Trial Outcomes & Findings for Interferon as a Mucosal Adjuvant for Influenza Vaccine Given Intranasally (NCT NCT00436046)
NCT ID: NCT00436046
Last Updated: 2011-06-13
Results Overview
Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at day 14 after immunization, relative to pre-immunization levels
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
95 participants
Primary outcome timeframe
14 days after immunization.
Results posted on
2011-06-13
Participant Flow
Healthy ambulatory adults were recruited from the surrounding community of the research clinic from March 16, 2007 through March 21, 2007.
Participant milestones
| Measure |
IVV With 1M IFN
IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given \[0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN\].
|
IVV Without IFN
IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
|
IVV With 10M IFN
IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given \[0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN\].
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
31
|
|
Overall Study
COMPLETED
|
32
|
32
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Interferon as a Mucosal Adjuvant for Influenza Vaccine Given Intranasally
Baseline characteristics by cohort
| Measure |
IVV With 1M IFN
n=32 Participants
IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given \[0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN\].
|
IVV Without IFN
n=32 Participants
IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
|
IVV With 10M IFN
n=31 Participants
IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given \[0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN\].
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age Continuous
|
25.3 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
25.2 years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
24.7 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
25.1 years
STANDARD_DEVIATION 4.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
32 participants
n=7 Participants
|
31 participants
n=5 Participants
|
95 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 14 days after immunization.Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at day 14 after immunization, relative to pre-immunization levels
Outcome measures
| Measure |
IVV With 1M IFN
n=32 Participants
IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given \[0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN\].
|
IVV Without IFN
n=32 Participants
IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
|
IVV With 10M IFN
n=31 Participants
IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given \[0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN\].
|
|---|---|---|---|
|
Antibody Responses in Nasal Secretions to Influenza A/H1N1 and A/H3N2 at 14 Days After Intranasal Immunization.
IgG to A/New Caledonia/20/99 at Day 14
|
3 Participants
|
3 Participants
|
5 Participants
|
|
Antibody Responses in Nasal Secretions to Influenza A/H1N1 and A/H3N2 at 14 Days After Intranasal Immunization.
IgA to A/New Caledonia/20/99 at Day 14
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Antibody Responses in Nasal Secretions to Influenza A/H1N1 and A/H3N2 at 14 Days After Intranasal Immunization.
IgG to A/Wisconsin/67/2005 at Day 14
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Antibody Responses in Nasal Secretions to Influenza A/H1N1 and A/H3N2 at 14 Days After Intranasal Immunization.
IgA to A/Wisconsin/67/2005 at Day 14
|
3 Participants
|
1 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 28 days after immunization.Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at day 28 after immunization, relative to pre-immunization levels.
Outcome measures
| Measure |
IVV With 1M IFN
n=32 Participants
IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given \[0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN\].
|
IVV Without IFN
n=32 Participants
IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
|
IVV With 10M IFN
n=31 Participants
IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given \[0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN\].
|
|---|---|---|---|
|
Antibody Responses in Nasal Secretions to Influenza A/H1N1 and A/H3N2 at 28 Days After Intranasal Immunization
IgG to A/New Caledonia/20/99 at Day 28
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Antibody Responses in Nasal Secretions to Influenza A/H1N1 and A/H3N2 at 28 Days After Intranasal Immunization
IgA to A/New Caledonia/20/99 at Day 28
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Antibody Responses in Nasal Secretions to Influenza A/H1N1 and A/H3N2 at 28 Days After Intranasal Immunization
IgG to A/Wisconsin/67/2005 at Day 28
|
3 Participants
|
4 Participants
|
6 Participants
|
|
Antibody Responses in Nasal Secretions to Influenza A/H1N1 and A/H3N2 at 28 Days After Intranasal Immunization
IgA to A/Wisconsin/67/2005 at Day 28
|
3 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 0-7 days following immunizationNumber of participants (frequency) reporting solicited (systematically collected on a Memory Aid) reactogenicity events of any severity and number reporting severe occurrences.
Outcome measures
| Measure |
IVV With 1M IFN
n=32 Participants
IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given \[0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN\].
|
IVV Without IFN
n=32 Participants
IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
|
IVV With 10M IFN
n=31 Participants
IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given \[0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN\].
|
|---|---|---|---|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Severe symptom
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Elevated Oral Temperature - Any severity
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Elevated Oral Temperature - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Feverishness - Any severity
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Feverishness - Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Malaise - Any severity
|
7 Participants
|
11 Participants
|
9 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Malaise - Severe
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Myalgia - Any severity
|
7 Participants
|
5 Participants
|
5 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Myalgia - Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Headache - Any severity
|
14 Participants
|
17 Participants
|
12 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Headache - Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Nausea - Any severity
|
1 Participants
|
1 Participants
|
6 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Nausea - Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Nasal Obstruction - Any severity
|
9 Participants
|
10 Participants
|
9 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Nasal Obstruction - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Nasal Discharge - Any severity
|
14 Participants
|
14 Participants
|
10 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Nasal Discharge - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Sneezing - Any severity
|
10 Participants
|
13 Participants
|
9 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Sneezing - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Sore Throat - Any severity
|
10 Participants
|
10 Participants
|
11 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Sore Throat - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Cough - Any severity
|
5 Participants
|
5 Participants
|
8 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Cough - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Any systemic symptom of any severity
|
21 Participants
|
21 Participants
|
20 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Severe systemic symptom
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Any local symptom of any severity
|
22 Participants
|
24 Participants
|
20 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Severe local symptom
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
Any symptom of any severity
|
27 Participants
|
28 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 14 days after immunization.Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at 14 days after immunization, relative to pre-immunization levels.
Outcome measures
| Measure |
IVV With 1M IFN
n=32 Participants
IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given \[0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN\].
|
IVV Without IFN
n=32 Participants
IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
|
IVV With 10M IFN
n=31 Participants
IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given \[0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN\].
|
|---|---|---|---|
|
Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza A/H1N1 and A/H3N2 at 14 Days After Intranasal Immunization.
HAI - A/New Caledonia/20/99 at Day 14
|
13 Participants
|
16 Participants
|
11 Participants
|
|
Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza A/H1N1 and A/H3N2 at 14 Days After Intranasal Immunization.
HAI - A/Wisconsin/67/2005 at Day 14
|
12 Participants
|
21 Participants
|
7 Participants
|
|
Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza A/H1N1 and A/H3N2 at 14 Days After Intranasal Immunization.
Neutralization - A/New Caledonia/20/99 at Day 14
|
12 Participants
|
13 Participants
|
9 Participants
|
|
Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza A/H1N1 and A/H3N2 at 14 Days After Intranasal Immunization.
Neutralization - A/Wisconsin/67/2005 at Day 14
|
13 Participants
|
16 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Non-serious AEs are collected through 28 days after vaccination. Serious AEs are collected through 180 days after vaccination.Population: A reporting threshold of 5.6% was selected after reviewing adverse event rates in healthy adult volunteers in similar studies sponsored by NIAID. We determined 5.6% to be the upper bound of the confidence interval to exclude reporting events that occur in 75% of healthy adults.
Number of subjects (frequency) with spontaneous reports of Adverse Events of any severity and severe or higher severity, during the 28 days after vaccination regardless of relatedness. Events reported by more than 5.6% of subjects in any group are reported by MedDRA Preferred Term.
Outcome measures
| Measure |
IVV With 1M IFN
n=32 Participants
IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given \[0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN\].
|
IVV Without IFN
n=32 Participants
IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
|
IVV With 10M IFN
n=31 Participants
IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given \[0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN\].
|
|---|---|---|---|
|
Unsolicited Adverse Events After Intranasal Immunization
Dizziness - Any severity
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Unsolicited Adverse Events After Intranasal Immunization
Dizziness - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Unsolicited Adverse Events After Intranasal Immunization
Dysphonia - Any severity
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Unsolicited Adverse Events After Intranasal Immunization
Dysphonia - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Unsolicited Adverse Events After Intranasal Immunization
Postnasal drip - Any severity
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Unsolicited Adverse Events After Intranasal Immunization
Postnasal drip - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Unsolicited Adverse Events After Intranasal Immunization
Diarrhoea - Any severity
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Unsolicited Adverse Events After Intranasal Immunization
Diarrhoea - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Unsolicited Adverse Events After Intranasal Immunization
Abdominal pain upper - Any severity
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Unsolicited Adverse Events After Intranasal Immunization
Abdominal pain upper - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Unsolicited Adverse Events After Intranasal Immunization
Upper respiratory tract infection - Any severity
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Unsolicited Adverse Events After Intranasal Immunization
Upper respiratory tract infection - Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Unsolicited Adverse Events After Intranasal Immunization
Dysgeusia - Any severity
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Unsolicited Adverse Events After Intranasal Immunization
Dysgeusia - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Unsolicited Adverse Events After Intranasal Immunization
Pharyngolaryngeal pain - Any severity
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Unsolicited Adverse Events After Intranasal Immunization
Pharyngolaryngeal pain - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Unsolicited Adverse Events After Intranasal Immunization
Rhinorrhoea - Any severity
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Unsolicited Adverse Events After Intranasal Immunization
Rhinorrhoea - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 days after immunizationNumber of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at 28 days after immunization, relative to pre-immunization levels.
Outcome measures
| Measure |
IVV With 1M IFN
n=32 Participants
IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given \[0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN\].
|
IVV Without IFN
n=32 Participants
IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
|
IVV With 10M IFN
n=31 Participants
IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given \[0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN\].
|
|---|---|---|---|
|
Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza A/H1N1 and A/H3N2 at 28 Days After Intranasal Immunization.
HAI - A/New Caledonia/20/99 at Day 28
|
14 Participants
|
17 Participants
|
11 Participants
|
|
Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza A/H1N1 and A/H3N2 at 28 Days After Intranasal Immunization.
HAI - A/Wisconsin/67/2005 at Day 28
|
20 Participants
|
23 Participants
|
7 Participants
|
|
Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza A/H1N1 and A/H3N2 at 28 Days After Intranasal Immunization.
Neutralization - A/New Caledonia/20/99 at Day 28
|
15 Participants
|
17 Participants
|
10 Participants
|
|
Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza A/H1N1 and A/H3N2 at 28 Days After Intranasal Immunization.
Neutralization - A/Wisconsin/67/2005 at Day 28
|
13 Participants
|
17 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days after immunizationNumber of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at 14 days after immunization, relative to pre-immunization levels.
Outcome measures
| Measure |
IVV With 1M IFN
n=32 Participants
IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given \[0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN\].
|
IVV Without IFN
n=32 Participants
IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
|
IVV With 10M IFN
n=31 Participants
IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given \[0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN\].
|
|---|---|---|---|
|
Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza B at 14 Days After Intranasal Immunization.
HAI - B/Malaysia/2506/2004 at Day 14
|
11 Participants
|
13 Participants
|
8 Participants
|
|
Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza B at 14 Days After Intranasal Immunization.
Neutralization - B/Malaysia/2506/2004 at Day 14
|
9 Participants
|
12 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 days after immunizationNumber of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at 28 days after immunization, relative to pre-immunization levels.
Outcome measures
| Measure |
IVV With 1M IFN
n=32 Participants
IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given \[0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN\].
|
IVV Without IFN
n=32 Participants
IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
|
IVV With 10M IFN
n=31 Participants
IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given \[0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN\].
|
|---|---|---|---|
|
Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza B at 28 Days After Intranasal Immunization.
HAI - B/Malaysia/2506/2004 at Day 28
|
16 Participants
|
14 Participants
|
9 Participants
|
|
Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza B at 28 Days After Intranasal Immunization.
Neutralization - B/Malaysia/2506/2004 at Day 28
|
13 Participants
|
16 Participants
|
13 Participants
|
Adverse Events
IVV With 1M IFN
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
IVV Without IFN
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
IVV With 10M IFN
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IVV With 1M IFN
n=32 participants at risk
IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given \[0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN\].
|
IVV Without IFN
n=32 participants at risk
IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
|
IVV With 10M IFN
n=31 participants at risk
IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given \[0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN\].
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
2/32 • Number of events 2 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
0.00%
0/32 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
0.00%
0/31 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/32 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
9.4%
3/32 • Number of events 3 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
0.00%
0/31 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
4/32 • Number of events 4 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
9.4%
3/32 • Number of events 3 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
9.7%
3/31 • Number of events 3 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
|
Nervous system disorders
Dizziness
|
6.2%
2/32 • Number of events 2 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
0.00%
0/32 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
0.00%
0/31 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
|
Nervous system disorders
Dysgeusia
|
6.2%
2/32 • Number of events 2 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
3.1%
1/32 • Number of events 1 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
0.00%
0/31 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/32 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
0.00%
0/32 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
6.5%
2/31 • Number of events 2 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
31.2%
10/32 • Number of events 10 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
31.2%
10/32 • Number of events 10 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
35.5%
11/31 • Number of events 11 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/32 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
0.00%
0/32 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
6.5%
2/31 • Number of events 2 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
43.8%
14/32 • Number of events 14 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
43.8%
14/32 • Number of events 14 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
32.3%
10/31 • Number of events 10 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.6%
5/32 • Number of events 5 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
15.6%
5/32 • Number of events 5 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
25.8%
8/31 • Number of events 8 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
|
General disorders
Feeling hot
|
0.00%
0/32 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
3.1%
1/32 • Number of events 1 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
6.5%
2/31 • Number of events 2 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
|
Nervous system disorders
Headache
|
43.8%
14/32 • Number of events 14 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
53.1%
17/32 • Number of events 17 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
38.7%
12/31 • Number of events 12 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
|
General disorders
Malaise
|
21.9%
7/32 • Number of events 7 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
34.4%
11/32 • Number of events 11 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
29.0%
9/31 • Number of events 9 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.9%
7/32 • Number of events 7 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
15.6%
5/32 • Number of events 5 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
16.1%
5/31 • Number of events 5 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
28.1%
9/32 • Number of events 9 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
31.2%
10/32 • Number of events 10 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
29.0%
9/31 • Number of events 9 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • Number of events 1 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
3.1%
1/32 • Number of events 1 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
19.4%
6/31 • Number of events 6 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
31.2%
10/32 • Number of events 10 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
40.6%
13/32 • Number of events 13 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
29.0%
9/31 • Number of events 9 • Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7)following vaccination. Unsolicited non-serious adverse events were collected for 28 days after vaccination and serious adverse events were collected through Day 180
The occurrence of a solicited symptom on any day(s) at any severity within the 8 day (Day 0-7) period was considered one event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60