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A Clinical Study to Evaluate an Experimental Universal Influenza Vaccine, INFLUENZA G1 mHA, in Healthy Adults

Primary Purpose

Influenza Prevention

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
INFLUENZA G1 mHA
Placebo
Al(OH)3
Sponsored by
Janssen Vaccines & Prevention B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza Prevention

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Must be healthy as confirmed by medical history, physical examination, vital signs, and clinical laboratory tests performed at screening Contraceptive (birth control) use by female participants should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies. Before randomization, participants who were born female must be either: a) not of childbearing potential; b) of childbearing potential and practicing a highly effective method of contraception and agreeing to remain on such a method of contraception from signing the informed consent until 3 months after the last dose of study vaccine. Use of hormonal contraception should start at least 28 days before the first administration of study vaccine. Highly effective methods for this study include: hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion/ligation procedures, vasectomized partner (the vasectomized partner should be the sole partner for that participant), and sexual abstinence All female participants of childbearing potential must: a) have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening; b) have a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration Must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the laboratory normal reference ranges and additionally within the limits of toxicity Grade 2 according to the US FDA toxicity scale the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator Exclusion Criteria: Contraindication to IM injections and blood draws, example, bleeding disorders Clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius (100.4 degree Fahrenheit) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor History of severe allergic reaction (for example, anaphylaxis) or other serious adverse reactions to vaccines or vaccine excipients (specifically the excipients of the study vaccine[s]) Abnormal function of the immune system resulting from: a) clinical conditions (example, autoimmune disease or immunodeficiency) or their treatments expected to have an impact on the immune response elicited by the study vaccine; b) chronic or recurrent use of systemic corticosteroids within 2 months before administration of study vaccine and during the study; c) administration of antineoplastic and immunomodulating agents or radiotherapy expected to have an impact on the immune response elicited by the study vaccine within 6 months before administration of study vaccine and during the study History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy Received treatment with immunoglobulins (including monoclonal antibodies) expected to impact the vaccine-induced immune response in the 2 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. Received an investigational drug or used an invasive investigational medical device within 30 days or received an investigational vaccine within 6 months before the planned administration of the first dose of study vaccine, or received an investigational biological product within 3 months or 5 half-lives, whichever is longer, before the planned study intervention, or is currently enrolled or plans to participate in another investigational study or observational clinical study during the course of this study Pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study vaccine. Oocyte donation is prohibited while enrolled in this study Received or plans to receive: licensed live attenuated vaccines - within 28 days before or after planned administration of the first or subsequent study vaccination[s]; other licensed (not live) vaccines (not including seasonal influenza vaccines) - within 14 days before or after planned administration of the first or subsequent study vaccination[s]; seasonal influenza vaccines - within 4 months before planned administration of the first study vaccination until the end of the study (that is, any individual who requires a seasonal influenza vaccination for occupational or other reasons will be excluded) Has received a pandemic influenza vaccine (other than Hemagglutinin Type 1 and Neuraminidase Type 1 [H1N1]) in a previous pandemic influenza vaccine study at any time prior to randomization

Sites / Locations

  • Floridian Clinical Research, LLC
  • Johnson County Clin-Trials
  • Clinical Trials Managements, LLC
  • CTI Clinical Trial and Consulting Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

INFLUENZA G1 mHA Dose Level 1

INFLUENZA G1 mHA Dose Level 1 along with Al(OH)3

Placebo

INFLUENZA G1 mHA Dose Level 2

INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3

INFLUENZA G1 mHA Dose Level 2 + Placebo

INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3 + Placebo

Arm Description

Participants will receive single intramuscular (IM) injection of INFLUENZA G1 mHA Dose level 1 on Days 1 and 57 in Cohort 1.

Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 1 with Aluminum Hydroxide (Al[OH])3 adjuvant on Days 1 and 57 in Cohort 1.

Participants will receive IM injection of placebo on Days 1 and 57 in Cohorts 1 and 2.

Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 on Days 1 and 57 in Cohort 2.

Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 with Al(OH)3 adjuvant on Days 1 and 57 in Cohort 2.

Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 on Day 1 and placebo on Day 57 in Cohort 2.

Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 with Al(OH)3 adjuvant on Day 1 and placebo on Day 57 in Cohort 2.

Outcomes

Primary Outcome Measures

Number of Participants with Solicited Local Adverse Events (AEs) at 7 Days Post-vaccination 1
Number of participants with solicited local AEs at 7 days post-vaccination 1 will be reported. 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 pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in 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 vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration.
Number of Participants with Solicited Local AEs at 7 Days Post-vaccination 2
Number of participants with solicited local AEs at 7 days post-vaccination 2 will be reported. 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 pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in their 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 vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration.
Number of Participants with Solicited Local AEs by Severity at 7 Days Post-vaccination 1
Number of participants with solicited local AEs by severity at 7 days post-vaccination 1 will be reported. 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 pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in their 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 vaccination site. Severity will be assessed using Food and Drug Administration (FDA) Toxicity grading scale which includes Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening).
Number of Participants with Solicited Local AEs by Severity at 7 Days Post-vaccination 2
Number of participants with solicited local AEs by severity at 7 days post-vaccination 2. 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 pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in their 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 vaccination site. Severity will be assessed using FDA Toxicity grading scale which includes Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening).
Duration of Solicited Local AEs at 7 Days Post-vaccination 1
Duration of solicited local AEs on at 7 days post-vaccination 1 will be reported. 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 pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in their 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 vaccination site.
Duration of Solicited Local AEs at 7 Days Post-vaccination 2
Duration of solicited local AEs at 7 days post-vaccination 2 will be reported. 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 pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in their 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 vaccination site.
Number of Participants with Solicited Systemic AEs at 7 Days Post-vaccination 1
Number of participants with solicited systemic AEs at 7 days post-vaccination 1 will be reported. 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. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea, and fever (body temperature greater than or equal to [>=] 38 degree C).
Number of Participants with Solicited Systemic AEs at 7 Days Post-vaccination 2
Number of participants with solicited systemic AEs at 7 days post-vaccination 2 will be reported. 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. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea, and fever (body temperature >=38 degree C).
Number of Participants with Solicited Systemic AEs by Severity at 7 Days Post-vaccination 1
Number of participants with solicited systemic AEs by severity at 7 days post-vaccination 1 will be reported. 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. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea, and fever (body temperature >=38 degree C). Severity will be assessed using FDA Toxicity grading scale which includes Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening).
Number of Participants with Solicited Systemic AEs by Severity at 7 Days Post-vaccination 2
Number of participants with solicited systemic AEs by severity at 7 days post-vaccination 2 will be reported. 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. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea and fever (body temperature >=38 degree C). Severity will be assessed using FDA Toxicity grading scale which includes Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening).
Duration of Solicited Systemic AEs at 7 Days Post-vaccination 1
Duration of solicited systemic AEs on at 7 days post-vaccination 1 will be reported. 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. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea and fever (body temperature >=38 degree C).
Duration of Solicited Systemic AEs at 7 Days Post-vaccination 2
Duration of solicited systemic AEs on at 7 days post-vaccination 2 will be reported. 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. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea, and fever (body temperature >=38 degree C).
Number of Participants with Solicited Systemic AEs Related to Study Vaccine at 7 Days Post-vaccination 1
Number of participants with solicited systemic AEs related to study vaccine at 7 days post-vaccination 1 will be reported. 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. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea, and fever (body temperature >=38 degree C).
Number of Participants with Solicited Systemic AEs Related to Study Vaccine at 7 Days Post-vaccination 2
Number of participants with solicited systemic AEs related to study vaccine at 7 days post-vaccination 2 will be reported. 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. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea, and fever (body temperature >=38 degree C).
Number of Participants with Unsolicited AEs at 28 Days Post-vaccination 1
Number of participants with unsolicited AEs at 28 days post-vaccination 1 will be reported. 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. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's diary.
Number of Participants with Unsolicited AEs at 28 Days Post-vaccination 2
Number of participants with unsolicited AEs at 28 days post-vaccination 2 will be reported. 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. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's diary.
Number of Participants with Unsolicited AEs by Severity at 28 Days Post-vaccination 1
Number of participants with unsolicited AEs by severity at 28 days post-vaccination 1 by severity will be reported. 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. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's diary. Severity will be assessed using FDA Toxicity grading scale which includes Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening).
Number of Participants with Unsolicited AEs by Severity at 28 Days Post-vaccination 2
Number of participants with unsolicited AEs by severity at 28 days post-vaccination 2 by severity will be reported. 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. Unsolicited AEs are all AEs for which the participant is not specifically questioned. Severity will be assessed using FDA Toxicity grading scale which includes Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening).
Duration of Unsolicited AEs at 28 Days Post-vaccination 1
Duration of unsolicited AEs at 28 days post-vaccination 1 will be reported. 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. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's diary.
Duration of Unsolicited AEs at 28 Days Post-vaccination 2
Duration of unsolicited AEs at 28 days post-vaccination 2 will be reported. 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. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's diary.
Number of Participants with Unsolicited AEs Related to Study Vaccine at 28 Days Post-vaccination 1
Number of participants with unsolicited AEs related to study vaccine at 28 days post-vaccination 1 will be reported. 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. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's diary.
Number of Participants with Unsolicited AEs Related to Study Vaccine at 28 Days Post-vaccination 2
Number of participants with unsolicited AEs related to study vaccine at 28 days post-vaccination 2 will be reported. 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. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's diary.
Number of Participants with Serious Adverse Events (SAEs)
An SAE is any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, or is medically important.
Number of Participants with Serious Adverse Events (SAEs) Related to Study Vaccine
An SAE is any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, or is medically important.

Secondary Outcome Measures

Quantification of Antibody Binding to Hemagglutinin (HA) Stem or Full-length Hemagglutinin as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
Antibodies targeting the stem domain of the influenza HA molecule will be quantified by ELISA using HA stem or full-length hemagglutinin antigens.

Full Information

First Posted
June 5, 2023
Last Updated
October 10, 2023
Sponsor
Janssen Vaccines & Prevention B.V.
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT05901636
Brief Title
A Clinical Study to Evaluate an Experimental Universal Influenza Vaccine, INFLUENZA G1 mHA, in Healthy Adults
Official Title
A Randomized, Double-blind, Placebo-controlled, First-in-human Phase 1/2a Study to Evaluate Safety, Reactogenicity and Immunogenicity of a Universal Influenza (Uniflu) Vaccine With INFLUENZA G1 mHA in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 17, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Vaccines & Prevention B.V.
Collaborators
Department of Health and Human Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary purpose of this study is to evaluate safety/ reactogenicity of INFLUENZA G1 mini-hemagglutinin stem-derived protein vaccine antigen (mHA), with or without Al(OH)3 adjuvant, in healthy adults greater than or equal to (>=) 18 to less than or equal to (<=) 45 years of age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
INFLUENZA G1 mHA Dose Level 1
Arm Type
Experimental
Arm Description
Participants will receive single intramuscular (IM) injection of INFLUENZA G1 mHA Dose level 1 on Days 1 and 57 in Cohort 1.
Arm Title
INFLUENZA G1 mHA Dose Level 1 along with Al(OH)3
Arm Type
Experimental
Arm Description
Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 1 with Aluminum Hydroxide (Al[OH])3 adjuvant on Days 1 and 57 in Cohort 1.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive IM injection of placebo on Days 1 and 57 in Cohorts 1 and 2.
Arm Title
INFLUENZA G1 mHA Dose Level 2
Arm Type
Experimental
Arm Description
Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 on Days 1 and 57 in Cohort 2.
Arm Title
INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3
Arm Type
Experimental
Arm Description
Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 with Al(OH)3 adjuvant on Days 1 and 57 in Cohort 2.
Arm Title
INFLUENZA G1 mHA Dose Level 2 + Placebo
Arm Type
Experimental
Arm Description
Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 on Day 1 and placebo on Day 57 in Cohort 2.
Arm Title
INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3 + Placebo
Arm Type
Experimental
Arm Description
Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 with Al(OH)3 adjuvant on Day 1 and placebo on Day 57 in Cohort 2.
Intervention Type
Biological
Intervention Name(s)
INFLUENZA G1 mHA
Intervention Description
INFLUENZA G1 mHA will be administered intramuscularly.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered intramuscularly.
Intervention Type
Biological
Intervention Name(s)
Al(OH)3
Intervention Description
Al(OH)3 will be administered intramuscularly.
Primary Outcome Measure Information:
Title
Number of Participants with Solicited Local Adverse Events (AEs) at 7 Days Post-vaccination 1
Description
Number of participants with solicited local AEs at 7 days post-vaccination 1 will be reported. 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 pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in 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 vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration.
Time Frame
7 Days after vaccination 1 on Day 1 (Day 8)
Title
Number of Participants with Solicited Local AEs at 7 Days Post-vaccination 2
Description
Number of participants with solicited local AEs at 7 days post-vaccination 2 will be reported. 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 pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in their 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 vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration.
Time Frame
7 Days after vaccination 2 on Day 57 (Day 64)
Title
Number of Participants with Solicited Local AEs by Severity at 7 Days Post-vaccination 1
Description
Number of participants with solicited local AEs by severity at 7 days post-vaccination 1 will be reported. 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 pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in their 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 vaccination site. Severity will be assessed using Food and Drug Administration (FDA) Toxicity grading scale which includes Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening).
Time Frame
7 Days after vaccination 1 on Day 1 (Day 8)
Title
Number of Participants with Solicited Local AEs by Severity at 7 Days Post-vaccination 2
Description
Number of participants with solicited local AEs by severity at 7 days post-vaccination 2. 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 pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in their 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 vaccination site. Severity will be assessed using FDA Toxicity grading scale which includes Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening).
Time Frame
7 Days after vaccination 2 on Day 57 (Day 64)
Title
Duration of Solicited Local AEs at 7 Days Post-vaccination 1
Description
Duration of solicited local AEs on at 7 days post-vaccination 1 will be reported. 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 pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in their 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 vaccination site.
Time Frame
7 Days after vaccination 1 on Day 1 (Day 8)
Title
Duration of Solicited Local AEs at 7 Days Post-vaccination 2
Description
Duration of solicited local AEs at 7 days post-vaccination 2 will be reported. 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 pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in their 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 vaccination site.
Time Frame
7 Days after vaccination 2 on Day 57 (Day 64)
Title
Number of Participants with Solicited Systemic AEs at 7 Days Post-vaccination 1
Description
Number of participants with solicited systemic AEs at 7 days post-vaccination 1 will be reported. 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. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea, and fever (body temperature greater than or equal to [>=] 38 degree C).
Time Frame
7 Days after vaccination 1 on Day 1 (Day 8)
Title
Number of Participants with Solicited Systemic AEs at 7 Days Post-vaccination 2
Description
Number of participants with solicited systemic AEs at 7 days post-vaccination 2 will be reported. 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. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea, and fever (body temperature >=38 degree C).
Time Frame
7 Days after vaccination 2 on Day 57 (Day 64)
Title
Number of Participants with Solicited Systemic AEs by Severity at 7 Days Post-vaccination 1
Description
Number of participants with solicited systemic AEs by severity at 7 days post-vaccination 1 will be reported. 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. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea, and fever (body temperature >=38 degree C). Severity will be assessed using FDA Toxicity grading scale which includes Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening).
Time Frame
7 Days after vaccination 1 on Day 1 (Day 8)
Title
Number of Participants with Solicited Systemic AEs by Severity at 7 Days Post-vaccination 2
Description
Number of participants with solicited systemic AEs by severity at 7 days post-vaccination 2 will be reported. 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. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea and fever (body temperature >=38 degree C). Severity will be assessed using FDA Toxicity grading scale which includes Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening).
Time Frame
7 Days after vaccination 2 on Day 57 (Day 64)
Title
Duration of Solicited Systemic AEs at 7 Days Post-vaccination 1
Description
Duration of solicited systemic AEs on at 7 days post-vaccination 1 will be reported. 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. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea and fever (body temperature >=38 degree C).
Time Frame
7 Days after vaccination 1 on Day 1 (Day 8)
Title
Duration of Solicited Systemic AEs at 7 Days Post-vaccination 2
Description
Duration of solicited systemic AEs on at 7 days post-vaccination 2 will be reported. 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. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea, and fever (body temperature >=38 degree C).
Time Frame
7 Days after vaccination 2 on Day 57 (Day 64)
Title
Number of Participants with Solicited Systemic AEs Related to Study Vaccine at 7 Days Post-vaccination 1
Description
Number of participants with solicited systemic AEs related to study vaccine at 7 days post-vaccination 1 will be reported. 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. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea, and fever (body temperature >=38 degree C).
Time Frame
7 Days after vaccination 1 on Day 1 (Day 8)
Title
Number of Participants with Solicited Systemic AEs Related to Study Vaccine at 7 Days Post-vaccination 2
Description
Number of participants with solicited systemic AEs related to study vaccine at 7 days post-vaccination 2 will be reported. 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. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea, and fever (body temperature >=38 degree C).
Time Frame
7 Days after vaccination 2 on Day 57 (Day 64)
Title
Number of Participants with Unsolicited AEs at 28 Days Post-vaccination 1
Description
Number of participants with unsolicited AEs at 28 days post-vaccination 1 will be reported. 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. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's diary.
Time Frame
28 Days after vaccination 1 on Day 1 (Day 29)
Title
Number of Participants with Unsolicited AEs at 28 Days Post-vaccination 2
Description
Number of participants with unsolicited AEs at 28 days post-vaccination 2 will be reported. 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. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's diary.
Time Frame
28 Days after vaccination 2 on Day 57 (Day 85)
Title
Number of Participants with Unsolicited AEs by Severity at 28 Days Post-vaccination 1
Description
Number of participants with unsolicited AEs by severity at 28 days post-vaccination 1 by severity will be reported. 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. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's diary. Severity will be assessed using FDA Toxicity grading scale which includes Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening).
Time Frame
28 Days after vaccination 1 on Day 1 (Day 29)
Title
Number of Participants with Unsolicited AEs by Severity at 28 Days Post-vaccination 2
Description
Number of participants with unsolicited AEs by severity at 28 days post-vaccination 2 by severity will be reported. 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. Unsolicited AEs are all AEs for which the participant is not specifically questioned. Severity will be assessed using FDA Toxicity grading scale which includes Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening).
Time Frame
28 Days after vaccination 2 on Day 57 (Day 85)
Title
Duration of Unsolicited AEs at 28 Days Post-vaccination 1
Description
Duration of unsolicited AEs at 28 days post-vaccination 1 will be reported. 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. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's diary.
Time Frame
28 Days after vaccination 1 on Day 1 (Day 29)
Title
Duration of Unsolicited AEs at 28 Days Post-vaccination 2
Description
Duration of unsolicited AEs at 28 days post-vaccination 2 will be reported. 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. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's diary.
Time Frame
28 Days after vaccination 2 on Day 57 (Day 85)
Title
Number of Participants with Unsolicited AEs Related to Study Vaccine at 28 Days Post-vaccination 1
Description
Number of participants with unsolicited AEs related to study vaccine at 28 days post-vaccination 1 will be reported. 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. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's diary.
Time Frame
28 Days after vaccination 1 on Day 1 (Day 29)
Title
Number of Participants with Unsolicited AEs Related to Study Vaccine at 28 Days Post-vaccination 2
Description
Number of participants with unsolicited AEs related to study vaccine at 28 days post-vaccination 2 will be reported. 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. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's diary.
Time Frame
28 Days after vaccination 2 on Day 57 (Day 85)
Title
Number of Participants with Serious Adverse Events (SAEs)
Description
An SAE is any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, or is medically important.
Time Frame
Day 1 up to Day 365
Title
Number of Participants with Serious Adverse Events (SAEs) Related to Study Vaccine
Description
An SAE is any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, or is medically important.
Time Frame
Day 1 up to Day 365
Secondary Outcome Measure Information:
Title
Quantification of Antibody Binding to Hemagglutinin (HA) Stem or Full-length Hemagglutinin as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
Description
Antibodies targeting the stem domain of the influenza HA molecule will be quantified by ELISA using HA stem or full-length hemagglutinin antigens.
Time Frame
Days 1, 8, 29, 57, 64, 85, 238 and 365

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Must be healthy as confirmed by medical history, physical examination, vital signs, and clinical laboratory tests performed at screening Contraceptive (birth control) use by female participants should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies. Before randomization, participants who were born female must be either: a) not of childbearing potential; b) of childbearing potential and practicing a highly effective method of contraception and agreeing to remain on such a method of contraception from signing the informed consent until 3 months after the last dose of study vaccine. Use of hormonal contraception should start at least 28 days before the first administration of study vaccine. Highly effective methods for this study include: hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion/ligation procedures, vasectomized partner (the vasectomized partner should be the sole partner for that participant), and sexual abstinence All female participants of childbearing potential must: a) have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening; b) have a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration Must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the laboratory normal reference ranges and additionally within the limits of toxicity Grade 2 according to the US FDA toxicity scale the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator Exclusion Criteria: Contraindication to IM injections and blood draws, example, bleeding disorders Clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius (100.4 degree Fahrenheit) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor History of severe allergic reaction (for example, anaphylaxis) or other serious adverse reactions to vaccines or vaccine excipients (specifically the excipients of the study vaccine[s]) Abnormal function of the immune system resulting from: a) clinical conditions (example, autoimmune disease or immunodeficiency) or their treatments expected to have an impact on the immune response elicited by the study vaccine; b) chronic or recurrent use of systemic corticosteroids within 2 months before administration of study vaccine and during the study; c) administration of antineoplastic and immunomodulating agents or radiotherapy expected to have an impact on the immune response elicited by the study vaccine within 6 months before administration of study vaccine and during the study History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy Received treatment with immunoglobulins (including monoclonal antibodies) expected to impact the vaccine-induced immune response in the 2 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. Received an investigational drug or used an invasive investigational medical device within 30 days or received an investigational vaccine within 6 months before the planned administration of the first dose of study vaccine, or received an investigational biological product within 3 months or 5 half-lives, whichever is longer, before the planned study intervention, or is currently enrolled or plans to participate in another investigational study or observational clinical study during the course of this study Pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study vaccine. Oocyte donation is prohibited while enrolled in this study Received or plans to receive: licensed live attenuated vaccines - within 28 days before or after planned administration of the first or subsequent study vaccination[s]; other licensed (not live) vaccines (not including seasonal influenza vaccines) - within 14 days before or after planned administration of the first or subsequent study vaccination[s]; seasonal influenza vaccines - within 4 months before planned administration of the first study vaccination until the end of the study (that is, any individual who requires a seasonal influenza vaccination for occupational or other reasons will be excluded) Has received a pandemic influenza vaccine (other than Hemagglutinin Type 1 and Neuraminidase Type 1 [H1N1]) in a previous pandemic influenza vaccine study at any time prior to randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Vaccines & Prevention B.V. Clinical Trial
Organizational Affiliation
Janssen Vaccines & Prevention B.V.
Official's Role
Study Director
Facility Information:
Facility Name
Floridian Clinical Research, LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Johnson County Clin-Trials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Clinical Trials Managements, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
CTI Clinical Trial and Consulting Services
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Clinical Study to Evaluate an Experimental Universal Influenza Vaccine, INFLUENZA G1 mHA, in Healthy Adults

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