Trial Outcomes & Findings for A Study of a Seasonal Trivalent Split, Inactivated Influenza Vaccine (NCT NCT02585700)
NCT ID: NCT02585700
Last Updated: 2019-01-15
Results Overview
Number of subjects with observed immediate adverse events, including allergic reaction or anaphylaxis, following administration of the study product.
COMPLETED
PHASE1
60 participants
30-minute post-vaccination period.
2019-01-15
Participant Flow
All volunteers were recruited at the Clinical Center of Serbia, Belgrade, Serbia.
66 people were screened for the study after signing consent. 6 subjects failed screening. A total of 60 subjects received vaccine or placebo.
Participant milestones
| Measure |
Vaccine Group
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of B/Massachusetts, H1/A/California, and H3/A/Texas
|
Placebo Group
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of a Seasonal Trivalent Split, Inactivated Influenza Vaccine
Baseline characteristics by cohort
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of B/Massachusetts, H1/A/California, and H3/A/Texas
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.00 years
STANDARD_DEVIATION 7.21 • n=5 Participants
|
30.70 years
STANDARD_DEVIATION 6.14 • n=7 Participants
|
30.85 years
STANDARD_DEVIATION 6.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30-minute post-vaccination period.Population: The analysis was conducted for subjects who were randomized and received a study vaccination
Number of subjects with observed immediate adverse events, including allergic reaction or anaphylaxis, following administration of the study product.
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of B/Massachusetts, H1/A/California, and H3/A/Texas
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Number of Subjects With Immediate Adverse Events
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 7-day period (Days 0-6) post-vaccination.Population: The analysis was conducted for subjects who were randomized and received a study vaccination
Number of subjects reporting solicited local reactions (redness, swelling, induration, pain and tenderness) at the injection site post-vaccination with study vaccine or placebo
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of B/Massachusetts, H1/A/California, and H3/A/Texas
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Number and Percentage of Subjects With Solicited Local Reactogenicity
Hardness
|
2 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With Solicited Local Reactogenicity
Pain
|
14 Participants
|
4 Participants
|
|
Number and Percentage of Subjects With Solicited Local Reactogenicity
Redness
|
6 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With Solicited Local Reactogenicity
Swelling
|
2 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With Solicited Local Reactogenicity
Tenderness
|
10 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 7-day period (Days 0-6) post-vaccination.Population: The analysis was conducted for subjects who were randomized and received a study vaccination
Number of subjects reporting solicited systemic reactions (fever, fatigue/malaise, muscle aches, joint aches, chills, nausea, vomiting, and headache) post-vaccination with study vaccine or Placebo
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of B/Massachusetts, H1/A/California, and H3/A/Texas
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Number and Percentage of Subjects With Solicited Systemic Reactogenicity
Temperature above 37 C
|
2 Participants
|
1 Participants
|
|
Number and Percentage of Subjects With Solicited Systemic Reactogenicity
Chills
|
2 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With Solicited Systemic Reactogenicity
Headache
|
5 Participants
|
2 Participants
|
|
Number and Percentage of Subjects With Solicited Systemic Reactogenicity
Joint aches
|
1 Participants
|
2 Participants
|
|
Number and Percentage of Subjects With Solicited Systemic Reactogenicity
Muscle aches
|
2 Participants
|
1 Participants
|
|
Number and Percentage of Subjects With Solicited Systemic Reactogenicity
Nausea
|
2 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With Solicited Systemic Reactogenicity
Tiredness
|
5 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With Solicited Systemic Reactogenicity
Vomiting
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 21 days post vaccinationPopulation: The analysis was conducted for subjects who were randomized and received a study vaccination
These data are presented broadly as number per group for the study. Please see AE reporting section for more specific details on AEs.
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of B/Massachusetts, H1/A/California, and H3/A/Texas
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Number and Percentage of Subjects With Occurrence of Unsolicited Adverse Events
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Over the entire study period (Day 90).Population: The analysis was conducted for subjects who were randomized and received a study vaccination
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of B/Massachusetts, H1/A/California, and H3/A/Texas
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Number and Percentage of Subjects With Occurrence of Serious Adverse Events (SAE)
Serious adverse events (SAEs)--related
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With Occurrence of Serious Adverse Events (SAE)
SAEs--not related
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 21Population: The analysis was conducted for subjects who were randomized and received a study vaccination
Seroconversion is defined as a serum HAI titer meeting the following criteria: * pre-vaccination titer \<1:10 and a post-vaccination titer ≥ 1:40 or * pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination measured on Day 21. The 3 influenza strains assessed were B/Massachusetts, H1/A/California and H3/A/Texas
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of B/Massachusetts, H1/A/California, and H3/A/Texas
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Number and Percentage of Seroconverted Subjects Against 3 Strains of Influenza Vaccine.
Seroconversion to H1
|
25 Participants
|
0 Participants
|
|
Number and Percentage of Seroconverted Subjects Against 3 Strains of Influenza Vaccine.
Seroconversion to H3
|
23 Participants
|
0 Participants
|
|
Number and Percentage of Seroconverted Subjects Against 3 Strains of Influenza Vaccine.
Seroconversion to B
|
21 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0 and Day 21 post vaccinationPopulation: All vaccinated subjects who have valid post vaccination immunogenicity measures with no major protocol violations
A seroprotected subject was defined as a vaccinated subject who had a serum Hemagluttination Inhibition (HAI) titer ≥ 1:40. The 3 influenza strains assessed were B/Massachusetts, H1/A/California an d H3/A/Texas
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of B/Massachusetts, H1/A/California, and H3/A/Texas
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine
H1
|
30 Participants
|
10 Participants
|
|
Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine
H3
|
30 Participants
|
19 Participants
|
|
Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine
B
|
26 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Pre- (Day 0) and post-vaccination (Day 21)Population: All vaccinated subjects with no major protocol violations who have valid post vaccination immunogenicity measures
The 3 influenza strains assessed were B/Massachusetts, H1/A/California an d H3/A/Texas
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of B/Massachusetts, H1/A/California, and H3/A/Texas
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens
GMT to H1 Day 0
|
15.97 Titers
Interval 11.3 to 23.1
|
21.19 Titers
Interval 14.82 to 30.29
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens
GMT to H1 Day 21
|
295.14 Titers
Interval 240.1 to 362.8
|
22.32 Titers
Interval 15.72 to 31.69
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens
GMT to H3 Day 0
|
37.75 Titers
Interval 25.88 to 55.07
|
41.41 Titers
Interval 28.02 to 61.2
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens
GMT to H3 Day 21
|
439.67 Titers
Interval 320.54 to 603.06
|
42.87 Titers
Interval 28.92 to 63.55
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens
GMT to B Day 0
|
10.47 Titers
Interval 7.91 to 13.86
|
10.72 Titers
Interval 7.72 to 14.89
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens
GMT to B Day 21
|
75.95 Titers
Interval 56.88 to 101.4
|
10.66 Titers
Interval 7.69 to 14.76
|
SECONDARY outcome
Timeframe: Pre- (Day 0) and post-vaccination (Day 21)Population: All vaccinated subjects who have valid post vaccination immunogenicity measures with no major protocol violations
The 3 influenza strains assessed were B/Massachusetts, H1/A/California an d H3/A/Texas
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of B/Massachusetts, H1/A/California, and H3/A/Texas
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Geometric Mean Fold Rises (GMFRs) of Serum (HAI) Antibodies (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens.
GMFR for H1
|
18.49 fold rise
Interval 12.22 to 27.95
|
1.05 fold rise
Interval 1.0 to 1.11
|
|
Geometric Mean Fold Rises (GMFRs) of Serum (HAI) Antibodies (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens.
GMFR for H3
|
11.65 fold rise
Interval 7.82 to 17.35
|
1.04 fold rise
Interval 0.99 to 1.08
|
|
Geometric Mean Fold Rises (GMFRs) of Serum (HAI) Antibodies (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens.
GMFR for B
|
7.25 fold rise
Interval 5.53 to 9.52
|
0.99 fold rise
Interval 0.96 to 1.03
|
SECONDARY outcome
Timeframe: Pre- (Day 0) and post-vaccination (Day 21)Population: All vaccinated subjects who have valid post vaccination immunogenicity measures with no major protocol violations
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of B/Massachusetts, H1/A/California, and H3/A/Texas
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens.
GMT to H1 Day 0
|
24.06 Titers
Interval 18.61 to 31.11
|
31.75 Titers
Interval 24.06 to 41.89
|
|
Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens.
GMT to H1 Day 21
|
211.12 Titers
Interval 164.95 to 270.22
|
40.00 Titers
Interval 30.47 to 52.52
|
|
Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens.
GMT to H3 Day 0
|
18.02 Titers
Interval 12.74 to 25.51
|
19.77 Titers
Interval 15.11 to 25.86
|
|
Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens.
GMT to H3 Day 21
|
125.53 Titers
Interval 87.82 to 179.45
|
24.34 Titers
Interval 18.39 to 32.22
|
|
Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens.
GMT to B Day 0
|
80.93 Titers
Interval 59.21 to 110.61
|
70.45 Titers
Interval 48.06 to 103.28
|
|
Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens.
GMT to B Day 21
|
331.28 Titers
Interval 278.78 to 393.68
|
105.56 Titers
Interval 75.73 to 147.15
|
SECONDARY outcome
Timeframe: Pre- (Day 0) and post-vaccination (Day 21)Population: All vaccinated subjects who have valid post vaccination immunogenicity measures with no major protocol violations
The 3 influenza strains assessed were B/Massachusetts, H1/A/California an d H3/A/Texas
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of B/Massachusetts, H1/A/California, and H3/A/Texas
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Geometric Mean Fold Rises (GMFRs) of MNT (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens.
GMFR for H1
|
8.77 fold rise
Interval 6.7 to 11.49
|
1.26 fold rise
Interval 1.09 to 1.45
|
|
Geometric Mean Fold Rises (GMFRs) of MNT (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens.
GMFR for H3
|
6.96 fold rise
Interval 4.89 to 9.92
|
1.23 fold rise
Interval 1.14 to 1.33
|
|
Geometric Mean Fold Rises (GMFRs) of MNT (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens.
GMFR for B
|
4.09 fold rise
Interval 3.11 to 5.38
|
1.50 fold rise
Interval 1.18 to 1.89
|
Adverse Events
Vaccine Group
Placebo Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vaccine Group
n=30 participants at risk
0.5 mL of influenza vaccine, split, inactivated with 15 mcg of HA of each of 3 strains:
* NYMC BX-51B reassortant of B/Massachusetts/2/2012
* X-181 reassortant of H1/A/California/7/2009
* X-223A reassortant of H3/A/Texas/50/2012.
|
Placebo Group
n=30 participants at risk
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Infection
|
3.3%
1/30 • 90 days
|
0.00%
0/30 • 90 days
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/30 • 90 days
|
3.3%
1/30 • 90 days
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/30 • 90 days
|
3.3%
1/30 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.3%
1/30 • 90 days
|
3.3%
1/30 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/30 • 90 days
|
3.3%
1/30 • 90 days
|
Additional Information
Dr. Goran Stevanovic
Clinical Center of Serbia-Clinic for Infectious and Tropical Diseases
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place