A Phase I clinical trial to assess safety and immune response of Influenza vaccine of Serum Institute of India Limited in Adults.

A Phase I clinical trial to assess safety and immune response of Trivalent, Live Attenuated Seasonal Influenza vaccine of SIIL in Adults.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/09/002033

Enrollment

Registered

2011-09-30

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

None listed

Interventions

Intervention1: Formulation A of Live attenuated Influenza virus vaccine: Single dose of 0.5ml by Intranasal route, Influenza vaccine containing Dose of Not less than log 7 of H1N1 and H3N2 and dose of

Eligibility

Inclusion criteria

Inclusion criteria: Normal healthy subjects of 18-49 years age

Exclusion criteria

Exclusion criteria: 1. Confirmed/suspected influenza infection or any influenza vaccination.2. Have a known allergy to eggs. 3. Pregnancy and breastfeeding women 4. Subject participating in other clinical trial 5. Altered immune status. 6. Acute febrile illness or acute infectious disease. 7. Any nasal pathology. 8. Asthma. 9. History of allergic reaction. 10. History of serious chronic illness. 11. Guillain-BarrÃ© Syndrome.

Design outcomes

Primary

Measure	Time frame
Safety- solicited, unsolicited, serious adverse events and new onset chronic medical conditionsTimepoint: Day 0,Day 7, Day 21 and Day 42	—

Secondary

Measure	Time frame
SeroconversionTimepoint: On day 7 & day 21	—

Countries

India

Contacts

Public ContactDr Prasad Kulkarni

Serum Institute of India Ltd.

drpsk@seruminstitute.com91-20-26602384

Outcome results