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
- Registration Number
- CTRI/2022/05/042514
- Lead Sponsor
- Cadila Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 346
1. 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.
4. Parents of subjects literate enough to fill the diary card
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 (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 studyTimepoint: Day 56
- Secondary Outcome Measures
Name Time Method Geometric mean titres for all the four viral strains in the two groups at the end of the <br/ ><br>studyTimepoint: Day 56;Safety: <br/ ><br>1. Solicited local and systemic adverse events reported during the study <br/ ><br>2. Unsolicited adverse events reported during the study <br/ ><br>3. Serious adverse events reported during the studyTimepoint: Day 0, Day 28 and Day 56;Seroconversion rate for all the four viral strains in the two groups at the end of studyTimepoint: Day 56