Immunity against Influenza virus disease and safety of FluQuadri (marketed vaccine with protection against 4 types of influenza virus) in children of age between 6 and 12 months

Phase 4

• Registration Number: CTRI/2021/10/037161
• Lead Sponsor: Seth GS Medical College and KEM Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

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 6 months â?? 12 months the day of the study

2. Written, informed consent from parents/guardians.

3. Parents/Guardians able to understand and comply with the study protocol requirements, including availability for all scheduled visits of the study.

Exclusion Criteria

1. Acute illness, at the time of study vaccine administration (once acute illness is resolved, if appropriate, as per investigator assessment, participant will be re-revaluated for eligibility).

2. Recorded fever (for eligibility purpose defined as a body temperature greater than 37.5°C) within 3 days prior to study vaccine administration (once fever/acute illness is resolved, if appropriate, as per investigator assessment, participant will be re-evaluated for eligibility.

3. Current or previous, laboratory confirmed case of influenza during the past 6 months, based on anamnesis or medical records (if available) at screening visit.

4. Administration of any vaccine within 28 days prior to enrolment in the study (except for influenza vaccine which should be >6 months prior to enrollment in the study) or planned administration of any vaccine during study participation

5. Use of any investigational or non-registered drug or vaccine within 30 days prior to the administration of study vaccines or planned during the study

6. 16.Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or make it unlikely that the participant could complete the protocol

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)Timepoint: Baseline and Day 58