Trial Outcomes & Findings for A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects (NCT NCT01144637)
NCT ID: NCT01144637
Last Updated: 2019-01-03
Results Overview
Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4005 participants
Primary outcome timeframe
2 weeks following the second vaccination
Results posted on
2019-01-03
Participant Flow
Participant milestones
| Measure |
Group 1
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 2
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 3
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 4
Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)
Placebo: 0.5 ml TBS
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
999
|
1005
|
999
|
1002
|
|
Overall Study
COMPLETED
|
925
|
929
|
939
|
946
|
|
Overall Study
NOT COMPLETED
|
74
|
76
|
60
|
56
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects
Baseline characteristics by cohort
| Measure |
Group 1
n=999 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 2
n=1005 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 3
n=999 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 4
n=1002 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)
Placebo: 0.5 ml TBS
|
Total
n=4005 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
27.6 years
STANDARD_DEVIATION 6.28 • n=93 Participants
|
27.5 years
STANDARD_DEVIATION 6.24 • n=4 Participants
|
28.0 years
STANDARD_DEVIATION 6.31 • n=27 Participants
|
27.7 years
STANDARD_DEVIATION 6.38 • n=483 Participants
|
27.7 years
STANDARD_DEVIATION 6.30 • n=36 Participants
|
|
Sex: Female, Male
Female
|
526 Participants
n=93 Participants
|
527 Participants
n=4 Participants
|
494 Participants
n=27 Participants
|
539 Participants
n=483 Participants
|
2086 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
473 Participants
n=93 Participants
|
478 Participants
n=4 Participants
|
505 Participants
n=27 Participants
|
463 Participants
n=483 Participants
|
1919 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 2 weeks following the second vaccinationPopulation: Per-protocol Set
Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.
Outcome measures
| Measure |
Group 1
n=637 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 2
n=628 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 3
n=641 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 4
n=643 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)
Placebo: 0.5 ml TBS
|
|---|---|---|---|---|
|
PRNT GMT
|
110.7 Titer
Interval 103.4 to 118.4
|
100.5 Titer
Interval 93.7 to 107.8
|
117.2 Titer
Interval 109.0 to 126.0
|
1.0 Titer
Interval 1.0 to 1.1
|
SECONDARY outcome
Timeframe: 2 weeks following the second vaccinationPopulation: Per-protocol Set
Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.
Outcome measures
| Measure |
Group 1
n=637 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 2
n=628 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 3
n=641 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 4
n=643 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)
Placebo: 0.5 ml TBS
|
|---|---|---|---|---|
|
ELISA GMT
|
901.0 Titer
Interval 844.8 to 961.1
|
794.4 Titer
Interval 738.1 to 855.0
|
946.7 Titer
Interval 888.2 to 1008.9
|
1.2 Titer
Interval 1.1 to 1.3
|
SECONDARY outcome
Timeframe: 2 weeks following the second vaccinationPopulation: Per-protocol Set
Seroconversion rate based on Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Outcome measures
| Measure |
Group 1
n=637 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 2
n=628 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 3
n=641 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 4
n=643 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)
Placebo: 0.5 ml TBS
|
|---|---|---|---|---|
|
PRNT Seroconversion Rate
|
99.8 percentage of subjects
Interval 99.1 to 100.0
|
99.7 percentage of subjects
Interval 98.9 to 100.0
|
99.8 percentage of subjects
Interval 99.1 to 100.0
|
1.4 percentage of subjects
Interval 0.6 to 2.6
|
SECONDARY outcome
Timeframe: 2 weeks following the second vaccinationPopulation: Per-protocol Set
Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Outcome measures
| Measure |
Group 1
n=637 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 2
n=628 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 3
n=641 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 4
n=643 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)
Placebo: 0.5 ml TBS
|
|---|---|---|---|---|
|
ELISA Seroconversion Rate
|
99.7 percentage of subjects
Interval 98.9 to 100.0
|
99.5 percentage of subjects
Interval 98.6 to 99.9
|
100.0 percentage of subjects
Interval 99.4 to 100.0
|
2.0 percentage of subjects
Interval 1.1 to 3.4
|
SECONDARY outcome
Timeframe: 2 weeks following the second vaccinationPopulation: Per-protocol Set
Pearson Correlation Coefficient between the log10 transformed PRNT titers and the log10 transformed ELISA titers
Outcome measures
| Measure |
Group 1
n=637 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 2
n=628 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 3
n=641 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 4
n=643 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)
Placebo: 0.5 ml TBS
|
|---|---|---|---|---|
|
Correlation PRNT vs ELISA Titers
|
0.581 Pearson correlation coefficient
Interval 0.527 to 0.63
|
0.620 Pearson correlation coefficient
Interval 0.569 to 0.666
|
0.612 Pearson correlation coefficient
Interval 0.561 to 0.658
|
0.486 Pearson correlation coefficient
Interval 0.424 to 0.543
|
SECONDARY outcome
Timeframe: within 30 weeksPopulation: Full Analysis Set
Incidence, relationship and intensity of any Serious Adverse Event (SAE)
Outcome measures
| Measure |
Group 1
n=999 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 2
n=1005 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 3
n=999 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 4
n=1002 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)
Placebo: 0.5 ml TBS
|
|---|---|---|---|---|
|
Serious Adverse Events
Any SAE
|
11 Participants
|
7 Participants
|
7 Participants
|
8 Participants
|
|
Serious Adverse Events
Any SAE with intensity >= Grade 3
|
8 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
|
Serious Adverse Events
Any SAE assessed as related to vaccine
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: within 30 weeksPopulation: Full Analysis Set
Incidence, relationship and intensity of any cardiac sign or symptom indicating a case of myo-/pericarditis (Adverse Event of Special Interest (AESI)). An AESI was defined in this trial as: * Any cardiac sign or symptom developed since the first vaccination * ECG changes determined to be clinically significant * Cardiac enzyme Troponin I \>= 2 x ULN (\>= Grade 2)
Outcome measures
| Measure |
Group 1
n=999 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 2
n=1005 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 3
n=999 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 4
n=1002 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)
Placebo: 0.5 ml TBS
|
|---|---|---|---|---|
|
Cardiac Signs or Symptoms
Any AESI with intensity >= Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cardiac Signs or Symptoms
Any AESI assessed as related to vaccine
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Cardiac Signs or Symptoms
Any AESI
|
2 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: within 29 days after any vaccinationPopulation: Full Analysis Set
Incidence of any Grade \>=3 Adverse Events probably, possibly or definitely related to the trial vaccine. Pooled solicited (general only) and unsolicited AEs
Outcome measures
| Measure |
Group 1
n=999 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 2
n=1005 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 3
n=999 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 4
n=1002 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)
Placebo: 0.5 ml TBS
|
|---|---|---|---|---|
|
Related Grade >=3 Adverse Events
|
58 Participants
|
57 Participants
|
53 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: within 29 days after any vaccinationPopulation: Full Analysis Set
Occurrence of unsolicited non-serious AEs by Intensity
Outcome measures
| Measure |
Group 1
n=999 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 2
n=1005 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 3
n=999 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 4
n=1002 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)
Placebo: 0.5 ml TBS
|
|---|---|---|---|---|
|
Unsolicited Non-serious AEs: Intensity
Total
|
288 events
|
350 events
|
320 events
|
280 events
|
|
Unsolicited Non-serious AEs: Intensity
Grade 1
|
190 events
|
236 events
|
218 events
|
192 events
|
|
Unsolicited Non-serious AEs: Intensity
Grade 2
|
88 events
|
100 events
|
94 events
|
82 events
|
|
Unsolicited Non-serious AEs: Intensity
Grade 3
|
10 events
|
14 events
|
8 events
|
6 events
|
|
Unsolicited Non-serious AEs: Intensity
Grade 4
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Unsolicited Non-serious AEs: Intensity
Missing
|
0 events
|
0 events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: within 29 days after any vaccinationPopulation: Full Analysis Set
Occurrence of unsolicited non-serious AEs by relationship to study vaccine
Outcome measures
| Measure |
Group 1
n=999 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 2
n=1005 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 3
n=999 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 4
n=1002 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)
Placebo: 0.5 ml TBS
|
|---|---|---|---|---|
|
Unsolicited Non-serious AEs: Relationship to Vaccination
Possible
|
28 events
|
42 events
|
34 events
|
29 events
|
|
Unsolicited Non-serious AEs: Relationship to Vaccination
Probable
|
5 events
|
6 events
|
7 events
|
6 events
|
|
Unsolicited Non-serious AEs: Relationship to Vaccination
Definite
|
28 events
|
27 events
|
35 events
|
4 events
|
|
Unsolicited Non-serious AEs: Relationship to Vaccination
Total
|
288 events
|
350 events
|
320 events
|
280 events
|
|
Unsolicited Non-serious AEs: Relationship to Vaccination
Unrelated/None
|
187 events
|
218 events
|
181 events
|
189 events
|
|
Unsolicited Non-serious AEs: Relationship to Vaccination
Unlikely
|
40 events
|
56 events
|
61 events
|
51 events
|
|
Unsolicited Non-serious AEs: Relationship to Vaccination
Missing
|
0 events
|
1 events
|
2 events
|
1 events
|
SECONDARY outcome
Timeframe: within 8 days after any vaccinationPopulation: Full Analysis Set
Incidence and intensity of solicited local AEs (redness, swelling, induration, pruritus and pain). Percentages based on subjects with at least one completed diary card.
Outcome measures
| Measure |
Group 1
n=985 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 2
n=976 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 3
n=982 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 4
n=980 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)
Placebo: 0.5 ml TBS
|
|---|---|---|---|---|
|
Solicited Local AEs
Pain: Any
|
846 Participants
|
823 Participants
|
830 Participants
|
187 Participants
|
|
Solicited Local AEs
Pain: Grade >=3
|
76 Participants
|
66 Participants
|
76 Participants
|
10 Participants
|
|
Solicited Local AEs
Erythema: Any
|
597 Participants
|
610 Participants
|
581 Participants
|
173 Participants
|
|
Solicited Local AEs
Erythema: Grade >=3
|
15 Participants
|
18 Participants
|
12 Participants
|
0 Participants
|
|
Solicited Local AEs
Swelling: Any
|
508 Participants
|
513 Participants
|
499 Participants
|
55 Participants
|
|
Solicited Local AEs
Pruritis: Any
|
430 Participants
|
424 Participants
|
414 Participants
|
115 Participants
|
|
Solicited Local AEs
Pruritis: Grade >=3
|
20 Participants
|
15 Participants
|
13 Participants
|
2 Participants
|
|
Solicited Local AEs
Swelling: Grade >=3
|
9 Participants
|
10 Participants
|
4 Participants
|
0 Participants
|
|
Solicited Local AEs
Induration: Any
|
454 Participants
|
439 Participants
|
442 Participants
|
45 Participants
|
|
Solicited Local AEs
Induration: Grade >=3
|
4 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: within 8 days after any vaccinationPopulation: Full Analysis Set
Incidence of solicited general AEs (pyrexia, headache, myalgia, chills, nausea, and fatigue): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.
Outcome measures
| Measure |
Group 1
n=985 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 2
n=976 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 3
n=982 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 4
n=980 Participants
Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)
Placebo: 0.5 ml TBS
|
|---|---|---|---|---|
|
Solicited General AEs
Fatigue: Any
|
305 Participants
|
303 Participants
|
287 Participants
|
201 Participants
|
|
Solicited General AEs
Fatigue: Related
|
276 Participants
|
279 Participants
|
267 Participants
|
176 Participants
|
|
Solicited General AEs
Fatigue: Grade >=3
|
32 Participants
|
27 Participants
|
29 Participants
|
13 Participants
|
|
Solicited General AEs
Pyrexia: Any
|
17 Participants
|
19 Participants
|
14 Participants
|
9 Participants
|
|
Solicited General AEs
Pyrexia: Grade >=3
|
2 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Solicited General AEs
Headache: Any
|
321 Participants
|
349 Participants
|
354 Participants
|
251 Participants
|
|
Solicited General AEs
Headache: Related
|
279 Participants
|
314 Participants
|
318 Participants
|
208 Participants
|
|
Solicited General AEs
Headache: Grade >=3
|
28 Participants
|
24 Participants
|
20 Participants
|
21 Participants
|
|
Solicited General AEs
Myalgia: Any
|
425 Participants
|
403 Participants
|
431 Participants
|
172 Participants
|
|
Solicited General AEs
Myalgia: Related
|
404 Participants
|
381 Participants
|
414 Participants
|
156 Participants
|
|
Solicited General AEs
Myalgia: Grade >=3
|
25 Participants
|
25 Participants
|
27 Participants
|
7 Participants
|
|
Solicited General AEs
Chills: Any
|
108 Participants
|
108 Participants
|
90 Participants
|
57 Participants
|
|
Solicited General AEs
Chills: Related
|
96 Participants
|
96 Participants
|
84 Participants
|
51 Participants
|
|
Solicited General AEs
Nausea: Related
|
146 Participants
|
158 Participants
|
144 Participants
|
99 Participants
|
|
Solicited General AEs
Nausea: Grade >=3
|
13 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
|
Solicited General AEs
Pyrexia: Related
|
13 Participants
|
15 Participants
|
14 Participants
|
6 Participants
|
|
Solicited General AEs
Chills: Grade >=3
|
10 Participants
|
7 Participants
|
12 Participants
|
3 Participants
|
|
Solicited General AEs
Nausea: Any
|
166 Participants
|
179 Participants
|
163 Participants
|
128 Participants
|
Adverse Events
Group 1
Serious events: 11 serious events
Other events: 53 other events
Deaths: 1 deaths
Group 2
Serious events: 7 serious events
Other events: 70 other events
Deaths: 0 deaths
Group 3
Serious events: 7 serious events
Other events: 65 other events
Deaths: 0 deaths
Group 4
Serious events: 8 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=999 participants at risk
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 2
n=1005 participants at risk
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 3
n=999 participants at risk
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 4
n=1002 participants at risk
Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)
Placebo: 0.5 ml TBS
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/999
|
0.00%
0/1005
|
0.10%
1/999
|
0.00%
0/1002
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/999
|
0.00%
0/1005
|
0.10%
1/999
|
0.00%
0/1002
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.10%
1/999
|
0.00%
0/1005
|
0.00%
0/999
|
0.00%
0/1002
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.10%
1/999
|
0.00%
0/1005
|
0.00%
0/999
|
0.00%
0/1002
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/999
|
0.10%
1/1005
|
0.00%
0/999
|
0.00%
0/1002
|
|
General disorders
Chest pain
|
0.10%
1/999
|
0.00%
0/1005
|
0.00%
0/999
|
0.00%
0/1002
|
|
Infections and infestations
Abscess limb
|
0.00%
0/999
|
0.00%
0/1005
|
0.10%
1/999
|
0.00%
0/1002
|
|
Infections and infestations
Appendicitis
|
0.00%
0/999
|
0.20%
2/1005
|
0.10%
1/999
|
0.00%
0/1002
|
|
Infections and infestations
Appendicitis perforated
|
0.10%
1/999
|
0.00%
0/1005
|
0.00%
0/999
|
0.00%
0/1002
|
|
Infections and infestations
Meningitis
|
0.00%
0/999
|
0.00%
0/1005
|
0.10%
1/999
|
0.00%
0/1002
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/999
|
0.00%
0/1005
|
0.00%
0/999
|
0.10%
1/1002
|
|
Injury, poisoning and procedural complications
Concussion
|
0.10%
1/999
|
0.10%
1/1005
|
0.00%
0/999
|
0.00%
0/1002
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/999
|
0.00%
0/1005
|
0.00%
0/999
|
0.10%
1/1002
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/999
|
0.00%
0/1005
|
0.00%
0/999
|
0.10%
1/1002
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/999
|
0.10%
1/1005
|
0.00%
0/999
|
0.00%
0/1002
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.10%
1/999
|
0.00%
0/1005
|
0.00%
0/999
|
0.00%
0/1002
|
|
Nervous system disorders
Ataxia
|
0.00%
0/999
|
0.10%
1/1005
|
0.00%
0/999
|
0.00%
0/1002
|
|
Nervous system disorders
Convulsion
|
0.00%
0/999
|
0.00%
0/1005
|
0.00%
0/999
|
0.10%
1/1002
|
|
Nervous system disorders
Headache
|
0.10%
1/999
|
0.00%
0/1005
|
0.00%
0/999
|
0.00%
0/1002
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/999
|
0.00%
0/1005
|
0.00%
0/999
|
0.10%
1/1002
|
|
Nervous system disorders
Syncope
|
0.00%
0/999
|
0.00%
0/1005
|
0.10%
1/999
|
0.00%
0/1002
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/999
|
0.00%
0/1005
|
0.10%
1/999
|
0.20%
2/1002
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.10%
1/999
|
0.00%
0/1005
|
0.00%
0/999
|
0.00%
0/1002
|
|
Psychiatric disorders
Completed suicide
|
0.10%
1/999
|
0.00%
0/1005
|
0.00%
0/999
|
0.00%
0/1002
|
|
Psychiatric disorders
Depression
|
0.00%
0/999
|
0.10%
1/1005
|
0.00%
0/999
|
0.10%
1/1002
|
|
Psychiatric disorders
Suicide attempt
|
0.10%
1/999
|
0.00%
0/1005
|
0.00%
0/999
|
0.10%
1/1002
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/999
|
0.00%
0/1005
|
0.10%
1/999
|
0.00%
0/1002
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.10%
1/999
|
0.00%
0/1005
|
0.00%
0/999
|
0.00%
0/1002
|
Other adverse events
| Measure |
Group 1
n=999 participants at risk
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 2
n=1005 participants at risk
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 3
n=999 participants at risk
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3
IMVAMUNE®: 0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
|
Group 4
n=1002 participants at risk
Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)
Placebo: 0.5 ml TBS
|
|---|---|---|---|---|
|
General disorders
Injection site haematoma
|
0.50%
5/999
|
1.1%
11/1005
|
0.80%
8/999
|
0.50%
5/1002
|
|
General disorders
Injection site induration
|
1.4%
14/999
|
1.5%
15/1005
|
2.1%
21/999
|
0.00%
0/1002
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
11/999
|
1.4%
14/1005
|
1.1%
11/999
|
0.30%
3/1002
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
17/999
|
2.1%
21/1005
|
2.0%
20/999
|
3.1%
31/1002
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.90%
9/999
|
0.90%
9/1005
|
0.60%
6/999
|
1.00%
10/1002
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place