Trial Outcomes & Findings for 2017 A/H7N9 IIV Revaccination (NCT NCT03738241)
NCT ID: NCT03738241
Last Updated: 2021-07-30
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
304 participants
Primary outcome timeframe
Day 22
Results posted on
2021-07-30
Participant Flow
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.
Participant milestones
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV
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.
|
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
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.
|
2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV
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.
|
2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03
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.
|
2013 A/H7N9 IIV|2017 A/H7N9 IIV
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.
|
2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03
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.
|
2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
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.
|
2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
38
|
40
|
24
|
18
|
40
|
44
|
20
|
16
|
29
|
35
|
|
Overall Study
COMPLETED
|
37
|
40
|
24
|
18
|
40
|
44
|
20
|
16
|
28
|
34
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV
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.
|
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
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.
|
2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV
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.
|
2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03
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.
|
2013 A/H7N9 IIV|2017 A/H7N9 IIV
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.
|
2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03
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.
|
2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
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.
|
2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
2017 A/H7N9 IIV Revaccination
Baseline characteristics by cohort
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV
n=38 Participants
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+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=29 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Age, Categorical · 19 - 35 years
|
9 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
20 Participants
n=114 Participants
|
19 Participants
|
83 Participants
n=19 Participants
|
|
Age, Customized
Age, Categorical · 36 - 50 years
|
14 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
10 Participants
|
89 Participants
n=19 Participants
|
|
Age, Customized
Age, Categorical · 51-70 years
|
15 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
24 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
9 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
6 Participants
|
132 Participants
n=19 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=31 Participants
|
25 Participants
n=30 Participants
|
11 Participants
n=3 Participants
|
13 Participants
n=6 Participants
|
16 Participants
n=114 Participants
|
15 Participants
|
172 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
19 Participants
n=30 Participants
|
9 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
13 Participants
n=114 Participants
|
20 Participants
|
132 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
4 Participants
|
21 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=31 Participants
|
41 Participants
n=30 Participants
|
20 Participants
n=3 Participants
|
14 Participants
n=6 Participants
|
25 Participants
n=114 Participants
|
31 Participants
|
283 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
2 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
2 Participants
|
13 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
10 Participants
n=114 Participants
|
11 Participants
|
42 Participants
n=19 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
34 Participants
n=31 Participants
|
34 Participants
n=30 Participants
|
18 Participants
n=3 Participants
|
11 Participants
n=6 Participants
|
12 Participants
n=114 Participants
|
20 Participants
|
229 Participants
n=19 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
1 Participants
|
16 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
2 Participants
n=19 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=99 Participants
|
40 participants
n=107 Participants
|
24 participants
n=206 Participants
|
18 participants
n=7 Participants
|
40 participants
n=31 Participants
|
44 participants
n=30 Participants
|
20 participants
n=3 Participants
|
16 participants
n=6 Participants
|
29 participants
n=114 Participants
|
35 participants
|
304 participants
n=19 Participants
|
|
Body Mass Index (BMI)
< 30 kg/m^2
|
25 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=31 Participants
|
28 Participants
n=30 Participants
|
15 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
17 Participants
n=114 Participants
|
26 Participants
|
203 Participants
n=19 Participants
|
|
Body Mass Index (BMI)
>= 30 kg/m^2
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
16 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
12 Participants
n=114 Participants
|
9 Participants
|
101 Participants
n=19 Participants
|
|
Prior Seasonal Influenza Vaccination
2017-2018 and 2018-2019
|
30 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=31 Participants
|
30 Participants
n=30 Participants
|
16 Participants
n=3 Participants
|
10 Participants
n=6 Participants
|
13 Participants
n=114 Participants
|
14 Participants
|
206 Participants
n=19 Participants
|
|
Prior Seasonal Influenza Vaccination
2017-2018 only
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
7 Participants
|
26 Participants
n=19 Participants
|
|
Prior Seasonal Influenza Vaccination
2018-2019 only
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
6 Participants
|
28 Participants
n=19 Participants
|
|
Prior Seasonal Influenza Vaccination
Neither
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
8 Participants
|
44 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Day 22Population: 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.
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).
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=28 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=35 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus
|
116.1 titer
Interval 82.1 to 164.2
|
77.7 titer
Interval 44.7 to 135.1
|
190.3 titer
Interval 100.9 to 358.9
|
10.9 titer
Interval 7.5 to 15.9
|
31.7 titer
Interval 21.3 to 47.0
|
33.1 titer
Interval 17.0 to 64.1
|
180.9 titer
Interval 100.5 to 325.7
|
6.6 titer
Interval 4.9 to 8.9
|
8.3 titer
Interval 6.0 to 11.5
|
22.7 titer
Interval 14.5 to 35.8
|
PRIMARY outcome
Timeframe: Day 22Population: 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.
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).
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=28 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=35 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus
|
367.6 titer
Interval 251.9 to 536.4
|
204.5 titer
Interval 112.6 to 371.6
|
870.9 titer
Interval 623.7 to 1216.0
|
28.6 titer
Interval 17.8 to 46.1
|
72.2 titer
Interval 47.3 to 110.2
|
115.1 titer
Interval 54.0 to 245.2
|
562.0 titer
Interval 316.0 to 999.4
|
5.8 titer
Interval 4.9 to 6.9
|
10.8 titer
Interval 7.7 to 15.1
|
64.3 titer
Interval 39.3 to 105.2
|
PRIMARY outcome
Timeframe: Day 1 through Day 366Population: The safety population includes all participants who received study vaccination.
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.
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=29 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=38 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 8Population: 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.
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.
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=29 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=38 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs)
ALT
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs)
Bilirubin
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs)
Creatinine
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs)
Hemoglobin
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs)
Platelets
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs)
WBC
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 8Population: The safety population includes all participants who received study vaccination.
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.
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=29 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=38 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Events
|
35 Participants
|
5 Participants
|
16 Participants
|
11 Participants
|
38 Participants
|
3 Participants
|
14 Participants
|
12 Participants
|
30 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 8Population: The safety population includes all participants who received study vaccination.
Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination.
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=29 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=38 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Solicited Systemic Reactogenicity Events
|
24 Participants
|
8 Participants
|
6 Participants
|
16 Participants
|
16 Participants
|
7 Participants
|
10 Participants
|
10 Participants
|
20 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Day 22Population: 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.
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).
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=28 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=35 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
88 percentage of participants
Interval 73.0 to 96.0
|
75 percentage of participants
Interval 53.0 to 90.0
|
89 percentage of participants
Interval 65.0 to 99.0
|
20 percentage of participants
Interval 9.0 to 36.0
|
59 percentage of participants
Interval 43.0 to 74.0
|
55 percentage of participants
Interval 32.0 to 77.0
|
94 percentage of participants
Interval 70.0 to 100.0
|
11 percentage of participants
Interval 2.0 to 28.0
|
9 percentage of participants
Interval 2.0 to 23.0
|
49 percentage of participants
Interval 31.0 to 66.0
|
PRIMARY outcome
Timeframe: Day 22Population: 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.
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).
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=28 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=35 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus
|
98 percentage of participants
Interval 87.0 to 100.0
|
92 percentage of participants
Interval 73.0 to 99.0
|
100 percentage of participants
Interval 81.0 to 100.0
|
43 percentage of participants
Interval 27.0 to 59.0
|
66 percentage of participants
Interval 50.0 to 80.0
|
75 percentage of participants
Interval 51.0 to 91.0
|
94 percentage of participants
Interval 70.0 to 100.0
|
4 percentage of participants
Interval 0.0 to 18.0
|
3 percentage of participants
Interval 0.0 to 15.0
|
69 percentage of participants
Interval 51.0 to 83.0
|
PRIMARY outcome
Timeframe: Day 22Population: 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.
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.
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=28 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=35 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus
|
88 percentage of participants
Interval 73.0 to 96.0
|
75 percentage of participants
Interval 53.0 to 90.0
|
83 percentage of participants
Interval 59.0 to 96.0
|
20 percentage of participants
Interval 9.0 to 36.0
|
52 percentage of participants
Interval 37.0 to 68.0
|
55 percentage of participants
Interval 32.0 to 77.0
|
88 percentage of participants
Interval 62.0 to 98.0
|
7 percentage of participants
Interval 1.0 to 24.0
|
6 percentage of participants
Interval 1.0 to 19.0
|
49 percentage of participants
Interval 31.0 to 66.0
|
PRIMARY outcome
Timeframe: Day 22Population: 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.
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.
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=28 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=35 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus
|
98 percentage of participants
Interval 87.0 to 100.0
|
83 percentage of participants
Interval 63.0 to 95.0
|
100 percentage of participants
Interval 81.0 to 100.0
|
43 percentage of participants
Interval 27.0 to 59.0
|
64 percentage of participants
Interval 48.0 to 78.0
|
75 percentage of participants
Interval 51.0 to 91.0
|
94 percentage of participants
Interval 70.0 to 100.0
|
4 percentage of participants
Interval 0.0 to 18.0
|
3 percentage of participants
Interval 0.0 to 15.0
|
69 percentage of participants
Interval 51.0 to 83.0
|
SECONDARY outcome
Timeframe: Day 8Population: 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.
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).
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=28 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=36 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 8 Against the 2017 Influenza A/ H7N9 Vaccine Virus
|
54.2 titer
Interval 33.4 to 87.7
|
36.2 titer
Interval 21.3 to 61.3
|
113.9 titer
Interval 62.2 to 208.5
|
9.9 titer
Interval 7.0 to 14.0
|
18.1 titer
Interval 12.1 to 27.2
|
16.8 titer
Interval 9.2 to 30.8
|
91.8 titer
Interval 46.8 to 180.0
|
6.1 titer
Interval 4.6 to 8.1
|
6.1 titer
Interval 4.8 to 7.7
|
13.9 titer
Interval 9.3 to 20.7
|
SECONDARY outcome
Timeframe: Day 181Population: 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.
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).
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=27 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=34 Participants
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|2017 A/H7N9 IIV
n=35 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 181 Against the 2017 Influenza A/ H7N9 Vaccine Virus
|
40.0 titer
Interval 25.6 to 62.4
|
35.1 titer
Interval 19.2 to 64.2
|
79.5 titer
Interval 40.6 to 155.6
|
9.9 titer
Interval 6.4 to 15.3
|
11.5 titer
Interval 8.3 to 15.9
|
9.5 titer
Interval 6.3 to 14.4
|
42.7 titer
Interval 23.3 to 78.1
|
5.1 titer
Interval 4.9 to 5.3
|
6.2 titer
Interval 4.8 to 7.9
|
10.5 titer
Interval 7.2 to 15.2
|
SECONDARY outcome
Timeframe: Day 8Population: 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.
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).
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=28 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=36 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus
|
153.2 titer
Interval 91.6 to 256.1
|
108.9 titer
Interval 62.4 to 189.8
|
482.5 titer
Interval 270.5 to 860.9
|
17.5 titer
Interval 12.1 to 25.2
|
31.4 titer
Interval 21.0 to 47.0
|
45.2 titer
Interval 20.8 to 97.9
|
320.0 titer
Interval 166.4 to 615.3
|
5.9 titer
Interval 4.8 to 7.3
|
7.0 titer
Interval 5.0 to 9.9
|
34.3 titer
Interval 21.4 to 55.1
|
SECONDARY outcome
Timeframe: Day 181Population: 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.
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).
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=19 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=27 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=34 Participants
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|2017 A/H7N9 IIV
n=35 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus
|
105.3 titer
Interval 65.8 to 168.2
|
73.4 titer
Interval 38.0 to 141.6
|
296.3 titer
Interval 147.4 to 595.6
|
14.3 titer
Interval 9.5 to 21.4
|
17.0 titer
Interval 12.2 to 23.9
|
34.6 titer
Interval 15.2 to 78.4
|
110.7 titer
Interval 56.1 to 218.4
|
5.4 titer
Interval 4.9 to 5.9
|
10.2 titer
Interval 7.8 to 13.4
|
24.1 titer
Interval 15.4 to 37.5
|
SECONDARY outcome
Timeframe: Day 22Population: 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.
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).
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=28 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=35 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
|
92.7 titer
Interval 62.4 to 137.6
|
62.6 titer
Interval 35.3 to 111.0
|
166.3 titer
Interval 87.5 to 315.9
|
9.0 titer
Interval 6.5 to 12.6
|
21.0 titer
Interval 14.6 to 30.0
|
27.3 titer
Interval 14.5 to 51.4
|
146.7 titer
Interval 80.1 to 268.7
|
5.3 titer
Interval 4.8 to 5.9
|
6.1 titer
Interval 4.8 to 7.8
|
18.7 titer
Interval 12.2 to 28.5
|
SECONDARY outcome
Timeframe: Day 22Population: 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.
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).
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=28 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=35 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
|
515.4 titer
Interval 367.1 to 723.5
|
329.4 titer
Interval 192.5 to 563.6
|
1015.9 titer
Interval 785.2 to 1314.5
|
39.3 titer
Interval 23.6 to 65.5
|
102.1 titer
Interval 64.9 to 160.8
|
171.5 titer
Interval 82.6 to 356.0
|
744.8 titer
Interval 449.7 to 1233.5
|
7.0 titer
Interval 5.1 to 9.5
|
10.1 titer
Interval 7.2 to 14.1
|
98.5 titer
Interval 59.8 to 162.2
|
SECONDARY outcome
Timeframe: Day 1 through Day 366Population: The safety population includes all participants who received study vaccination.
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.
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=29 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=38 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)
MAAE
|
8 Participants
|
5 Participants
|
6 Participants
|
13 Participants
|
7 Participants
|
8 Participants
|
4 Participants
|
10 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)
NOCMC
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)
PIMMC
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 22Population: The safety population includes all participants who received study vaccination.
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through 21 days after study vaccination.
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=29 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=38 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Unsolicited Non-serious AEs
|
10 Participants
|
3 Participants
|
4 Participants
|
15 Participants
|
10 Participants
|
7 Participants
|
5 Participants
|
8 Participants
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 8Population: 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.
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).
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=28 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=36 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
65 percentage of participants
Interval 48.0 to 79.0
|
63 percentage of participants
Interval 41.0 to 81.0
|
83 percentage of participants
Interval 59.0 to 96.0
|
18 percentage of participants
Interval 7.0 to 33.0
|
41 percentage of participants
Interval 26.0 to 57.0
|
35 percentage of participants
Interval 15.0 to 59.0
|
81 percentage of participants
Interval 54.0 to 96.0
|
7 percentage of participants
Interval 1.0 to 24.0
|
6 percentage of participants
Interval 1.0 to 19.0
|
28 percentage of participants
Interval 14.0 to 45.0
|
SECONDARY outcome
Timeframe: Day 181Population: 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.
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).
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=27 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=34 Participants
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|2017 A/H7N9 IIV
n=35 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
55 percentage of participants
Interval 38.0 to 71.0
|
54 percentage of participants
Interval 33.0 to 74.0
|
78 percentage of participants
Interval 52.0 to 94.0
|
18 percentage of participants
Interval 7.0 to 33.0
|
25 percentage of participants
Interval 13.0 to 40.0
|
20 percentage of participants
Interval 6.0 to 44.0
|
56 percentage of participants
Interval 30.0 to 80.0
|
0 percentage of participants
Interval 0.0 to 13.0
|
6 percentage of participants
Interval 1.0 to 20.0
|
20 percentage of participants
Interval 8.0 to 37.0
|
SECONDARY outcome
Timeframe: Day 8Population: 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.
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).
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=28 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=36 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus
|
80 percentage of participants
Interval 64.0 to 91.0
|
79 percentage of participants
Interval 58.0 to 93.0
|
100 percentage of participants
Interval 81.0 to 100.0
|
33 percentage of participants
Interval 19.0 to 49.0
|
48 percentage of participants
Interval 32.0 to 63.0
|
55 percentage of participants
Interval 32.0 to 77.0
|
94 percentage of participants
Interval 70.0 to 100.0
|
4 percentage of participants
Interval 0.0 to 18.0
|
9 percentage of participants
Interval 2.0 to 23.0
|
53 percentage of participants
Interval 35.0 to 70.0
|
SECONDARY outcome
Timeframe: Day 181Population: 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.
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).
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=19 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=27 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=34 Participants
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|2017 A/H7N9 IIV
n=35 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus
|
75 percentage of participants
Interval 59.0 to 87.0
|
67 percentage of participants
Interval 45.0 to 84.0
|
94 percentage of participants
Interval 73.0 to 100.0
|
23 percentage of participants
Interval 11.0 to 38.0
|
32 percentage of participants
Interval 19.0 to 48.0
|
42 percentage of participants
Interval 20.0 to 67.0
|
88 percentage of participants
Interval 62.0 to 98.0
|
0 percentage of participants
Interval 0.0 to 13.0
|
9 percentage of participants
Interval 2.0 to 24.0
|
31 percentage of participants
Interval 17.0 to 49.0
|
SECONDARY outcome
Timeframe: Day 8Population: 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.
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.
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=28 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=36 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus
|
60 percentage of participants
Interval 43.0 to 75.0
|
58 percentage of participants
Interval 37.0 to 78.0
|
83 percentage of participants
Interval 59.0 to 96.0
|
18 percentage of participants
Interval 7.0 to 33.0
|
34 percentage of participants
Interval 20.0 to 50.0
|
35 percentage of participants
Interval 15.0 to 59.0
|
75 percentage of participants
Interval 48.0 to 93.0
|
4 percentage of participants
Interval 0.0 to 18.0
|
3 percentage of participants
Interval 0.0 to 15.0
|
28 percentage of participants
Interval 14.0 to 45.0
|
SECONDARY outcome
Timeframe: Day 181Population: 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.
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.
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=27 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=34 Participants
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|2017 A/H7N9 IIV
n=35 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus
|
53 percentage of participants
Interval 36.0 to 68.0
|
50 percentage of participants
Interval 29.0 to 71.0
|
72 percentage of participants
Interval 47.0 to 90.0
|
18 percentage of participants
Interval 7.0 to 33.0
|
18 percentage of participants
Interval 8.0 to 33.0
|
20 percentage of participants
Interval 6.0 to 44.0
|
50 percentage of participants
Interval 25.0 to 75.0
|
0 percentage of participants
Interval 0.0 to 13.0
|
3 percentage of participants
Interval 0.0 to 15.0
|
20 percentage of participants
Interval 8.0 to 37.0
|
SECONDARY outcome
Timeframe: Day 8Population: 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.
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.
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=28 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=36 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus
|
80 percentage of participants
Interval 64.0 to 91.0
|
75 percentage of participants
Interval 53.0 to 90.0
|
100 percentage of participants
Interval 81.0 to 100.0
|
33 percentage of participants
Interval 19.0 to 49.0
|
48 percentage of participants
Interval 32.0 to 63.0
|
55 percentage of participants
Interval 32.0 to 77.0
|
88 percentage of participants
Interval 62.0 to 98.0
|
4 percentage of participants
Interval 0.0 to 18.0
|
9 percentage of participants
Interval 2.0 to 23.0
|
53 percentage of participants
Interval 35.0 to 70.0
|
SECONDARY outcome
Timeframe: Day 181Population: 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.
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.
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=19 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=27 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=34 Participants
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|2017 A/H7N9 IIV
n=35 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus
|
73 percentage of participants
Interval 56.0 to 85.0
|
63 percentage of participants
Interval 41.0 to 81.0
|
94 percentage of participants
Interval 73.0 to 100.0
|
23 percentage of participants
Interval 11.0 to 38.0
|
32 percentage of participants
Interval 19.0 to 48.0
|
42 percentage of participants
Interval 20.0 to 67.0
|
88 percentage of participants
Interval 62.0 to 98.0
|
0 percentage of participants
Interval 0.0 to 13.0
|
9 percentage of participants
Interval 2.0 to 24.0
|
31 percentage of participants
Interval 17.0 to 49.0
|
SECONDARY outcome
Timeframe: Day 22Population: 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.
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).
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=28 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=35 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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)
|
85 percentage of participants
Interval 70.0 to 94.0
|
75 percentage of participants
Interval 53.0 to 90.0
|
94 percentage of participants
Interval 73.0 to 100.0
|
15 percentage of participants
Interval 6.0 to 30.0
|
45 percentage of participants
Interval 30.0 to 61.0
|
55 percentage of participants
Interval 32.0 to 77.0
|
94 percentage of participants
Interval 70.0 to 100.0
|
0 percentage of participants
Interval 0.0 to 12.0
|
3 percentage of participants
Interval 0.0 to 15.0
|
34 percentage of participants
Interval 19.0 to 52.0
|
SECONDARY outcome
Timeframe: Day 22Population: 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.
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).
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=28 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=35 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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)
|
98 percentage of participants
Interval 87.0 to 100.0
|
96 percentage of participants
Interval 79.0 to 100.0
|
100 percentage of participants
Interval 81.0 to 100.0
|
50 percentage of participants
Interval 34.0 to 66.0
|
84 percentage of participants
Interval 70.0 to 93.0
|
90 percentage of participants
Interval 68.0 to 99.0
|
100 percentage of participants
Interval 79.0 to 100.0
|
4 percentage of participants
Interval 0.0 to 18.0
|
6 percentage of participants
Interval 1.0 to 19.0
|
74 percentage of participants
Interval 57.0 to 88.0
|
SECONDARY outcome
Timeframe: Day 22Population: 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.
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.
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=28 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=35 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
|
85 percentage of participants
Interval 70.0 to 94.0
|
75 percentage of participants
Interval 53.0 to 90.0
|
89 percentage of participants
Interval 65.0 to 99.0
|
15 percentage of participants
Interval 6.0 to 30.0
|
45 percentage of participants
Interval 30.0 to 61.0
|
55 percentage of participants
Interval 32.0 to 77.0
|
94 percentage of participants
Interval 70.0 to 100.0
|
0 percentage of participants
Interval 0.0 to 12.0
|
3 percentage of participants
Interval 0.0 to 15.0
|
34 percentage of participants
Interval 19.0 to 52.0
|
SECONDARY outcome
Timeframe: Day 22Population: 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.
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.
Outcome measures
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
n=40 Participants
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+AS03|2017 A/H7N9 IIV
n=24 Participants
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+AS03|2017 A/H7N9 IIV+AS03
n=18 Participants
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|2017 A/H7N9 IIV
n=40 Participants
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|2017 A/H7N9 IIV+AS03
n=44 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 Participants
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=28 Participants
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 Participants
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|2017 A/H7N9 IIV
n=35 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
|
98 percentage of participants
Interval 87.0 to 100.0
|
96 percentage of participants
Interval 79.0 to 100.0
|
100 percentage of participants
Interval 81.0 to 100.0
|
50 percentage of participants
Interval 34.0 to 66.0
|
84 percentage of participants
Interval 70.0 to 93.0
|
90 percentage of participants
Interval 68.0 to 99.0
|
100 percentage of participants
Interval 79.0 to 100.0
|
4 percentage of participants
Interval 0.0 to 18.0
|
3 percentage of participants
Interval 0.0 to 15.0
|
74 percentage of participants
Interval 57.0 to 88.0
|
Adverse Events
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
2013 A/H7N9 IIV|2017 A/H7N9 IIV
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
A/H7 IIV Naïve |2017 A/H7N9 IIV
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV
n=38 participants at risk
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+MF59|2017 A/H7N9 IIV+AS03
n=40 participants at risk
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+AS03|2017 A/H7N9 IIV
n=24 participants at risk
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+AS03|2017 A/H7N9 IIV+AS03
n=18 participants at risk
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|2017 A/H7N9 IIV
n=40 participants at risk
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|2017 A/H7N9 IIV+AS03
n=44 participants at risk
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 participants at risk
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 participants at risk
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=29 participants at risk
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Chest Pain
|
0.00%
0/38 • 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
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.
|
2.5%
1/40 • Number of events 1 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
0.00%
0/16 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Infections and infestations
Sepsis
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
0.00%
0/16 • 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
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.
|
3.4%
1/29 • Number of events 1 • 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
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.
|
0.00%
0/35 • 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
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.
|
Other adverse events
| Measure |
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV
n=38 participants at risk
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+MF59|2017 A/H7N9 IIV+AS03
n=40 participants at risk
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+AS03|2017 A/H7N9 IIV
n=24 participants at risk
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+AS03|2017 A/H7N9 IIV+AS03
n=18 participants at risk
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|2017 A/H7N9 IIV
n=40 participants at risk
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|2017 A/H7N9 IIV+AS03
n=44 participants at risk
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV
n=20 participants at risk
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 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03
n=16 participants at risk
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV
n=29 participants at risk
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.
|
A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
n=35 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Ocular Hyperaemia
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
5.6%
1/18 • Number of events 1 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
0.00%
0/16 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Eye disorders
Swelling of Eyelid
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
5.6%
1/18 • Number of events 1 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
0.00%
0/16 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
1/38 • Number of events 1 • 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
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.
|
2.5%
1/40 • Number of events 1 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
0.00%
0/40 • 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
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.
|
4.5%
2/44 • Number of events 2 • 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
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.
|
10.0%
2/20 • Number of events 2 • 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
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.
|
6.2%
1/16 • Number of events 1 • 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
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.
|
0.00%
0/29 • 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
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.
|
5.7%
2/35 • Number of events 2 • 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
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.
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/38 • Number of events 1 • 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
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.
|
0.00%
0/40 • 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
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.
|
8.3%
2/24 • Number of events 2 • 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
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.
|
0.00%
0/18 • 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
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.
|
5.0%
2/40 • Number of events 2 • 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
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.
|
6.8%
3/44 • Number of events 3 • 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
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.
|
0.00%
0/20 • 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
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.
|
25.0%
4/16 • Number of events 4 • 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
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.
|
3.4%
1/29 • Number of events 1 • 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
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.
|
5.7%
2/35 • Number of events 2 • 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
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.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/38 • Number of events 1 • 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
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.
|
2.5%
1/40 • Number of events 1 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
6.2%
1/16 • Number of events 1 • 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
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.
|
3.4%
1/29 • Number of events 1 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
General disorders
Fatigue
|
18.4%
7/38 • Number of events 7 • 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
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.
|
37.5%
15/40 • Number of events 15 • 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
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.
|
12.5%
3/24 • Number of events 3 • 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
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.
|
11.1%
2/18 • Number of events 2 • 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
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.
|
27.5%
11/40 • Number of events 11 • 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
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.
|
20.5%
9/44 • Number of events 9 • 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
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.
|
25.0%
5/20 • Number of events 5 • 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
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.
|
37.5%
6/16 • Number of events 7 • 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
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.
|
24.1%
7/29 • Number of events 7 • 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
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.
|
28.6%
10/35 • Number of events 10 • 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
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.
|
|
General disorders
Feeling Hot
|
5.3%
2/38 • Number of events 2 • 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
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.
|
10.0%
4/40 • Number of events 4 • 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
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.
|
8.3%
2/24 • Number of events 2 • 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
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.
|
11.1%
2/18 • Number of events 2 • 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
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.
|
7.5%
3/40 • Number of events 3 • 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
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.
|
6.8%
3/44 • Number of events 3 • 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
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.
|
10.0%
2/20 • Number of events 2 • 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
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.
|
6.2%
1/16 • Number of events 1 • 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
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.
|
10.3%
3/29 • Number of events 3 • 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
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.
|
14.3%
5/35 • Number of events 5 • 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
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.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/38 • 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
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.
|
2.5%
1/40 • Number of events 1 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
6.2%
1/16 • Number of events 1 • 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
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.
|
3.4%
1/29 • Number of events 1 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
General disorders
Injection Site Erythema
|
13.2%
5/38 • Number of events 5 • 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
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.
|
25.0%
10/40 • Number of events 10 • 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
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.
|
12.5%
3/24 • Number of events 3 • 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
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.
|
22.2%
4/18 • Number of events 4 • 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
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.
|
12.5%
5/40 • Number of events 5 • 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
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.
|
22.7%
10/44 • Number of events 10 • 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
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.
|
5.0%
1/20 • Number of events 1 • 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
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.
|
31.2%
5/16 • Number of events 5 • 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
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.
|
27.6%
8/29 • Number of events 8 • 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
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.
|
20.0%
7/35 • Number of events 7 • 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
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.
|
|
General disorders
Injection Site Haemorrhage
|
2.6%
1/38 • Number of events 1 • 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
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.
|
5.0%
2/40 • Number of events 2 • 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
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.
|
8.3%
2/24 • Number of events 2 • 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
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.
|
11.1%
2/18 • Number of events 2 • 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
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.
|
0.00%
0/40 • 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
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.
|
13.6%
6/44 • Number of events 6 • 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
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.
|
0.00%
0/20 • 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
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.
|
12.5%
2/16 • Number of events 2 • 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
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.
|
3.4%
1/29 • Number of events 1 • 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
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.
|
11.4%
4/35 • Number of events 4 • 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
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.
|
|
General disorders
Injection Site Induration
|
2.6%
1/38 • Number of events 1 • 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
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.
|
17.5%
7/40 • Number of events 7 • 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
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.
|
4.2%
1/24 • Number of events 1 • 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
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.
|
22.2%
4/18 • Number of events 4 • 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
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.
|
5.0%
2/40 • Number of events 2 • 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
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.
|
15.9%
7/44 • Number of events 7 • 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
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.
|
5.0%
1/20 • Number of events 1 • 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
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.
|
18.8%
3/16 • Number of events 3 • 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
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.
|
6.9%
2/29 • Number of events 2 • 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
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.
|
22.9%
8/35 • Number of events 8 • 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
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.
|
|
General disorders
Injection Site Pain
|
0.00%
0/38 • 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
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.
|
55.0%
22/40 • Number of events 22 • 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
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.
|
0.00%
0/24 • 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
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.
|
44.4%
8/18 • Number of events 9 • 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
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.
|
5.0%
2/40 • Number of events 2 • 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
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.
|
40.9%
18/44 • Number of events 18 • 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
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.
|
5.0%
1/20 • Number of events 1 • 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
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.
|
81.2%
13/16 • Number of events 13 • 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
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.
|
10.3%
3/29 • Number of events 3 • 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
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.
|
48.6%
17/35 • Number of events 17 • 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
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.
|
|
General disorders
Injection Site Pain (Tenderness)
|
18.4%
7/38 • Number of events 7 • 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
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.
|
77.5%
31/40 • Number of events 31 • 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
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.
|
4.2%
1/24 • Number of events 1 • 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
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.
|
77.8%
14/18 • Number of events 14 • 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
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.
|
15.0%
6/40 • Number of events 6 • 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
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.
|
77.3%
34/44 • Number of events 34 • 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
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.
|
5.0%
1/20 • Number of events 1 • 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
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.
|
81.2%
13/16 • Number of events 13 • 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
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.
|
13.8%
4/29 • Number of events 4 • 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
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.
|
80.0%
28/35 • Number of events 28 • 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
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.
|
|
General disorders
Injection Site Pruritus
|
0.00%
0/38 • 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
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.
|
7.5%
3/40 • Number of events 3 • 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
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.
|
0.00%
0/24 • 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
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.
|
11.1%
2/18 • Number of events 2 • 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
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.
|
0.00%
0/40 • 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
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.
|
2.3%
1/44 • Number of events 1 • 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
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.
|
0.00%
0/20 • 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
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.
|
12.5%
2/16 • Number of events 2 • 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
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.
|
0.00%
0/29 • 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
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.
|
2.9%
1/35 • Number of events 1 • 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
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.
|
|
General disorders
Malaise
|
10.5%
4/38 • Number of events 4 • 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
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.
|
22.5%
9/40 • Number of events 9 • 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
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.
|
12.5%
3/24 • Number of events 3 • 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
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.
|
11.1%
2/18 • Number of events 2 • 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
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.
|
20.0%
8/40 • Number of events 9 • 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
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.
|
13.6%
6/44 • Number of events 6 • 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
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.
|
10.0%
2/20 • Number of events 2 • 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
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.
|
18.8%
3/16 • Number of events 3 • 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
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.
|
10.3%
3/29 • Number of events 3 • 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
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.
|
14.3%
5/35 • Number of events 5 • 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
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.
|
|
General disorders
Pyrexia
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
2.5%
1/40 • Number of events 1 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
6.2%
1/16 • Number of events 1 • 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
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.
|
0.00%
0/29 • 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
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.
|
2.9%
1/35 • Number of events 1 • 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
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.
|
|
General disorders
Vaccination Site Lymphadenopathy
|
0.00%
0/38 • 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
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.
|
2.5%
1/40 • Number of events 1 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
6.2%
1/16 • Number of events 1 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/38 • 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
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.
|
2.5%
1/40 • Number of events 1 • 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
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.
|
0.00%
0/24 • 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
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.
|
5.6%
1/18 • Number of events 1 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
0.00%
0/16 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Infections and infestations
Influenza
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
6.2%
1/16 • Number of events 1 • 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
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.
|
3.4%
1/29 • Number of events 1 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
1/38 • Number of events 1 • 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
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.
|
2.5%
1/40 • Number of events 1 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
5.0%
2/40 • Number of events 3 • 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
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.
|
4.5%
2/44 • Number of events 2 • 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
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.
|
5.0%
1/20 • Number of events 1 • 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
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.
|
0.00%
0/16 • 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
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.
|
3.4%
1/29 • Number of events 1 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Infections and infestations
Respiratory Tract Infection
|
2.6%
1/38 • Number of events 1 • 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
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.
|
2.5%
1/40 • Number of events 1 • 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
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.
|
4.2%
1/24 • Number of events 1 • 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
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.
|
0.00%
0/18 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
6.2%
1/16 • Number of events 1 • 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
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.
|
3.4%
1/29 • Number of events 1 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
5.6%
1/18 • Number of events 1 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
0.00%
0/16 • 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
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.
|
3.4%
1/29 • Number of events 1 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.3%
2/38 • Number of events 2 • 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
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.
|
2.5%
1/40 • Number of events 2 • 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
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.
|
0.00%
0/24 • 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
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.
|
11.1%
2/18 • Number of events 2 • 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
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.
|
10.0%
4/40 • Number of events 4 • 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
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.
|
4.5%
2/44 • Number of events 3 • 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
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.
|
0.00%
0/20 • 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
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.
|
6.2%
1/16 • Number of events 1 • 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
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.
|
3.4%
1/29 • Number of events 1 • 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
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.
|
2.9%
1/35 • Number of events 1 • 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
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.
|
|
Injury, poisoning and procedural complications
Chest Injury
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
5.0%
1/20 • Number of events 1 • 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
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.
|
0.00%
0/16 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
5.6%
1/18 • Number of events 1 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
0.00%
0/16 • 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
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.
|
3.4%
1/29 • Number of events 1 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Nervous system disorders
Dizziness
|
2.6%
1/38 • Number of events 1 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
5.6%
1/18 • Number of events 1 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
0.00%
0/16 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
6.2%
1/16 • Number of events 1 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
5.0%
1/20 • Number of events 1 • 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
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.
|
0.00%
0/16 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Investigations
Alanine Aminotransferase Increased
|
2.6%
1/38 • Number of events 2 • 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
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.
|
0.00%
0/40 • 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
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.
|
12.5%
3/24 • Number of events 3 • 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
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.
|
0.00%
0/18 • 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
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.
|
7.5%
3/40 • Number of events 5 • 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
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.
|
0.00%
0/44 • 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
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.
|
5.0%
1/20 • Number of events 1 • 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
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.
|
18.8%
3/16 • Number of events 4 • 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
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.
|
0.00%
0/29 • 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
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.
|
2.9%
1/35 • Number of events 1 • 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
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.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/38 • 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
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.
|
2.5%
1/40 • Number of events 2 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
5.0%
2/40 • Number of events 3 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
0.00%
0/16 • 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
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.
|
0.00%
0/29 • 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
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.
|
2.9%
1/35 • Number of events 1 • 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
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.
|
|
Investigations
Hemoglobin Decreased
|
5.3%
2/38 • Number of events 2 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
5.6%
1/18 • Number of events 1 • 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
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.
|
5.0%
2/40 • Number of events 2 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
6.2%
1/16 • Number of events 1 • 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
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.
|
3.4%
1/29 • Number of events 1 • 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
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.
|
8.6%
3/35 • Number of events 4 • 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
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.
|
|
Investigations
Platelet Count Increased
|
2.6%
1/38 • Number of events 1 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
0.00%
0/16 • 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
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.
|
0.00%
0/29 • 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
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.
|
5.7%
2/35 • Number of events 3 • 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
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.
|
|
Investigations
White Blood Cell Count Decreased
|
7.9%
3/38 • Number of events 3 • 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
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.
|
2.5%
1/40 • Number of events 1 • 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
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.
|
4.2%
1/24 • Number of events 1 • 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
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.
|
0.00%
0/18 • 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
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.
|
10.0%
4/40 • Number of events 5 • 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
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.
|
6.8%
3/44 • Number of events 3 • 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
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.
|
0.00%
0/20 • 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
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.
|
6.2%
1/16 • Number of events 1 • 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
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.
|
3.4%
1/29 • Number of events 1 • 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
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.
|
5.7%
2/35 • Number of events 2 • 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
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.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
6.2%
1/16 • Number of events 1 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.5%
4/38 • Number of events 4 • 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
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.
|
5.0%
2/40 • Number of events 2 • 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
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.
|
0.00%
0/24 • 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
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.
|
11.1%
2/18 • Number of events 2 • 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
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.
|
2.5%
1/40 • Number of events 1 • 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
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.
|
4.5%
2/44 • Number of events 2 • 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
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.
|
20.0%
4/20 • Number of events 4 • 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
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.
|
0.00%
0/16 • 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
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.
|
3.4%
1/29 • Number of events 1 • 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
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.
|
11.4%
4/35 • Number of events 4 • 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
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.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
2.5%
1/40 • Number of events 1 • 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
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.
|
2.3%
1/44 • Number of events 1 • 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
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.
|
5.0%
1/20 • Number of events 1 • 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
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.
|
0.00%
0/16 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
5.0%
1/20 • Number of events 1 • 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
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.
|
0.00%
0/16 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.5%
4/38 • Number of events 4 • 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
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.
|
27.5%
11/40 • Number of events 11 • 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
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.
|
0.00%
0/24 • 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
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.
|
5.6%
1/18 • Number of events 1 • 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
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.
|
2.5%
1/40 • Number of events 1 • 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
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.
|
18.2%
8/44 • Number of events 8 • 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
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.
|
25.0%
5/20 • Number of events 5 • 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
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.
|
12.5%
2/16 • Number of events 2 • 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
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.
|
13.8%
4/29 • Number of events 4 • 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
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.
|
25.7%
9/35 • Number of events 9 • 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
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.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
5.0%
1/20 • Number of events 1 • 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
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.
|
0.00%
0/16 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/38 • 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
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.
|
2.5%
1/40 • Number of events 2 • 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
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.
|
4.2%
1/24 • Number of events 1 • 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
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.
|
0.00%
0/18 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
10.0%
2/20 • Number of events 2 • 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
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.
|
0.00%
0/16 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
5.6%
1/18 • Number of events 1 • 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
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.
|
2.5%
1/40 • Number of events 1 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
0.00%
0/16 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Nervous system disorders
Headache
|
21.1%
8/38 • Number of events 8 • 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
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.
|
27.5%
11/40 • Number of events 11 • 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
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.
|
25.0%
6/24 • Number of events 6 • 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
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.
|
22.2%
4/18 • Number of events 4 • 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
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.
|
27.5%
11/40 • Number of events 12 • 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
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.
|
18.2%
8/44 • Number of events 8 • 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
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.
|
10.0%
2/20 • Number of events 2 • 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
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.
|
43.8%
7/16 • Number of events 7 • 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
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.
|
20.7%
6/29 • Number of events 6 • 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
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.
|
25.7%
9/35 • Number of events 9 • 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
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.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
0.00%
0/40 • 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
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.
|
2.3%
1/44 • Number of events 1 • 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
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.
|
0.00%
0/20 • 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
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.
|
12.5%
2/16 • Number of events 2 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
5.0%
1/20 • Number of events 1 • 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
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.
|
0.00%
0/16 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Reproductive system and breast disorders
Menopausal Symptoms
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
5.0%
1/20 • Number of events 1 • 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
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.
|
0.00%
0/16 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
5.6%
1/18 • Number of events 1 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
0.00%
0/16 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
5.6%
1/18 • Number of events 1 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
0.00%
0/20 • 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
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.
|
0.00%
0/16 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
5.6%
1/18 • Number of events 1 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
5.0%
1/20 • Number of events 1 • 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
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.
|
0.00%
0/16 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
|
Surgical and medical procedures
Bone Lesion Excision
|
0.00%
0/38 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/24 • 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
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.
|
0.00%
0/18 • 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
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.
|
0.00%
0/40 • 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
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.
|
0.00%
0/44 • 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
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.
|
5.0%
1/20 • Number of events 1 • 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
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.
|
0.00%
0/16 • 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
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.
|
0.00%
0/29 • 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
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.
|
0.00%
0/35 • 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
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60