Immunity against Influenza virus disease and safety of FluQuadri (marketed vaccine with protection against 4 types of influenza virus) in children of age between 3 and 8 years
Phase 4
- Registration Number
- CTRI/2021/10/037159
- Lead Sponsor
- Seth GS Medical College KEM Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Healthy children or children with well controlled pre-existing medical conditions (as concluded from the medical history, physical examination and clinical judgement) age range >=3 and <=9 years old on the day of the study
2. Written, informed consent from parents/guardians.
3. Oral assent for 7-8 years of aged children.
4. Parents/Guardians able to understand and comply with the study protocol requirements, including availability for all scheduled visits of the study.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Haemagglutinin Antibody Inhibition (HAI) antibody titres on D0 and D58; Proportion of participants with HAI titres â?¥ 40 (1/dilution) at D58; HAI antibody titres fold increase between D0 and D58; Proportion of participants with Seroconversion (titre 10 [1/dilution] at D0 and post-vaccination titre â?¥ 40 [1/dilution] at D58, or titre â?¥ 10 [1/dilution] at D0 and a â?¥ 4-fold increase in titre [1/dilution] at D58; Proportion of high and low responders (HAI titres 40 (1/dilution) at D58) <br/ ><br>Timepoint: Day 0 and Day 58
- Secondary Outcome Measures
Name Time Method