None listed
Conditions
Sponsors
Seth GS Medical College and KEM Hospital
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of AEs and SAEs reported until D58Timepoint: Days 0, 3, 7, 28 and 58 or any time during the study period;Neutralizing Ab titres will be measured for each vaccine strain with the microneutralization (MN) assayTimepoint: Days 0, 30 and 58;Anti-Haemagglutinin (HA) and Neuraminidase (NA) antibody titres to vaccine strain and antibody avidity.Timepoint: Day 0 and Day 58;Level (mean fluorescence intensity) and avidity (avidity index) of influenza-specific antibody isotypes. Level of influenza-specific antibody isotypes triggering Fc-dependent effector functions (proportion of activated cells, phagocytic score or mean fluorescence intensity)Timepoint: Day 0 and Day 58;Proportions of influenza-specific peripheral blood T cells with effector or regulatory phenotypes; Proportions of peripheral blood B cells with effector or regulatory phenotypes; Proportionâ??s influenza-specific IgG Fc expressing individual glycans; Level of binding (mean fluorescence intensity) of Fc receptors and complement by influenza-specific antibodies.Timepoint: Day 0 and Day 58;Level of cytokines (pg/ml) and mRNA (arbitrary units) induced by microbial products in an ex vivo whole blood assay; Number (n per microliter) and proportions of immune cell subsets in peripheral bloodTimepoint: Day 0 only;Level of expression of peripheral blood cell mRNA, plasma metabolites and plasma proteins (arbitrary units)Timepoint: Day 0 and Day 3 | — |
Countries
India
Contacts
Public ContactDr Jeffrey Pradeep Raj
Seth GS Medical College and KEM Hospital
Outcome results
None listed