neomycin, formaldehyde or octoxinol-9).
6.Uncontrolled medical illness (unstable for the past 3 months) as indicated by the investigator.
7.Past or current history of any neurological disorder,e.g. Guillain-Barré syndrome and seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years.
8.History of asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.
9.Malignancy that is active, or treated for which there is not reasonable assurance of sustained cure, or that is likely to recur during the period of the study.
10.Asthma that is unstable or requires emergent care,hospitalization or intubation during the past two years or that is expected to require the use of oral or intravenous corticosteroids.
11.History of hereditary angioedema, acquired angioedema and/or idiopathic forms of angioedema.
12.History of idiopathic urticaria within the past year.
13.History of heavy smoking, drug/alcohol abuse/addiction or psychiatric condition which in the investigator’s opinion.
14.A rash, dermatological condition, or tattoos that would, in the opinion of the investigator, interfere with injection local reaction rating.
15.Receipt of a seasonal or pandemic influenza vaccination 6 months before administration of the study vaccine or planning to receive the influenza vaccination during the study period.
16.Receipt of an investigational pandemic influenza vaccine 6 months before administration of study vaccine or planning to receive such a product during the study period.
17.Receipt of a live attenuated vaccine, or subunit or inactivated vaccines 28 days prior to administration of the study vaccine, other than seasonal or pandemic influenza vaccination, excluding COVID-19 vaccine.
18.Receipt of a COVID-19 vaccine 7 days before administration of study vaccine.
19.Planning to receive any vaccine (other than influenza) during the first 28 days following the administration of the study vaccine.
20.Currently participating in another clinical study, or planning to participate in another study during the study period, or administration of any investigational drug or medical device in the 4 weeks prior to study vaccination.
21.Prior receipt of blood, blood-derived products, or immunoglobulins in the 6 months prior to administration of study vaccine, or planning to receipt such product during the study period.
22.Use of drugs that can affect immune response such as systemic corticosteroids (excluding topical preparations and inhaled preparations) or immunosuppressive drugs in the 30 days before study vaccination and/or in the first 28 days following study vaccination, with the exception that a short course of corticosteroids less than or equal to 10 days duration or a single injection for a self-limited condition at least 2 weeks prior to enrolment will not exclude study participation.
23.Current intake of drugs that increase bleeding risk, e.g. anticoagulant medication.
24.Current anti-tuberculosis prophylaxis or therapy.
25.Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and/or planning a medical procedure under full anaesthesia on the day of study vaccination and/or in the first 14 days following study vaccination with the exception of a medical indication.
26.WOCBP who are pregnant, breastfeeding or planning to become pregnant during the study.
27.Participants with a history of any medical conditions that, in the opinion of the investigator, might interfere with the results of the study.
28.Current febrile illness (oral temperature more than 38.0 °C) or other acute illness prior to vaccine administration.
29.Intake of antipyretics and/or analgesic medications within 24 hours prior to study vaccination.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
To evaluate the safety and tolerability of a single administration of TETRALITE(3 microgram VaxiFlu-4™+0.5mg or 1mg adjuvant)versus15 microgram VaxiFlu 4™ without adjuvant in healthy participants(18-50years).
1.Occurrence of solicited local and systemic adverse events (AEs) for 7 days after vaccination.
2.Occurrence of unsolicited AEs for 28 days after vaccination.
3.Occurrence of serious adverse events (SAEs), potential immune-mediated disorders (pIMDs), and adverse events of special interest (AESIs) for 180 days after vaccination.
4.Occurrence of clinically abnormal haematology and serum biochemistry laboratory values at 7 days, 28 days, and 180 days after vaccination versus baseline (Day1, pre-vaccination).
Secondary Outcome
Outcome
TimePoints
To evaluate humoral immune responses from a single administration of TETRALITE (3 microgram VaxiFlu-4™ + 1mg adjuvant) versus VaxiFlu-4™ without adjuvant (3 microgram and 15 microgram) in healthy participants (18-50 years).
Immunogenicity of TETRALITE will be determined by:
1. HI antibody titre in serum samples against the 4 vaccine influenza strains at 7 days, 28 days, and 180 days after vaccination versus baseline (Day 1, pre-vaccination)
2. MN antibody titre in serum samples against the 4 vaccine influenza strains at 7 days, 28 days, and 180 days after vaccination versus baseline (Day 1, pre-vaccination).
To evaluate the T cell immune responses from a single administration of TETRALITE (3 microgram VaxiFlu-4™ + 0.5 mg or 1mg adjuvant) versus 15 microgram VaxiFlu-4™ without adjuvant in healthy participants (18-50 years).
1. T cell-mediated immune response in PBMCs at 7 days, 28 days, and 180 days after vaccination versus baseline (Day 1, pre-vaccination) confirmed by the presence of influenza-specific CD4 plus and CD8 plus T cells producing at least CD40L, IL-2, Interferon gamma and/or TNF alpha, measured by flow cytometry (intracellular cytokine staining).
2. Additional assays may include but are not limited to genetic analysis and omics approaches such as transcriptomics, proteomics, and metabolomics.
To further evaluate the humoral response from a single administration of TETRALITE (3 microgram VaxiFlu-4™ + 0.5 mg or 1mg adjuvant) versus 15 microgram VaxiFlu-4™ without adjuvant in healthy participants (18-50 years).
Additional assays may include but are not limited to cross-reactive antibodies.
To identify participants who have been infected with influenza virus during the study.
The measurement of anti-nucleoprotein (NP) Immunoglobulin G (IgG) concentration in serum samples at baseline (Day 1, pre-vaccination), 28 days, and 180 days after vaccination.
Target Sample Size
Total Sample Size="75" Sample Size from India="75" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 1
Date of First Enrollment (India)
01/05/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a Phase 1, randomized, controlled, observer-blinded clinical trial designed to evaluate the safety, tolerability, and immunogenicity of an investigational adjuvanted influenza vaccine, TETRALITE, in healthy adult volunteers in India.
The study will be conducted in healthy male and female adults aged 18 to 50 years who meet all eligibility criteria and provide written informed consent. Individuals with significant acute or chronic medical conditions, immunosuppressive disorders, or recent receipt of influenza vaccination within the protocol-defined exclusion period will be excluded.
Eligible participants will be randomized to one of three study arms:
• Intervention Arm 1: A single intramuscular injection of TETRALITE consisting of one-fifth dose of a licensed tetravalent inactivated split virion influenza vaccine (VaxiFlu-4™) combined with 0.5 mg of the novel adjuvant LVA.
• Intervention Arm 2: A single intramuscular injection of TETRALITE consisting of one-fifth dose of VaxiFlu-4™ combined with 1 mg of the novel adjuvant LVA.
• Comparator Arm: A single intramuscular injection of the full licensed dose of VaxiFlu-4™ (15 micrograms of hemagglutinin per strain) without adjuvant.
Randomization will be performed by an independent statistician using a computer-generated randomization sequence. Allocation concealment will be ensured using Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE). The study will be observer-blinded; participants and outcome assessors will remain blinded to treatment allocation, while designated unblinded personnel will be responsible for vaccine preparation and administration.
The primary objectives of the study are to evaluate the safety and tolerability of a single dose of TETRALITE compared with the licensed influenza vaccine. Safety assessments will include monitoring of solicited local and systemic adverse events, unsolicited adverse events, and serious adverse events.
Secondary objectives include assessment of immunogenicity. Immune responses will be evaluated by measuring hemagglutination inhibition (HI) and microneutralization (MN) antibody titres against vaccine strains.
Following vaccination, participants will be observed on-site for a minimum of 60 minutes for immediate adverse events. Scheduled follow-up visits will occur on Day 8, Day 29, and Day 181 post-vaccination for safety assessments and collection of blood samples for immunogenicity analysis, as specified in the study protocol.
The total duration of individual participation in the study will be approximately six months. This Phase 1 study is intended to generate preliminary safety, tolerability, and immunogenicity data to support further clinical development of LVA-adjuvanted influenza vaccines and to inform the design of subsequent studies, including evaluation in older adults who represent the primary target population for influenza vaccination.