Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Taiwanese Adults 65 Years of Age and Older
- Conditions
- Influenza (Healthy Volunteers)
- Interventions
- Biological: High-Dose Quadrivalent Influenza VaccineBiological: Standard-Dose Quadrivalent Influenza Vaccine
- Registration Number
- NCT04537234
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
Primary Objective:
Immunogenicity: To describe the immune response induced by high-dose quadrivalent influenza vaccine (QIV-HD) and AdimFlu-S (QIS) by hemagglutinin inhibition (HAI) measurement method in all participants.
Safety: To describe the safety profile of all participants in each study groups.
- Detailed Description
The duration of each participant's participation was approximately 28 days (Day 0 through Day 28 \[+ 7 days\]).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 165
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Quadrivalent Influenza Vaccine Participants received a single injection of 0.7 milliliters (mL) QIV-HD, intramuscularly (IM) at Day 0. Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) Standard-Dose Quadrivalent Influenza Vaccine Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0 Day 0 (pre-vaccination) Antibody titer was measured by using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).
Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28 Day 28 (post-vaccination) GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Titers were expressed in terms of 1/dilution.
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens Day 28 (post-vaccination) Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer less than (\<) 10 (1/dilution) at Day 0 and a post-vaccination titer greater than or equal to (\>=) 40 (1/dilution) at Day 28 or a pre-vaccination titer \>=10 (1/dilution) at Day 0 and a \>= four-fold increase in post-vaccination titer at Day 28.
Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28 Day 28 (post-vaccination) Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).
Number of Participants With Solicited Injection Site and Systemic Reactions Within 7 days post-vaccination A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to the product administered. Solicited injection site reactions included pain, erythema, swelling, induration, and bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering.
Number of Participants With Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs) From Day 0 up to 28 days post-vaccination An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs was defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 Day 0 (pre-vaccination) GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria Lineage), and B2 (B Yamagata Lineage). Titers were expressed in terms of 1/dilution.
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) Within 30 minutes post-vaccination An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Number of Participants With Unsolicited Adverse Events Within 28 days post-vaccination An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination.
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies Day 0 (pre-vaccination), Day 28 (post-vaccination) GMTRs of anti-influenza antibodies were measured by using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Investigational Site Number 1580001
🇨🇳Taipei, Taiwan
Investigational Site Number 1580002
🇨🇳Taipei, Taiwan
Investigational Site Number 1580003
🇨🇳Taoyuan, Taiwan
Investigational Site Number 1580004
🇨🇳Taichung, Taiwan