Immunity against Influenza virus disease and safety of FluQuadri (marketed vaccine with protection against 4 types of influenza virus) in participants 60 years of age and older

Immunogenicity, molecular profiling and safety of a marketed quadrivalent influenza vaccine (FluQuadriTM) administered by the intramuscular route in participants 60 years of age and older - INCENTIVE: QIV-1

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/09/027913

Enrollment

100

Registered

2020-09-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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 arm: single dose of Intramuscular injection of quadrivalent influenza vaccine (Fluquadri) in the deltoid muscle (arm) Control Intervention1: Not applicable: Not applicable - i

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female of no child bearing potential 60 years and above at the time of study vaccine administration. 2. Provide written informed consent. 3. The participant is willing to comply with study protocol requirements, including availability for all scheduled visits of the study. 4. Healthy, as determined by medical history and clinical assessment of the investigator.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Haemagglutinin Antibody Inhibition (HAI) antibody titresTimepoint: Day 28	—

Secondary

Measure	Time frame
Safety: Occurrence of any adverse event (AE) – solicited AEs, unsolicited AEs and Serious AEs as well as effects on safety blood laboratory values. These measures relate to the safety and tolerability of the quadrivalent inactivated influenza vaccine (FluQuadriTM)Timepoint: Day 7;Individual HAI titres ratio D28/D0, Proportion of participants with titres = 40 (1/dilution), Proportion of participants with Seroconversion (titre 10 [1/dilution] and post-vaccination titre = 40 [1/dilution], or titre = 10 [1/dilution] and a = 4-fold increase in titre [1/dilution] Timepoint: day 0 and day 28;Neutralising antibody titres, Anti-N1 and -N2 titres, Detectable ELLA (ELLA Ab titre = 10 [1/dilution]), Proportions of influenza-specific IgG subclasses, Proportions of influenza-specific peripheral blood T cells, Proportions of peripheral blood B cells with effector or regulatory phenotypesTimepoint: Day 0 and Day 28;Proportions influenza-specific IgG Fc expressing individual glycans , Level of binding (mean fluorescence intensity) of Fc receptors and complement by influenza-specific antibodies, Cell activation (proportion of cells expressing markers of activation and phagocytic score) by influenza specific antibodiesTimepoint: Day 0 and Day 28;Level of cytokines (pg/ml) and mRNA (arbitrary units) induced by microbial products in peripheral blood, Number (n per microliter) and proportions of immune cell subsets in peripheral blood, Level of expression of mRNA, metabolites and proteins (arbitrary units) in peripheral bloodTimepoint: Day 0 and Day 28	—

Measure

Time frame

Safety: Occurrence of any adverse event (AE) – solicited AEs, unsolicited AEs and Serious AEs as well as effects on safety blood laboratory values. These measures relate to the safety and tolerability of the quadrivalent inactivated influenza vaccine (FluQuadriTM)Timepoint: Day 7;Individual HAI titres ratio D28/D0, Proportion of participants with titres = 40 (1/dilution), Proportion of participants with Seroconversion (titre 10 [1/dilution] and post-vaccination titre = 40 [1/dilution], or titre = 10 [1/dilution] and a = 4-fold increase in titre [1/dilution] Timepoint: day 0 and day 28;Neutralising antibody titres, Anti-N1 and -N2 titres, Detectable ELLA (ELLA Ab titre = 10 [1/dilution]), Proportions of influenza-specific IgG subclasses, Proportions of influenza-specific peripheral blood T cells, Proportions of peripheral blood B cells with effector or regulatory phenotypesTimepoint: Day 0 and Day 28;Proportions influenza-specific IgG Fc expressing individual glycans , Level of binding (mean fluorescence intensity) of Fc receptors and complement by influenza-specific antibodies, Cell activation (proportion of cells expressing markers of activation and phagocytic score) by influenza specific antibodiesTimepoint: Day 0 and Day 28;Level of cytokines (pg/ml) and mRNA (arbitrary units) induced by microbial products in peripheral blood, Number (n per microliter) and proportions of immune cell subsets in peripheral blood, Level of expression of mRNA, metabolites and proteins (arbitrary units) in peripheral bloodTimepoint: Day 0 and Day 28

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Countries

India

Contacts

Public ContactDr Nithya Gogtay

Seth GSMC & KEM Hospital

njgogtay@hotmail.com919820495836

Outcome results