A multicentric clinical trial of SIIL's H1N1 vaccine (Inactivated) in Adults, Elderly and Children.

A Phase II/III clinical trial to assess safety and immunogenicity of the Influenza Vaccine (whole virion, Inactivated) A/H1N1 (Pandemic) Administered at two dose levels in Adults, Elderly and Pediatric Populations.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000093

Enrollment

330

Registered

2010-03-11

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: Influenza Vaccine (whole virion, Inactivated) A/H1N1 (Pandemic) (10 mcg): 0.5 ml, Intramuscular on Day 0, 21 Intervention2: Influenza Vaccine (whole virion, Inactivated) A/H1N1 (Pandemi

Eligibility

Inclusion criteria

Inclusion criteria: 1.Normal healthy subjects of appropriate age. 2.Free of obvious health problems.

Exclusion criteria

Exclusion criteria: 1.Have a known allergy to eggs or other components of the vaccine.2. pregnancy 3. participating in other clinical trial during the present trial period 4. Altered immune status 5. Acute febrile illness or acute infectious disease. 6. History of a previous severe allergic reaction. 7. History of H1N1 Influenza infection or any influenza vaccination. 8. History of Guillain-BarrÃ© Syndrome. 9. Known history of a bleeding disorder contraindicating intramuscular vaccination

Design outcomes

Primary

Measure	Time frame
immunogenicity assessmentTimepoint: On day 0, 21 and 42	—

Secondary

Measure	Time frame
SafetyTimepoint: Solicited reactions for 7 days for each dose, unsolicited reactions for 42 days and serious adverse events (SAEs) and new onset chronic medical conditions throughout the entire study period	—

Countries

India

Contacts

Public ContactDr. Prasad Kulkarni

drpsk@seruminstitute.com91-20-26602384

Outcome results