A clinical trial to study the immunogenicity and safety of Inactivated Influenza Vaccine in healthy adult volunteers

An open label, phase II/III clinical study to assess the immunogenicity and safety of Inactivated Influenza Vaccine (Whole Virion) IP (Pandemic Influenza (H1N1) 2009 Monovalent Vaccine) in healthy adult volunteers

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000182

Enrollment

200

Registered

2010-03-02

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 (Pandemic Influenza (H1N1) 2009 Monovalent Vaccine): 0.5 ml single intramuscular (I.M.) dose of the vaccine Control Intervention1: None:

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy adult volunteers of either gender more than 18 years of age (No upper age limit was mentioned in our Protocol for this clinical trial). 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. Willing to sign Informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnancy & Lactation. 2. Subjects with a history of anaphylaxis or serious reactions to vaccines; hypersensitivity to influenzal viral protein, egg proteins, neomycin or polymixin, or products containing mercury. 3. Subjects who are taking immunostimulant therapy (e.g. interferons) or immunosuppressant medications (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.). 4. Subjects who are known to be suffering from diseases which can affect immune competence e.g. diabetes, immunodeficiency disorders or known to be HIV positive. 5. Subjects who have received blood products or immunoglobulins parenterally during the preceding 3 months. 6. Subjects who have had acute respiratory pathology or infections requiring systemic antibiotic or antiviral therapy during the preceding 7 days or individuals who have had suspected/confirmed pandemic influenza H1N1 infection. 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 continuing history of alcohol and / or drug abuse.

Design outcomes

Primary

Measure	Time frame
Assessment of immunogenicity and safetyTimepoint: 0,3,7,14,21 & 42 days	—

Secondary

Measure	Time frame
NoneTimepoint: Not Applicable	—

Countries

India

Contacts

Public ContactDr Ravindra Mittal

Cadila Healthcare Ltd

r.mittal@zyduscadila.com07926868926

Outcome results

None listed

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