Clinical study to evaluate the immune response and safety of four valent flu vaccine manufactured by Cadila Healthcare Ltd. in healthy children aged 6 months to 17 years

Phase 3

• Conditions: Health Condition 1: Z23- Encounter for immunization

• Registration Number: CTRI/2017/08/009204
• Lead Sponsor: Cadila Healthcare Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Healthy subject of either gender 6 months to 17 years of age

2. Written informed consent from subjectâ??s either parent (mother / father) and

written assent from subjects more than 7 years of age

3. Subjectâ??s either parent (mother / father) literate enough to fill the diary card

Exclusion Criteria

1. Past history of hypersensitivity reaction, neurological disorder (Guillainâ??Barré

syndrome or others) or any serious adverse event to any vaccine, egg,

chicken proteins, aminoglycoside antibiotics

2. Subjects with history of administration of any influenza vaccine or subjects

with laboratory confirmed influenza in past

3. Subjects with thrombocytopenia or any coagulation disorder, or subjects on

anticoagulation therapy

4. Subjects with confirmed or suspected immunosuppressive or

immunodeficiency disorder; or subjects on any immunosuppressive or

immunostimulant therapy

5. Clinically significant systemic disorder such as cardiovascular, respiratory,

neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or

immunological disorder

6. Subjects with febrile illness (temperature >= 37.5°C) at the time of enrolment,

or acute respiratory pathology or infections requiring systemic antibiotic or

antiviral therapy during the preceding 7 days

7. Subjects administered blood, blood containing products or immunoglobulins

within the last 3 months or planned administration during the study

8. Any other vaccine administration within the last 30 days or planned to be

administered during the study period

9. Pregnant and lactating girls & female subjects of child bearing age not using

acceptable contraceptive measures (double barrier methods, oral or

injectable hormonal contraceptives or surgical sterilization)

10. Participation in another clinical trial in the past 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified