A Study of an Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the immunogenicity and safety of Ad26.RSV.preF-based vaccine and quadrivalent high-dose seasonal influenza vaccine when administered either concomitantly or separately.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1: Coadministration (CoAd) Group Participants will receive Ad26.RSV.preF-based vaccine and quadrivalent high dose influenza vaccine concomitantly on Day 1 and placebo on Day 29. |
Biological: Ad26.RSV.preF-based vaccine
Ad26.RSV.preF-based vaccine will be administered as single IM injection.
Biological: Quadrivalent High-dose Influenza Vaccine
Quadrivalent High-dose Influenza Vaccine will be administered as IM injection.
Biological: Placebo
Placebo will be administered as IM injection to Ad26.RSV.preF-based vaccine.
|
| Experimental: Group 2: Control Group Participants will receive placebo and quadrivalent high-dose influenza vaccine on Day 1 and Ad26.RSV.preF-based vaccine on Day 29. |
Biological: Ad26.RSV.preF-based vaccine
Ad26.RSV.preF-based vaccine will be administered as single IM injection.
Biological: Quadrivalent High-dose Influenza Vaccine
Quadrivalent High-dose Influenza Vaccine will be administered as IM injection.
Biological: Placebo
Placebo will be administered as IM injection to Ad26.RSV.preF-based vaccine.
|
Outcome Measures
Primary Outcome Measures
- Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Influenza Vaccine Strains [28 days after first vaccination (Day 29)]
HI antibody titers against each of the four influenza vaccine strains (28 days after the administration of a quadrivalent high-dose seasonal influenza vaccine) will be reported.
- Prefusion F protein (preF) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers [28 days after first vaccination (Day 29)]
PreF ELISA antibody titers (28 days after the administration of Ad26.RSV.preF-based vaccine) will be reported.
Secondary Outcome Measures
- Percentage of Participants with Solicited Local (INJECTION SITE) Adverse Events (AEs) for 7 Days After Each Vaccination [Up to 7 days after each vaccination (Day 8 and Day 36)]
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site) and systemic events for which participants will be specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs are: injection site pain/tenderness, erythema and swelling at the study vaccine injection site.
- Percentage of Participants with Solicited Systemic AEs for 7 Days After Each Vaccination [Up to 7 days after each vaccination (Day 8 and Day 36)]
Solicited systemic AEs include following events: fatigue, headache, nausea, and myalgia. Participants will be instructed on how to note signs and symptoms in the participant diary on a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days) for these events.
- Percentage of Participants with Unsolicited AEs for 28 Days After Each Vaccination [Up to 28 days after each vaccination (Day 29 and Day 57)]
Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
- Percentage of Participants with Serious Adverse Events (SAEs) Until 6 Months After the Second Study Vaccination [Up to 6 months after the second study vaccination (Day 211)]
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
- Percentage of Participants with Adverse Event of interest (AESI) Until 6 Months After the Second Study Vaccination [Up to 6 months after the second study vaccination (Day 211)]
Percentage of participants with AESI will be reported. Thrombosis with thrombocytopenia syndrome (TTS) is considered to be an AESI.
- Percentage of Participants with Seroconversion [28 days after first vaccination (Day 29)]
Seroconversion is defined for each of the 4 influenza vaccine strains at 28 days after the administration of a quadrivalent high-dose seasonal influenza vaccine: 1) HI titer greater than or equal to (>=) 1:40 in participants with a pre-vaccination HI titer of less than (<) 1:10, or 2) a >=4-fold HI titer increase in participants with a pre-vaccination HI titer of >=1:10.
- Percentage of Participants with Seroprotection [28 days after first vaccination (Day 29)]
Seroprotection is defined for each of the 4 influenza vaccine strains as HI titer >=1:40 at 28 days after the administration of a quadrivalent high-dose seasonal influenza vaccine.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Willing and able to adhere to the prohibitions and restrictions specified in this protocol
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In the investigator's clinical judgment, the participant must be in stable health at the time of vaccination. Participants will be included on the basis of medical history and vital signs performed between informed consent from (ICF) signature and vaccination
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Before randomization, a participant must be not intending to conceive by any methods, postmenopausal or surgically sterile
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From the time of vaccination through 3 months after vaccination, agrees not to donate blood
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Must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study
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Participant must be able to work with smartphones/tablets/computers
Exclusion Criteria:
- History of malignancy within 5 years before screening not in the following categories:
- participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator; b) participants with a history of malignancy within 5 years before screening, with minimal risk of recurrence per investigator's judgement, can be enrolled
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Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
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History of severe allergic reactions (example, anaphylaxis) to any component of the Quadrivalent high-dose influenza vaccine, including egg protein, or following a previous dose of any influenza vaccine
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Has abnormal function of the immune system resulting from either clinical condition, chronic or recurrent use of systemic corticosteroids within 2 months prior to study vaccination, or immunomodulating agents within 6 months prior to study vaccination
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Per medical history, participant has chronic active hepatitis B or hepatitis C infection
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History of acute polyneuropathy (example, Guillain-Barre syndrome) or chronic idiopathic demyelinating polyneuropathy
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Has a serious chronic disorder, example, chronic obstructive pulmonary disease or congestive heart failure, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition, including conditions placing the participant at high risk for severe influenza, for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
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Received vaccination with seasonal influenza vaccine for the current influenza season in the Northern Hemisphere
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ark Clinical Research | Long Beach | California | United States | 90806 |
| 2 | Research Centers of America, LLC | Hollywood | Florida | United States | 33024 |
| 3 | Progressive Medical Research | Port Orange | Florida | United States | 32127 |
| 4 | Synexus Clinical Research US, Inc | The Villages | Florida | United States | 32162 |
| 5 | Synexus Clinical Research US, Inc | Chicago | Illinois | United States | 60602 |
| 6 | Meridian Clinical Research, LLC | Rockville | Maryland | United States | 20854 |
| 7 | Sundance Clinical Research | Saint Louis | Missouri | United States | 63141 |
| 8 | Synexus Clinical Research US, Inc | Saint Louis | Missouri | United States | 63141 |
| 9 | Meridian Clinical Research, LLC | Grand Island | Nebraska | United States | 68803 |
| 10 | Meridian Clinical Research, LLC | Lincoln | Nebraska | United States | 68510 |
| 11 | Meridian Clinical Research, LLC | Norfolk | Nebraska | United States | 68701 |
| 12 | Meridian Clinical Research, LLC | Omaha | Nebraska | United States | 68134 |
| 13 | Tekton Research Inc. | Yukon | Oklahoma | United States | 73099 |
| 14 | Coastal Carolina Research Center | North Charleston | South Carolina | United States | 29405 |
| 15 | VitaLink Research Spartanburg | Spartanburg | South Carolina | United States | 29303 |
| 16 | AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company | Knoxville | Tennessee | United States | 37920 |
| 17 | Optimal Research | Austin | Texas | United States | 78705 |
| 18 | Tekton Research Inc. | Austin | Texas | United States | 78745 |
| 19 | DM Clinical Research | Tomball | Texas | United States | 77375 |
Sponsors and Collaborators
- Janssen Vaccines & Prevention B.V.
Investigators
- Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial, Janssen Vaccines & Prevention B.V.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR109064
- VAC18193RSV3005