Study to Assess the Immuno 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 Japanese Adults 60 Years of Age and Older

JRCT ID: jRCT2051200067

Registered date:20/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Influenza (Healthy volunteers)
• Date of first enrollment: 21/10/2020
• Target sample size: 2100
• Study type: Interventional

Intervention(s)

Biological: High-Dose Quadrivalent Influenza Vaccine, (Zonal Purified, Split Virus) 2020-2021 Strains (QIV-HD)
Pharmaceutical form:Suspension for injection in pre-filled syringe
Route of administration: Intramuscular
Other Name: QIV-HD

Biological: Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains (QIV-SD)
Pharmaceutical form:Suspension for injection in pre-filled syringe
Route of administration: Subcutaneous
Other Name: QIV-SD

Outcome(s)

Primary Outcome

1. Geometric Mean Titers (GMTs) of influenza vaccine antibodies (post-vaccination) [ Time Frame: Day 28 (post-vaccination) ], Antibody titers will be measured by hemagglutination inhibition (HAI) assay
2. Percentage of participants achieving serconversion [ Time Frame: Day 28 (post-vaccination) ], Antibody titers will be measured by HAI assay

Secondary Outcome

1. GMTs of influenza vaccine antibodies (pre- and post-vaccination) [ Time Frame: Day 0 (pre-vaccination) and Day 28 (post-vaccination) ], Antibody titers will be measured by HAI assay
2. Geometric Mean Titers Ratio (GMTR) of influenza vaccine antibodies (post-/prevaccination) [ Time Frame: Day 0 (pre-vaccination) and Day 28 (post-vaccination) ], Antibody titers will be measured by HAI assay
3. Percentage of participants achieving serconversion [ Time Frame: Day 28 (post-vaccination) ], Antibody titers will be measured by HAI assay
4. Percentage of participants with antibody titers >= 40 (1/dil) against influenza antigens [ Time Frame: Day 0 (pre-vaccination) and Day 28 (post-vaccination) ], Antibody titers will be measured by HAI assay
5. Number of participants reporting immediate adverse events (AEs) [ Time Frame: Within 30 minutes post-vaccination ], Medically relevant unsolicited systemic AEs, including those related to the product administered
6. Number of participants reporting solicited injection site reactions and systemic reactions [ Time Frame: Within 7 days post-vaccination ], Adverse reactions prelisted in the (electronic) case report book (CRB). Injection site reactions: pain, erythema, swelling, induration and bruising. Systemic reactions: fever, headache, malaise, myalgia and shivering
7. Number of participants reporting unsolicited AEs [ Time Frame: Within 28 days post-vaccination ], AEs that other than solicited reactions
8. Number of participants reporting serious adverse events (SAEs) [ Time Frame: Within 28 days post-vaccination ], SAEs, including adverse event of special interest (AESIs)

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Aged >= 60 years on the day of inclusion
- Able to attend all scheduled visits and to comply with all study procedures

Exclude criteria

- Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccination with live vaccines within the past 27 days preceding the study vaccination or any vaccination with inactivated vaccines within the past 6 days preceding the study vaccination, or planned receipt of any vaccine prior to V02
- Previous vaccination against influenza (in the preceding 6 months) with either the study vaccine or another vaccine
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances
- Thrombocytopenia or bleeding disorder, contraindicating intramuscular (IM) vaccination based on Investigator's judgment
- Alcohol or substance abuse that, in the opinion of the Investigator might interfere with the study conduct or completion.
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
- Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e.,parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
- Personal or family history of Guillain-Barre syndrome
- Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy and participants who have a history of neoplastic disease and have been disease free for >=5 years)
- Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature >=37.5 C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
- History of convulsions
- Any condition that in the opinion of the Investigator could interfere with the evaluation of the vaccine

Related Information

• Primary Sponsor: Tanaka Tomoyuki
• Secondary ID(s): NCT04498832