Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent Inactivated Split Virion Influenza Vaccine, in Healthy Thai Elderly
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Influenza
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: non-inferiority double-blinded, randomized, controlled trialMasking: Double (Participant, Investigator)Masking Description: double blindedPrimary Purpose: Prevention
Participation Requirements
- Age
- Between 65 years and 125 years
- Gender
- Both males and females
Description
This is a phase III, non-inferiority double-blinded, randomized, controlled trial of immunogenicity with two groups of participants who will received a seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or an active comparator (licensed influenza vaccine). A total of abou...
This is a phase III, non-inferiority double-blinded, randomized, controlled trial of immunogenicity with two groups of participants who will received a seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or an active comparator (licensed influenza vaccine). A total of about 816 healthy Thai male and female adult volunteers ? 65 years of age; 408 participants will be randomized to receive the GPO Tri Fluvac and 408 will receive an active comparator (a 1:1 ratio).
Tracking Information
- NCT #
- NCT04548518
- Collaborators
- The Government Pharmaceutical Organization
- Investigators
- Principal Investigator: Punnee Pitisuttithum Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University,
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