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2017 A/H7N9 IIV Revaccination

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT03738241
Collaborator
(none)
304
Enrollment
9
Locations
5
Arms
18
Actual Duration (Months)
33.8
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase II clinical trial in up to 420 males and non-pregnant females, 19 to 70 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of one dose of a monovalent inactivated split influenza 2017 A/H7N9 virus vaccine (2017 A/H7N9 IIV), administered intramuscularly (IM) at 3.75 mcg hemagglutinin (HA) per dose, given with or without AS03 adjuvant to subjects primed with a monovalent inactivated split influenza 2013 A/H7N9 virus vaccine (2013 A/H7N9 IIV) in DMID Protocols 13-0032 and 13-0033, or to those who are A/H7 IIV-naïve. Phosphate buffered saline (PBS) diluent will be used to achieve the targeted dosage. The study will be conducted at 9 Vaccine and Treatment Evaluation Unit (VTEU) sites (including their subcontractors). Study duration is approximately 17 months with subject participation duration up to 13 months. The primary objectives are: 1) to assess the safety and reactogenicity of 2017 A/H7N9 IIV given with or without AS03 adjuvant following receipt of one dose of study vaccine; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of the study vaccine.

Condition or Disease Intervention/Treatment Phase
  • Biological: A/H7N9
  • Drug: AS03
  • Other: Phosphate Buffered Saline (PBS) diluent
 Phase 2

Detailed Description

This is a Phase II clinical trial in up to 420 males and non-pregnant females, 19 to 70 years of age, inclusive, who are in good health and meet all eligibility criteria, which include a screening erythrocyte sedimentation rate (ESR) laboratory evaluation. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of one dose of a monovalent inactivated split influenza 2017 A/H7N9 virus vaccine (2017 A/H7N9 IIV) manufactured by Sanofi Pasteur (SP), administered intramuscularly (IM) at 3.75 mcg hemagglutinin (HA) per dose, given with or without AS03 adjuvant manufactured by GlaxoSmithKline Biologicals (GSK), to subjects primed with a monovalent inactivated split influenza 2013 A/H7N9 virus vaccine (2013 A/H7N9 IIV) in DMID Protocols 13-0032 and 13-0033, or to those who are A/H7 IIV-naïve. Phosphate buffered saline (PBS) diluent manufactured by Patheon Manufacturing Services LLC will be used to achieve the targeted dosage. Subjects who received the 2013 A/H7N9 IIV in DMID Protocols 13-0032 and 13-0033 or are A/H7 IIV-naïve will be stratified by prior receipt of 2013 A/H7N9 IIV, as well as by site and prior receipt of licensed, seasonal influenza vaccine (defined as receipt of at least one of the 2017-2018 and/or 2018-2019 licensed, seasonal influenza vaccines versus none), then randomly assigned in a 1:1 ratio to 1 of 2 treatment arms to receive 1 dose of 2017 A/H7N9 IIV at 3.75 mcg HA per dose with or without AS03 adjuvant. The study will be conducted at 9 Vaccine and Treatment Evaluation Unit (VTEU) sites (including their subcontractors). Study duration is approximately 17 months with subject participation duration up to 13 months. The primary objectives are: 1) to assess the safety and reactogenicity of 2017 A/H7N9 IIV given with or without AS03 adjuvant following receipt of one dose of study vaccine; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of the study vaccine. Secondary objectives are: 1) to assess unsolicited non-serious adverse events (AEs) following receipt of the study vaccine; 2) to assess medically-attended adverse events (MAAEs), including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated medical conditions (PIMMCs), following receipt of the study vaccine; 3) To assess the kinetics and durability of serum HAI and Neut antibody responses following receipt of the study vaccine.

Study Design

Study Type:
Interventional
Actual Enrollment :
304 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
A Phase II Study to Assess the Safety, Reactogenicity and Immunogenicity of a Single Dose of 2017 A/H7N9 Inactivated Influenza Vaccine (IIV) Administered Intramuscularly With or Without AS03 Adjuvant in 2013 A/H7N9 IIV Primed or A/H7 IIV Naïve Subjects
Actual Study Start Date :
Dec 18, 2018
Actual Primary Completion Date :
Jun 19, 2020
Actual Study Completion Date :
Jun 19, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

Participants will have prior administration of 2013 A/H7N9 IIV with MF59. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 (n=50) or 3.75 mcg HA per 0.5 ml dose of 2017 A/H7N9 IIV unadjuvanted administered intramuscularly on Day 1 (n=50). Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.

Biological: A/H7N9
Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).

Drug: AS03
AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer.

Other: Phosphate Buffered Saline (PBS) diluent
0.006M PBS diluent for Influenza Virus Vaccine.
Experimental: Arm 2

Participants will have prior administration of 2013 A/H7N9 IIV with AS03. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 (n=50) or 3.75 mcg HA per 0.5 ml dose of 2017 A/H7N9 IIV unadjuvanted administered intramuscularly on Day 1 (n=50). Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.

Biological: A/H7N9
Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).

Drug: AS03
AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer.

Other: Phosphate Buffered Saline (PBS) diluent
0.006M PBS diluent for Influenza Virus Vaccine.
Experimental: Arm 3

Participants will have prior administration of 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 (n=50) or 3.75 mcg HA per 0.5 ml dose of 2017 A/H7N9 IIV unadjuvanted administered intramuscularly on Day 1 (n=50). Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.

Biological: A/H7N9
Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).

Drug: AS03
AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer.

Other: Phosphate Buffered Saline (PBS) diluent
0.006M PBS diluent for Influenza Virus Vaccine.
Experimental: Arm 4

Participants will have prior administration of 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 (n=30) or 3.75 mcg HA per 0.5 ml dose of 2017 A/H7N9 IIV unadjuvanted administered intramuscularly on Day 1 (n=30). Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.

Biological: A/H7N9
Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).

Drug: AS03
AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer.

Other: Phosphate Buffered Saline (PBS) diluent
0.006M PBS diluent for Influenza Virus Vaccine.
Experimental: Arm 5

Participants who are A/H7 IIV-Naïve. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1 (n=30) or 3.75 mcg HA per 0.5 ml dose of 2017 A/H7N9 IIV unadjuvanted administered intramuscularly on Day 1 (n=30). Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.

Biological: A/H7N9
Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).

Drug: AS03
AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer.

Other: Phosphate Buffered Saline (PBS) diluent
0.006M PBS diluent for Influenza Virus Vaccine.

Outcome Measures

Primary Outcome Measures

  1. Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus [Day 22]

    Blood was collected for HAI assay which was 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 and stratum from the available results at 21 days post study vaccination (Day 22).

  2. Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus [Day 22]

    Blood was collected for Neutralizing assay which was 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 and stratum from the available results at 21 days post study vaccination (Day 22).

  3. Number of Participants Reporting Serious Adverse Events (SAEs) [Day 1 through Day 366]

    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.

  4. Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) [Day 1 to Day 8]

    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.

  5. Number of Participants Reporting Solicited Injection Site Reactogenicity Events [Day 1 through Day 8]

    Injection site AEs solicited on a memory aid provided to participants included 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 (any measured value >0mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination.

  6. Number of Participants Reporting Solicited Systemic Reactogenicity Events [Day 1 through Day 8]

    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 at or following the first vaccination.

  7. Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus [Day 22]

    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. The percentage of participants with HAI titer >= 1:40 was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).

  8. Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus [Day 22]

    Blood was collected for the Neutralizing 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 percentage of participants with Neut titer >= 1:40 was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).

  9. Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus [Day 22]

    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 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after study vaccination is Day 22.

  10. Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus [Day 22]

    Blood was collected for the Neutralizing 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 Neut pre-vaccination titer <1:10 and post-vaccination titer >= 1:40 or pre-vaccination titer >= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after study vaccination is Day 22.

Secondary Outcome Measures

  1. Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 8 Against the 2017 Influenza A/ H7N9 Vaccine Virus [Day 8]

    Blood was collected for HAI assay which was 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 and stratum from the available results at 7 days post study vaccination (Day 8).

  2. Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 181 Against the 2017 Influenza A/ H7N9 Vaccine Virus [Day 181]

    Blood was collected for HAI assay which was 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 and stratum from the available results at 180 days post study vaccination (Day 181).

  3. Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus [Day 8]

    Blood was collected for Neutralizing assay which was 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 and stratum from the available results at 7 days post study vaccination (Day 8).

  4. Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus [Day 181]

    Blood was collected for Neutralizing assay which was 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 and stratum from the available results at 180 days post study vaccination (Day 181).

  5. Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) [Day 22]

    Blood was collected for HAI assay which was conducted with the 2013 H7N9 priming 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 and stratum from the available results at 21 days post study vaccination (Day 22).

  6. Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) [Day 22]

    Blood was collected for Neutralizing assay which was conducted with the 2013 H7N9 priming 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 and stratum from the available results at 21 days post study vaccination (Day 22).

  7. Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) [Day 1 through Day 366]

    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.

  8. Number of Participants Reporting Unsolicited Non-serious AEs [Day 1 through Day 22]

    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 21 days after study vaccination.

  9. Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus [Day 8]

    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. The percentage of participants with HAI titer >= 1:40 was calculated for each study arm and stratum from the available results at 7 days post second vaccination (Day 8).

  10. Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus [Day 181]

    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. The percentage of participants with HAI titer >= 1:40 was calculated for each study arm and stratum from the available results at 180 days post second vaccination (Day 181).

  11. Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus [Day 8]

    Blood was collected for the Neutralizing 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 percentage of participants with Neut titer >= 1:40 was calculated for each study arm and stratum from the available results at 7 days post study vaccination (Day 8).

  12. Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus [Day 181]

    Blood was collected for the Neutralizing 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 percentage of participants with Neut titer >= 1:40 was calculated for each study arm and stratum from the available results at 180 days post study vaccination (Day 181).

  13. Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus [Day 8]

    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 and minimum 4-fold rise in post-vaccination antibody titer. Day 8 is 7 days post study vaccination.

  14. Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus [Day 181]

    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 and minimum 4-fold rise in post-vaccination antibody titer. Day 181 is 180 days post study vaccination.

  15. Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus [Day 8]

    Blood was collected for the Neutralizing 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 Neut pre-vaccination titer <1:10 and post-vaccination titer >= 1:40 or pre-vaccination titer >= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 7 days after study vaccination is Day 8.

  16. Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus [Day 181]

    Blood was collected for the Neutralizing 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 Neut pre-vaccination titer <1:10 and post-vaccination titer >= 1:40 or pre-vaccination titer >= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 180 days after study vaccination is Day 181.

  17. Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) [Day 22]

    Blood was collected for the HAI assay conducted with the 2013 H7N9 priming 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 percentage of participants with HAI titer >= 1:40 was calculated for each study arm and stratum from the available results at 21 days post second vaccination (Day 22).

  18. Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) [Day 22]

    Blood was collected for the Neutralizing assay conducted with the 2013 H7N9 priming 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 percentage of participants with Neut titer >= 1:40 was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).

  19. Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) [Day 22]

    Blood was collected for the HAI assay conducted with the 2013 H7N9 priming 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 and minimum 4-fold rise in post-vaccination antibody titer. Day 22 is 21 days post study vaccination.

  20. Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus) [Day 22]

    Blood was collected for the Neutralizing assay conducted with the 2013 H7N9 priming 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 Neut pre-vaccination titer <1:10 and post-vaccination titer >= 1:40 or pre-vaccination titer >= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after study vaccination is Day 22.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Subjects eligible to participate in this trial must meet all of the following inclusion criteria:

  1. Provide written informed consent prior to initiation of any study procedures.

  2. Are able to understand and comply with planned study procedures and be available for all study visits.

  3. Must agree to the collection of venous blood per protocol.

  4. Must agree to have residual specimens and samples/specimens collected during this trial specifically for the purpose of future research stored for future research use.

  5. Are males or non-pregnant females, 19 to 70 years of age, inclusive.

  6. Are in good health* *As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days, which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, emergency room or urgent care for condition and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose or frequency as a result of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site PI or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal and inhaled medications (except inhaled corticosteroids as outlined in the Subject Exclusion Criteria as well as herbals, vitamins and supplements are permitted.

  7. Oral temperature is less than 100.0 degrees Fahrenheit.

  8. Pulse is 47 to 100 beats per minute, inclusive.

  9. Systolic blood pressure is 85 to 150 mmHg, inclusive.

  10. Diastolic blood pressure is 55 to 95 mmHg, inclusive.

  11. Erythrocyte Sedimentation Rate (ESR) is less than 30 mm per hour.

  12. Women of childbearing potential** must use an acceptable contraception method*** from 30 days before study vaccination until 60 days after study vaccination.

**Not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure(R) placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year has passed since the last menses if menopausal.

***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 study vaccination, barrier methods such as condoms or diaphragms/cervical cap with spermicide, effective intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill").

  1. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.

  2. Received 1 or 2 doses of 2013 A/H7N9 IIV with or without AS03 or MF59 adjuvant in DMID Protocols 13-0032 or 13-0033, or are A/H7 IIV-naïve.

Exclusion Criteria:

Subjects eligible to participate in this trial must not meet any of the following exclusion criteria:

  1. Have an acute illness*, as determined by the site PI or appropriate sub-investigator, within 72 hours prior to study vaccination.

*An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.

  1. Have any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, is a contraindication to study participation**.

**Including acute or chronic medical disease or condition, defined as persisting for at least 90 days, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.

  1. Have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy.

  2. Use of cytotoxic anticancer chemotherapy or radiation therapy within 3 years prior to study vaccination.

  3. Have known active neoplastic disease or a history of any hematologic malignancy. Non-melanoma, treated, skin cancers are permitted.

  4. Have known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection.

  5. Have known hypersensitivity or allergy to eggs, egg or chicken protein, squalene-based adjuvants, or other components of the study vaccine.

  6. Have a history of severe reactions following previous immunization with licensed or unlicensed influenza vaccines.

  7. Have a personal or family history of narcolepsy.

  8. Have a history of Guillain-Barré Syndrome (GBS).

  9. Have a history of convulsions or encephalomyelitis within 90 days prior to study vaccination.

  10. Have a history of Potentially Immune-Mediated Medical Conditions (PIMMCs).

  11. Have a history of alcohol or drug abuse within 5 years prior to study vaccination.

  12. Have any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere*** with subject compliance or safety evaluations.

***As determined by the site PI or appropriate sub-investigator.

  1. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 10 years prior to study vaccination.

  2. Have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to study vaccination.

  3. Have taken high-dose inhaled corticosteroids**** within 30 days prior to study vaccination.

****High-dose defined as per age as using inhaled high-dose per reference chart in the National Heart, Lung and Blood Institute Guidelines for the Diagnosis and Management of Asthma (EPR-3) or other lists published in UPTODATE.

  1. Received or plan to receive a licensed, live vaccine within 30 days before or after study vaccination.

  2. Received or plan to receive a licensed, inactivated vaccine (excluding all licensed, seasonal IIVs) within 14 days before or after study vaccination.

  3. Received or plan to receive a licensed, seasonal IIV within 21 days before or after study vaccination.

  4. Received immunoglobulin or other blood products (except Rho D immunoglobulin) within 90 days prior to study vaccination.

  5. Received an experimental agent***** within 30 days prior to study vaccination or expect to receive an experimental agent****** during the trial-reporting period*******.

*****Including vaccine, drug, biologic, device, blood product, or medication.

******Other than from participation in this trial.

*******Approximately 12 months after study vaccination.

  1. Are participating or plan to participate in another clinical trial with an interventional agent******** that will be received during the trial-reporting period*********.

********Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication.

*********Approximately 12 months after study vaccination.

  1. Have a history of influenza A/H7 subtype infection.

  2. Had substantial direct contact********** with live or freshly slaughtered poultry or pigeons while in mainland China within the past five years.

**********Substantial direct contact is defined as visited a poultry farm and/or a live poultry market.

  1. Occupational exposure to or substantial direct physical contact*********** with birds in the past year and through 21 days after study vaccination.

***********Exposure to free range chickens in the yard is exclusionary. Casual contact with birds at petting zoos or county or state fairs or having pet birds does not exclude subjects from study participation.

  1. Female subjects who are breastfeeding.

  2. Plan to travel outside the US (continental US, Hawaii and Alaska) from the time of study vaccination through 21 days after study vaccination.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Emory Children's Center - Pediatric Infectious Diseases Atlanta Georgia United States 30322-1014
2 University of Iowa - Vaccine Research and Education Unit Iowa City Iowa United States 52242-2600
3 University of Maryland Baltimore - School of Medicine - Medicine Baltimore Maryland United States 21201-1509
4 Saint Louis University - Center for Vaccine Development Saint Louis Missouri United States 63104-1015
5 Cincinnati Children's Hospital Medical Center - Infectious Diseases Cincinnati Ohio United States 45229-3039
6 Vanderbilt University Medical Center - Infectious Diseases Nashville Tennessee United States 37232-0011
7 The University of Texas Medical Branch - Sealy Center for Vaccine Development (SCVD) Galveston Texas United States 77555-1121
8 Baylor College of Medicine - Molecular Virology and Microbiology Houston Texas United States 77030-3411
9 Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases Seattle Washington United States 98101-1466

Sponsors and Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT03738241
Other Study ID Numbers:
  • 17-0090
  • HHSN272201300015I
First Posted:
Nov 13, 2018
Last Update Posted:
Jul 30, 2021
Last Verified:
Nov 8, 2018
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
A/H7N9 Inactivated Influenza Vaccine
AS03 Adjuvant
Immunogenicity
Influenza
Phase II
Reactogenicity
Safety
Vaccine
Additional relevant MeSH terms:
Influenza, Human
Influenza in Birds

Study Results

Participant Flow

Recruitment Details Participants were healthy males and non-pregnant females between 19 and 70 years old, inclusively. They were recruited from the communities at large around the clinical sites. Participants were enrolled between 18DEC2018 and 19MAR2019.
Pre-assignment Detail
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description Participants will have prior administration of 2013 A/H7N9 IIV with MF59. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages. Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose). Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine. Participants will have prior administration of 2013 A/H7N9 IIV with MF59. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages. Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose). Drug: AS03 AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer. Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine. Participants will have prior administration of 2013 A/H7N9 IIV with AS03. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages. Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose). Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine. Participants will have prior administration of 2013 A/H7N9 IIV with AS03. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages. Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose). Drug: AS03 AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer. Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine. Participants will have prior administration of 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages. Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose). Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine. Participants will have prior administration of 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages. Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose). Drug: AS03 AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer. Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine. Participants will have prior administration of 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages. Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose). Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine. Participants will have prior administration of 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages. Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose). Drug: AS03 AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer. Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine. Participants who are A/H7 IIV-Naïve. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages. Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose). Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine. Participants who are A/H7 IIV-Naïve. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages. Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose). Drug: AS03 AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer. Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine.
Period Title: Overall Study
STARTED 38 40 24 18 40 44 20 16 29 35
COMPLETED 37 40 24 18 40 44 20 16 28 34
NOT COMPLETED 1 0 0 0 0 0 0 0 1 1

Baseline Characteristics

Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 Total
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. Total of all reporting groups
Overall Participants 38 40 24 18 40 44 20 16 29 35 304
Age, Customized (Count of Participants)
19 - 35 years
9
23.7%
4
10%
5
20.8%
1
5.6%
11
27.5%
5
11.4%
5
25%
4
25%
20
69%
19
54.3%
83
27.3%
36 - 50 years
14
36.8%
18
45%
6
25%
6
33.3%
11
27.5%
15
34.1%
3
15%
3
18.8%
3
10.3%
10
28.6%
89
29.3%
51-70 years
15
39.5%
18
45%
13
54.2%
11
61.1%
18
45%
24
54.5%
12
60%
9
56.3%
6
20.7%
6
17.1%
132
43.4%
Sex: Female, Male (Count of Participants)
Female
18
47.4%
21
52.5%
11
45.8%
16
88.9%
26
65%
25
56.8%
11
55%
13
81.3%
16
55.2%
15
42.9%
172
56.6%
Male
20
52.6%
19
47.5%
13
54.2%
2
11.1%
14
35%
19
43.2%
9
45%
3
18.8%
13
44.8%
20
57.1%
132
43.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
1
2.6%
2
5%
3
12.5%
0
0%
2
5%
3
6.8%
0
0%
2
12.5%
4
13.8%
4
11.4%
21
6.9%
Not Hispanic or Latino
37
97.4%
38
95%
21
87.5%
18
100%
38
95%
41
93.2%
20
100%
14
87.5%
25
86.2%
31
88.6%
283
93.1%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
6.3%
0
0%
1
2.9%
2
0.7%
Asian
0
0%
1
2.5%
1
4.2%
0
0%
1
2.5%
2
4.5%
1
5%
1
6.3%
4
13.8%
2
5.7%
13
4.3%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Black or African American
6
15.8%
3
7.5%
1
4.2%
2
11.1%
2
5%
4
9.1%
0
0%
3
18.8%
10
34.5%
11
31.4%
42
13.8%
White
30
78.9%
35
87.5%
22
91.7%
13
72.2%
34
85%
34
77.3%
18
90%
11
68.8%
12
41.4%
20
57.1%
229
75.3%
More than one race
2
5.3%
1
2.5%
0
0%
2
11.1%
2
5%
4
9.1%
1
5%
0
0%
3
10.3%
1
2.9%
16
5.3%
Unknown or Not Reported
0
0%
0
0%
0
0%
1
5.6%
1
2.5%
0
0%
0
0%
0
0%
0
0%
0
0%
2
0.7%
Region of Enrollment (participants) [Number]
United States
38
100%
40
100%
24
100%
18
100%
40
100%
44
100%
20
100%
16
100%
29
100%
35
100%
304
100%
Body Mass Index (BMI) (Count of Participants)
< 30 kg/m^2
25
65.8%
26
65%
16
66.7%
13
72.2%
29
72.5%
28
63.6%
15
75%
8
50%
17
58.6%
26
74.3%
203
66.8%
>= 30 kg/m^2
13
34.2%
14
35%
8
33.3%
5
27.8%
11
27.5%
16
36.4%
5
25%
8
50%
12
41.4%
9
25.7%
101
33.2%
Prior Seasonal Influenza Vaccination (Count of Participants)
2017-2018 and 2018-2019
30
78.9%
32
80%
17
70.8%
13
72.2%
31
77.5%
30
68.2%
16
80%
10
62.5%
13
44.8%
14
40%
206
67.8%
2017-2018 only
0
0%
2
5%
3
12.5%
1
5.6%
2
5%
2
4.5%
1
5%
2
12.5%
6
20.7%
7
20%
26
8.6%
2018-2019 only
3
7.9%
3
7.5%
0
0%
1
5.6%
2
5%
6
13.6%
0
0%
3
18.8%
4
13.8%
6
17.1%
28
9.2%
Neither
5
13.2%
3
7.5%
4
16.7%
3
16.7%
5
12.5%
6
13.6%
3
15%
1
6.3%
6
20.7%
8
22.9%
44
14.5%

Outcome Measures

1. Primary Outcome
Title Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus
Description Blood was collected for HAI assay which was 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 and stratum from the available results at 21 days post study vaccination (Day 22).
Time Frame Day 22

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 35 40 24 18 40 44 20 16 28 35
Number (95% Confidence Interval) [titer]
22.7
116.1
77.7
190.3
10.9
31.7
33.1
180.9
6.6
8.3
2. Primary Outcome
Title Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus
Description Blood was collected for Neutralizing assay which was 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 and stratum from the available results at 21 days post study vaccination (Day 22).
Time Frame Day 22

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 35 40 24 18 40 44 20 16 28 35
Number (95% Confidence Interval) [titer]
64.3
367.6
204.5
870.9
28.6
72.2
115.1
562.0
5.8
10.8
3. Primary Outcome
Title Number of Participants Reporting Serious Adverse Events (SAEs)
Description 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.
Time Frame Day 1 through Day 366

Outcome Measure Data

Analysis Population Description
The safety population includes all participants who received study vaccination.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 38 40 24 18 40 44 20 16 29 35
Count of Participants [Participants]
0
0%
1
2.5%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
3.4%
0
0%
4. Primary Outcome
Title Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs)
Description 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 1 to Day 8

Outcome Measure Data

Analysis Population Description
The safety population includes all participants who received study vaccination. Participants with at least one lab result reported for Day 8 were included for this outcome measure.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 38 40 24 18 40 44 20 16 29 35
ALT
1
2.6%
0
0%
3
12.5%
0
0%
3
7.5%
0
0%
1
5%
3
18.8%
0
0%
1
2.9%
Bilirubin
0
0%
0
0%
1
4.2%
0
0%
0
0%
0
0%
0
0%
0
0%
1
3.4%
0
0%
Creatinine
0
0%
1
2.5%
0
0%
0
0%
2
5%
0
0%
0
0%
0
0%
0
0%
1
2.9%
Hemoglobin
2
5.3%
0
0%
0
0%
1
5.6%
2
5%
0
0%
0
0%
1
6.3%
1
3.4%
3
8.6%
Platelets
2
5.3%
0
0%
1
4.2%
0
0%
1
2.5%
0
0%
0
0%
0
0%
0
0%
2
5.7%
WBC
3
7.9%
2
5%
2
8.3%
0
0%
3
7.5%
3
6.8%
0
0%
1
6.3%
1
3.4%
3
8.6%
5. Primary Outcome
Title Number of Participants Reporting Solicited Injection Site Reactogenicity Events
Description Injection site AEs solicited on a memory aid provided to participants included 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 (any measured value >0mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination.
Time Frame Day 1 through Day 8

Outcome Measure Data

Analysis Population Description
The safety population includes all participants who received study vaccination.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 38 40 24 18 40 44 20 16 29 35
Count of Participants [Participants]
11
28.9%
35
87.5%
5
20.8%
16
88.9%
11
27.5%
38
86.4%
3
15%
14
87.5%
12
41.4%
30
85.7%
6. Primary Outcome
Title Number of Participants Reporting Solicited Systemic Reactogenicity Events
Description 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 at or following the first vaccination.
Time Frame Day 1 through Day 8

Outcome Measure Data

Analysis Population Description
The safety population includes all participants who received study vaccination.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 38 40 24 18 40 44 20 16 29 35
Count of Participants [Participants]
12
31.6%
24
60%
8
33.3%
6
33.3%
16
40%
16
36.4%
7
35%
10
62.5%
10
34.5%
20
57.1%
7. Primary Outcome
Title Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus
Description 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. The percentage of participants with HAI titer >= 1:40 was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Time Frame Day 22

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 35 40 24 18 40 44 20 16 28 35
Number (95% Confidence Interval) [percentage of participants]
49
128.9%
88
220%
75
312.5%
89
494.4%
20
50%
59
134.1%
55
275%
94
587.5%
11
37.9%
9
25.7%
8. Primary Outcome
Title Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus
Description Blood was collected for the Neutralizing 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 percentage of participants with Neut titer >= 1:40 was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Time Frame Day 22

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 35 40 24 18 40 44 20 16 28 35
Number (95% Confidence Interval) [percentage of participants]
69
181.6%
98
245%
92
383.3%
100
555.6%
43
107.5%
66
150%
75
375%
94
587.5%
4
13.8%
3
8.6%
9. Primary Outcome
Title Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus
Description 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 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after study vaccination is Day 22.
Time Frame Day 22

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 35 40 24 18 40 44 20 16 28 35
Number (95% Confidence Interval) [percentage of participants]
49
128.9%
88
220%
75
312.5%
83
461.1%
20
50%
52
118.2%
55
275%
88
550%
7
24.1%
6
17.1%
10. Primary Outcome
Title Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus
Description Blood was collected for the Neutralizing 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 Neut pre-vaccination titer <1:10 and post-vaccination titer >= 1:40 or pre-vaccination titer >= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after study vaccination is Day 22.
Time Frame Day 22

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 35 40 24 18 40 44 20 16 28 35
Number (95% Confidence Interval) [percentage of participants]
69
181.6%
98
245%
83
345.8%
100
555.6%
43
107.5%
64
145.5%
75
375%
94
587.5%
4
13.8%
3
8.6%
11. Secondary Outcome
Title Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 8 Against the 2017 Influenza A/ H7N9 Vaccine Virus
Description Blood was collected for HAI assay which was 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 and stratum from the available results at 7 days post study vaccination (Day 8).
Time Frame Day 8

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 36 40 24 18 40 44 20 16 28 35
Geometric Mean (95% Confidence Interval) [titer]
13.9
54.2
36.2
113.9
9.9
18.1
16.8
91.8
6.1
6.1
12. Secondary Outcome
Title Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 181 Against the 2017 Influenza A/ H7N9 Vaccine Virus
Description Blood was collected for HAI assay which was 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 and stratum from the available results at 180 days post study vaccination (Day 181).
Time Frame Day 181

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 35 40 24 18 40 44 20 16 27 34
Geometric Mean (95% Confidence Interval) [titer]
10.5
40.0
35.1
79.5
9.9
11.5
9.5
42.7
5.1
6.2
13. Secondary Outcome
Title Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus
Description Blood was collected for Neutralizing assay which was 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 and stratum from the available results at 7 days post study vaccination (Day 8).
Time Frame Day 8

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 36 40 24 18 40 44 20 16 28 35
Geometric Mean (95% Confidence Interval) [titer]
34.3
153.2
108.9
482.5
17.5
31.4
45.2
320.0
5.9
7.0
14. Secondary Outcome
Title Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus
Description Blood was collected for Neutralizing assay which was 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 and stratum from the available results at 180 days post study vaccination (Day 181).
Time Frame Day 181

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 35 40 24 18 40 44 19 16 27 34
Geometric Mean (95% Confidence Interval) [titer]
24.1
105.3
73.4
296.3
14.3
17.0
34.6
110.7
5.4
10.2
15. Secondary Outcome
Title Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
Description Blood was collected for HAI assay which was conducted with the 2013 H7N9 priming 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 and stratum from the available results at 21 days post study vaccination (Day 22).
Time Frame Day 22

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 35 40 24 18 40 44 20 16 28 35
Geometric Mean (95% Confidence Interval) [titer]
18.7
92.7
62.6
166.3
9.0
21.0
27.3
146.7
5.3
6.1
16. Secondary Outcome
Title Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
Description Blood was collected for Neutralizing assay which was conducted with the 2013 H7N9 priming 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 and stratum from the available results at 21 days post study vaccination (Day 22).
Time Frame Day 22

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 35 40 24 18 40 44 20 16 28 35
Geometric Mean (95% Confidence Interval) [titer]
98.5
515.4
329.4
1015.9
39.3
102.1
171.5
744.8
7.0
10.1
17. Secondary Outcome
Title Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)
Description 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 through Day 366

Outcome Measure Data

Analysis Population Description
The safety population includes all participants who received study vaccination.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 38 40 24 18 40 44 20 16 29 35
MAAE
5
13.2%
8
20%
5
20.8%
6
33.3%
13
32.5%
7
15.9%
8
40%
4
25%
10
34.5%
3
8.6%
NOCMC
1
2.6%
0
0%
0
0%
0
0%
1
2.5%
2
4.5%
0
0%
0
0%
0
0%
1
2.9%
PIMMC
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
18. Secondary Outcome
Title Number of Participants Reporting Unsolicited Non-serious AEs
Description 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 21 days after study vaccination.
Time Frame Day 1 through Day 22

Outcome Measure Data

Analysis Population Description
The safety population includes all participants who received study vaccination.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 38 40 24 18 40 44 20 16 29 35
Count of Participants [Participants]
9
23.7%
10
25%
3
12.5%
4
22.2%
15
37.5%
10
22.7%
7
35%
5
31.3%
8
27.6%
7
20%
19. Secondary Outcome
Title Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus
Description 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. The percentage of participants with HAI titer >= 1:40 was calculated for each study arm and stratum from the available results at 7 days post second vaccination (Day 8).
Time Frame Day 8

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 36 40 24 18 40 44 20 16 28 35
Number (95% Confidence Interval) [percentage of participants]
28
73.7%
65
162.5%
63
262.5%
83
461.1%
18
45%
41
93.2%
35
175%
81
506.3%
7
24.1%
6
17.1%
20. Secondary Outcome
Title Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus
Description 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. The percentage of participants with HAI titer >= 1:40 was calculated for each study arm and stratum from the available results at 180 days post second vaccination (Day 181).
Time Frame Day 181

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 35 40 24 18 40 44 20 16 27 34
Number (95% Confidence Interval) [percentage of participants]
20
52.6%
55
137.5%
54
225%
78
433.3%
18
45%
25
56.8%
20
100%
56
350%
0
0%
6
17.1%
21. Secondary Outcome
Title Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus
Description Blood was collected for the Neutralizing 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 percentage of participants with Neut titer >= 1:40 was calculated for each study arm and stratum from the available results at 7 days post study vaccination (Day 8).
Time Frame Day 8

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 36 40 24 18 40 44 20 16 28 35
Number (95% Confidence Interval) [percentage of participants]
53
139.5%
80
200%
79
329.2%
100
555.6%
33
82.5%
48
109.1%
55
275%
94
587.5%
4
13.8%
9
25.7%
22. Secondary Outcome
Title Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus
Description Blood was collected for the Neutralizing 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 percentage of participants with Neut titer >= 1:40 was calculated for each study arm and stratum from the available results at 180 days post study vaccination (Day 181).
Time Frame Day 181

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 35 40 24 18 40 44 19 16 27 34
Number (95% Confidence Interval) [percentage of participants]
31
81.6%
75
187.5%
67
279.2%
94
522.2%
23
57.5%
32
72.7%
42
210%
88
550%
0
0%
9
25.7%
23. Secondary Outcome
Title Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus
Description 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 and minimum 4-fold rise in post-vaccination antibody titer. Day 8 is 7 days post study vaccination.
Time Frame Day 8

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 36 40 24 18 40 44 20 16 28 35
Number (95% Confidence Interval) [percentage of participants]
28
73.7%
60
150%
58
241.7%
83
461.1%
18
45%
34
77.3%
35
175%
75
468.8%
4
13.8%
3
8.6%
24. Secondary Outcome
Title Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus
Description 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 and minimum 4-fold rise in post-vaccination antibody titer. Day 181 is 180 days post study vaccination.
Time Frame Day 181

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 35 40 24 18 40 44 20 16 27 34
Number (95% Confidence Interval) [percentage of participants]
20
52.6%
53
132.5%
50
208.3%
72
400%
18
45%
18
40.9%
20
100%
50
312.5%
0
0%
3
8.6%
25. Secondary Outcome
Title Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus
Description Blood was collected for the Neutralizing 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 Neut pre-vaccination titer <1:10 and post-vaccination titer >= 1:40 or pre-vaccination titer >= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 7 days after study vaccination is Day 8.
Time Frame Day 8

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 36 40 24 18 40 44 20 16 28 35
Number (95% Confidence Interval) [percentage of participants]
53
139.5%
80
200%
75
312.5%
100
555.6%
33
82.5%
48
109.1%
55
275%
88
550%
4
13.8%
9
25.7%
26. Secondary Outcome
Title Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus
Description Blood was collected for the Neutralizing 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 Neut pre-vaccination titer <1:10 and post-vaccination titer >= 1:40 or pre-vaccination titer >= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 180 days after study vaccination is Day 181.
Time Frame Day 181

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 35 40 24 18 40 44 19 16 27 34
Number (95% Confidence Interval) [percentage of participants]
31
81.6%
73
182.5%
63
262.5%
94
522.2%
23
57.5%
32
72.7%
42
210%
88
550%
0
0%
9
25.7%
27. Secondary Outcome
Title Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
Description Blood was collected for the HAI assay conducted with the 2013 H7N9 priming 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 percentage of participants with HAI titer >= 1:40 was calculated for each study arm and stratum from the available results at 21 days post second vaccination (Day 22).
Time Frame Day 22

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 35 40 24 18 40 44 20 16 28 35
Number (95% Confidence Interval) [percentage of participants]
34
89.5%
85
212.5%
75
312.5%
94
522.2%
15
37.5%
45
102.3%
55
275%
94
587.5%
0
0%
3
8.6%
28. Secondary Outcome
Title Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
Description Blood was collected for the Neutralizing assay conducted with the 2013 H7N9 priming 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 percentage of participants with Neut titer >= 1:40 was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Time Frame Day 22

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 35 40 24 18 40 44 20 16 28 35
Number (95% Confidence Interval) [percentage of participants]
74
194.7%
98
245%
96
400%
100
555.6%
50
125%
84
190.9%
90
450%
100
625%
4
13.8%
6
17.1%
29. Secondary Outcome
Title Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
Description Blood was collected for the HAI assay conducted with the 2013 H7N9 priming 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 and minimum 4-fold rise in post-vaccination antibody titer. Day 22 is 21 days post study vaccination.
Time Frame Day 22

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 35 40 24 18 40 44 20 16 28 35
Number (95% Confidence Interval) [percentage of participants]
34
89.5%
85
212.5%
75
312.5%
89
494.4%
15
37.5%
45
102.3%
55
275%
94
587.5%
0
0%
3
8.6%
30. Secondary Outcome
Title Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
Description Blood was collected for the Neutralizing assay conducted with the 2013 H7N9 priming 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 Neut pre-vaccination titer <1:10 and post-vaccination titer >= 1:40 or pre-vaccination titer >= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after study vaccination is Day 22.
Time Frame Day 22

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Measure Participants 35 40 24 18 40 44 20 16 28 35
Number (95% Confidence Interval) [percentage of participants]
74
194.7%
98
245%
96
400%
100
555.6%
50
125%
84
190.9%
90
450%
100
625%
4
13.8%
3
8.6%

Adverse Events

Time Frame Solicited events and clinical safety laboratory AEs were collected from the time of study vaccination through 7 days after study vaccination. Unsolicited, non-serious AEs were collected from the time of study vaccination through approximately 21 days after study vaccination. SAEs, MAAEs, including NOCMCs and PIMMCs were collected from the time of study vaccination through approximately 12 months after study vaccination
Adverse Event Reporting Description AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
All Cause Mortality
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/38 (0%) 0/40 (0%) 0/24 (0%) 0/18 (0%) 0/40 (0%) 0/44 (0%) 0/20 (0%) 0/16 (0%) 0/29 (0%) 0/35 (0%)
Serious Adverse Events
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/38 (0%) 1/40 (2.5%) 0/24 (0%) 0/18 (0%) 0/40 (0%) 0/44 (0%) 0/20 (0%) 0/16 (0%) 1/29 (3.4%) 0/35 (0%)
General disorders
Chest Pain 0/38 (0%) 0 1/40 (2.5%) 1 0/24 (0%) 0 0/18 (0%) 0 0/40 (0%) 0 0/44 (0%) 0 0/20 (0%) 0 0/16 (0%) 0 0/29 (0%) 0 0/35 (0%) 0
Infections and infestations
Sepsis 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 0/18 (0%) 0 0/40 (0%) 0 0/44 (0%) 0 0/20 (0%) 0 0/16 (0%) 0 1/29 (3.4%) 1 0/35 (0%) 0
Other (Not Including Serious) Adverse Events
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 25/38 (65.8%) 37/40 (92.5%) 12/24 (50%) 16/18 (88.9%) 29/40 (72.5%) 40/44 (90.9%) 13/20 (65%) 15/16 (93.8%) 19/29 (65.5%) 34/35 (97.1%)
Eye disorders
Ocular Hyperaemia 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 1/18 (5.6%) 1 0/40 (0%) 0 0/44 (0%) 0 0/20 (0%) 0 0/16 (0%) 0 0/29 (0%) 0 0/35 (0%) 0
Swelling of Eyelid 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 1/18 (5.6%) 1 0/40 (0%) 0 0/44 (0%) 0 0/20 (0%) 0 0/16 (0%) 0 0/29 (0%) 0 0/35 (0%) 0
Gastrointestinal disorders
Diarrhoea 1/38 (2.6%) 1 1/40 (2.5%) 1 0/24 (0%) 0 0/18 (0%) 0 0/40 (0%) 0 2/44 (4.5%) 2 2/20 (10%) 2 1/16 (6.3%) 1 0/29 (0%) 0 2/35 (5.7%) 2
Nausea 1/38 (2.6%) 1 0/40 (0%) 0 2/24 (8.3%) 2 0/18 (0%) 0 2/40 (5%) 2 3/44 (6.8%) 3 0/20 (0%) 0 4/16 (25%) 4 1/29 (3.4%) 1 2/35 (5.7%) 2
Vomiting 1/38 (2.6%) 1 1/40 (2.5%) 1 0/24 (0%) 0 0/18 (0%) 0 0/40 (0%) 0 0/44 (0%) 0 0/20 (0%) 0 1/16 (6.3%) 1 1/29 (3.4%) 1 0/35 (0%) 0
General disorders
Fatigue 7/38 (18.4%) 7 15/40 (37.5%) 15 3/24 (12.5%) 3 2/18 (11.1%) 2 11/40 (27.5%) 11 9/44 (20.5%) 9 5/20 (25%) 5 6/16 (37.5%) 7 7/29 (24.1%) 7 10/35 (28.6%) 10
Feeling Hot 2/38 (5.3%) 2 4/40 (10%) 4 2/24 (8.3%) 2 2/18 (11.1%) 2 3/40 (7.5%) 3 3/44 (6.8%) 3 2/20 (10%) 2 1/16 (6.3%) 1 3/29 (10.3%) 3 5/35 (14.3%) 5
Influenza Like Illness 0/38 (0%) 0 1/40 (2.5%) 1 0/24 (0%) 0 0/18 (0%) 0 0/40 (0%) 0 0/44 (0%) 0 0/20 (0%) 0 1/16 (6.3%) 1 1/29 (3.4%) 1 0/35 (0%) 0
Injection Site Erythema 5/38 (13.2%) 5 10/40 (25%) 10 3/24 (12.5%) 3 4/18 (22.2%) 4 5/40 (12.5%) 5 10/44 (22.7%) 10 1/20 (5%) 1 5/16 (31.3%) 5 8/29 (27.6%) 8 7/35 (20%) 7
Injection Site Haemorrhage 1/38 (2.6%) 1 2/40 (5%) 2 2/24 (8.3%) 2 2/18 (11.1%) 2 0/40 (0%) 0 6/44 (13.6%) 6 0/20 (0%) 0 2/16 (12.5%) 2 1/29 (3.4%) 1 4/35 (11.4%) 4
Injection Site Induration 1/38 (2.6%) 1 7/40 (17.5%) 7 1/24 (4.2%) 1 4/18 (22.2%) 4 2/40 (5%) 2 7/44 (15.9%) 7 1/20 (5%) 1 3/16 (18.8%) 3 2/29 (6.9%) 2 8/35 (22.9%) 8
Injection Site Pain 0/38 (0%) 0 22/40 (55%) 22 0/24 (0%) 0 8/18 (44.4%) 9 2/40 (5%) 2 18/44 (40.9%) 18 1/20 (5%) 1 13/16 (81.3%) 13 3/29 (10.3%) 3 17/35 (48.6%) 17
Injection Site Pain (Tenderness) 7/38 (18.4%) 7 31/40 (77.5%) 31 1/24 (4.2%) 1 14/18 (77.8%) 14 6/40 (15%) 6 34/44 (77.3%) 34 1/20 (5%) 1 13/16 (81.3%) 13 4/29 (13.8%) 4 28/35 (80%) 28
Injection Site Pruritus 0/38 (0%) 0 3/40 (7.5%) 3 0/24 (0%) 0 2/18 (11.1%) 2 0/40 (0%) 0 1/44 (2.3%) 1 0/20 (0%) 0 2/16 (12.5%) 2 0/29 (0%) 0 1/35 (2.9%) 1
Malaise 4/38 (10.5%) 4 9/40 (22.5%) 9 3/24 (12.5%) 3 2/18 (11.1%) 2 8/40 (20%) 9 6/44 (13.6%) 6 2/20 (10%) 2 3/16 (18.8%) 3 3/29 (10.3%) 3 5/35 (14.3%) 5
Pyrexia 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 0/18 (0%) 0 1/40 (2.5%) 1 0/44 (0%) 0 0/20 (0%) 0 1/16 (6.3%) 1 0/29 (0%) 0 1/35 (2.9%) 1
Vaccination Site Lymphadenopathy 0/38 (0%) 0 1/40 (2.5%) 1 0/24 (0%) 0 0/18 (0%) 0 0/40 (0%) 0 0/44 (0%) 0 0/20 (0%) 0 1/16 (6.3%) 1 0/29 (0%) 0 0/35 (0%) 0
Infections and infestations
Bronchitis 0/38 (0%) 0 1/40 (2.5%) 1 0/24 (0%) 0 1/18 (5.6%) 1 0/40 (0%) 0 0/44 (0%) 0 0/20 (0%) 0 0/16 (0%) 0 0/29 (0%) 0 0/35 (0%) 0
Influenza 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 0/18 (0%) 0 0/40 (0%) 0 0/44 (0%) 0 0/20 (0%) 0 1/16 (6.3%) 1 1/29 (3.4%) 1 0/35 (0%) 0
Nasopharyngitis 1/38 (2.6%) 1 1/40 (2.5%) 1 0/24 (0%) 0 0/18 (0%) 0 2/40 (5%) 3 2/44 (4.5%) 2 1/20 (5%) 1 0/16 (0%) 0 1/29 (3.4%) 1 0/35 (0%) 0
Respiratory Tract Infection 1/38 (2.6%) 1 1/40 (2.5%) 1 1/24 (4.2%) 1 0/18 (0%) 0 0/40 (0%) 0 0/44 (0%) 0 0/20 (0%) 0 1/16 (6.3%) 1 1/29 (3.4%) 1 0/35 (0%) 0
Sinusitis 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 1/18 (5.6%) 1 0/40 (0%) 0 0/44 (0%) 0 0/20 (0%) 0 0/16 (0%) 0 1/29 (3.4%) 1 0/35 (0%) 0
Upper Respiratory Tract Infection 2/38 (5.3%) 2 1/40 (2.5%) 2 0/24 (0%) 0 2/18 (11.1%) 2 4/40 (10%) 4 2/44 (4.5%) 3 0/20 (0%) 0 1/16 (6.3%) 1 1/29 (3.4%) 1 1/35 (2.9%) 1
Injury, poisoning and procedural complications
Chest Injury 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 0/18 (0%) 0 0/40 (0%) 0 0/44 (0%) 0 1/20 (5%) 1 0/16 (0%) 0 0/29 (0%) 0 0/35 (0%) 0
Contusion 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 1/18 (5.6%) 1 0/40 (0%) 0 0/44 (0%) 0 0/20 (0%) 0 0/16 (0%) 0 1/29 (3.4%) 1 0/35 (0%) 0
Fibula Fracture 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 0/18 (0%) 0 0/40 (0%) 0 0/44 (0%) 0 0/20 (0%) 0 1/16 (6.3%) 1 0/29 (0%) 0 0/35 (0%) 0
Skin Laceration 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 0/18 (0%) 0 0/40 (0%) 0 0/44 (0%) 0 1/20 (5%) 1 0/16 (0%) 0 0/29 (0%) 0 0/35 (0%) 0
Investigations
Alanine Aminotransferase Increased 1/38 (2.6%) 2 0/40 (0%) 0 3/24 (12.5%) 3 0/18 (0%) 0 3/40 (7.5%) 5 0/44 (0%) 0 1/20 (5%) 1 3/16 (18.8%) 4 0/29 (0%) 0 1/35 (2.9%) 1
Blood Creatinine Increased 0/38 (0%) 0 1/40 (2.5%) 2 0/24 (0%) 0 0/18 (0%) 0 2/40 (5%) 3 0/44 (0%) 0 0/20 (0%) 0 0/16 (0%) 0 0/29 (0%) 0 1/35 (2.9%) 1
Hemoglobin Decreased 2/38 (5.3%) 2 0/40 (0%) 0 0/24 (0%) 0 1/18 (5.6%) 1 2/40 (5%) 2 0/44 (0%) 0 0/20 (0%) 0 1/16 (6.3%) 1 1/29 (3.4%) 1 3/35 (8.6%) 4
Platelet Count Increased 1/38 (2.6%) 1 0/40 (0%) 0 0/24 (0%) 0 0/18 (0%) 0 0/40 (0%) 0 0/44 (0%) 0 0/20 (0%) 0 0/16 (0%) 0 0/29 (0%) 0 2/35 (5.7%) 3
White Blood Cell Count Decreased 3/38 (7.9%) 3 1/40 (2.5%) 1 1/24 (4.2%) 1 0/18 (0%) 0 4/40 (10%) 5 3/44 (6.8%) 3 0/20 (0%) 0 1/16 (6.3%) 1 1/29 (3.4%) 1 2/35 (5.7%) 2
Metabolism and nutrition disorders
Decreased Appetite 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 0/18 (0%) 0 0/40 (0%) 0 0/44 (0%) 0 0/20 (0%) 0 1/16 (6.3%) 1 0/29 (0%) 0 0/35 (0%) 0
Musculoskeletal and connective tissue disorders
Arthralgia 4/38 (10.5%) 4 2/40 (5%) 2 0/24 (0%) 0 2/18 (11.1%) 2 1/40 (2.5%) 1 2/44 (4.5%) 2 4/20 (20%) 4 0/16 (0%) 0 1/29 (3.4%) 1 4/35 (11.4%) 4
Back Pain 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 0/18 (0%) 0 1/40 (2.5%) 1 1/44 (2.3%) 1 1/20 (5%) 1 0/16 (0%) 0 0/29 (0%) 0 0/35 (0%) 0
Intervertebral Disc Protrusion 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 0/18 (0%) 0 0/40 (0%) 0 0/44 (0%) 0 1/20 (5%) 1 0/16 (0%) 0 0/29 (0%) 0 0/35 (0%) 0
Myalgia 4/38 (10.5%) 4 11/40 (27.5%) 11 0/24 (0%) 0 1/18 (5.6%) 1 1/40 (2.5%) 1 8/44 (18.2%) 8 5/20 (25%) 5 2/16 (12.5%) 2 4/29 (13.8%) 4 9/35 (25.7%) 9
Osteoporosis 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 0/18 (0%) 0 0/40 (0%) 0 0/44 (0%) 0 1/20 (5%) 1 0/16 (0%) 0 0/29 (0%) 0 0/35 (0%) 0
Pain in Extremity 0/38 (0%) 0 1/40 (2.5%) 2 1/24 (4.2%) 1 0/18 (0%) 0 0/40 (0%) 0 0/44 (0%) 0 2/20 (10%) 2 0/16 (0%) 0 0/29 (0%) 0 0/35 (0%) 0
Rotator Cuff Syndrome 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 1/18 (5.6%) 1 1/40 (2.5%) 1 0/44 (0%) 0 0/20 (0%) 0 0/16 (0%) 0 0/29 (0%) 0 0/35 (0%) 0
Nervous system disorders
Dizziness 1/38 (2.6%) 1 0/40 (0%) 0 0/24 (0%) 0 1/18 (5.6%) 1 0/40 (0%) 0 0/44 (0%) 0 0/20 (0%) 0 0/16 (0%) 0 0/29 (0%) 0 0/35 (0%) 0
Headache 8/38 (21.1%) 8 11/40 (27.5%) 11 6/24 (25%) 6 4/18 (22.2%) 4 11/40 (27.5%) 12 8/44 (18.2%) 8 2/20 (10%) 2 7/16 (43.8%) 7 6/29 (20.7%) 6 9/35 (25.7%) 9
Psychiatric disorders
Insomnia 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 0/18 (0%) 0 0/40 (0%) 0 1/44 (2.3%) 1 0/20 (0%) 0 2/16 (12.5%) 2 0/29 (0%) 0 0/35 (0%) 0
Renal and urinary disorders
Nephrolithiasis 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 0/18 (0%) 0 0/40 (0%) 0 0/44 (0%) 0 1/20 (5%) 1 0/16 (0%) 0 0/29 (0%) 0 0/35 (0%) 0
Reproductive system and breast disorders
Menopausal Symptoms 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 0/18 (0%) 0 0/40 (0%) 0 0/44 (0%) 0 1/20 (5%) 1 0/16 (0%) 0 0/29 (0%) 0 0/35 (0%) 0
Respiratory, thoracic and mediastinal disorders
Asthma 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 1/18 (5.6%) 1 0/40 (0%) 0 0/44 (0%) 0 0/20 (0%) 0 0/16 (0%) 0 0/29 (0%) 0 0/35 (0%) 0
Cough 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 1/18 (5.6%) 1 0/40 (0%) 0 0/44 (0%) 0 0/20 (0%) 0 0/16 (0%) 0 0/29 (0%) 0 0/35 (0%) 0
Oropharyngeal Pain 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 1/18 (5.6%) 1 0/40 (0%) 0 0/44 (0%) 0 1/20 (5%) 1 0/16 (0%) 0 0/29 (0%) 0 0/35 (0%) 0
Surgical and medical procedures
Bone Lesion Excision 0/38 (0%) 0 0/40 (0%) 0 0/24 (0%) 0 0/18 (0%) 0 0/40 (0%) 0 0/44 (0%) 0 1/20 (5%) 1 0/16 (0%) 0 0/29 (0%) 0 0/35 (0%) 0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title Hana El Sahly, MD, FIDSA
Organization Baylor College of Medicine
Phone 713-798-2058
Email hana.elsahly@bcm.edu
Responsible Party:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT03738241
Other Study ID Numbers:
  • 17-0090
  • HHSN272201300015I
First Posted:
Nov 13, 2018
Last Update Posted:
Jul 30, 2021
Last Verified:
Nov 8, 2018