A clinical trial to evaluate the immunogenicity and safety of Quadrivalent seasonal influenza vaccine.
- Registration Number
- CTRI/2021/11/038282
- Lead Sponsor
- Cadila Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 660
1.Healthy subjects of either gender, with more than 6 month (included) to �65 years of age with no prior history of influenza vaccination.
2.Subjects who are in good health at the time of randomization into the study.
3.For subjects aged 6 to 35 months only: born at full term of pregnancy ( >37
weeks) or birth weight >2.5 kg or both.
4.Subject, subjectââ?¬•s parent(s) or LAR(s) agrees to comply with protocol requirements and able to sign and date a written, ICF and assent form.
5.Documented negative test for human immunodeficiency virus (HIV-1/2),HBsAg or HCV.
6.Female subject with negative Urine pregnancy test.
1.Any condition determined likely to interfere with evaluation of the vaccine or having potential health risk to the subject or make it unlikely that the subject would complete the study.
2.Subjects with history of administration of any influenza vaccine or subjects with laboratory confirmed influenza in past one year.
3.Screening serum transaminase or alkaline phosphatase, creatinine and total bilirubin >1.5 times of ULN.
4.History of hypersensitivity to any component of the vaccines.
5.Any known immunocompromising condition or immunosuppressive therapy within 6 months preceding enrolment.
6.History of any use of systemic glucocorticoids and influenza antiviral medication.
7.History of underlying medical conditions, seizures or any progressive neurological disease, any congenital abnormalities, including hemoglobinopathies.
8.Children and adolescents receiving aspirin- or salicylate-containing medications and who might be at risk for experiencing Reye syndrome after influenza virus infection.
9.History of multiple sclerosis, lupus, Guillain-Barr�© syndrome, thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy.
10.Immunocompromised subjects
11.Subjects administered blood, blood containing products or Immunoglobulins within the last 3 months or planned administration during the study.
12.Any other vaccine administration within the last 30 days or planned to be administered during the study period.
13.Documented fever of > 100.4 �°F or above as axillary temperature in the preceding 14 days before screening.
14.Pregnant and lactating girls and female subjects of child bearing age not using acceptable contraceptive measures.
15.Participation in another clinical trial during past 3 month prior to screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method