A Phase 2 interventional study of AS03 and Inactivated influenza H7N9 vaccine in Avian Influenza, Influenza and Influenza Immunisation, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 4 sites in United States. Open to participants aged 19 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-06.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Prevention
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Among 45 studies in Influenza in Birds by National Institute of Allergy and Infectious Diseases (NIAID) — none open to participants now, none under way, none of them phase 3. Influenza in Birds · National Institute of Allergy and Infectious Diseases (NIAID).
Among the 45 studies in Influenza in Birds by National Institute of Allergy and Infectious Diseases (NIAID), this one is the 18th largest by enrollment of the 43 interventional ones that give a count, is one of 6 that started in 2018, is one of 14 in phase 2, and was the 40th registered.
96 studies on the registry are indexed under Influenza in Birds; 2 are open to participants now.
Browse Influenza in Birds studies →None of the 45 studies in Influenza in Birds by National Institute of Allergy and Infectious Diseases (NIAID) is open now. The open studies under Influenza in Birds, anywhere →
Of the 1 Influenza in Birds study recruiting now, 1 sets no upper age limit and none stop at 75 or younger; none take children under 18; 1 takes healthy volunteers.
This study: 19 Years to 64 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
45 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 29 · Phase 2 20
First in 2005; this study’s year is marked. 6 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 149 is close to the median of 150 across 88 interventional studies indexed under Influenza in Birds.
Median enrollment 95 across the 43 interventional studies, 2,050 across the 2 observational. Of the 44 that completed or were terminated, 11 (25%) have results posted.
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National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 406 completed or terminated interventional studies of FDA-regulated products, 302 (74%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 45 studies in Influenza in Birds by National Institute of Allergy and Infectious Diseases (NIAID), from their registry updates:
Nothing recorded among them since 2026-09-25.
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This is a randomized, un-blinded, Phase II study in males and non-pregnant females, who are in good health, 19 to 64 years of age. This study is designed to assess the safety, reactogenicity, and immunogenicity of a pre-pandemic AS03 (GSK) adjuvanted 2017 monovalent inactivated influenza A/H7N9 vaccine, when two doses are administered 21 days apart either sequentially or simultaneously (within 15 minutes) with licensed seasonal influenza vaccine. Subjects will be randomized into one of three treatment groups. The study will enroll approximately 150 individuals who have no history of influenza A/H7N9 infection or prior receipt of an influenza virus H7 subtype vaccine. Study duration is approximately 16 months with subject participation duration of approximately 13 months. The primary objectives of this study are: 1) to assess the safety and reactogenicity following sequential or simultaneous IM administration of 2 doses of AS03-adjuvanted 2017 H7N9 IIV and one dose of seasonal influenza vaccine (IIV4); 2) to assess the serum HAI and Neut antibody responses against A/H7N9 at approximately 21 days following receipt of two doses of AS03-adjuvanted 2017 H7N9 IIV administered IM approximately 21 days apart; 3) to assess the serum HAI and Neut antibody responses against the seasonal influenza strains at approximately 21 days following receipt of IIV4.
This is a randomized, un-blinded, Phase II study in males and non-pregnant females, who are in good health, 19 to 64 years of age. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of a pre-pandemic AS03 (GSK) adjuvanted 2017 monovalent inactivated influenza A/H7N9 vaccine (2017 H7N9 IIV) manufactured by Sanofi Pasteur (3.75 mcg of HA per dose with Phosphate Buffered Saline (PBS) diluent), when two doses are administered 21 days apart either sequentially or simultaneously (within 15 minutes) with licensed seasonal influenza vaccine. Subjects will be randomized into one of three treatment groups. Group 1 will receive two doses of AS03-adjuvanted 2017 H7N9 IIV, each dose administered IM approximately 21 days apart, and one dose of licensed seasonal IIV4 will be administered IM simultaneously (within 15 minutes) with the first dose of AS03 adjuvanted 2017 H7N9 IIV. Group 2 will receive one dose of IIV4 approximately 21 days prior to the IM administration of two doses of AS03-adjuvanted 2017 H7N9 IIV; each dose of AS03-adjuvanted 2017 H7N9 IIV will be given approximately 21 days apart. Group 3 will receive one dose IM of IIV4 as an un-blinded comparator. The study will enroll approximately 150 individuals who have no history of influenza A/H7N9 infection or prior receipt of an influenza virus H7 subtype vaccine. Study duration is approximately 16 months with subject participation duration of approximately 13 months. The primary objectives of this study are: 1) to assess the safety and reactogenicity following sequential or simultaneous IM administration of 2 doses of AS03-adjuvanted 2017 H7N9 IIV and one dose of seasonal influenza vaccine (IIV4); 2) to assess the serum HAI and Neut antibody responses against A/H7N9 at approximately 21 days following receipt of two doses of AS03-adjuvanted 2017 H7N9 IIV administered IM approximately 21 days apart; 3) to assess the serum HAI and Neut antibody responses against the seasonal influenza strains at approximately 21 days following receipt of IIV4. The secondary objectives are: 1) to assess unsolicited non-SAEs following sequential or simultaneous IM administration of AS03-adjuvanted 2017 H7N9 IIV and seasonal influenza vaccine (IIV4); 2) to assess MAAEs, including NOCMCs and PIMMCs, following sequential or simultaneous IM administration of AS03-adjuvanted 2017 H7N9 IIV and IIV4; 3) to assess the HAI and Neut antibody responses at 21 days following receipt of 1 dose of AS03-adjuvanted 2017 H7N9 IIV.
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.
Women of must use an acceptable method from 30 days before first study vaccination until 60 days after last study vaccination.
-- Includes non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving the first study vaccination, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing®, and licensed hormonal methods such as implants, injectables, or oral contraceptives ("the pill").
Exclusion Criteria:
Have an acute illness, as determined by the site principal investigator or appropriate sub-investigator, within 72 hours prior to study vaccination.
Have any medical disease or condition that, in the opinion of the site principal investigator or appropriate sub-investigator, is a to study participation.
Have taken high-dose inhaled corticosteroids within 30 days prior to each study vaccination.
Received an experimental agent within 30 days prior to the first study vaccination, or expect to receive an experimental agent during the 13-month trial-reporting period.
-- Other than from participation in this trial.
Are participating or plan to participate in another clinical trial with an interventional agent that will be received during the 13-month trial-reporting period.
Received or plan to receive an influenza A/H7 vaccine or have a history of influenza A/H7 subtype infection.
Have traveled to mainland China and had substantial direct contact with live or freshly slaughtered poultry or pigeons within the past five years.
Occupational exposure to or substantial direct physical contact with birds in the past year and through the 21 days after the last study vaccination.
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.
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.
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.
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.
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.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
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.
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.
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.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
3.75 mcg HA per 0.5 mL dose of H7N9 vaccine in PBS diluent + GSK AS03 adjuvant and 0.5 ml dose of IIV4 vaccine, both administered intramuscularly within 15 minutes on day 1, and 3.75 mcg HA per 0.5 mL dose of H7N9 vaccine in PBS diluent + GSK AS03 adjuvant intramuscularly on day 22, n=60
Drug: AS03 · Biological: Inactivated influenza H7N9 vaccine · Biological: Influenza Virus Quadrivalent Inactivated Vaccine · Other: Phosphate Buffered Saline (PBS) diluent
0.5 ml dose of IIV4 vaccine intramuscularly on day 1 and 3.75 mcg HA per 0.5 ml dose of H7N9 vaccine in PBS diluent + GSK AS03 adjuvant intramuscularly on day 22 and day 43, n=60
Drug: AS03 · Biological: Inactivated influenza H7N9 vaccine · Biological: Influenza Virus Quadrivalent Inactivated Vaccine · Other: Phosphate Buffered Saline (PBS) diluent
0.5 ml dose of IIV4 vaccine intramuscularly on day 1, n=30
Biological: Influenza Virus Quadrivalent Inactivated Vaccine
AS03 oil-in-water emulsion adjuvant.
Monovalent 2017 H7N9 inactivated influenza vaccine
A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N2) and 2 influenza B subtypes (B Yamata lineage and B Victoria lineage).
Diluent for Adjuvanted 2017 Monovalent Inactivated Influenza A/H7N9 vaccine (2017 H7N9IIV)
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the 2017 H7N9 Inactivated Influenza Vaccine (IIV) Strain After Second H7N9 Vaccination
Blood was collected for HAI assay at conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days after the second dose of H7N9, which is Day 43 for Group 1 and Day 64 for Group 2.
Time frame: 21 days after second dose of H7N9
GMTs of Serum HAI Antibodies Against Each of the 2017 IIV4 Strains
Blood was collected for HAI assay at conducted with the IIV4 vaccine viruses as the antigens. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results.
Time frame: Day 22
GMTs of Serum Neutralizing Antibodies Against Each of the 2017 IIV4 Strains
Blood was collected for the serum neutralizing antibody assay conducted with the IIV4 vaccine viruses as the antigens. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results.
Time frame: Day 22
GMTs of Serum Neutralizing Antibodies Against the 2017 H7N9 IIV Strain After the Second H7N9 Vaccination
Blood was collected for the serum neutralizing antibody assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days after second dose of H7N9, which is Day 43 for Group 1 and Day 64 for Group 2.
Time frame: 21 days after second dose of H7N9
Number of Participants Reporting Serious Adverse Events (SAEs)
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. All events are included regardless of relationship to the study product.
Time frame: Day 1 up to Day 408
Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination
Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher.
Time frame: Day 8
Number of Participants Assessed With Clinical Safety Laboratory AEs After Second Vaccination
Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher.
Time frame: Day 29
Number of Participants Assessed With Clinical Safety Laboratory AEs After Third Vaccination
Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher.
Time frame: Day 50
Number of Participants Reporting Solicited Injection Site AEs After First Vaccination
Injection site AEs solicited on a memory aid provided to participants included . Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days following vaccination Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (measurement grade)
Time frame: Day 1 up to day 8
Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination
Injection site AEs solicited on a memory aid provided to participants included . Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days following vaccination Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (measurement grade)
Time frame: Day 22 up to day 29
Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination
Injection site AEs solicited on a memory aid provided to participants included . Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days following vaccination Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (measurement grade)
Time frame: Day 43 up to day 50
Occurrence of Study Vaccine-related SAEs
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. Events are included if deemed by the investigator to be related to the study product.
Time frame: Day 1 up to day 408
Number of Participants Reporting Solicited Systemic AEs After First Vaccination
Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days following vaccination.
Time frame: Day 1 up to day 8
Number of Participating Reporting Solicited Systemic AEs After Second Vaccination
Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days following vaccination.
Time frame: Day 22 up to day 29
Number of Participants Reporting Solicited Systemic AEs After Third Vaccination
Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days following vaccination.
Time frame: Day 43 up to day 50
Percentage of Participants Achieving HAI Seroconversion Against 2017 H7N9 Study Vaccine After Second H7N9 Vaccination
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer = / \>1:40 or pre-vaccination titer 1:10 or greater and min. 4-fold rise in post-vaccination antibody titer. 21 days after second dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
Time frame: 21 days after second dose of H7N9
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against 2017 H7N9 Study Vaccine After Second H7N9 Vaccination
Blood was collected for the serum neutralizing antibody assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as neutralizing antibody pre-vaccination titer \<1:10 and post-vaccination titer 1:40 or greater, or pre-vaccination titer 1:10 or greater and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
Time frame: 21 days after second dose of H7N9
Percentage of Participants Achieving HAI Seroconversion Against Each of the Study IIV4 Strains
Blood was collected for the HAI assay conducted with the IIV4 vaccine viruses as the antigens. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer = / \>1:40 or pre-vaccination titer 1:10 or greater and min. 4-fold rise in post-vaccination antibody titer.
Time frame: Day 22
Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains
Blood was collected for the HAI assay conducted with the IIV4 vaccine viruses as the antigens. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result.
Time frame: Day 22
Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against the Influenza 2017 H7N9 Study Vaccine Strain After Second H7N9 Vaccination
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. 21 days after second dose of H7N9 is Day 43 for Group 1 and Day 64 for Group 2
Time frame: 21 days after second dose of H7N9
Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains
Blood was collected for the serum neutralizing antibody assay conducted with the IIV4 vaccine viruses as the antigens. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result.
Time frame: Day 22
Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against the Influenza 2017 H7N9 Study Vaccine Strain After Second H7N9 Vaccination
Blood was collected for the serum neutralizing antibody assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. 21 days after second dose of H7N9 is Day 43 for Group 1 and Day 64 for Group 2
Time frame: 21 days after second dose of H7N9
GMTs of Serum HAI Antibodies Against the Influenza 2017 H7N9 Vaccine Virus at Baseline
Blood was collected for HAI assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results.
Time frame: Day 1
GMTs of Serum HAI Antibodies Against the Influenza 2017 H7N9 Vaccine Virus After First H7N9 Vaccination
Blood was collected for HAI assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results. 21 days after first dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
Time frame: 21 days after first dose of H7N9
GMTs of Serum Neutralizing Antibodies Against the Influenza 2017 H7N9 Vaccine Virus at Baseline
Blood was collected for the serum neutralizing antibody assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results.
Time frame: Day 1
GMTs of Serum Neutralizing Antibodies Against the Influenza 2017 H7N9 Vaccine Virus After First H7N9 Vaccination
Blood was collected for serum neutralizing antibody assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results. 21 days after first dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
Time frame: 21 days after first dose of H7N9
Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Time frame: Approximately 21 days after first vaccination
Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Time frame: Approximately 21 days after second vaccination
Number of Participants Reporting Unsolicited Non-serious AEs After Third Vaccination
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Time frame: Approximately 21 days after third vaccination
Number of Participants Reporting of Medically-Attended Adverse Events (MAAEs), Including New-Onset Chronic Medical Conditions (NOCMCs) and Potentially Immune-Mediated Medical Conditions (PIMMCs)
Participants were queried at each visit for the occurrence of medically-attended adverse events (MAAEs), including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated medical conditions (PIMMCs) throughout the duration of the study.
Time frame: Day 1 up to day 408
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. The site investigator determined vaccine related as "a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE." Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Time frame: Approximately 21 days after first vaccination
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. The site investigator determined vaccine related as "a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE." Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Time frame: Approximately 21 days after second vaccination
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Third Vaccination
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. The site investigator determined vaccine related as "a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE." Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Time frame: Approximately 21 days after third vaccination
Percentage of Participants Achieving HAI Antibody Seroconversion Against the 2017 H7N9 Vaccine Strain After First H7N9 Vaccination
Blood was collected for HAI assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer 1:40 or greater, or pre-vaccination titer 1:10 or greater and min. 4-fold rise in post-vaccination antibody titer. 21 days after first dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
Time frame: 21 days after first dose of H7N9
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the 2017 H7N9 Vaccine Strain After First H7N9 Vaccination
Blood was collected for serum neutralizing antibody assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as a pre-vaccination titer \<1:10 and post-vaccination titer 1:40 or greater, or pre-vaccination titer 1:10 or greater and min. 4-fold rise in post-vaccination antibody titer. 21 days after first dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
Time frame: 21 days after first dose of H7N9
Percentage of Participants Achieving Serum HAI Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain at Baseline
Blood was collected for HAI assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result.
Time frame: Day 1
Percentage of Participants Achieving Serum HAI Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain After First H7N9 Vaccination
Blood was collected for serum neutralizing antibody assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. 21 days after first H7N9 vaccination was Day 22 for Group 1 and Day 43 for Group 2
Time frame: 21 days after first dose of H7N9
Percentage of Participants Achieving Serum Neutralizing Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain at Baseline
Blood was collected for serum neutralizing antibody assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result.
Time frame: Day 1
Percentage of Participants Achieving Serum Neutralizing Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain After First H7N9 Vaccination
Blood was collected for serum neutralizing antibody assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. 21 days after first H7N9 vaccination was Day 22 for Group 1 and Day 43 for Group 2
Time frame: 21 days after first dose of H7N9
Healthy adult participants 19-64 years of age were recruited from the communities surrounding each clinical site, and were enrolled between 20FEB2018 and 29JUN2018.
| Milestone | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only |
|---|---|---|---|
| Started | 62 | 53 | 34 |
| Received first vaccination | 62 | 53 | 34 |
| Received second vaccination | 59 | 48 | 0 |
| Received third vaccination | 0 | 46 | 0 |
| Completed | 58 | 50 | 30 |
| Not completed | 4 | 3 | 4 |
| Withdrew: Lost to follow-up | 3 | 2 | 1 |
| Withdrew: Protocol violation | 1 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 2 |
Blood was collected for HAI assay at conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days after the second dose of H7N9, which is Day 43 for Group 1 and Day 64 for Group 2.
| titer | Group 1 Simultaneous Administration | Group 2 Sequential Administration |
|---|---|---|
| Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the 2017 H7N9 Inactivated Influenza Vaccine (IIV) Strain After Second H7N9 Vaccination | 36.8 (27.7 to 48.8) | 22.7 (16.9 to 30.6) |
Blood was collected for HAI assay at conducted with the IIV4 vaccine viruses as the antigens. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results.
| titer | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only |
|---|---|---|---|
| A/Michigan/45/2015 x-275 (H1N1) | 547.7 (431.0 to 696.1) | 503.6 (360.6 to 703.1) | 480.4 (290.1 to 795.7) |
| A/Hong Kong/4801/2014 X-263B (H3N2) | 284.0 (201.6 to 400.0) | 289.8 (202.5 to 414.7) | 462.6 (314.6 to 680.2) |
| B/Phuket/3073/2013 (B Yamagata lineage) | 20.8 (15.2 to 28.4) | 23.05 (17.3 to 31.9) | 44.4 (29.7 to 66.3) |
| B/Brisbane/60/2008 (B Victoria lineage) | 46.1 (33.6 to 63.2) | 61.8 (46.0 to 82.9) | 64.1 (44.3 to 92.7) |
Blood was collected for the serum neutralizing antibody assay conducted with the IIV4 vaccine viruses as the antigens. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results.
| titer | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only |
|---|---|---|---|
| A/Michigan/45/2015 x-275 (H1N1) | 230.4 (169.2 to 313.6) | 186.0 (123.0 to 281.1) | 227.6 (133.9 to 386.9) |
| A/Hong Kong/4801/2014 X-263B (H3N2) | 481.3 (343.7 to 674.0) | 518.4 (358.1 to 750.5) | 788.9 (584.0 to 1065.6) |
| B/Phuket/3073/2013 (B Yamagata lineage) | 237.9 (176.8 to 320.0) | 251.5 (193.9 to 326.2) | 452.5 (327.7 to 625.0) |
| B/Brisbane/60/2008 (B Victoria lineage) | 118.9 (90.5 to 156.3) | 157.4 (117.9 to 210.2) | 202.0 (145.0 to 281.4) |
Blood was collected for the serum neutralizing antibody assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days after second dose of H7N9, which is Day 43 for Group 1 and Day 64 for Group 2.
| titer | Group 1 Simultaneous Administration | Group 2 Sequential Administration |
|---|---|---|
| GMTs of Serum Neutralizing Antibodies Against the 2017 H7N9 IIV Strain After the Second H7N9 Vaccination | 88.4 (63.2 to 123.9) | 50.5 (37.4 to 68.0) |
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. All events are included regardless of relationship to the study product.
| Participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only |
|---|---|---|---|
| Number of Participants Reporting Serious Adverse Events (SAEs) | 0 | 1 | 0 |
Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher.
| Participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only |
|---|---|---|---|
| ALT | 3 | 1 | 0 |
| bilirubin | 1 | 0 | 0 |
| creatinine | 3 | 0 | 0 |
| hemoglobin | 4 | 6 | 3 |
| platelets | 1 | 1 | 0 |
| WBC | 5 | 4 | 2 |
Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher.
| Participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration |
|---|---|---|
| ALT | 5 | 0 |
| bilirubin | 1 | 1 |
| creatinine | 1 | 0 |
| hemoglobin | 2 | 4 |
| platelets | 3 | 0 |
| WBC | 3 | 6 |
Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher.
| Participants | Group 2 Sequential Administration |
|---|---|
| ALT | 0 |
| bilirubin | 0 |
| creatinine | 1 |
| hemoglobin | 4 |
| platelets | 1 |
| WBC | 5 |
Injection site AEs solicited on a memory aid provided to participants included . Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days following vaccination Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (measurement grade)
| Participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only |
|---|---|---|---|
| Pain | 44 | 18 | 14 |
| Tenderness | 44 | 30 | 17 |
| Itching/Pruritus | 5 | 2 | 2 |
| Ecchymosis/Bruising (functional grade) | 4 | 2 | 1 |
| Ecchymosis/Bruising (measured) | 4 | 2 | 1 |
| Erythema/Redness (functional grade) | 15 | 5 | 4 |
| Erythema/Redness (measured) | 14 | 5 | 4 |
| Induration/Swelling (functional grade) | 13 | 5 | 0 |
| Induration/Swelling (measured) | 11 | 5 | 0 |
Injection site AEs solicited on a memory aid provided to participants included . Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days following vaccination Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (measurement grade)
| Participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration |
|---|---|---|
| Pain | 24 | 24 |
| Tenderness | 32 | 32 |
| Itching/Pruritus | 4 | 3 |
| Ecchymosis/Bruising (functional grade) | 5 | 2 |
| Ecchymosis/Bruising (measured) | 5 | 2 |
| Erythema/Redness (functional grade) | 13 | 7 |
| Erythema/Redness (measured) | 12 | 7 |
| Induration/Swelling (functional grade) | 13 | 9 |
| Induration/Swelling (measured) | 12 | 9 |
Injection site AEs solicited on a memory aid provided to participants included . Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days following vaccination Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (measurement grade)
| Participants | Group 2 Sequential Administration |
|---|---|
| Pain | 17 |
| Tenderness | 30 |
| Itching/Pruritus | 2 |
| Ecchymosis/Bruising (functional grade) | 2 |
| Ecchymosis/Bruising (measured) | 2 |
| Erythema/Redness (functional grade) | 4 |
| Erythema/Redness (measured) | 4 |
| Induration/Swelling (functional grade) | 5 |
| Induration/Swelling (measured) | 5 |
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. Events are included if deemed by the investigator to be related to the study product.
| Participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only |
|---|---|---|---|
| Occurrence of Study Vaccine-related SAEs | 0 | 0 | 0 |
Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days following vaccination.
| Participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only |
|---|---|---|---|
| Elevated Oral Temperature | 1 | 0 | 2 |
| Feverishness | 13 | 0 | 3 |
| Fatigue | 25 | 11 | 7 |
| Malaise | 19 | 6 | 8 |
| Myalgia | 28 | 7 | 9 |
| Arthralgia | 8 | 4 | 4 |
| Headache | 17 | 7 | 8 |
| Nausea | 2 | 1 | 5 |
Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days following vaccination.
| Participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration |
|---|---|---|
| Elevated Oral Temperature | 0 | 1 |
| Feverishness | 8 | 7 |
| Fatigue | 17 | 14 |
| Malaise | 13 | 9 |
| Myalgia | 19 | 8 |
| Arthralgia | 9 | 5 |
| Headache | 13 | 8 |
| Nausea | 6 | 6 |
Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days following vaccination.
| Participants | Group 2 Sequential Administration |
|---|---|
| Elevated Oral Temperature | 0 |
| Feverishness | 2 |
| Fatigue | 10 |
| Malaise | 5 |
| Myalgia | 11 |
| Arthralgia | 4 |
| Headache | 4 |
| Nausea | 3 |
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer = / \>1:40 or pre-vaccination titer 1:10 or greater and min. 4-fold rise in post-vaccination antibody titer. 21 days after second dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
| percentage of participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration |
|---|---|---|
| Percentage of Participants Achieving HAI Seroconversion Against 2017 H7N9 Study Vaccine After Second H7N9 Vaccination | 51 (37 to 64) | 38 (25 to 54) |
Blood was collected for the serum neutralizing antibody assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as neutralizing antibody pre-vaccination titer \<1:10 and post-vaccination titer 1:40 or greater, or pre-vaccination titer 1:10 or greater and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
| percentage of participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration |
|---|---|---|
| Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against 2017 H7N9 Study Vaccine After Second H7N9 Vaccination | 82 (70 to 91) | 74 (60 to 86) |
Blood was collected for the HAI assay conducted with the IIV4 vaccine viruses as the antigens. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer = / \>1:40 or pre-vaccination titer 1:10 or greater and min. 4-fold rise in post-vaccination antibody titer.
| percentage of participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only |
|---|---|---|---|
| A/Michigan/45/2015 x-275 (H1N1) | 53 (39 to 66) | 58 (44 to 72) | 55 (36 to 74) |
| A/Hong Kong/4801/2014 X-263B (H3N2) | 49 (36 to 63) | 55 (40 to 68) | 72 (53 to 87) |
| B/Phuket/3073/2013 (B Yamagata lineage) | 19 (10 to 31) | 13 (5 to 25) | 41 (24 to 61) |
| B/Brisbane/60/2008 (B Victoria lineage) | 29 (18 to 42) | 47 (33 to 61) | 48 (29 to 67) |
Blood was collected for the HAI assay conducted with the IIV4 vaccine viruses as the antigens. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result.
| percentage of participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only |
|---|---|---|---|
| A/Michigan/45/2015 x-275 (H1N1) | 100 (94 to 100) | 96 (87 to 100) | 93 (77 to 99) |
| A/Hong Kong/4801/2014 X-263B (H3N2) | 93 (84 to 98) | 94 (84 to 99) | 100 (88 to 100) |
| B/Phuket/3073/2013 (B Yamagata lineage) | 25 (15 to 38) | 30 (18 to 44) | 62 (42 to 79) |
| B/Brisbane/60/2008 (B Victoria lineage) | 54 (41 to 67) | 72 (58 to 83) | 76 (56 to 90) |
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. 21 days after second dose of H7N9 is Day 43 for Group 1 and Day 64 for Group 2
| percentage of participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration |
|---|---|---|
| Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against the Influenza 2017 H7N9 Study Vaccine Strain After Second H7N9 Vaccination | 51 (37 to 64) | 38 (25 to 54) |
Blood was collected for the serum neutralizing antibody assay conducted with the IIV4 vaccine viruses as the antigens. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result.
| percentage of participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only |
|---|---|---|---|
| A/Michigan/45/2015 x-275 (H1N1) | 98 (91 to 100) | 85 (72 to 93) | 93 (77 to 99) |
| A/Hong Kong/4801/2014 X-263B (H3N2) | 93 (84 to 98) | 94 (84 to 99) | 100 (88 to 100) |
| B/Phuket/3073/2013 (B Yamagata lineage) | 95 (86 to 99) | 100 (93 to 100) | 100 (88 to 100) |
| B/Brisbane/60/2008 (B Victoria lineage) | 90 (79 to 96) | 96 (87 to 100) | 100 (88 to 100) |
Blood was collected for the serum neutralizing antibody assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. 21 days after second dose of H7N9 is Day 43 for Group 1 and Day 64 for Group 2
| percentage of participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration |
|---|---|---|
| Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against the Influenza 2017 H7N9 Study Vaccine Strain After Second H7N9 Vaccination | 84 (72 to 93) | 74 (60 to 86) |
Blood was collected for HAI assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results.
| titer | Group 1 Simultaneous Administration | Group 2 Sequential Administration |
|---|---|---|
| GMTs of Serum HAI Antibodies Against the Influenza 2017 H7N9 Vaccine Virus at Baseline | 5.7 (5.5 to 6.0) | 5.7 (5.3 to 6.1) |
Blood was collected for HAI assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results. 21 days after first dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
| titer | Group 1 Simultaneous Administration | Group 2 Sequential Administration |
|---|---|---|
| GMTs of Serum HAI Antibodies Against the Influenza 2017 H7N9 Vaccine Virus After First H7N9 Vaccination | 9.9 (7.7 to 12.7) | 6.6 (5.9 to 7.4) |
Blood was collected for the serum neutralizing antibody assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results.
| titer | Group 1 Simultaneous Administration | Group 2 Sequential Administration |
|---|---|---|
| GMTs of Serum Neutralizing Antibodies Against the Influenza 2017 H7N9 Vaccine Virus at Baseline | 5.9 (5.4 to 6.6) | 5.4 (5.1 to 5.7) |
Blood was collected for serum neutralizing antibody assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results. 21 days after first dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
| titer | Group 1 Simultaneous Administration | Group 2 Sequential Administration |
|---|---|---|
| GMTs of Serum Neutralizing Antibodies Against the Influenza 2017 H7N9 Vaccine Virus After First H7N9 Vaccination | 22.3 (16.2 to 30.8) | 18.4 (14.5 to 23.4) |
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
| Participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only |
|---|---|---|---|
| Any SOC | 18 | 11 | 4 |
| Blood And Lymphatic System Disorders | 0 | 1 | 0 |
| Eye Disorders | 0 | 1 | 0 |
| Gastrointestinal Disorders | 2 | 1 | 0 |
| General Disorders / Administration Site Conditions | 3 | 1 | 0 |
| Infections And Infestations | 8 | 2 | 3 |
| Injury, Poisoning And Procedural Complications | 0 | 1 | 0 |
| Investigations | 3 | 3 | 0 |
| Musculoskeletal And Connective Tissue Disorders | 1 | 0 | 1 |
| Nervous System Disorders | 3 | 1 | 0 |
| Psychiatric Disorders | 1 | 0 | 0 |
| Reproductive System And Breast Disorders | 1 | 0 | 0 |
| Respiratory, Thoracic And Mediastinal Disorders | 1 | 0 | 0 |
| Vascular Disorders | 0 | 1 | 0 |
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
| Participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration |
|---|---|---|
| Any SOC | 12 | 6 |
| Gastrointestinal Disorders | 2 | 1 |
| General Disorders / Administration Site Conditions | 1 | 1 |
| Infections And Infestations | 5 | 2 |
| Injury, Poisoning And Procedural Complications | 1 | 0 |
| Investigations | 2 | 0 |
| Musculoskeletal And Connective Tissue Disorders | 2 | 0 |
| Nervous System Disorders | 1 | 1 |
| Psychiatric Disorders | 0 | 1 |
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
| Participants | Group 2 Sequential Administration |
|---|---|
| Any SOC | 4 |
| General Disorders / Administration Site Conditions | 1 |
| Investigations | 1 |
| Musculoskeletal And Connective Tissue Disorders | 1 |
| Nervous System Disorders | 1 |
Participants were queried at each visit for the occurrence of medically-attended adverse events (MAAEs), including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated medical conditions (PIMMCs) throughout the duration of the study.
| Participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only |
|---|---|---|---|
| MAAE | 6 | 6 | 2 |
| NOCMC | 1 | 2 | 0 |
| PIMMC | 0 | 0 | 0 |
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. The site investigator determined vaccine related as "a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE." Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
| Participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only |
|---|---|---|---|
| Any SOC | 7 | 2 | 0 |
| Gastrointestinal Disorders | 1 | 1 | 0 |
| General Disorders / Administration Site Conditions | 2 | 1 | 0 |
| Infections And Infestations | 1 | 0 | 0 |
| Investigations | 1 | 0 | 0 |
| Nervous System Disorders | 2 | 0 | 0 |
| Psychiatric Disorders | 1 | 0 | 0 |
| Respiratory, Thoracic And Mediastinal Disorders | 1 | 0 | 0 |
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. The site investigator determined vaccine related as "a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE." Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
| Participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration |
|---|---|---|
| Any SOC | 3 | 3 |
| Gastrointestinal Disorders | 1 | 1 |
| General Disorders / Administration Site Conditions | 1 | 0 |
| Infections And Infestations | 0 | 1 |
| Musculoskeletal And Connective Tissue Disorders | 1 | 0 |
| Nervous System Disorders | 0 | 1 |
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. The site investigator determined vaccine related as "a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE." Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
| Participants | Group 2 Sequential Administration |
|---|---|
| Any SOC | 2 |
| Investigations | 1 |
| Nervous System Disorders | 1 |
Blood was collected for HAI assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer 1:40 or greater, or pre-vaccination titer 1:10 or greater and min. 4-fold rise in post-vaccination antibody titer. 21 days after first dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
| percentage of participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration |
|---|---|---|
| Percentage of Participants Achieving HAI Antibody Seroconversion Against the 2017 H7N9 Vaccine Strain After First H7N9 Vaccination | 14 (6 to 26) | 2 (0 to 11) |
Blood was collected for serum neutralizing antibody assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as a pre-vaccination titer \<1:10 and post-vaccination titer 1:40 or greater, or pre-vaccination titer 1:10 or greater and min. 4-fold rise in post-vaccination antibody titer. 21 days after first dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
| percentage of participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration |
|---|---|---|
| Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the 2017 H7N9 Vaccine Strain After First H7N9 Vaccination | 34 (22 to 47) | 28 (16 to 42) |
Blood was collected for HAI assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result.
| percentage of participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration |
|---|---|---|
| Percentage of Participants Achieving Serum HAI Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain at Baseline | 0 (0 to 6) | 0 (0 to 7) |
Blood was collected for serum neutralizing antibody assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. 21 days after first H7N9 vaccination was Day 22 for Group 1 and Day 43 for Group 2
| percentage of participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration |
|---|---|---|
| Percentage of Participants Achieving Serum HAI Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain After First H7N9 Vaccination | 14 (6 to 26) | 2 (0 to 11) |
Blood was collected for serum neutralizing antibody assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result.
| percentage of participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration |
|---|---|---|
| Percentage of Participants Achieving Serum Neutralizing Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain at Baseline | 2 (0 to 9) | 0 (0 to 7) |
Blood was collected for serum neutralizing antibody assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. 21 days after first H7N9 vaccination was Day 22 for Group 1 and Day 43 for Group 2
| percentage of participants | Group 1 Simultaneous Administration | Group 2 Sequential Administration |
|---|---|---|
| Percentage of Participants Achieving Serum Neutralizing Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain After First H7N9 Vaccination | 34 (22 to 47) | 28 (16 to 42) |
Collected over Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 Simultaneous Administration | 0/62 (0%) | 0/62 (0%) | 57/62 (91.9%) |
| Group 2 Sequential Administration | 0/53 (0%) | 1/53 (1.9%) | 48/53 (90.6%) |
| Group 3 IIV4 Only | 0/34 (0%) | 0/34 (0%) | 25/34 (73.5%) |
| Event | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only |
|---|---|---|---|
| Myocardial InfarctionCardiac disorders | 0/62 | 1/53 | 0/34 |
| Event | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only |
|---|---|---|---|
| Injection site painGeneral disorders | 48/62 | 40/53 | 17/34 |
| Injection site painGeneral disorders | 45/62 | 33/53 | 14/34 |
| MyalgiaMusculoskeletal and connective tissue disorders | 33/62 | 17/53 | 9/34 |
| FatigueGeneral disorders | 27/62 | 23/53 | 7/34 |
| HeadacheNervous system disorders | 27/62 | 15/53 | 8/34 |
| MalaiseGeneral disorders | 24/62 | 15/53 | 8/34 |
| Injection site erythemaGeneral disorders | 20/62 | 13/53 | 4/34 |
| Injection site indurationGeneral disorders | 19/62 | 16/53 | 0/34 |
| Feeling hotGeneral disorders | 17/62 | 9/53 | 3/34 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 13/62 | 9/53 | 4/34 |
The baseline analysis population includes all randomized participants.
| Age, Categorical(Participants) | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 62 | 53 | 34 | 149 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only | Total |
|---|---|---|---|---|
| Mean | 39.1 ± 13.1 | 38.1 ± 11.5 | 35.7 ± 10.6 | 38.0 ± 12.0 |
| Sex: Female, Male(Participants) | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only | Total |
|---|---|---|---|---|
| Female | 26 | 26 | 13 | 65 |
| Male | 36 | 27 | 21 | 84 |
| Ethnicity (NIH/OMB)(Participants) | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only | Total |
|---|---|---|---|---|
| Hispanic or Latino | 60 | 52 | 31 | 143 |
| Not Hispanic or Latino | 2 | 1 | 3 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 3 | 3 | 0 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 1 |
| Black or African American | 36 | 29 | 17 | 82 |
| White | 22 | 17 | 14 | 53 |
| More than one race | 1 | 4 | 2 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Group 1 Simultaneous Administration | Group 2 Sequential Administration | Group 3 IIV4 Only | Total |
|---|---|---|---|---|
| United States | 62 | 53 | 34 | 149 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2018 to primary completion in Jul 2019, 17 months.
Results were first posted in Aug 2020, 1 year after primary completion.
Of 11 phase 2 interventional studies under Influenza in Birds, half reached primary completion within 17 months of starting (the median); a quarter within 4 and three quarters within 19. This study's 17 months is close to that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: AS03
National Institute of Allergy and Infectious Diseases (NIAID) →