A clinical trial to evaluate the immunogenicity and safety of Quadrivalent seasonal influenza vaccine.

Phase 3

Completed

• Conditions: Healthy pediatric andadult population

• Registration Number: CTRI/2021/11/038282
• Lead Sponsor: Cadila Pharmaceuticals Limited

Brief Summary

This is a phase-III, prospective, randomized, double-blind, active-controlled, parallel, multicentric, clinical trial to evaluate the immunogenicity and safety of Quadrivalent Seasonal Influenza VLP Vaccine in healthy pediatric and adult population of different age groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-30
• Last Update Posted: 2022-06-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

• 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, subject’s parent(s) or LAR(s) agrees to comply with protocol requirements and able to sign and date a written, ICF and assent form.
• 6.Female subject with negative Urine pregnancy test.

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-Barré 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.
• 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
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.	28 days after last vaccination for all age groups

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of study vaccines.	Solicited AE: 7 days after vaccination for all age groups
Comparison of Immunogenicity results between test and reference vaccine for all four vaccine strains	28 days after last vaccination for all age group

Trial Locations

Locations (10)

AII India Institute of Medical Sciences, Raipur; 🇮🇳 Raipur, CHHATTISGARH, India

Downtown Hospital; 🇮🇳 Kamrup, ASSAM, India

Dr. DY Patil Hospital & Research Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Grant Govt. Medical College & Sir JJ Groups of Hospitals; 🇮🇳 Mumbai, MAHARASHTRA, India

HCC Happiness Care and Cure Multispecialty Hospital LLP; 🇮🇳 Ahmadabad, GUJARAT, India

Panimalar Medical College Hospital & Research Institute; 🇮🇳 Chennai, TAMIL NADU, India

Priyadarshani Nursing Home; 🇮🇳 Mumbai, MAHARASHTRA, India

Sanjivani Hospital and Research Center; 🇮🇳 Lucknow, UTTAR PRADESH, India

Sardar Patel Medical College & AG Hospital, P.B.M. Hospital; 🇮🇳 Bikaner, RAJASTHAN, India

SSG Hospital; 🇮🇳 Vadodara, GUJARAT, India

AII India Institute of Medical Sciences, Raipur

🇮🇳Raipur, CHHATTISGARH, India

Dr Atul Jindal

Principal investigator

8224014667

dratuljindal@mail.com