Trial Outcomes & Findings for Safety Trial of Monovalent Whole Virus Influenza (H1N1) Vaccine (NCT NCT01507779)
NCT ID: NCT01507779
Last Updated: 2019-02-27
Results Overview
Systemic and local reactogenicity data were collected on Study Days 0, 7, 21 and 28, prevaccination, and within 60 minutes post-vaccination by clinic staff. Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Solicited systemic reactogenicity events included body temperature, feverishness, chills, cough, difficulty breathing, runny nose, nasal congestion, sore throat, hoarseness of voice, headache, confusion, convulsions/seizures, fatigue/malaise, muscle aches, joint pain, pink or red eyes, sore eyes, itchy eyes, drainage from eyes, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting and jaundice. Solicited local reactogenicity included size of redness, size of swelling, size of induration, pain, and tenderness.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
7 days
Results posted on
2019-02-27
Participant Flow
Participant milestones
| Measure |
Influenza Vaccine
Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21
IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
|
Placebo
Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
25
|
|
Overall Study
COMPLETED
|
23
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Trial of Monovalent Whole Virus Influenza (H1N1) Vaccine
Baseline characteristics by cohort
| Measure |
Influenza Vaccine
n=23 Participants
Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21
IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
|
Placebo
n=25 Participants
Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.3 years
STANDARD_DEVIATION 6.31 • n=93 Participants
|
31.3 years
STANDARD_DEVIATION 5.11 • n=4 Participants
|
29.9 years
STANDARD_DEVIATION 5.85 • n=27 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Kinh
|
23 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Region of Enrollment
Vietnam
|
23 participants
n=93 Participants
|
25 participants
n=4 Participants
|
48 participants
n=27 Participants
|
|
Handedness
Left-handed
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Handedness
Right-handed
|
18 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Height
|
160.5 centimeters
STANDARD_DEVIATION 6.01 • n=93 Participants
|
156.9 centimeters
STANDARD_DEVIATION 5.90 • n=4 Participants
|
158.7 centimeters
STANDARD_DEVIATION 6.16 • n=27 Participants
|
|
Weight
|
55.7 kilograms
STANDARD_DEVIATION 7.76 • n=93 Participants
|
55.1 kilograms
STANDARD_DEVIATION 7.74 • n=4 Participants
|
55.4 kilograms
STANDARD_DEVIATION 7.67 • n=27 Participants
|
PRIMARY outcome
Timeframe: 7 daysSystemic and local reactogenicity data were collected on Study Days 0, 7, 21 and 28, prevaccination, and within 60 minutes post-vaccination by clinic staff. Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Solicited systemic reactogenicity events included body temperature, feverishness, chills, cough, difficulty breathing, runny nose, nasal congestion, sore throat, hoarseness of voice, headache, confusion, convulsions/seizures, fatigue/malaise, muscle aches, joint pain, pink or red eyes, sore eyes, itchy eyes, drainage from eyes, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting and jaundice. Solicited local reactogenicity included size of redness, size of swelling, size of induration, pain, and tenderness.
Outcome measures
| Measure |
Placebo
n=25 Participants
Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
|
Influenza Vaccine
n=23 Participants
Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21
IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
|
|---|---|---|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Any systemic symptoms · None
|
16 Participants
|
15 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Any systemic symptoms · Mild
|
9 Participants
|
6 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Any systemic symptoms · Moderate
|
0 Participants
|
2 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Feverishness/subjective fever · None
|
25 Participants
|
22 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Feverishness/subjective fever · Mild
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Feverishness/subjective fever · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Chills · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Chills · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Chills · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Cough · None
|
24 Participants
|
22 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Cough · Mild
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Cough · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Difficulty breathing · None
|
25 Participants
|
22 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Difficulty breathing · Mild
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Difficulty breathing · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Runny nose · None
|
23 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Runny nose · Mild
|
2 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Runny nose · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Nasal congestion · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Nasal congestion · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Nasal congestion · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Sore throat · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Sore throat · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Sore throat · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Hoarseness of voice · None
|
24 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Hoarseness of voice · Mild
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Hoarseness of voice · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Headache · None
|
22 Participants
|
19 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Headache · Mild
|
3 Participants
|
2 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Headache · Moderate
|
0 Participants
|
2 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Confusion · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Confusion · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Confusion · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Seizure · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Seizure · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Seizure · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Fatigue/malaise · None
|
23 Participants
|
20 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Fatigue/malaise · Mild
|
2 Participants
|
3 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Fatigue/malaise · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Muscle aches (generalized) · None
|
24 Participants
|
21 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Muscle aches (generalized) · Mild
|
1 Participants
|
2 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Muscle aches (generalized) · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Joint pain · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Joint pain · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Joint pain · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Pink or red eyes · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Pink or red eyes · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Pink or red eyes · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Sore eyes · None
|
25 Participants
|
22 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Sore eyes · Mild
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Sore eyes · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Itchy eyes · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Itchy eyes · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Itchy eyes · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Drainage from eyes · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Drainage from eyes · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Drainage from eyes · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Ear pain or discharge · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Ear pain or discharge · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Ear pain or discharge · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Rash · None
|
24 Participants
|
22 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Rash · Mild
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Rash · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Abdominal pain · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Abdominal pain · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Abdominal pain · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Diarrhea · None
|
24 Participants
|
22 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Diarrhea · Mild
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Diarrhea · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Vomiting · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Vomiting · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Vomiting · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Jaundice · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Jaundice · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 1
Jaundice · Moderate
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 7 daysSystemic and local reactogenicity data were collected on Study Days 0, 7, 21 and 28, prevaccination, and within 60 minutes post-vaccination by clinic staff. Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Solicited systemic reactogenicity events included body temperature, feverishness, chills, cough, difficulty breathing, runny nose, nasal congestion, sore throat, hoarseness of voice, headache, confusion, convulsions/seizures, fatigue/malaise, muscle aches, joint pain, pink or red eyes, sore eyes, itchy eyes, drainage from eyes, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting and jaundice. Solicited local reactogenicity included size of redness, size of swelling, size of induration, pain, and tenderness.
Outcome measures
| Measure |
Placebo
n=25 Participants
Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
|
Influenza Vaccine
n=23 Participants
Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21
IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
|
|---|---|---|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Pink or red eyes · None
|
25 Participants
|
22 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Pink or red eyes · Mild
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Pink or red eyes · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Sore eyes · None
|
24 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Sore eyes · Mild
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Any systemic symptoms · None
|
13 Participants
|
19 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Any systemic symptoms · Mild
|
10 Participants
|
3 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Any systemic symptoms · Moderate
|
2 Participants
|
1 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Feverishness/subjective fever · None
|
25 Participants
|
21 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Feverishness/subjective fever · Mild
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Feverishness/subjective fever · Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Chills · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Chills · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Chills · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Cough · None
|
24 Participants
|
20 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Cough · Mild
|
1 Participants
|
3 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Cough · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Difficulty breathing · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Difficulty breathing · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Difficulty breathing · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Sore eyes · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Runny nose · None
|
20 Participants
|
21 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Runny nose · Mild
|
5 Participants
|
1 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Runny nose · Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Nasal congestion · None
|
23 Participants
|
22 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Nasal congestion · Mild
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Nasal congestion · Moderate
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Sore throat · None
|
23 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Sore throat · Mild
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Sore throat · Moderate
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Hoarseness of voice · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Hoarseness of voice · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Hoarseness of voice · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Headache · None
|
20 Participants
|
21 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Headache · Mild
|
3 Participants
|
1 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Headache · Moderate
|
2 Participants
|
1 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Confusion · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Confusion · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Confusion · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Seizure · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Seizure · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Seizure · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Fatigue/malaise · None
|
23 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Fatigue/malaise · Mild
|
2 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Fatigue/malaise · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Muscle aches (generalized) · None
|
24 Participants
|
22 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Muscle aches (generalized) · Mild
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Muscle aches (generalized) · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Itchy eyes · None
|
25 Participants
|
22 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Joint pain · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Joint pain · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Joint pain · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Itchy eyes · Mild
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Itchy eyes · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Drainage from eyes · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Drainage from eyes · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Drainage from eyes · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Ear pain or discharge · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Ear pain or discharge · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Ear pain or discharge · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Rash · None
|
22 Participants
|
22 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Rash · Mild
|
3 Participants
|
1 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Rash · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Abdominal pain · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Abdominal pain · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Abdominal pain · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Diarrhea · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Diarrhea · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Diarrhea · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Vomiting · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Vomiting · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Vomiting · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Jaundice · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Jaundice · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Systemic Reaction After Vaccination 2
Jaundice · Moderate
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 7 daysSystemic and local reactogenicity data were collected on Study Days 0, 7, 21 and 28, prevaccination, and within 60 minutes post-vaccination by clinic staff. Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Solicited local reactogenicity included size of redness, size of swelling, size of induration, pain, and tenderness.
Outcome measures
| Measure |
Placebo
n=25 Participants
Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
|
Influenza Vaccine
n=23 Participants
Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21
IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
|
|---|---|---|
|
Number of Participants With Maximum Local Reaction After Vaccination 1
Painful feeling after injection · Mild
|
0 Participants
|
3 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 1
Pain when touching to the injection · None
|
20 Participants
|
21 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 1
Pain when touching to the injection · Mild
|
5 Participants
|
2 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 1
Any local symptoms · None
|
20 Participants
|
19 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 1
Any local symptoms · Mild
|
5 Participants
|
4 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 1
Swollen after injection · None
|
24 Participants
|
23 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 1
Swollen after injection · Mild
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 1
Red after injection · None
|
24 Participants
|
23 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 1
Red after injection · Mild
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 1
Hardness after injection · None
|
24 Participants
|
23 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 1
Hardness after injection · Mild
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 1
Painful feeling after injection · None
|
25 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: 7 daysSystemic and local reactogenicity data were collected on Study Days 0, 7, 21 and 28, prevaccination, and within 60 minutes post-vaccination by clinic staff. Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Solicited local reactogenicity included size of redness, size of swelling, size of induration, pain, and tenderness.
Outcome measures
| Measure |
Placebo
n=25 Participants
Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
|
Influenza Vaccine
n=23 Participants
Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21
IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
|
|---|---|---|
|
Number of Participants With Maximum Local Reaction After Vaccination 2
Any local symptoms · None
|
21 Participants
|
21 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 2
Any local symptoms · Mild
|
4 Participants
|
2 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 2
Swollen after injection · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 2
Swollen after injection · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 2
Red after injection · None
|
24 Participants
|
22 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 2
Red after injection · Mild
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 2
Hardness after injection · None
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 2
Hardness after injection · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 2
Painful feeling after injection · None
|
25 Participants
|
22 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 2
Pain when touching to the injection · Mild
|
3 Participants
|
0 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 2
Painful feeling after injection · Mild
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Local Reaction After Vaccination 2
Pain when touching to the injection · None
|
22 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: 7 days after each dose (Day 7 and Day 28)Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Adverse events were collected throughout the study period, and were graded for severity; however unsolicited adverse events were assessed only for relationship to vaccine if the events were immediate reactions or considered to be serious adverse events.
Outcome measures
| Measure |
Placebo
n=23 Participants
Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
|
Influenza Vaccine
n=25 Participants
Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21
IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
|
|---|---|---|
|
Unsolicited, Non-serious Adverse Events
Mild
|
5 adverse events
|
14 adverse events
|
|
Unsolicited, Non-serious Adverse Events
Moderate
|
12 adverse events
|
11 adverse events
|
SECONDARY outcome
Timeframe: Day 0, Day 21 and Day 42Day 0, 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells.
Outcome measures
| Measure |
Placebo
n=23 Participants
Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
|
Influenza Vaccine
n=25 Participants
Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21
IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
|
|---|---|---|
|
Geometric Mean Titer of Hemagglutination-inhibition Antibodies (HAI)
Day 0
|
13.5 titer
Interval 8.5 to 21.6
|
11.5 titer
Interval 7.7 to 17.2
|
|
Geometric Mean Titer of Hemagglutination-inhibition Antibodies (HAI)
Day 21
|
306.6 titer
Interval 165.1 to 569.6
|
11.2 titer
Interval 7.7 to 16.3
|
|
Geometric Mean Titer of Hemagglutination-inhibition Antibodies (HAI)
Day 42
|
283.7 titer
Interval 161.7 to 497.5
|
11.8 titer
Interval 8.1 to 17.3
|
SECONDARY outcome
Timeframe: Day 0, Day 21 and Day 42Day 0, 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells.
Outcome measures
| Measure |
Placebo
n=23 Participants
Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
|
Influenza Vaccine
n=25 Participants
Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21
IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
|
|---|---|---|
|
Ratio of Geometric Mean Titer of Hemagglutination-inhibition Antibodies (HAI)
Day 21/Day 0
|
22.69 ratio
Interval 11.0 to 46.64
|
0.97 ratio
Interval 0.9 to 1.08
|
|
Ratio of Geometric Mean Titer of Hemagglutination-inhibition Antibodies (HAI)
Day 42/Day 0
|
20.99 ratio
Interval 10.6 to 41.45
|
1.03 ratio
Interval 0.8 to 1.17
|
|
Ratio of Geometric Mean Titer of Hemagglutination-inhibition Antibodies (HAI)
Day 42/Day 21
|
0.93 ratio
Interval 0.7 to 1.18
|
1.06 ratio
Interval 1.0 to 1.14
|
SECONDARY outcome
Timeframe: Day 21 and Day 42Day 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells.
Outcome measures
| Measure |
Placebo
n=23 Participants
Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
|
Influenza Vaccine
n=25 Participants
Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21
IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
|
|---|---|---|
|
Number and Percentage of All Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI)
Day 21 · 4-fold rise or higher
|
20 Participants
|
0 Participants
|
|
Number and Percentage of All Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI)
Day 21 · Less than 4-fold rise
|
3 Participants
|
25 Participants
|
|
Number and Percentage of All Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI)
Day 42 · 4-fold rise or higher
|
21 Participants
|
0 Participants
|
|
Number and Percentage of All Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI)
Day 42 · Less than 4-fold rise
|
2 Participants
|
25 Participants
|
|
Number and Percentage of All Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI)
Day 21 or 42 · 4-fold rise or higher
|
22 Participants
|
0 Participants
|
|
Number and Percentage of All Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI)
Day 21 or 42 · Less than 4-fold rise
|
1 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Day 21 and Day 42Population: Subjects with baseline titer \<40
Day 21 and Day 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells.
Outcome measures
| Measure |
Placebo
n=17 Participants
Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
|
Influenza Vaccine
n=18 Participants
Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21
IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
|
|---|---|---|
|
Number and Percentage of Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI) Among Subjects With Baseline Titer Less Than 40
Day 21 · 4-fold rise or higher
|
15 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI) Among Subjects With Baseline Titer Less Than 40
Day 21 · Less than 4-fold rise
|
2 Participants
|
18 Participants
|
|
Number and Percentage of Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI) Among Subjects With Baseline Titer Less Than 40
Day 42 · 4-fold rise or higher
|
17 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI) Among Subjects With Baseline Titer Less Than 40
Day 42 · Less than 4-fold rise
|
0 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Day 21 and Day 42Population: Subjects with baseline titer \>=40
Day 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells.
Outcome measures
| Measure |
Placebo
n=6 Participants
Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
|
Influenza Vaccine
n=7 Participants
Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21
IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
|
|---|---|---|
|
Number and Percentage of Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI) Among Subjects With Baseline Titer Greater Than 40
Day 21 · 4-fold rise or higher
|
5 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI) Among Subjects With Baseline Titer Greater Than 40
Day 21 · Less than 4-fold rise
|
1 Participants
|
7 Participants
|
|
Number and Percentage of Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI) Among Subjects With Baseline Titer Greater Than 40
Day 42 · 4-fold rise or higher
|
4 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI) Among Subjects With Baseline Titer Greater Than 40
Day 42 · Less than 4-fold rise
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 21 and Day 42Population: Includes subjects who had a baseline titer of \<1:40.
Seroprotection defined as an HAI titer ≥1:40. Day 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells.
Outcome measures
| Measure |
Placebo
n=17 Participants
Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
|
Influenza Vaccine
n=18 Participants
Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21
IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
|
|---|---|---|
|
Number and Percentage of Subjects Developing a Seroprotective Hemagglutination-inhibition (HAI) Antibody Titer
Day 21 · Response
|
15 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Developing a Seroprotective Hemagglutination-inhibition (HAI) Antibody Titer
Day 21 · No response
|
2 Participants
|
18 Participants
|
|
Number and Percentage of Subjects Developing a Seroprotective Hemagglutination-inhibition (HAI) Antibody Titer
Day 42 · Response
|
17 Participants
|
1 Participants
|
|
Number and Percentage of Subjects Developing a Seroprotective Hemagglutination-inhibition (HAI) Antibody Titer
Day 42 · No response
|
0 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Day 0, Day 21 and Day 42Day 0, 21 and 42 specimens were tested in the microneutralization (MN) assay. The microneutralization assay determines the titer of neutralizing antibodies against influenza A/H1N1. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The 50% neutralizing antibody titer is the reciprocal of the corresponding serum dilution. The geometric mean titers (GMT) and corresponding confidence intervals were based on a log 10 scale.
Outcome measures
| Measure |
Placebo
n=23 Participants
Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
|
Influenza Vaccine
n=25 Participants
Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21
IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
|
|---|---|---|
|
Geometric Mean Titer of Microneutralizing (MN) Antibodies
Day 0
|
21.2 titer
Interval 11.8 to 38.4
|
17.7 titer
Interval 9.8 to 31.9
|
|
Geometric Mean Titer of Microneutralizing (MN) Antibodies
Day 21
|
595.1 titer
Interval 287.8 to 1230.5
|
18.9 titer
Interval 10.6 to 33.9
|
|
Geometric Mean Titer of Microneutralizing (MN) Antibodies
Day 42
|
725.7 titer
Interval 411.3 to 1280.3
|
18.9 titer
Interval 10.3 to 34.9
|
SECONDARY outcome
Timeframe: Day 0, Day 21 and Day 42Day 0, 21 and 42 specimens were tested in the microneutralization (MN) assay. The microneutralization assay determines the titer of neutralizing antibodies against influenza A/H1N1. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The 50% neutralizing antibody titer is the reciprocal of the corresponding serum dilution. The geometric mean titers (GMT) and corresponding confidence intervals were based on a log 10 scale.
Outcome measures
| Measure |
Placebo
n=23 Participants
Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
|
Influenza Vaccine
n=25 Participants
Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21
IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
|
|---|---|---|
|
Ratio of Geometric Mean Titer of Microneutralization (MN) Antibodies
Day 21/Day 0
|
28.01 ratio
Interval 12.0 to 65.24
|
1.07 ratio
Interval 1.0 to 1.2
|
|
Ratio of Geometric Mean Titer of Microneutralization (MN) Antibodies
Day 42/Day 0
|
34.16 ratio
Interval 16.8 to 69.4
|
1.07 ratio
Interval 1.0 to 1.16
|
|
Ratio of Geometric Mean Titer of Microneutralization (MN) Antibodies
Day 42/Day 21
|
1.22 ratio
Interval 0.9 to 1.61
|
1.00 ratio
Interval 0.9 to 1.12
|
SECONDARY outcome
Timeframe: Day 21 and Day 42Day 21 and 42 specimens were tested in the microneutralization (MN) assay. The microneutralization assay determines the titer of neutralizing antibodies against influenza A/H1N1. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The 50% neutralizing antibody titer is the reciprocal of the corresponding serum dilution. The geometric mean titers (GMT) and corresponding confidence intervals were based on a log 10 scale.
Outcome measures
| Measure |
Placebo
n=23 Participants
Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
|
Influenza Vaccine
n=25 Participants
Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21
IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
|
|---|---|---|
|
Number and Percentage of All Subjects Achieving a Four-fold Rise in Microneutralization (MN) Antibodies
Day 21 · 4-fold rise or higher
|
19 Participants
|
0 Participants
|
|
Number and Percentage of All Subjects Achieving a Four-fold Rise in Microneutralization (MN) Antibodies
Day 21 · Less than 4-fold rise
|
4 Participants
|
25 Participants
|
|
Number and Percentage of All Subjects Achieving a Four-fold Rise in Microneutralization (MN) Antibodies
Day 42 · 4-fold rise or higher
|
22 Participants
|
0 Participants
|
|
Number and Percentage of All Subjects Achieving a Four-fold Rise in Microneutralization (MN) Antibodies
Day 42 · Less than 4-fold rise
|
1 Participants
|
25 Participants
|
|
Number and Percentage of All Subjects Achieving a Four-fold Rise in Microneutralization (MN) Antibodies
Day 21 or 42 · 4-fold rise or higher
|
22 Participants
|
0 Participants
|
|
Number and Percentage of All Subjects Achieving a Four-fold Rise in Microneutralization (MN) Antibodies
Day 21 or 42 · Less than 4-fold rise
|
1 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Day 21 and Day 42Population: Subjects with baseline titer \<40
Day 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells.
Outcome measures
| Measure |
Placebo
n=11 Participants
Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
|
Influenza Vaccine
n=15 Participants
Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21
IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
|
|---|---|---|
|
Number and Percentage of Subjects Achieving a Four-fold Rise in Microneutralizing (MN) Antibodies Among Subjects With Baseline Titer Less Than 40
Day 21 · 4-fold rise or higher
|
10 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Achieving a Four-fold Rise in Microneutralizing (MN) Antibodies Among Subjects With Baseline Titer Less Than 40
Day 21 · Less than 4-fold rise
|
1 Participants
|
15 Participants
|
|
Number and Percentage of Subjects Achieving a Four-fold Rise in Microneutralizing (MN) Antibodies Among Subjects With Baseline Titer Less Than 40
Day 42 · 4-fold rise or higher
|
11 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Achieving a Four-fold Rise in Microneutralizing (MN) Antibodies Among Subjects With Baseline Titer Less Than 40
Day 42 · Less than 4-fold rise
|
0 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Day 21 and Day 42Population: Subjects with baseline titer \>=40
Day 21 and 42 specimens were tested in the microneutralization (MN) assay. The microneutralization assay determines the titer of neutralizing antibodies against influenza A/H1N1. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The 50% neutralizing antibody titer is the reciprocal of the corresponding serum dilution. The geometric mean titers (GMT) and corresponding confidence intervals were based on a log 10 scale.
Outcome measures
| Measure |
Placebo
n=12 Participants
Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
|
Influenza Vaccine
n=10 Participants
Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21
IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
|
|---|---|---|
|
Number and Percentage of Subjects Achieving a Four-fold Rise in Microneutralizing (MN) Antibodies Among Subjects With Baseline Titer Greater Than 40
Day 21 · 4-fold rise or higher
|
9 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Achieving a Four-fold Rise in Microneutralizing (MN) Antibodies Among Subjects With Baseline Titer Greater Than 40
Day 21 · Less than 4-fold rise
|
3 Participants
|
10 Participants
|
|
Number and Percentage of Subjects Achieving a Four-fold Rise in Microneutralizing (MN) Antibodies Among Subjects With Baseline Titer Greater Than 40
Day 42 · 4-fold rise or higher
|
11 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Achieving a Four-fold Rise in Microneutralizing (MN) Antibodies Among Subjects With Baseline Titer Greater Than 40
Day 42 · Less than 4-fold rise
|
1 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Day 21 and Day 42Population: Includes subjects who had a baseline titer of \<1:40.
Seroprotection defined as an antibody titer of 1:40 or greater. Day 21 and 42 specimens were tested in the microneutralization (MN) assay. The microneutralization assay determines the titer of neutralizing antibodies against influenza A/H1N1. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The 50% neutralizing antibody titer is the reciprocal of the corresponding serum dilution. The geometric mean titers (GMT) and corresponding confidence intervals were based on a log 10 scale.
Outcome measures
| Measure |
Placebo
n=11 Participants
Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
|
Influenza Vaccine
n=15 Participants
Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21
IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
|
|---|---|---|
|
Number and Percentage of Subjects Developing a Seroprotective Microneutralizing (MN) Antibody Titer
Day 21 · Seroprotection
|
9 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Developing a Seroprotective Microneutralizing (MN) Antibody Titer
Day 21 · No seroprotection
|
2 Participants
|
15 Participants
|
|
Number and Percentage of Subjects Developing a Seroprotective Microneutralizing (MN) Antibody Titer
Day 42 · Seroprotection
|
11 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Developing a Seroprotective Microneutralizing (MN) Antibody Titer
Day 42 · No seroprotection
|
0 Participants
|
15 Participants
|
Adverse Events
Influenza Vaccine
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Influenza Vaccine
n=23 participants at risk
Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21
IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
|
Placebo
n=25 participants at risk
Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
4.0%
1/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
Other adverse events
| Measure |
Influenza Vaccine
n=23 participants at risk
Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21
IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
|
Placebo
n=25 participants at risk
Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.7%
2/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
0.00%
0/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
4.0%
1/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
4.0%
1/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
4.3%
1/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
0.00%
0/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
4.0%
1/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
|
General disorders
Fatigue
|
0.00%
0/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
8.0%
2/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
8.0%
2/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
|
Skin and subcutaneous tissue disorders
Generalized erythema
|
0.00%
0/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
4.0%
1/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
|
Nervous system disorders
Headache
|
17.4%
4/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
12.0%
3/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
4.0%
1/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
4.3%
1/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
8.0%
2/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
|
Nervous system disorders
Neuropathy peripheral
|
4.3%
1/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
0.00%
0/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
|
Eye disorders
Ocular hyperaemia
|
4.3%
1/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
0.00%
0/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.7%
2/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
4.0%
1/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
|
Ear and labyrinth disorders
Otorrhoea
|
4.3%
1/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
0.00%
0/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
|
Skin and subcutaneous tissue disorders
Piloerection
|
0.00%
0/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
4.0%
1/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
|
General disorders
Pyrexia
|
4.3%
1/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
16.0%
4/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
4.0%
1/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
|
Immune system disorders
Rhinitis allergic
|
0.00%
0/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
4.0%
1/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
|
Musculoskeletal and connective tissue disorders
Sciatica
|
0.00%
0/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
4.0%
1/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/23 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
4.0%
1/25 • 7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place