Trial Outcomes & Findings for Seasonal Trivalent Inactivated Split Virion Influenza Vaccine Clinical Trial (IVACFLU-S) - PHASE 2/3 (NCT NCT03095599)
NCT ID: NCT03095599
Last Updated: 2019-07-22
Results Overview
Solicited local AEs were assessed by study staff 30 minutes after vaccination.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
889 participants
Primary outcome timeframe
Within 30 minutes of vaccination
Results posted on
2019-07-22
Participant Flow
Phase 2 was conducted at the District Health Center (DHC) of Ben Luc, Long An Province and involved 252 subjects. After positive safety review of Day 8 data, Phase 3 was at 2 sites: the DHC of Ben Luc, Long An Province and the DHC of Long Thanh, Dong Nai Province. In total, of the 1399 subjects who were screened, 888 subjects were rand
Participant milestones
| Measure |
Vaccine
IVACFLU-S: Trivalent inactivated split virion influenza vaccine
|
Placebo
PBS with pH 7.2; 0.5 ml/per dose
|
|---|---|---|
|
Overall Study
STARTED
|
741
|
148
|
|
Overall Study
Withdrawal Before Vaccination
|
1
|
0
|
|
Overall Study
Vaccinated
|
740
|
148
|
|
Overall Study
COMPLETED
|
738
|
148
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Vaccine
IVACFLU-S: Trivalent inactivated split virion influenza vaccine
|
Placebo
PBS with pH 7.2; 0.5 ml/per dose
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal prior to vaccination
|
1
|
0
|
Baseline Characteristics
Seasonal Trivalent Inactivated Split Virion Influenza Vaccine Clinical Trial (IVACFLU-S) - PHASE 2/3
Baseline characteristics by cohort
| Measure |
Vaccine
n=740 Participants
IVACFLU-S: Trivalent inactivated split virion influenza vaccine
|
Placebo
n=148 Participants
PBS with pH 7.2; 0.5 ml/per dose
|
Total
n=888 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.8 years
n=99 Participants
|
42.8 years
n=107 Participants
|
42.8 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
431 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
520 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
309 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
368 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Kinh
|
735 Participants
n=99 Participants
|
148 Participants
n=107 Participants
|
883 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Khmer
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hoa
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
Vietnam
|
740 participants
n=99 Participants
|
148 participants
n=107 Participants
|
888 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Within 30 minutes of vaccinationPopulation: All recipients of the vaccine in Phases 2 and 3
Solicited local AEs were assessed by study staff 30 minutes after vaccination.
Outcome measures
| Measure |
Vaccine
n=740 Participants
Received one dose of IVACFLU-S vaccine intramuscularly.
|
Placebo
n=148 Participants
Received one dose of placebo intramuscularly.
|
|---|---|---|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE)
Induration
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE)
Redness
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE)
Pain
|
24 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE)
Swelling
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE)
Tenderness
|
14 Participants
|
1 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE)
No report of solicited local AE
|
711 Participants
|
147 Participants
|
PRIMARY outcome
Timeframe: Within 30 minutes of vaccinationPopulation: All recipients of the vaccine in Phases 2 and 3
Solicited systemic AEs were assessed by study staff 30 minutes after vaccination.
Outcome measures
| Measure |
Vaccine
n=740 Participants
Received one dose of IVACFLU-S vaccine intramuscularly.
|
Placebo
n=148 Participants
Received one dose of placebo intramuscularly.
|
|---|---|---|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE)
No report of solicited systemic AEs
|
733 Participants
|
148 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE)
Chills
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE)
Fatigue/Malaise
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE)
Generalized muscle aches
|
5 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE)
Headaches
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE)
Joint aches
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE)
Nausea
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE)
Vomiting
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7Population: All recipients of the vaccine in Phases 2 and 3
Solicited local AEs were assessed by study staff 30 minutes after vaccination then daily for 7 days by the subjects. Subjects were provided a thermometer, ruler and a diary to record the presence or absence of solicited AEs, severity of the solicited AE and use of concomitant medication. AEs were graded as follows: * Mild: Mild symptoms causing no or minimal interference with usual social and functional activities with intervention not indicated. * Moderate: Moderate symptoms causing greater than minimal interference with usual social and functional activities with intervention indicated. * Severe: Severe symptoms causing inability to perform usual social and functional activities with intervention or hospitalization indicated. * Life-threatening: Potentially life-threatening symptoms causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death.
Outcome measures
| Measure |
Vaccine
n=740 Participants
Received one dose of IVACFLU-S vaccine intramuscularly.
|
Placebo
n=148 Participants
Received one dose of placebo intramuscularly.
|
|---|---|---|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Pain · None reported
|
279 Participants
|
122 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Hardness · Mild
|
23 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Hardness · Moderate
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Hardness · Severe
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Hardness · Life threatening
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Hardness · None reported
|
716 Participants
|
148 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Pain · Mild
|
405 Participants
|
25 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Pain · Moderate
|
55 Participants
|
1 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Pain · Severe
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Pain · Life threatening
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Redness · Mild
|
18 Participants
|
1 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Redness · Moderate
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Redness · Severe
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Redness · Life threatening
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Redness · None reported
|
721 Participants
|
147 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Swelling · Mild
|
20 Participants
|
1 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Swelling · Moderate
|
6 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Swelling · Severe
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Swelling · Life threatening
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Swelling · None reported
|
714 Participants
|
147 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Tenderness · Mild
|
441 Participants
|
30 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Tenderness · Moderate
|
54 Participants
|
2 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Tenderness · Severe
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Tenderness · Life threatening
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
Tenderness · None reported
|
244 Participants
|
116 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7Population: All recipients of the vaccine in Phases 2 and 3
Solicited systemic AEs were assessed by study staff 30 minutes after vaccination then daily for 7 days by the subjects. Subjects were provided a thermometer, ruler and a diary to record the presence or absence of solicited AEs, severity of the solicited AE and use of concomitant medication. AEs were graded as follows: * Mild: Mild symptoms causing no or minimal interference with usual social and functional activities with intervention not indicated. * Moderate: Moderate symptoms causing greater than minimal interference with usual social and functional activities with intervention indicated. * Severe: Severe symptoms causing inability to perform usual social and functional activities with intervention or hospitalization indicated. * Life-threatening: Potentially life-threatening symptoms causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death.
Outcome measures
| Measure |
Vaccine
n=740 Participants
Received one dose of IVACFLU-S vaccine intramuscularly.
|
Placebo
n=148 Participants
Received one dose of placebo intramuscularly.
|
|---|---|---|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Generalized muscle aches · None reported
|
603 Participants
|
132 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Headaches · Mild
|
93 Participants
|
23 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Nausea · Mild
|
14 Participants
|
4 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Vomiting · Life threatening
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Chills · Mild
|
36 Participants
|
10 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Chills · Moderate
|
9 Participants
|
2 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Chills · Severe
|
0 Participants
|
1 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Chills · Life threatening
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Chills · None reported
|
695 Participants
|
135 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Fatigue/Malaise · Mild
|
111 Participants
|
18 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Fatigue/Malaise · Moderate
|
29 Participants
|
8 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Fatigue/Malaise · Severe
|
2 Participants
|
1 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Fatigue/Malaise · Life threatening
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Fatigue/Malaise · None reported
|
598 Participants
|
121 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Generalized muscle aches · Mild
|
114 Participants
|
14 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Generalized muscle aches · Moderate
|
23 Participants
|
1 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Generalized muscle aches · Severe
|
0 Participants
|
1 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Generalized muscle aches · Life threatening
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Headaches · Moderate
|
27 Participants
|
4 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Headaches · Severe
|
1 Participants
|
2 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Headaches · Life threatening
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Headaches · None reported
|
619 Participants
|
119 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Joint aches · Mild
|
42 Participants
|
11 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Joint aches · Moderate
|
16 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Joint aches · Severe
|
0 Participants
|
1 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Joint aches · Life threatening
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Joint aches · None reported
|
682 Participants
|
136 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Nausea · Moderate
|
2 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Nausea · Severe
|
1 Participants
|
1 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Nausea · Life threatening
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Nausea · None reported
|
723 Participants
|
143 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Vomiting · Mild
|
3 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Vomiting · Moderate
|
2 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Vomiting · Severe
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
Vomiting · None reported
|
734 Participants
|
148 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7Population: All recipients of the vaccine in Phases 2 and 3
Subjects reporting body temperature by maximum severity; Grade 0: \<38°C, Grade 1: 38.0 - \<38.6°C, Grade 2: 38.6 - \<39.3°C, Grade 3: 39.3 - \<40.0°C, Grade 4: \>= 40.0°C
Outcome measures
| Measure |
Vaccine
n=740 Participants
Received one dose of IVACFLU-S vaccine intramuscularly.
|
Placebo
n=148 Participants
Received one dose of placebo intramuscularly.
|
|---|---|---|
|
Number and Percentage of Subjects Experiencing Fever
Grade 0
|
729 Participants
|
146 Participants
|
|
Number and Percentage of Subjects Experiencing Fever
Grade 1
|
5 Participants
|
1 Participants
|
|
Number and Percentage of Subjects Experiencing Fever
Grade 2
|
5 Participants
|
1 Participants
|
|
Number and Percentage of Subjects Experiencing Fever
Grade 3
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Fever
Grade 4
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 21Population: All recipients of the vaccine in Phases 2 and 3
Unsolicited AEs were observed by study staff while the subject is at a clinic for a study visit or reported by the subject at any time. Any sign or symptom that would normally be considered a "solicited AE" (for example, fever, nausea, injection site pain) starting after 7 days post-vaccination was to be recorded as an unsolicited AE. The clinician determined whether there was a reasonable possibility that the investigational product(s) caused or contributed to an AE. The following guidelines were used: * Related: There is a reasonable possibility that the study vaccine caused the AE. "Reasonable possibility" means that there is evidence to suggest a causal relationship between the study product and the AE. * Not Related: There is not a reasonable possibility that the administration of the study product caused the event.
Outcome measures
| Measure |
Vaccine
n=740 Participants
Received one dose of IVACFLU-S vaccine intramuscularly.
|
Placebo
n=148 Participants
Received one dose of placebo intramuscularly.
|
|---|---|---|
|
Number and Percentage of Subjects Experiencing Unsolicited Adverse Events (AE)
At least one unsolicited AE
|
110 Participants
|
17 Participants
|
|
Number and Percentage of Subjects Experiencing Unsolicited Adverse Events (AE)
At least one vaccine-related unsolicited AE
|
3 Participants
|
1 Participants
|
|
Number and Percentage of Subjects Experiencing Unsolicited Adverse Events (AE)
At least one severe unsolicited AE
|
2 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Unsolicited Adverse Events (AE)
At least one life threatening unsolicited AE
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Unsolicited Adverse Events (AE)
Subjects requiring treatment during the study
|
64 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 91Population: All recipients of the vaccine in Phases 2 and 3
Unsolicited AEs were observed by study staff while the subject is at a clinic for a study visit or reported by the subject at any time. Any sign or symptom that would normally be considered a "solicited AE" (for example, fever, nausea, injection site pain) starting after 7 days post-vaccination was to be recorded as an unsolicited AE. The clinician determined whether there was a reasonable possibility that the investigational product(s) caused or contributed to an AE. The following guidelines were used: * Related: There is a reasonable possibility that the study vaccine caused the AE. "Reasonable possibility" means that there is evidence to suggest a causal relationship between the study product and the AE. * Not Related: There is not a reasonable possibility that the administration of the study product caused the event.
Outcome measures
| Measure |
Vaccine
n=740 Participants
Received one dose of IVACFLU-S vaccine intramuscularly.
|
Placebo
n=148 Participants
Received one dose of placebo intramuscularly.
|
|---|---|---|
|
Number and Percentage of Subjects Experiencing Unsolicited Serious Adverse Events (SAE)
Related to vaccine
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Experiencing Unsolicited Serious Adverse Events (SAE)
Not related to vaccine
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 22Population: Phase 3 participants who were participated in the study through at least day 22, overall and by age group.
Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine (A/H1N1, B, and A/H3N2). This testing was performed by VisMederi SRL laboratory (Siena, Italy), by using a validated assay. Sample collection on Day 1 was prior to administration of study product. Seroconversion is defined as a serum HAI antibody titer meeting the following criteria: * pre-vaccination titer \< 1:10 and a post-vaccination titer measured on Day 22 of ≥ 1:40, or * pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination measured on Day 22
Outcome measures
| Measure |
Vaccine
n=209 Participants
Received one dose of IVACFLU-S vaccine intramuscularly.
|
Placebo
n=42 Participants
Received one dose of placebo intramuscularly.
|
|---|---|---|
|
Number and Percentage of Subjects With Seroconversion of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens, Overall and by Age Group
Ages 46-60: A/H3N2
|
85 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With Seroconversion of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens, Overall and by Age Group
Overall: A/H1N1
|
147 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With Seroconversion of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens, Overall and by Age Group
Overall: A/H3N2
|
159 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With Seroconversion of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens, Overall and by Age Group
Overall: B
|
113 Participants
|
1 Participants
|
|
Number and Percentage of Subjects With Seroconversion of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens, Overall and by Age Group
Ages 18-45: A/H1N1
|
73 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With Seroconversion of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens, Overall and by Age Group
Ages 18-45: AH3N2
|
74 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With Seroconversion of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens, Overall and by Age Group
Ages 18-45: B
|
52 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With Seroconversion of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens, Overall and by Age Group
Ages 46-60: A/H1N1
|
74 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With Seroconversion of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens, Overall and by Age Group
Ages 46-60: B
|
61 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 22Population: Phase 3 participants who were participated in the study through at least day 22, overall and by age group.
Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine (A/H1N1, B, and A/H3N2). This testing was performed by VisMederi SRL laboratory (Siena, Italy), by using a validated assay. Sample collection on Day 1 was prior to administration of study product.
Outcome measures
| Measure |
Vaccine
n=209 Participants
Received one dose of IVACFLU-S vaccine intramuscularly.
|
Placebo
n=42 Participants
Received one dose of placebo intramuscularly.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22, Overall and by Age Group
Ages 18-45: A/H1N1: Day 1
|
12.65 titer
Interval 10.102 to 15.837
|
15.49 titer
Interval 8.399 to 28.553
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22, Overall and by Age Group
Overall: A/H1N1: Day 1
|
9.93 titer
Interval 8.593 to 11.465
|
13.51 titer
Interval 9.288 to 19.665
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22, Overall and by Age Group
Overall: A/H1N1: Day 22
|
130.48 titer
Interval 107.898 to 157.78
|
13.46 titer
Interval 9.438 to 19.192
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22, Overall and by Age Group
Overall: A/H3N2: Day 1
|
12.92 titer
Interval 11.256 to 14.831
|
12.65 titer
Interval 8.836 to 18.115
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22, Overall and by Age Group
Overall: A/H3N2: Day 22
|
153.12 titer
Interval 127.996 to 183.17
|
12.65 titer
Interval 8.859 to 18.068
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22, Overall and by Age Group
Overall: B: Day 1
|
7.17 titer
Interval 6.62 to 7.756
|
6.35 titer
Interval 5.468 to 7.379
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22, Overall and by Age Group
Overall: B: Day 22
|
42.04 titer
Interval 35.654 to 49.57
|
6.79 titer
Interval 5.58 to 8.251
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22, Overall and by Age Group
Ages 18-45: A/H1N1: Day 22
|
149.19 titer
Interval 119.134 to 186.81
|
15.74 titer
Interval 8.732 to 28.386
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22, Overall and by Age Group
Ages 18-45: A/H3N2: Day 1
|
16.16 titer
Interval 13.008 to 20.072
|
21.36 titer
Interval 11.9 to 38.359
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22, Overall and by Age Group
Ages 18-45: A/H3N2: Day 22
|
145.26 titer
Interval 114.633 to 184.07
|
22.26 titer
Interval 12.528 to 39.569
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22, Overall and by Age Group
Ages 18-45: B: Day 1
|
6.48 titer
Interval 5.915 to 7.108
|
6.20 titer
Interval 5.273 to 7.282
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22, Overall and by Age Group
Ages 18-45: B: Day 22
|
38.18 titer
Interval 30.703 to 47.469
|
6.62 titer
Interval 5.278 to 8.302
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22, Overall and by Age Group
Ages 46-60: A/H1N1: Day 1
|
7.81 titer
Interval 6.569 to 9.278
|
11.79 titer
Interval 7.278 to 19.112
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22, Overall and by Age Group
Ages 46-60: A/H1N1: Day 22
|
114.26 titer
Interval 84.025 to 155.382
|
11.51 titer
Interval 7.418 to 17.846
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22, Overall and by Age Group
Ages 46-60: A/H3N2: Day 1
|
10.35 titer
Interval 8.79 to 12.193
|
7.49 titer
Interval 5.447 to 10.304
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22, Overall and by Age Group
Ages 46-60: A/H3N2: Day 22
|
161.33 titer
Interval 122.86 to 211.83
|
7.19 titer
Interval 5.363 to 9.635
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22, Overall and by Age Group
Ages 46-60: B: Day 1
|
7.91 titer
Interval 6.964 to 8.986
|
6.51 titer
Interval 4.979 to 8.514
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22, Overall and by Age Group
Ages 46-60: B: Day 22
|
46.25 titer
Interval 36.051 to 59.341
|
6.96 titer
Interval 4.95 to 9.773
|
PRIMARY outcome
Timeframe: Day 1, Day 22Population: Phase 3 participants who were participated in the study through at least day 22, overall and by age group.
Fold change in titer between Day 1 and Day 22. Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine (A/H1N1, B, and A/H3N2). This testing was performed by VisMederi SRL laboratory (Siena, Italy), by using a validated assay. Sample collection on Day 1 was prior to administration of study product.
Outcome measures
| Measure |
Vaccine
n=209 Participants
Received one dose of IVACFLU-S vaccine intramuscularly.
|
Placebo
n=42 Participants
Received one dose of placebo intramuscularly.
|
|---|---|---|
|
Geometric Mean Fold Change of Serum Hemagglutination Inhibition (HAI) Antibody Titer, Overall and by Age Group
Ages 46-60: B
|
5.85 fold change
Interval 4.615 to 7.407
|
1.07 fold change
Interval 0.797 to 1.433
|
|
Geometric Mean Fold Change of Serum Hemagglutination Inhibition (HAI) Antibody Titer, Overall and by Age Group
Overall: A/H3N2
|
11.85 fold change
Interval 9.762 to 14.388
|
1.00 fold change
Interval 0.939 to 1.065
|
|
Geometric Mean Fold Change of Serum Hemagglutination Inhibition (HAI) Antibody Titer, Overall and by Age Group
Overall: B
|
5.87 fold change
Interval 4.987 to 6.902
|
1.07 fold change
Interval 0.895 to 1.275
|
|
Geometric Mean Fold Change of Serum Hemagglutination Inhibition (HAI) Antibody Titer, Overall and by Age Group
Ages 18-45: A/H1N1
|
11.79 fold change
Interval 8.832 to 15.752
|
1.02 fold change
Interval 0.852 to 1.213
|
|
Geometric Mean Fold Change of Serum Hemagglutination Inhibition (HAI) Antibody Titer, Overall and by Age Group
Ages 18-45: AH3N2
|
8.99 fold change
Interval 6.878 to 11.75
|
1.04 fold change
Interval 0.935 to 1.162
|
|
Geometric Mean Fold Change of Serum Hemagglutination Inhibition (HAI) Antibody Titer, Overall and by Age Group
Ages 46-60: A/H1N1
|
14.64 fold change
Interval 10.669 to 20.078
|
0.98 fold change
Interval 0.908 to 1.048
|
|
Geometric Mean Fold Change of Serum Hemagglutination Inhibition (HAI) Antibody Titer, Overall and by Age Group
Ages 46-60: AH3N2
|
15.58 fold change
Interval 11.839 to 20.512
|
0.96 fold change
Interval 0.895 to 1.029
|
|
Geometric Mean Fold Change of Serum Hemagglutination Inhibition (HAI) Antibody Titer, Overall and by Age Group
Overall: A/H1N1
|
13.15 fold change
Interval 10.623 to 16.268
|
1.00 fold change
Interval 0.909 to 1.091
|
|
Geometric Mean Fold Change of Serum Hemagglutination Inhibition (HAI) Antibody Titer, Overall and by Age Group
Ages 18-45: B
|
5.89 fold change
Interval 4.694 to 7.385
|
1.07 fold change
Interval 0.852 to 1.34
|
SECONDARY outcome
Timeframe: Day 22Population: Phase 3 participants who were participated in the study through at least day 22, overall and by age group.
Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine (A/H1N1, B, and A/H3N2). This testing was performed by VisMederi SRL laboratory (Siena, Italy), by using a validated assay. Sample collection on Day 1 was prior to administration of study product.
Outcome measures
| Measure |
Vaccine
n=209 Participants
Received one dose of IVACFLU-S vaccine intramuscularly.
|
Placebo
n=42 Participants
Received one dose of placebo intramuscularly.
|
|---|---|---|
|
Number and Percentage of Subjects With at Least a 4-fold Increase in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age 46-60 A/H3N2; baseline ≥1:10
|
45 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With at Least a 4-fold Increase in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age 18-45 A/H1N1; baseline ≥1:10
|
28 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With at Least a 4-fold Increase in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age 46-60 B; baseline ≥1:10
|
28 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With at Least a 4-fold Increase in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Overall A/H1N1; baseline <1:10
|
97 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With at Least a 4-fold Increase in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Overall for A/H1N1; baseline ≥1:10
|
50 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With at Least a 4-fold Increase in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Overall A/H3N2; baseline <1:10
|
66 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With at Least a 4-fold Increase in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age 46-60 A/H1N1; baseline ≥1:10
|
22 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With at Least a 4-fold Increase in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age 46-60 A/H3N2; baseline <1:10
|
40 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With at Least a 4-fold Increase in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age 46-60 B; baseline <1:10
|
33 Participants
|
1 Participants
|
|
Number and Percentage of Subjects With at Least a 4-fold Increase in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Overall A/H3N2; baseline ≥1:10
|
93 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With at Least a 4-fold Increase in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Overall B; baseline <1:10
|
71 Participants
|
1 Participants
|
|
Number and Percentage of Subjects With at Least a 4-fold Increase in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Overall B; baseline ≥1:10
|
42 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With at Least a 4-fold Increase in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age18-45 A/H1N1; baseline <1:10
|
45 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With at Least a 4-fold Increase in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age18-45 A/H3N2; baseline <1:10
|
26 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With at Least a 4-fold Increase in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age 18-45 A/H3N2; baseline ≥1:10
|
48 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With at Least a 4-fold Increase in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age18-45 B; baseline <1:10
|
38 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With at Least a 4-fold Increase in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age 18-45 B; baseline ≥1:10
|
14 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With at Least a 4-fold Increase in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age 46-60 A/H1N1; baseline <1:10
|
52 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 22Population: Phase 3 participants who were participated in the study through at least day 22.
Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine (A/H1N1, B, and A/H1N1). This testing was performed by VisMederi SRL laboratory (Siena, Italy), by using a validated assay. Sample collection on Day 1 was prior to administration of study product.
Outcome measures
| Measure |
Vaccine
n=209 Participants
Received one dose of IVACFLU-S vaccine intramuscularly.
|
Placebo
n=42 Participants
Received one dose of placebo intramuscularly.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: All Subjects
A/H1N1, Day 1: baseline <1:10
|
5 titer
Standard Deviation 1
|
5 titer
Standard Deviation 1
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: All Subjects
A/H1N1, Day 22: baseline <1:10
|
99.78 titer
Standard Deviation 4.88
|
5.45 titer
Standard Deviation 1.31
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: All Subjects
A/H1N1, Day 22: baseline ≥1:10
|
204.75 titer
Standard Deviation 2.27
|
30.60 titer
Standard Deviation 2.69
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: All Subjects
A/H3N2 Day 22: baseline <1:10
|
97.17 titer
Standard Deviation 4.72
|
5 titer
Standard Deviation 1
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: All Subjects
A/H3N2 Day 22: baseline ≥1:10
|
215.97 titer
Standard Deviation 2.65
|
32.01 titer
Standard Deviation 2.54
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: All Subjects
A/H1N1, Day 1: baseline ≥1:10
|
31.40 titer
Standard Deviation 2.55
|
33.37 titer
Standard Deviation 2.76
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: All Subjects
A/H3N2 Day 1: baseline <1:10
|
5 titer
Standard Deviation 1
|
5 titer
Standard Deviation 1
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: All Subjects
A/H3N2 Day 1: baseline ≥1:10
|
26.49 titer
Standard Deviation 2.16
|
32.01 titer
Standard Deviation 2.60
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: All Subjects
B, Day 1: baseline <1:10
|
5 titer
Standard Deviation 1
|
5 titer
Standard Deviation 1
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: All Subjects
B, Day 1: baseline ≥1:10
|
14.64 titer
Standard Deviation 1.63
|
13.66 titer
Standard Deviation 1.56
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: All Subjects
B, Day 22: baseline <1:10
|
33.10 titer
Standard Deviation 3.45
|
5.95 titer
Standard Deviation 1.80
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: All Subjects
B, Day 22: baseline ≥1:10
|
67.61 titer
Standard Deviation 2.71
|
10.35 titer
Standard Deviation 1.78
|
SECONDARY outcome
Timeframe: Day 1, Day 22Population: Phase 3 participants who were age 18-45 and participated in the study through at least day 22.
Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine (A/H1N1, B, and A/H3N2). This testing was performed by VisMederi SRL laboratory (Siena, Italy), by using a validated assay. Sample collection on Day 1 was prior to administration of study product.
Outcome measures
| Measure |
Vaccine
n=104 Participants
Received one dose of IVACFLU-S vaccine intramuscularly.
|
Placebo
n=21 Participants
Received one dose of placebo intramuscularly.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 18-45
B, Day 22: baseline <1:10
|
34.97 titer
Standard Deviation 3.22
|
6.02 titer
Standard Deviation 1.66
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 18-45
A/H1N1, Day 1: baseline <1:10
|
5 titer
Standard Deviation 1
|
5 titer
Standard Deviation 1
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 18-45
A/H1N1, Day 1: baseline ≥1:10
|
35.85 titer
Standard Deviation 2.41
|
43.28 titer
Standard Deviation 2.95
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 18-45
A/H1N1, Day 22: baseline <1:10
|
117.13 titer
Standard Deviation 4.11
|
5.95 titer
Standard Deviation 1.45
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 18-45
A/H1N1, Day 22: baseline ≥1:10
|
195.73 titer
Standard Deviation 2
|
38.15 titer
Standard Deviation 3.29
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 18-45
A/H3N2 Day 1: baseline <1:10
|
5 titer
Standard Deviation 1
|
5 titer
Standard Deviation 1
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 18-45
A/H3N2 Day 1: baseline ≥1:10
|
30.07 titer
Standard Deviation 2.42
|
38.19 titer
Standard Deviation 2.85
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 18-45
A/H3N2 Day 22: baseline <1:10
|
88.51 titer
Standard Deviation 4.49
|
5 titer
Standard Deviation 1
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 18-45
A/H3N2 Day 22: baseline ≥1:10
|
188.82 titer
Standard Deviation 2.58
|
40.46 titer
Standard Deviation 2.64
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 18-45
B, Day 1: baseline <1:10
|
5 titer
Standard Deviation 1
|
5 titer
Standard Deviation 1
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 18-45
B, Day 1: baseline ≥1:10
|
13.13 titer
Standard Deviation 1.46
|
10.59 titer
Standard Deviation 1.15
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 18-45
B, Day 22: baseline ≥1:10
|
48.46 titer
Standard Deviation 2.59
|
8.41 titer
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: Day 1, Day 22Population: Phase 3 participants who were age 46-60 and participated in the study through at least day 22.
Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine (A/H1N1, B, and A/H3N2). This testing was performed by VisMederi SRL laboratory (Siena, Italy), by using a validated assay. Sample collection on Day 1 was prior to administration of study product.
Outcome measures
| Measure |
Vaccine
n=105 Participants
Received one dose of IVACFLU-S vaccine intramuscularly.
|
Placebo
n=21 Participants
Received one dose of placebo intramuscularly.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 46-60
A/H1N1, Day 22: baseline <1:10
|
88.85 titer
Standard Deviation 5.47
|
5 titer
Standard Deviation 1
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 46-60
A/H3N2 Day 1: baseline ≥1:10
|
22.37 titer
Standard Deviation 1.74
|
20.59 titer
Standard Deviation 1.64
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 46-60
A/H3N2 Day 22: baseline <1:10
|
103.41 titer
Standard Deviation 4.93
|
5 titer
Standard Deviation 1
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 46-60
A/H3N2 Day 22: baseline ≥1:10
|
258.34 titer
Standard Deviation 2.70
|
17.82 titer
Standard Deviation 1.69
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 46-60
B, Day 1: baseline <1:10
|
5 titer
Standard Deviation 1
|
5 titer
Standard Deviation 1
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 46-60
B, Day 1: baseline ≥1:10
|
15.74 titer
Standard Deviation 1.72
|
20 titer
Standard Deviation 1.63
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 46-60
A/H1N1, Day 1: baseline <1:10
|
5 titer
Standard Deviation 1
|
5 titer
Standard Deviation 1
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 46-60
A/H1N1, Day 1: baseline ≥1:10
|
25.10 titer
Standard Deviation 2.72
|
25.73 titer
Standard Deviation 2.50
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 46-60
A/H1N1, Day 22: baseline ≥1:10
|
220.93 titer
Standard Deviation 2.74
|
24.55 titer
Standard Deviation 2.08
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 46-60
A/H3N2 Day 1: baseline <1:10
|
5 titer
Standard Deviation 1
|
5 titer
Standard Deviation 1
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 46-60
B, Day 22: baseline <1:10
|
30.97 titer
Standard Deviation 3.75
|
5.89 titer
Standard Deviation 1.96
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 46-60
B, Day 22: baseline ≥1:10
|
84.41 titer
Standard Deviation 2.64
|
14.14 titer
Standard Deviation 2
|
SECONDARY outcome
Timeframe: Day 1, Day 22Population: Phase 3 participants who were participated in the study through at least day 22, overall and by age group.
Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine (A/H1N1, B, and A/H3N2). This testing was performed by VisMederi SRL laboratory (Siena, Italy), by using a validated assay. Sample collection on Day 1 was prior to administration of study product.
Outcome measures
| Measure |
Vaccine
n=209 Participants
Received one dose of IVACFLU-S vaccine intramuscularly.
|
Placebo
n=42 Participants
Received one dose of placebo intramuscularly.
|
|---|---|---|
|
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Overall A/H1N1; baseline <1:10
|
19.96 fold change
Standard Deviation 4.88
|
1.09 fold change
Standard Deviation 1.31
|
|
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Overall for A/H1N1; baseline ≥1:10
|
6.52 fold change
Standard Deviation 3.48
|
0.92 fold change
Standard Deviation 1.34
|
|
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Overall A/H3N2; baseline <1:10
|
19.43 fold change
Standard Deviation 4.72
|
1 fold change
Standard Deviation 1
|
|
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Overall A/H3N2; baseline ≥1:10
|
8.15 fold change
Standard Deviation 3.30
|
1 fold change
Standard Deviation 1
|
|
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Overall B; baseline <1:10
|
6.62 fold change
Standard Deviation 3.45
|
1.19 fold change
Standard Deviation 1.80
|
|
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Overall B; baseline ≥1:10
|
4.62 fold change
Standard Deviation 2.89
|
0.76 fold change
Standard Deviation 1.38
|
|
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age18-45 A/H1N1; baseline <1:10
|
23.43 fold change
Standard Deviation 4.11
|
1.19 fold change
Standard Deviation 1.45
|
|
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age 18-45 A/H1N1; baseline ≥1:10
|
5.46 fold change
Standard Deviation 3.20
|
0.88 fold change
Standard Deviation 1.43
|
|
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age18-45 A/H3N2; baseline <1:10
|
17.70 fold change
Standard Deviation 4.49
|
1.00 fold change
Standard Deviation 1.00
|
|
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age 18-45 A/H3N2; baseline ≥1:10
|
6.28 fold change
Standard Deviation 3.21
|
1.06 fold change
Standard Deviation 1.33
|
|
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age18-45 B; baseline <1:10
|
6.99 fold change
Standard Deviation 3.22
|
1.20 fold change
Standard Deviation 1.66
|
|
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age 18-45 B; baseline ≥1:10
|
3.69 fold change
Standard Deviation 2.81
|
0.79 fold change
Standard Deviation 1.43
|
|
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age 46-60 A/H1N1; baseline <1:10
|
17.77 fold change
Standard Deviation 5.47
|
1.00 fold change
Standard Deviation 1.00
|
|
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age 46-60 A/H1N1; baseline ≥1:10
|
8.80 fold change
Standard Deviation 3.84
|
0.95 fold change
Standard Deviation 1.25
|
|
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age 46-60 A/H3N2; baseline <1:10
|
20.68 fold change
Standard Deviation 4.93
|
1.00 fold change
Standard Deviation 1.00
|
|
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age 46-60 A/H3N2; baseline ≥1:10
|
11.55 fold change
Standard Deviation 3.16
|
0.87 fold change
Standard Deviation 1.32
|
|
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age 46-60 B; baseline <1:10
|
6.19 fold change
Standard Deviation 3.75
|
1.18 fold change
Standard Deviation 1.96
|
|
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Age 46-60 B; baseline ≥1:10
|
5.36 fold change
Standard Deviation 2.90
|
0.71 fold change
Standard Deviation 1.33
|
Adverse Events
Vaccine
Serious events: 4 serious events
Other events: 110 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vaccine
n=740 participants at risk
IVACFLU-S: Trivalent inactivated split virion influenza vaccine
|
Placebo
n=148 participants at risk
PBS with pH 7.2; 0.5 ml/per dose
|
|---|---|---|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.14%
1/740 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.14%
1/740 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.14%
1/740 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.14%
1/740 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.00%
0/740 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.68%
1/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/740 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.68%
1/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
Other adverse events
| Measure |
Vaccine
n=740 participants at risk
IVACFLU-S: Trivalent inactivated split virion influenza vaccine
|
Placebo
n=148 participants at risk
PBS with pH 7.2; 0.5 ml/per dose
|
|---|---|---|
|
Infections and infestations
Acute Sinusitis
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Infections and infestations
Conjunctivitis
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/740 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.68%
1/148 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Infections and infestations
Hordeolum
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Infections and infestations
Pharyngitis
|
1.1%
8/740 • Number of events 8 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.68%
1/148 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Infections and infestations
Sinusitis
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Infections and infestations
Tonsillitis
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.27%
2/740 • Number of events 2 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.68%
1/148 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Infections and infestations
Urinary Tract Infection
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Infections and infestations
Viral Infection
|
0.27%
2/740 • Number of events 2 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.41%
3/740 • Number of events 3 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Investigations
Blood Pressure Increased
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/740 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.68%
1/148 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/740 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.68%
1/148 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/740 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.68%
1/148 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Nervous system disorders
Dizziness
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Nervous system disorders
Headache
|
0.95%
7/740 • Number of events 7 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.68%
1/148 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Nervous system disorders
Hypoaesthesia
|
0.27%
2/740 • Number of events 2 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Nervous system disorders
Intercostal Neuralgia
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/740 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.68%
1/148 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Psychiatric disorders
Nervousness
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/740 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.68%
1/148 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
12/740 • Number of events 12 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.41%
3/740 • Number of events 3 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.68%
1/148 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.54%
4/740 • Number of events 4 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.5%
11/740 • Number of events 11 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.68%
1/148 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
1.6%
12/740 • Number of events 12 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.68%
1/148 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.27%
2/740 • Number of events 2 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage Subcutaneous
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.68%
1/148 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Ear and labyrinth disorders
Vertigo
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.27%
2/740 • Number of events 2 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Eye disorders
Eye pain
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.27%
2/740 • Number of events 2 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.68%
1/148 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.54%
4/740 • Number of events 4 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.41%
3/740 • Number of events 3 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Gastrointestinal disorders
Gingival Swelling
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Gastrointestinal disorders
Toothache
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
General disorders
Injection Site Haemorrhage
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
General disorders
Injection Site Pruritus
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
General disorders
Peripheral Swelling
|
0.00%
0/740 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.68%
1/148 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Immune system disorders
Food Allergy
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalised
|
0.00%
0/740 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.68%
1/148 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Vascular disorders
Hypertension
|
1.5%
11/740 • Number of events 11 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/740 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.68%
1/148 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/740 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.68%
1/148 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.14%
1/740 • Number of events 1 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
0.00%
0/148 • 22 days for non-serious adverse events; 91 days for serious adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place