A clinical study to compare the immunogenicity and safety of Inactivated Influenza vaccine (split virion) I.P. (Tetravalent) 0.5ml in healthy children aged 6 to 35 months

Phase 3

Completed

• Conditions: healthy children aged 6 to 35 months

• Registration Number: CTRI/2022/05/042514
• Lead Sponsor: Cadila Healthcare Limited

Brief Summary

This is A prospective, randomized, two arm, parallel, active controlled, multicentre, phase III clinical study to compare the immunogenicity and safety of Inactivated Influenza vaccine (split virion) I.P. (Tetravalent) 0.5ml of M/s Cadila  Healthcare Limited with Fluarix-Tetra of M/s GlaxoSmithKline Pharmaceuticals Limited. A total of 346 healthy children aged 6 to 35 months will be enrolled in this study. The primary objective of this clinical study is to compare Seroprotection rate for all the four viral strains in the two groups at the end of the study. The secondary objective is to evaluate the Immunogenicity and Safety of the vaccines. For immunogenicity - Seroconversion rate for all the four viral strains in the two groups at the end of study and Geometric mean titres for all the four viral strains in the two groups at the end of the study will be eavaluated. For Safety Safety: 1. Solicited local and systemic adverse events reported during the study, 2. Unsolicited adverse events reported during the study, 3. Serious adverse events reported during the study will be evaluated.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-15
• Study Completion: 2022-06-10
• Last Update Posted: 2022-11-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 346

Inclusion Criteria

• Healthy subject of either gender 6 months to 35 months of age at the time of enrolment 2.
• Subjects should be in a good health as determined by the medical history and physical examination based on clinical judgment of the investigator 3.
• Informed consent from the parents of subjects.
• Parents of subjects literate enough to fill the diary card.

Exclusion Criteria

• Past history of hypersensitivity reaction, neurological disorder (Guillain–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 (body 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.
• Participation in another clinical trial in the past 3 months 10.
• Have any condition that in opinion of the investigator would make the subject unsuitable for participation in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Seroprotection rate for all the four viral strains in the two groups at the end of the study	Day 56

Secondary Outcome Measures

Name	Time	Method
Safety:	1. Solicited local and systemic adverse events reported during the study
Seroconversion rate for all the four viral strains in the two groups at the end of study	Day 56
Geometric mean titres for all the four viral strains in the two groups at the end of the	study

Trial Locations

Locations (5)

Aartham Multi Super Speciality Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Aatman Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Maharaja Agrasen Superspeciality Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Niloufer Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Sparsh Hospital & Critical Care Pvt Ltd; 🇮🇳 Khordha, ORISSA, India

Aartham Multi Super Speciality Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr Kairav Kothari

Principal investigator

9824076534

dranjalikothari@hotmail.com