None listed
Conditions
Interventions
Intervention1: Quadrivalent seasonal Influenza VLP Vaccine, manufactured by Cadila Pharmaceuticals Limited, India: Intramuscular (IM) injection of 0.5 ml, One dose for 9 to 65 year and Two dose for 6
Sponsors
Cadila Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy subjects of either gender, with more than 6 month (included) to ââ?°Â¤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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Quadrivalent Seasonal Influenza VLP vaccine of Cadila Pharmaceuticals Limited, India based on HI antibody response for at least one of the criteria i.e. seroconversion rate, seroprotection rate and increase in geometric mean HI titer.Timepoint: 28 days after last vaccination for all age groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of Immunogenicity results between test and reference vaccine for all four vaccine strainsTimepoint: 28 days after last vaccination for all age group;To evaluate the safety and tolerability of study vaccines.Timepoint: Solicited AE: 7 days after vaccination for all age groups Unsolicited AE: 28 days after vaccination for all age groups | — |
Countries
India
Contacts
Public ContactDr Seema Sharma
Cadila Pharmaceuticals Limited
Outcome results
None listed