An clinical trial to assess the immunogenicity and safety of Influenza Vaccine in healthy adult persons

An open label, multicentric, phase I/II clinical trial to assess the immunogenicity and safety of Inactivated Influenza Vaccine (Whole Virion) IP, Trivalent in healthy adult subjects

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/04/001700

Enrollment

Registered

2011-04-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: Z23- Encounter for immunization

Interventions

Intervention1: Inactivated Influenza Vaccine (Whole Virion) IP, Trivalent: 0.5 ml single dose on Day 0 by intramuscular injection in deltoid muscle Control Intervention1: None: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy volunteers of the age 18-60 years age. 2. If female, not pregnant or lactating at the time of enrolment and not planning pregnancy during the study period. 3. Subjects likely to be available for all visits during the follow-up period. 4. Informed consent of the subject/relative

Exclusion criteria

Exclusion criteria: 1. Pregnancy & Lactation. 2. Subjects with a history of anaphylaxis or serious reactions to vaccines; influenzal viral protein, egg proteins, neomycin or polymyxin. 3. Subjects who are taking immunostimulant therapy or immunosuppressant medications. 4. Subjects who are known to be suffering from diseases which can affect immune competence. 5. Subjects who have received blood products or immunoglobulins parenterally during the preceding 3 months. 6. Subjects who have recently had acute respiratory pathology or infections requiring systemic antibiotic or antiviral therapy. 7. Subjects having received influenza vaccine within the previous six months. 8. Subjects who have received any other vaccine or investigational medicinal product in the preceding 3 months. 9. Subjects with any other clinically significant concurrent illness. 10. Subjects with continuing history of alcohol and / or drug abuse

Design outcomes

Primary

Measure	Time frame
1. Number of seroconversions or significant increase in anti-haemagglutinin antibody titre 2. Increase in Geometric Mean Titre (GMT) 3. The proportion of subjects achieving an HI titre more than or equal to 1:40Timepoint: Day 0 & Day 21	—

Secondary

Measure	Time frame
Safety AssessmentsTimepoint: Day 0, 7, 21 & 42	—

Countries

India

Contacts

Public ContactDr Amit Kubavat

amitkubavat@zyduscadila.com079-26868812

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026