A Phase 3 Randomized Double-blind Controlled Study to Evaluate the Immunogenicity, Safety, and Reactogenicity of ExPEC9V and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older

Phase 1

• Conditions: Prevention of invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2023-504168-40-00
• Lead Sponsor: Janssen Vaccines & Prevention B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-11
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 932

Inclusion Criteria

1.=65 years ofage, inclusive, on the day of signing the ICF, 10.must be able to work with smartphones/tablets/computers., 2.must be medically stable at the time ofvaccination such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain on study through the end of protocol- specified follow-up. A stable medical condition is defined as disease not requiring significant change in therapy during the 6 weeks before enrollment and when hospitalization for worsening of the disease is not anticipated. Participants will be included on the basis of physical examination, medical history, and vital signs performed between ICF signature and vaccination., 3. Male or female, 4. before randomization, a participant must be: a.postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and b.not intending to conceive by any methods. Note: Surgically sterile participants are also eligible for the study., 5.must sign an ICF indicating that the participant understands the purpose, procedures and potential risks and benefits ofthe study, and is willing to participate in the study., 6.willing and able to adhere to the lifestyle restrictions specified in this protocol., 7.agrees to not donate blood from the time of vaccination until 3 months after receiving the last dose of study vaccine., 8.must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study., 9.must be able to read, understand, and complete the eDiary.

Exclusion Criteria

1.history of an underlying clinically significant acute or uncontrolled chronic medical condition or significant cognitive impairment or physical examination findings for which, in the opinion ofthe investigator, participation would not be in the best interest ofthe participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments, 10.received hematopoietic stem cell transplant based on medical history, treatment with immunoglobulins in the 2 months, apheresis therapies in the 4 months, or blood products in the 3 months before the planned administration of the first dose of study vaccine or has any plans to receive such treatment during the study. Note: Given that not all immunoglobulins/monoclonal antibodies are expected to impact the vaccine-induced immune response, the investigator should contact the sponsor to discuss eligibility ofparticipants on immunoglobulin treatment., 11.received or plans to receive: a.licensed live attenuated vaccines - within 28 days before or after planned administration ofthe first or subsequent study vaccinations. b.other licensed (not live) vaccines - within 14 days before or after planned administration of the first or subsequent study vaccinations. c.vaccination with a vaccine authorized for emergency use (eg, EUA, CMA, or a similar program) is permitted when given at least 28 days before or after planned administration of the first or subsequent study vaccinations., 12.received vaccination with seasonal influenza vaccine for the current influenza season in the Northern Hemisphere., 13.received any E. coli1 or ExPEC vaccine., 14.received an investigational drug or used an invasive investigational medical device within 90 days, or received an investigational vaccine within 90 days before the planned administration of the first dose of study vaccine, or is currently enrolled or plans to participate in another investigational study during the course of this study and before 6 months after administration of the study vaccine., 15.has uncontrolled HIV type 1 or type 2 infection. Note: a participant with a stable/well-controlled HIVinfection is allowed., 16.has a diagnosis ofchronic active hepatitis B or hepatitis C infection that is not medically stable, based on judgement of the investigator. Note: a participant with a stable and virologically suppressed hepatitis B or hepatitis C infection is allowed., 17.employee ofthe investigator or study site with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members ofthe employees or the investigator, or an employee ofthe sponsor or CRO., 18.cannot communicate reliably with the investigator., 19.who, in the opinion of the investigator, is unlikely to adhere to the requirements ofthe study, or is unlikely to complete the full course of vaccination and observation., 2.abnormal function of the immune system resulting from: a.clinical conditions or their treatments expected to have an impact on the immune response elicited by the study vaccine. Participants with clinical conditions that are stable under treatment without the use of prohibited therapies may be enrolled at the discretion of the investigator. b.chronic or recurrent use of systemic corticosteroids within 3 months before administration of study vaccine and during the study. A substantially immunosuppressive steroid dose is considered to be =2 weeks of d

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified