Cross-sectional Study to Assess Tolerability of the Trivalent Recombinant Vaccine in Individuals Between 18 and 64 Years Old Using the Vaccinees Perception of Injection

NCT06765187 | Completed FDA Drug

• 1 other identifier: VAP00035
• Study Type: observational
• Target: 447
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess patient-reported experiences post-vaccination with RIV3 using the VAPI instrument, identify drivers for vaccine choice in each case, and assess the cross-validity of VAPI, by establishing magnitude of correlations to EQ-5D-5L domains. As a feasibility endpoint, this study aims to describe the socio-demographic differences and feasibility of matching between recipients of RIV3 vaccine and mRNA vaccines for COVID-19.

Conditions

Influenza Immunization; Health Volunteers

Outcome Measures

Primary Outcomes (5)

• Incidence of reactions (local)

  Vaccinees' Perception of Injection (VAPI) and EQ-5D-5L questionnaires will be used. VAPI questionnaire consists of four dimensions. The first dimension collects information on discomfort caused by reactions at the injection site. The second dimension covers local reactions. The third dimension gathers data on pain. The fourth dimension collects information on acceptability and intentions for vaccination in the next year. The EQ-5D-5L instrument consists of two main components. The first part includes five dimensions of health: Mobility, Self-care, Usual activities, Pain/discomfort, and Anxiety/depression. The second part comprises a vertical scale where respondents rate their overall health. The higher the score the worse is the experience.

  At the time of inclusion in the study

• Incidence of reactions (systemic)

  Vaccinees' Perception of Injection (VAPI) and EQ-5D-5L questionnaires will be used. VAPI questionnaire consists of four dimensions. The first dimension collects information on discomfort caused by reactions at the injection site. The second dimension covers local reactions. The third dimension gathers data on pain. The fourth dimension collects information on acceptability and intentions for vaccination in the next year. The EQ-5D-5L instrument consists of two main components. The first part includes five dimensions of health: Mobility, Self-care, Usual activities, Pain/discomfort, and Anxiety/depression. The second part comprises a vertical scale where respondents rate their overall health. The higher the score the worse is the experience.

  At the time of inclusion in the study

• Severity of reactions (local and systemic)

  Vaccinees' Perception of Injection (VAPI) and EQ-5D-5L questionnaires will be used. VAPI questionnaire consists of four dimensions. The first dimension collects information on discomfort caused by reactions at the injection site. The second dimension covers local reactions. The third dimension gathers data on pain. The fourth dimension collects information on acceptability and intentions for vaccination in the next year. The EQ-5D-5L instrument consists of two main components. The first part includes five dimensions of health: Mobility, Self-care, Usual activities, Pain/discomfort, and Anxiety/depression. The second part comprises a vertical scale where respondents rate their overall health. The higher the score the worse is the experience.

  At the time of inclusion in the study

• vaccine acceptability score

  VAPI and EQ-5D-5L questionnaires will be used.

  At the time of inclusion in the study

• impact on daily life activities score

  VAPI and EQ-5D-5L questionnaires will be used.

  At the time of inclusion in the study

Secondary Outcomes (3)

• Frequencies of factors driving patient choices of RIV3 score

  At the time of inclusion in the study

• Proportions of factors driving patient choices of RIV3 score

  At the time of inclusion in the study

• Correlation score between EQ-5D-5L and VAPI questionaries

  At the time of inclusion in the study

Study Arms (1)

Group 1

Individuals who have received flu vaccine RIV3 within 2 months prior to being contacted

Biological: RIV3

Interventions

RIV3 BIOLOGICAL

intramuscular injection

Group 1

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Vaccine recipients who meet the inclusion criteria will be recruited from the United States of America (USA) over a period of 3 to 4 months. The study will include a sample of vaccine recipients, called group 1, and will recruit individuals who have received flu vaccine RIV3.

You may qualify if:

• Be aged 18-64 years old
• to 64 years will be the main age group for recruitment
• to 49 years will allow flexibility to face potential recruitment challenges
• Have received a RIV3 vaccine within the last 2 months
• Be able to provide explicit consent to participate in the study
• Reside in continental US (Puerto Rico is excluded)
• Communicate and read fluently in English (US)
• Be physically able to participate in a 30 min online survey using an internet-enabled computer or other device (such as a tablet or smartphone)

You may not qualify if:

• Inability to participate in survey
• Receipt of any other vaccine outside those pre-specified within the past three weeks, and including concomitant vaccination
• Receipt of co-administered vaccination

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Investigational site

Swiftwater, Pennsylvania, 18370, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 9, 2025
• Study Start: November 18, 2024
• Primary Completion: January 4, 2025
• Study Completion: January 4, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)