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

Immunogenicity, molecular profiling and safety of a marketed Quadrivalent Influenza Vaccine (FluQuadri TM ) administered by the intramuscular route in children 3-8 years old - INCENTIVE: QIV-2

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037159

Enrollment

100

Registered

2021-10-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Fluquadri Vaccine (Quadrivalent influenza vaccine): Two doses of Intramuscular injection of quadrivalent influenza vaccine (Fluquadri) approximately one month apart (28 - 32 days) Contr

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 â?¥3 and â?¤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

Exclusion criteria:

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: Day 0 and Day 58	—

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: Day 0 and Day 58

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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;a. Neutralizing Ab titres will be measured for each vaccine strain with the microneutralization (MN) assay.Timepoint: Days 0, 30 and 58;b. Anti-Haemagglutinin (HA) and Neuraminidase (NA) antibody titres to vaccine strain and antibody avidity.Timepoint: Days 0 and 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: Days 0 and 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: Days 0 and 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 blood Timepoint: Day 0 only;k. Level of expression of peripheral blood cell mRNA, plasma metabolites and plasma proteins (arbitrary units)Timepoint: Days 0 and 3	—

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;a. Neutralizing Ab titres will be measured for each vaccine strain with the microneutralization (MN) assay.Timepoint: Days 0, 30 and 58;b. Anti-Haemagglutinin (HA) and Neuraminidase (NA) antibody titres to vaccine strain and antibody avidity.Timepoint: Days 0 and 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: Days 0 and 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: Days 0 and 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 blood Timepoint: Day 0 only;k. Level of expression of peripheral blood cell mRNA, plasma metabolites and plasma proteins (arbitrary units)Timepoint: Days 0 and 3

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Countries

India

Contacts

Public ContactDr Jeffrey Pradeep Raj

Seth GS Medical College & KEM Hospital

jpraj.m07@gmail.com7904286189

Outcome results