CTRI/2025/10/095731 [Registered on: 08/10/2025] Trial Registered Prospectively
Last Modified On:
21/05/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Vaccine
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
A Study to check Immunogenicity and Safety of A Trivalent Nanoparticle Influenza Vaccine and Covid-Influenza Combination Vaccine in Adults
Scientific Title of Study
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
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CIC-tNIV-01 version 4.0 dated 09Jul2025
Protocol Number
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Dr Prasad Kulkarni
Designation
Executive Director
Affiliation
Serum Institute of India Private Limited (SIIPL)
Address
Serum Institute of India Private Limited (SIIPL), 212/2, Off Soli
Poonawalla Road,Hadapsar, Pune - 411028, Maharashtra, India
Pune
MAHARASHTRA
Pune MAHARASHTRA 411028 India
Phone
912071946820
Fax
Email
drpsk@seruminstitute.com
Details of Contact Person Public Query
Name
Dr Prasad Kulkarni
Designation
Executive Director
Affiliation
Serum Institute of India Private Limited (SIIPL)
Address
Serum Institute of India Private Limited (SIIPL), 212/2, Off Soli
Poonawalla Road,Hadapsar, Pune - 411028, Maharashtra, India
Pune
MAHARASHTRA
MAHARASHTRA 411028 India
Phone
912071946820
Fax
Email
drpsk@seruminstitute.com
Source of Monetary or Material Support
Serum Institute of India Pvt Ltd 212 2 Off soli Poonawalla Road Hadapsar Pune
Primary Sponsor
Name
Serum Institute of India Private Limited (SIIPL)
Address
Serum Institute of India Private Limited 212,2, Off Soli
Poonawalla Road, Hadapsar, Pune 411028, Maharashtra, India
Sati Joymati Road, Athgaon, Guwahati-781008 Kamrup ASSAM
9864061456
drdinesh944@gmail.com
Dr Ajeet Saoji
N K P Salve Institute of Medical Sciences and Research Centre
room no 5 medicine department first floor Nagpur MAHARASHTRA
9822715183
ajeet.saoji@rediffmail.com
Dr Madhu Gupta
Post Graduate Institute of Medical Education and Research, PGIMER
Department of Community Medicine,
School of Public Health, Post Graduate Institute of Medical Education and
Research, PGIMER, Chandigarh- 160012, India Chandigarh CHANDIGARH
7009769629
madhugupta21@gmail.com
Dr Parikshit Thakre
Radiant Superspeciality Hospital
Research Department room no 3, 03 floor radiant rehabilitation building Sabnis plot near kalyan square Amravati 444606 India Amravati MAHARASHTRA
Institutional Ethics Committee for M.V. Hospital & research Centre
Approved
Institutional Ethics Committee HIMSR and Associated HAH Centenary Hospital
Approved
Institutional Ethics Committee JSS Medical College
Approved
Institutional Ethics Committee Post Graduate Institute of Medical Education and Research
Submittted/Under Review
Institutional Ethics Committee, BGS Global Institute of Medical Sciences
Approved
Institutional Ethics committee, BGS Global Institute of Medical Sciences
Approved
Institutional Ethics Committee, Kurnool medical College
Approved
Institutional Ethics Committee, SRM Medical College Hospital and Research Centre
Approved
Institutional Ethics Committee, Topiwala National Medical College & BYL Nair CH. Hospital
Approved
Institutional Ethics committee-Human Research Lokmanya Tilak Municipal Medical College & general Hospital
Approved
Institutional Human Ethics Committee for Faculty Research
Approved
Institutional Human Ethics committee, AIIMS Gorakhpur
Approved
Intuitional Human Ethics Committee
Approved
KEM Hospital Research Centre Ethics Committee
Approved
LifePoint Research-Ethics Committee
Approved
Radiant Superspeciality Hospital Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Influenza and COVID-19
Intervention / Comparator Agent
Type
Name
Details
Intervention
COVID-Influenza Combination (CIC) Vaccine
COVID-influenza combination vaccine is a novel recombinant, Spodoptera frugiperda (Sf22A-Influenza and Sf9-SARS-CoV-2) insect cell/baculovirus system derived, trivalent HA nanoparticle (rHA) and SARS-CoV-2 recombinant (r) spike (S) protein nanoparticle vaccine (SARS-CoV-2 rS - Omicron variant JN.1 strain)
Comparator Agent
COVOVAX
COVOVAX is a novel recombinant, Spodoptera frugiperda (Sf9) insect cell/baculovirus system derived, SARS-CoV-2 recombinant (r) spike (S) protein nanoparticle vaccine (SARS-CoV-2 rS: JN.1 Variant)
Comparator Agent
Quadrivalent Inactivated Influenza Vaccine
Quadrivalent Inactivated Influenza Vaccine (split virion) is an inactivated influenza vaccine containing split viruses, prepared from influenza viruses propagated in embryonated chicken eggs.
tNIV is a novel recombinant, trivalent HA nanoparticle influenza vaccine adjuvanted with Matrix-M. It contains purified, recombinant, full-length HA (rHA)
Inclusion Criteria
Age From
18.00 Year(s)
Age To
85.00 Year(s)
Gender
Both
Details
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
ExclusionCriteria
Details
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-Barré 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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
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 29
baseline and day 29 post vaccination
Secondary Outcome
Outcome
TimePoints
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-vaccination
baseline and day 29 post vaccination
Target Sample Size
Total Sample Size="2400" Sample Size from India="2400" 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 2/ Phase 3
Date of First Enrollment (India)
27/10/2025
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="2" Months="5" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
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 2/3 randomized, double blind, active control, multi-center clinical study to evaluate immunogenicity and safety of trivalent nanoparticle influenza vaccine and covid-influenza combined vaccine compared with licensed influenza and covid vaccine in adults