An extension study of participants 60 years of age and older participated in a marketed quadrivalent influenza vaccine to check the long term immunity

Long term immunogenicity of a marketed quadrivalent influenza vaccine (FluQuadriTM) administered in participants 60 years of age and older- An extension study [of EC/GOVT-02/2020] - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/069627

Enrollment

Registered

2024-06-27

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

None listed

Interventions

Intervention1: FluQuadriTM: Two doses of 0.5ml each 28 days apart of marketed qudrivalent influenza vaccine Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: 1 The participants recruited in the INCENTIVE QIV1 study. 2 Participants from INCENTIVE QIV1 [original study] now willing to participate and provide a written informed consent

Exclusion criteria

Exclusion criteria: 1 History of any influenza vaccine administration during the past 6 months prior to the present study. 2 Current or previous, laboratory confirmed case of influenza during the past 6 months, based on anamnesis at screening visit. 3 Household contact with and/or intimate exposure to an individual with any laboratory confirmed influenza infection within 90 days prior to vaccination. 4 Have any bleeding disorder which is considered as a contraindication to blood draw according to the opinion of the investigator. 5 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 titresTimepoint: Baseline	—

Secondary

Measure	Time frame
Anti-Haemagglutinin (HA) & Neuraminidase (NA) antibody titres to vaccine strain & antibody avidityTimepoint: Baseline;Individual MN Ab titreTimepoint: Baseline;Level of binding (mean fluorescence intensity) of Fc receptors & complement by influenza-specific antibodiesTimepoint: Baseline;Level of expression of peripheral blood cell mRNA, plasma metabolites & plasma proteins (arbitrary units)Timepoint: Baseline;Neutralizing Ab titres will be measured for each vaccine strain with the microneutralization (MN) assayTimepoint: Baseline;Number (n per microliter) & proportions of immune cell subsets in peripheral bloodTimepoint: Baseline;Proportions influenza-specific IgG Fc expressing individual glycansTimepoint: Baseline;Proportions of influenza-specific peripheral blood T cells with effector or regulatory phenotypesTimepoint: Baseline;Proportions of peripheral blood B cells with effector or regulatory phenotypesTimepoint: Baseline	—

Measure

Time frame

Anti-Haemagglutinin (HA) & Neuraminidase (NA) antibody titres to vaccine strain & antibody avidityTimepoint: Baseline;Individual MN Ab titreTimepoint: Baseline;Level of binding (mean fluorescence intensity) of Fc receptors & complement by influenza-specific antibodiesTimepoint: Baseline;Level of expression of peripheral blood cell mRNA, plasma metabolites & plasma proteins (arbitrary units)Timepoint: Baseline;Neutralizing Ab titres will be measured for each vaccine strain with the microneutralization (MN) assayTimepoint: Baseline;Number (n per microliter) & proportions of immune cell subsets in peripheral bloodTimepoint: Baseline;Proportions influenza-specific IgG Fc expressing individual glycansTimepoint: Baseline;Proportions of influenza-specific peripheral blood T cells with effector or regulatory phenotypesTimepoint: Baseline;Proportions of peripheral blood B cells with effector or regulatory phenotypesTimepoint: Baseline

—

Countries

India

Contacts

Public ContactDr Vijaya Chaudhari Gunjal

Seth GSMC and KEMH Mumbai

vijugmc@yahoo.co.in8097092722

Outcome results