A Phase 1/2 interventional study of INFLUENZA G1 mHA and Placebo in Influenza Prevention, sponsored by Janssen Vaccines & Prevention B.V.. Completed at 4 sites in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by Janssen Vaccines & Prevention B.V. (part of Johnson & Johnson) · Phase 1/2, Interventional, and Prevention
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.
2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
This study's enrollment of 170 is below the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Janssen Vaccines & Prevention B.V. is the lead sponsor of 49 studies on the registry; none are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 32 (86%) have results posted.
First submitted after Janssen Vaccines & Prevention B.V. became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive single intramuscular (IM) injection of INFLUENZA G1 mHA Dose level 1 on Days 1 and 57 in Cohort 1.
Biological: INFLUENZA G1 mHA
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.
Biological: INFLUENZA G1 mHA · Biological: Al(OH)3
Participants will receive IM injection of placebo on Days 1 and 57 in Cohorts 1 and 2.
Biological: Placebo
Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 on Days 1 and 57 in Cohort 2.
Biological: INFLUENZA G1 mHA
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.
Biological: INFLUENZA G1 mHA · Biological: Al(OH)3
Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 on Day 1 and placebo on Day 57 in Cohort 2.
Biological: INFLUENZA G1 mHA
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.
Biological: INFLUENZA G1 mHA · Biological: Al(OH)3
INFLUENZA G1 mHA will be administered intramuscularly.
Placebo will be administered intramuscularly.
Al(OH)3 will be administered intramuscularly.
Number of Participants With Solicited Local Adverse Events (AEs) Within 7 Days After Vaccination 1
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.
Time frame: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)
Number of Participants With Solicited Local AEs Within 7 Days After Vaccination 2
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.
Time frame: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)
Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 1
AE: any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have a causal relationship with intervention. Solicited local AEs used to assess reactogenicity of vaccine. Pre-defined local AEs (pain/tenderness, erythema and swelling at injection site) were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity was assessed using food and drug administration (FDA) toxicity grading scale- Pain: Grade (G) 1 (mild; does not interfere with activity); G2 (moderate; requires modification in activity/use of medications); G3 (severe; inability to do usual activities/use of narcotic pain reliever); G4 (life threatening; hospitalization), Erythema and swelling: G 1 (mild; 25 -50 millimeter \[mm\]); G2 (moderate; 51 -100 mm); G3 (severe; greater than \[\>\] 100 mm); G4 (life threatening; hospitalization/necrosis or exfoliative dermatitis).
Time frame: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)
Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 2
AE: any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have a causal relationship with intervention. Solicited local AEs used to assess reactogenicity of vaccine. Pre-defined local AEs (pain/tenderness, erythema and swelling at injection site) were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity was assessed using FDA toxicity grading scale- Pain: Grade 1 (mild; does not interfere with activity); Grade 2 (moderate; requires modification in activity/use of medications); Grade 3 (severe; inability to do usual activities/use of narcotic pain reliever); Grade 4 (life threatening; hospitalization), Erythema and swelling: Grade 1 (mild; 25 -50 mm); Grade 2 (moderate; 51 -100 mm); Grade 3 (severe; \>100 mm); Grade 4 (life threatening; hospitalization/necrosis or exfoliative dermatitis).
Time frame: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)
Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1
Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.
Time frame: From Day 1 up to Day 365
Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 2
Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.
Time frame: From Day 57 up to Day 365
Number of Participants With Solicited Systemic AEs Within 7 Days After Vaccination 1
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Time frame: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)
Number of Participants With Solicited Systemic AE Within 7 Days After Vaccination 2
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Time frame: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)
Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AEs Within 7 Days After Vaccination 1
AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have causal relationship with intervention. Solicited systemic AEs used to assess reactogenicity of vaccine. Systemic events (fatigue, headache, nausea, myalgia, fever) for which participants were specifically questioned and were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity assessed by FDA toxicity grading scale- Fever: Grade (G) 1 (mild; 38.0-38.4 degrees Celsius \[C\]), G2 (moderate; 38.5-38.9 degrees C), G3 (severe; 39.0-40.0 degrees C), G4 (\>40.0 degrees C); fatigue, headache, nausea and myalgia: G1 (mild; does not interfere with activity), G2 (moderate; requires modification in activity/use of medications), G3 (severe; inability to do usual activities/use of medications); G4 (life threatening; hospitalization).
Time frame: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)
Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AE Within 7 Days After Vaccination 2
AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have causal relationship with intervention. Solicited systemic AEs used to assess reactogenicity of vaccine. Systemic events (fatigue, headache, nausea, myalgia, fever) for which participants were specifically questioned and were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity assessed by FDA toxicity grading scale- Fever: Grade (G) 1 (mild; 38.0-38.4 degrees Celsius \[C\]), G2 (moderate; 38.5-38.9 degrees C), G3 (severe; 39.0-40.0 degrees C), G4 (\>40.0 degrees C); fatigue, headache, nausea and myalgia: G1 (mild; does not interfere with activity), G2 (moderate; requires modification in activity/use of medications), G3 (severe; inability to do usual activities/use of medications); G4 (life threatening; hospitalization).
Time frame: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)
Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1
Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Time frame: From Day 1 up to Day 365
Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2
Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Time frame: From Day 57 up to Day 365
Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 1
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Number of participants with solicited systemic AEs related to study vaccine were reported.
Time frame: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)
Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 2
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Number of participants with solicited systemic AEs related to study vaccine were reported.
Time frame: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)
Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 1
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary.
Time frame: Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29)
Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 2
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary.
Time frame: Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85)
Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 1
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. The severity of AEs was assessed by FDA toxicity grading scale: Grade 1 (mild; symptoms causing no or minimal interference with usual social and functional activities); Grade 2 (moderate; symptoms causing greater than minimal interference with usual social and functional activities; Grade 3 (severe; symptoms causing inability to perform usual social and functional activities and requires medical intervention); Grade 4 (life threatening; hospitalization).
Time frame: Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29)
Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 2
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. The severity of AEs was assessed by FDA toxicity grading scale: Grade 1 (mild; symptoms causing no or minimal interference with usual social and functional activities); Grade 2 (moderate; symptoms causing greater than minimal interference with usual social and functional activities; Grade 3 (severe; symptoms causing inability to perform usual social and functional activities and requires medical intervention); Grade 4 (life threatening; hospitalization).
Time frame: Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85)
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 1
Duration of unsolicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Unsolicited AEs that occurred within 28 days after vaccination 1 are reported below.
Time frame: From Day 1 up to Day 365
Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2
Duration of unsolicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Unsolicited AEs that occurred within 28 days after vaccination 2 are reported below.
Time frame: From Day 57 up to Day 365
Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 1
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Number of participants with any unsolicited AEs related to study vaccine were reported.
Time frame: Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29)
Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 2
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Number of participants with any unsolicited AEs related to study vaccine were reported.
Time frame: Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85)
Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Serious AE was the AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with SAEs and SAEs related to study vaccine were reported.
Time frame: From first vaccination (Day 1) up to Day 365
Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Geometric mean concentration of antibodies binding to HA stem or full-length HA protein as measured by ELISA (H5-ELISA and mHA ELISA) was reported. HA stem derived protein vaccine antigen (mHA) derived from H1N1 A/California/07/2009 virus strain. Per-protocol Immunogenicity population was denoted as PPI. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
Time frame: Days 29 and 85
| Milestone | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Started | 25 | 25 | 25 | 25 | 25 | 25 | 20 |
| Number of participants who received vaccination 1 | 25 | 25 | 25 | 25 | 25 | 25 | 20 |
| Number of participants who received vaccination 2 | 24 | 23 | 23 | 25 | 23 | 24 | 20 |
| Number of participants who received 2 doses of placebo in group 3 | 0 | 0 | 0 | 0 | 0 | 0 | 10 |
| Number of participants who received 2 doses of placebo in group 8 | 0 | 0 | 0 | 0 | 0 | 0 | 10 |
| Completed | 24 | 23 | 22 | 22 | 23 | 21 | 17 |
| Not completed | 1 | 2 | 3 | 3 | 2 | 4 | 3 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 1 | 1 | 3 | 1 |
| Withdrew: Non- compliance with study schedule | 0 | 0 | 2 | 1 | 0 | 0 | 2 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 | 0 | 1 | 1 | 0 |
| Withdrew: Other | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.
| Participants | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Number of Participants With Solicited Local Adverse Events (AEs) Within 7 Days After Vaccination 1 | 5 | 12 | 3 | 13 | 6 | 14 | 1 |
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.
| Participants | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Number of Participants With Solicited Local AEs Within 7 Days After Vaccination 2 | 5 | 9 | 5 | 8 | 2 | 5 | 2 |
AE: any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have a causal relationship with intervention. Solicited local AEs used to assess reactogenicity of vaccine. Pre-defined local AEs (pain/tenderness, erythema and swelling at injection site) were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity was assessed using food and drug administration (FDA) toxicity grading scale- Pain: Grade (G) 1 (mild; does not interfere with activity); G2 (moderate; requires modification in activity/use of medications); G3 (severe; inability to do usual activities/use of narcotic pain reliever); G4 (life threatening; hospitalization), Erythema and swelling: G 1 (mild; 25 -50 millimeter \[mm\]); G2 (moderate; 51 -100 mm); G3 (severe; greater than \[\>\] 100 mm); G4 (life threatening; hospitalization/necrosis or exfoliative dermatitis).
| Participants | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
AE: any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have a causal relationship with intervention. Solicited local AEs used to assess reactogenicity of vaccine. Pre-defined local AEs (pain/tenderness, erythema and swelling at injection site) were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity was assessed using FDA toxicity grading scale- Pain: Grade 1 (mild; does not interfere with activity); Grade 2 (moderate; requires modification in activity/use of medications); Grade 3 (severe; inability to do usual activities/use of narcotic pain reliever); Grade 4 (life threatening; hospitalization), Erythema and swelling: Grade 1 (mild; 25 -50 mm); Grade 2 (moderate; 51 -100 mm); Grade 3 (severe; \>100 mm); Grade 4 (life threatening; hospitalization/necrosis or exfoliative dermatitis).
| Participants | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.
| Days | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Vaccination site erythema | 1.0 (1 to 1) | 1.0 (1 to 1) | 1.0 (1 to 1) | — | — | 1.0 (1 to 1) | — |
| Vaccination site swelling | 1.0 (1 to 1) | 1.0 (1 to 1) | 5.0 (5 to 5) | — | — | — | — |
| Vaccination site pain | 1.0 (1 to 2) | 2.5 (1 to 7) | 4.0 (3 to 5) | 2.0 (1 to 4) | 1.0 (1 to 1) | 2.0 (1 to 7) | 3.0 (3 to 3) |
Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.
| Days | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Vaccination site erythema | — | — | — | — | — | — | 1.0 (1 to 1) |
| Vaccination site swelling | — | — | — | — | — | — | 1.0 (1 to 1) |
| Vaccination site pain | 1.0 (1 to 2) | 2.0 (1 to 6) | 2.0 (1 to 4) | 1.5 (1 to 3) | 1.0 (1 to 1) | 1.0 (1 to 2) | 1.0 (1 to 1) |
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
| Participants | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Number of Participants With Solicited Systemic AEs Within 7 Days After Vaccination 1 | 7 | 12 | 6 | 9 | 7 | 12 | 4 |
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
| Participants | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Number of Participants With Solicited Systemic AE Within 7 Days After Vaccination 2 | 4 | 8 | 7 | 9 | 6 | 8 | 4 |
AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have causal relationship with intervention. Solicited systemic AEs used to assess reactogenicity of vaccine. Systemic events (fatigue, headache, nausea, myalgia, fever) for which participants were specifically questioned and were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity assessed by FDA toxicity grading scale- Fever: Grade (G) 1 (mild; 38.0-38.4 degrees Celsius \[C\]), G2 (moderate; 38.5-38.9 degrees C), G3 (severe; 39.0-40.0 degrees C), G4 (\>40.0 degrees C); fatigue, headache, nausea and myalgia: G1 (mild; does not interfere with activity), G2 (moderate; requires modification in activity/use of medications), G3 (severe; inability to do usual activities/use of medications); G4 (life threatening; hospitalization).
| Participants | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AEs Within 7 Days After Vaccination 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have causal relationship with intervention. Solicited systemic AEs used to assess reactogenicity of vaccine. Systemic events (fatigue, headache, nausea, myalgia, fever) for which participants were specifically questioned and were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity assessed by FDA toxicity grading scale- Fever: Grade (G) 1 (mild; 38.0-38.4 degrees Celsius \[C\]), G2 (moderate; 38.5-38.9 degrees C), G3 (severe; 39.0-40.0 degrees C), G4 (\>40.0 degrees C); fatigue, headache, nausea and myalgia: G1 (mild; does not interfere with activity), G2 (moderate; requires modification in activity/use of medications), G3 (severe; inability to do usual activities/use of medications); G4 (life threatening; hospitalization).
| Participants | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AE Within 7 Days After Vaccination 2 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
| Days | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Fatigue | 2.0 (1 to 7) | 3.0 (1 to 6) | 1.5 (1 to 3) | 1 (1 to 1) | 1.5 (1 to 5) | 4.5 (1 to 8) | 1.0 (1 to 7) |
| Headache | 3.0 (2 to 4) | 4.0 (1 to 6) | 1.5 (1 to 2) | 1.0 (1 to 1) | 5.5 (4 to 7) | 4.5 (1 to 6) | — |
| Nausea | 1.0 (1 to 1) | 1.0 (1 to 1) | 1.0 (1 to 1) | — | 1.0 (1 to 1) | 5.0 (2 to 7) | — |
| Myalgia | 1.0 (1 to 2) | 3.0 (1 to 6) | 1.0 (1 to 5) | 1.0 (1 to 2) | 3.5 (1 to 6) | 1.0 (1 to 5) | 1.0 (1 to 1) |
Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
| Days | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Fatigue | 6.0 (2 to 15) | 6.0 (4 to 8) | 1.0 (1 to 5) | 1.0 (1 to 9) | 1.0 (1 to 4) | 4.0 (1 to 7) | 1.0 (1 to 2) |
| Headache | 9.0 (1 to 17) | 5.0 (1 to 8) | 3.0 (2 to 6) | 3.0 (2 to 7) | 2.0 (2 to 2) | 4.0 (1 to 7) | 2.0 (2 to 2) |
| Nausea | 1.0 (1 to 1) | — | — | 1.0 (1 to 1) | — | 3.5 (1 to 6) | 1.5 (1 to 2) |
| Myalgia | 1.5 (1 to 2) | 2.5 (1 to 5) | 2.0 (1 to 3) | 2.0 (1 to 3) | — | 1.0 (1 to 6) | — |
| Pyrexia | — | — | — | — | — | — | 8.0 (8 to 8) |
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Number of participants with solicited systemic AEs related to study vaccine were reported.
| Participants | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 1 | 7 | 12 | 6 | 9 | 7 | 12 | 4 |
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Number of participants with solicited systemic AEs related to study vaccine were reported.
| Participants | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 2 | 4 | 8 | 7 | 9 | 6 | 8 | 3 |
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary.
| Participants | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 1 | 1 | 1 | 0 | 1 | 0 | 1 | 1 |
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary.
| Participants | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 2 | 1 | 1 | 2 | 3 | 2 | 2 | 1 |
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. The severity of AEs was assessed by FDA toxicity grading scale: Grade 1 (mild; symptoms causing no or minimal interference with usual social and functional activities); Grade 2 (moderate; symptoms causing greater than minimal interference with usual social and functional activities; Grade 3 (severe; symptoms causing inability to perform usual social and functional activities and requires medical intervention); Grade 4 (life threatening; hospitalization).
| Participants | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. The severity of AEs was assessed by FDA toxicity grading scale: Grade 1 (mild; symptoms causing no or minimal interference with usual social and functional activities); Grade 2 (moderate; symptoms causing greater than minimal interference with usual social and functional activities; Grade 3 (severe; symptoms causing inability to perform usual social and functional activities and requires medical intervention); Grade 4 (life threatening; hospitalization).
| Participants | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 2 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
Duration of unsolicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Unsolicited AEs that occurred within 28 days after vaccination 1 are reported below.
| Days | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Anaemia | — | — | — | — | — | — | 57.0 (57 to 57) |
| Dermatitis contact | — | — | — | — | — | 11.0 (11 to 11) | — |
| Diarrhoea | — | 1.0 (1 to 1) | — | — | — | — | — |
| Nasopharyngitis | 11.0 (11 to 11) | — | — | — | — | — | — |
| Ventricular extrasystoles | — | — | — | 1.0 (1 to 1) | — | — | — |
Duration of unsolicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Unsolicited AEs that occurred within 28 days after vaccination 2 are reported below.
| Days | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Anaemia | — | — | — | — | 34.0 (34 to 34) | — | — |
| Arthralgia | — | 3.0 (3 to 3) | — | — | — | — | — |
| Blood pressure increased | — | — | — | 20.0 (20 to 20) | — | — | — |
| Gastroenteritis | — | — | — | 7.0 (7 to 7) | — | — | — |
| Hypertension | — | — | — | 252.0 (252 to 252) | — | — | — |
| Influenza like illness | — | — | 6.0 (6 to 6) | 7.0 (7 to 7) | 4.0 (4 to 4) | 7.0 (7 to 7) | — |
| Leukopenia | — | — | 52.0 (52 to 52) | — | — | — | — |
| Nephrolithiasis | 14.0 (14 to 14) | — | — | — | — | — | — |
| Otitis media acute | — | — | — | 7.0 (7 to 7) | — | — | — |
| Pulmonary embolism | — | — | — | — | — | — | 92.0 (92 to 92) |
| Rhinorrhoea | — | — | — | 2.0 (2 to 2) | — | — | — |
| Sinusitis | — | — | — | — | — | 8.0 (8 to 8) | — |
| Transient ischaemic attack | — | — | — | 3.0 (3 to 3) | — | — | — |
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Number of participants with any unsolicited AEs related to study vaccine were reported.
| Participants | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Number of participants with any unsolicited AEs related to study vaccine were reported.
| Participants | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Serious AE was the AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with SAEs and SAEs related to study vaccine were reported.
| Participants | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| SAE | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| SAE related to study vaccine | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Geometric mean concentration of antibodies binding to HA stem or full-length HA protein as measured by ELISA (H5-ELISA and mHA ELISA) was reported. HA stem derived protein vaccine antigen (mHA) derived from H1N1 A/California/07/2009 virus strain. Per-protocol Immunogenicity population was denoted as PPI. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
| ELISA Unit per milliliter (EU)/mL | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| H5 A/Vietnam/1203/2004 ELISA: Day 29 | 2919 (1563 to 5450) | 2990 (1970 to 4538) | 3240 (1750 to 5998) | 4468 (2659 to 7507) | 3998 (2262 to 7068) | 5468 (3429 to 8717) | 329 (197 to 549) |
| H5 A/Vietnam/1203/2004 ELISA: Day 85 | 3015 (1738 to 5233) | 2892 (1879 to 4450) | 3413 (1984 to 5870) | 4276 (2755 to 6638) | 3044 (1774 to 5224) | 3087 (1955 to 4874) | 363 (228 to 578) |
| H1 mHA A/California/07/2009 ELISA: Day 29 | 27285 (16056 to 46368) | 28343 (20284 to 39604) | 31894 (17465 to 58242) | 43631 (28230 to 67437) | 44575 (28632 to 69397) | 57306 (41346 to 79426) | 3337 (2109 to 5280) |
| H1 mHA A/California/07/2009 ELISA: Day 85 | 28875 (18668 to 44665) | 29496 (21477 to 40509) | 36459 (23450 to 56686) | 45667 (33342 to 62547) | 31845 (20601 to 49224) | 32809 (24239 to 44409) | 3383 (2136 to 5358) |
Collected over All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | 0/25 (0%) | 0/25 (0%) | 9/25 (36%) |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | 0/25 (0%) | 0/25 (0%) | 16/25 (64%) |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | 0/25 (0%) | 0/25 (0%) | 8/25 (32%) |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | 0/25 (0%) | 2/25 (8%) | 18/25 (72%) |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | 0/25 (0%) | 0/25 (0%) | 9/25 (36%) |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | 0/25 (0%) | 0/25 (0%) | 16/25 (64%) |
| Group 3 and Group 8: Placebo (Two Doses) | 0/20 (0%) | 0/20 (0%) | 9/20 (45%) |
| Event | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Transient Ischaemic AttackNervous system disorders | 0/25 | 0/25 | 0/25 | 1/25 | 0/25 | 0/25 | 0/20 |
| Abortion SpontaneousPregnancy, puerperium and perinatal conditions | 0/25 | 0/25 | 0/25 | 1/25 | 0/25 | 0/25 | 0/20 |
| Event | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) |
|---|---|---|---|---|---|---|---|
| Vaccination Site Pain (Solicited)General disorders | 7/25 | 13/25 | 5/25 | 14/25 | 7/25 | 15/25 | 3/20 |
| Fatigue (Solicited)General disorders | 8/25 | 8/25 | 7/25 | 10/25 | 7/25 | 8/25 | 5/20 |
| Myalgia (Solicited)Musculoskeletal and connective tissue disorders | 5/25 | 10/25 | 4/25 | 5/25 | 2/25 | 10/25 | 1/20 |
| Headache (Solicited)Nervous system disorders | 3/25 | 7/25 | 5/25 | 6/25 | 3/25 | 9/25 | 1/20 |
| Nausea (Solicited)Gastrointestinal disorders | 3/25 | 2/25 | 2/25 | 1/25 | 4/25 | 3/25 | 2/20 |
| Vaccination Site Erythema (Solicited)General disorders | 1/25 | 1/25 | 1/25 | 0/25 | 0/25 | 2/25 | 1/20 |
| Vaccination Site Swelling (Solicited)General disorders | 1/25 | 2/25 | 1/25 | 0/25 | 0/25 | 0/25 | 1/20 |
| AnaemiaBlood and lymphatic system disorders | 0/25 | 0/25 | 0/25 | 0/25 | 1/25 | 0/25 | 1/20 |
| Pyrexia (Solicited)General disorders | 0/25 | 0/25 | 0/25 | 0/25 | 0/25 | 0/25 | 1/20 |
| Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders | 0/25 | 0/25 | 0/25 | 0/25 | 0/25 | 0/25 | 1/20 |
| Age, Continuous(Years) | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 31.6 ± 7.77 | 31.2 ± 8.31 | 34.3 ± 7.13 | 35.1 ± 7.22 | 32.0 ± 7.06 | 32.5 ± 7.96 | 31.6 ± 7.69 | 32.7 ± 7.6 |
| Sex: Female, Male(Participants) | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 8 | 7 | 15 | 18 | 13 | 16 | 12 | 89 |
| Male | 17 | 18 | 10 | 7 | 12 | 9 | 8 | 81 |
| Ethnicity (NIH/OMB)(Participants) | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) | Total |
|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 6 | 11 | 12 | 11 | 12 | 7 | 9 | 68 |
| Not Hispanic or Latino | 19 | 14 | 13 | 14 | 13 | 18 | 11 | 102 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) | Total |
|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Black or African American | 9 | 6 | 5 | 5 | 5 | 5 | 3 | 38 |
| White | 15 | 18 | 19 | 20 | 20 | 20 | 17 | 129 |
| More than one race | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 3 and Group 8: Placebo (Two Doses) | Total |
|---|---|---|---|---|---|---|---|---|
| United States | 25 | 25 | 25 | 25 | 25 | 25 | 20 | 170 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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
Data sharing details ↗ · www.janssen.com
Ran from May 2023 to primary completion in Aug 2024, 15 months.
Results were first posted in Sep 2025, 1 year after primary completion.
Of 41 industry-sponsored phase 1/2 interventional studies under Influenza, Human, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 16. This study's 15 months is above that.
Counting every sponsor, half of 43 studies reached it within 12 months; a quarter within 7 and three quarters within 16.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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