A Study to check Immunogenicity and Safety of A Trivalent Nanoparticle Influenza Vaccine and Covid-Influenza Combination Vaccine in Adults

A Phase II/III, Multicentre, Observer-Blind, Randomized, Active-Controlled Study to Evaluate Immunogenicity and Safety of A Trivalent Nanoparticle Influenza Vaccine and Covid-Influenza Combination Vaccine Compared with Licensed Influenza and COVID -19 Vaccines in Adults - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/095731

Enrollment

2400

Registered

2025-10-08

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Trivalent Hemagglutinin Nanoparticle Influenza Vaccine (tNIV): tNIV is a novel recombinant, trivalent HA nanoparticle influenza vaccine adjuvanted with Matrix-M. It contains purified, r

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult Male or female participants 2. Participants must be healthy / clinically stable. 3. Willing to adhere to the protocol requirements and to provide informed consent. 4. Intend to remain residing in study area during study period. 5. History of having completed primary vaccination against SARS-CoV-2 6. Female participants of childbearing potential having a negative urine pregnancy test and agreeing to practice adequate contraception during specific study period

Exclusion criteria

Exclusion criteria: 1. Fever or any clinically significant acute infection 2. Respiratory symptoms 3. A known hypersensitivity to any of the vaccine components 4. History of myocarditis or pericarditis, Guillain-Barr Syndrome (GBS), any prior motor neuropathy, receipt of any influenza vaccine. 5. Laboratory-confirmed COVID-19, asymptomatic SARS-CoV-2 infection, or influenza. 6. Known or suspected congenital or acquired immunodeficiency 7. History of chronic administration of immunosuppressant or other immune modifying drugs preceding study vaccination. 8. Presence of any uncontrolled systemic disorder 9. Receipt of any blood products, COVID-19 monoclonal antibodies or antibody cocktails 10. Participation in a clinical trial 11. Blood disorder contraindicating injections or blood sampling. 12. Lactating or pregnant women. 13. History or presence of alcoholism or drug abuse. 14. Employees of the Sponsor or Investigator or study centre 15. Any other condition which in the opinion of the investigator will jeopardize the safety or rights of the participant.

Design outcomes

Primary

Measure	Time frame
HAI Seroconversion for all 3 influenza strains at Day 29 post vaccination HAI titer for all 3 influenza strains at Day 29 post-vaccination nAbs assessed by MN assay using vaccine homologous virus (Omicron variant JN.1 strain) at Day 29Timepoint: baseline and day 29 post vaccination	—

Secondary

Measure	Time frame
Immediate adverse events within 30 (+15) minutes of study vaccination Post-vaccination reactogenicity through 7 days o Solicited local adverse events (Pain, Tenderness, Erythema, Swelling, induration) o Solicited systemic adverse events (Fever, Nausea/Vomiting, Headache, Malaise, Myalgia, Arthralgia, Fatigue) All unsolicited adverse events, including MAAEs 28 days postvaccination SAEs and AESIs which encompasses PIMMCs through 180 days post-vaccinationTimepoint: baseline and day 29 post vaccination	—

Measure

Time frame

Immediate adverse events within 30 (+15) minutes of study vaccination Post-vaccination reactogenicity through 7 days o Solicited local adverse events (Pain, Tenderness, Erythema, Swelling, induration) o Solicited systemic adverse events (Fever, Nausea/Vomiting, Headache, Malaise, Myalgia, Arthralgia, Fatigue) All unsolicited adverse events, including MAAEs 28 days postvaccination SAEs and AESIs which encompasses PIMMCs through 180 days post-vaccinationTimepoint: baseline and day 29 post vaccination

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Countries

India

Contacts

Public ContactDr Prasad Kulkarni

Serum Institute of India Private Limited (SIIPL)

drpsk@seruminstitute.com912071946820

Outcome results