A clinical trial of SIIL's H1N1 vaccine (Inactivated) in Adults.

A Phase I clinical trial to assess safety of the Influenza Vaccine (whole virion, Inactivated) A/H1N1 (Pandemic) in Adults

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000082

Enrollment

Registered

2010-01-25

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) 10 mcg: Single dose of 0.5 ml, IM Control Intervention1: Influenza vaccine (whole virion, inactivated) 15 mcg: Single dose of 0.5 ml, IM

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1) Normal healthy subjects of 18-49 years age at the time of screening. 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. Acute febrile illness or acute infectious disease 5.History of a previous severe allergic reaction. 6. History of H1N1 Influenza infection or any influenza vaccination. 7. Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen. 8.History of Guillain-BarrÃ© Syndrome. 9. Known history of a bleeding disorder

Design outcomes

Primary

Measure	Time frame
Safety- Solicited, Unsolicited, Serious Adverse Events And New Onsent Chronic Medical ConditionTimepoint: Solicited Adverse Reaction For Day 7 And Unsolicited, Serious Adverse Events And New Onsent Chronic Medical Conditions Through Out Subject Participation Period.	—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactDr Prasad Kulkarni

Serum Institute of India Limited

drpsk@seruminstitute.com91-20-26602384

Outcome results