Trial Outcomes & Findings for Study of BPZE1 Intranasal Pertussis Vaccine (Administered Via VaxINator(TM)), Prime + Boost, in Healthy Adults (NCT NCT03942406)
NCT ID: NCT03942406
Last Updated: 2023-06-27
Results Overview
Number of participants who achieve mucosal seroconversion (IgA) against at least 1 anti-pertussis antibody for whole cell extract (WCE), pertussis toxin (PT), filamentous hemagglutinin (FHA), or pertactin (PRN) on Day 29 or Day 113. Mucosal seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value was below the detection limits of the assay).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
300 participants
Primary outcome timeframe
Days 29 and 113
Results posted on
2023-06-27
Participant Flow
Period 1 (Day 1): Prime; Period 2 (Day 85): Boost 300 participants: * 20 received BPZE1 10\^7 CFU as a Safety Lead-in cohort (Prime/Boost: BPZE1/BPZE1 \[n=8\]; BPZE1/Placebo \[n=8\]; Boostrix/BPZE1 \[n=4\]). Safety Lead-in cohort used for one secondary endpoint (abnormal laboratory) and Safety. * 280 in 10\^9 ITT Analysis Set (Prime/Boost: BPZE 10\^9/BPZE1 10\^9 \[n=92\]; BPZE1 10\^9/Placebo \[n=92\]; Boostrix/BPZE1 10\^9 \[n=46\], and Boostrix/Placebo \[n=50\]).
Participant milestones
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of intramuscular (IM) placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
(10\^9 ITT Analysis Set)
|
BPZE1 Intranasal Prime, Placebo Boost
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
(10\^9 ITT Analysis Set)
|
Boostrix IM Prime, BPZE1 Boost
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
(10\^9 ITT Analysis Set)
|
Boostrix IM Prime, Placebo Boost
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
(10\^9 ITT Analysis Set)
|
BPZE1 (10^7) Intranasal Prime, BPZE1 (10^7) Boost
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
(10\^7 Safety Lead-in Analysis Set)
|
BPZE1 (10^7) Intranasal Prime, Placebo Boost
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
(10\^7 Safety Lead-in Analysis Set)
|
Boostrix IM Prime, BPZE1 (10^7) Boost
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
(10\^7 Safety Lead-in Analysis Set)
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
92
|
92
|
46
|
50
|
8
|
8
|
4
|
|
Overall Study
COMPLETED
|
81
|
85
|
41
|
40
|
6
|
7
|
4
|
|
Overall Study
NOT COMPLETED
|
11
|
7
|
5
|
10
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of intramuscular (IM) placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
(10\^9 ITT Analysis Set)
|
BPZE1 Intranasal Prime, Placebo Boost
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
(10\^9 ITT Analysis Set)
|
Boostrix IM Prime, BPZE1 Boost
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
(10\^9 ITT Analysis Set)
|
Boostrix IM Prime, Placebo Boost
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
(10\^9 ITT Analysis Set)
|
BPZE1 (10^7) Intranasal Prime, BPZE1 (10^7) Boost
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
(10\^7 Safety Lead-in Analysis Set)
|
BPZE1 (10^7) Intranasal Prime, Placebo Boost
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
(10\^7 Safety Lead-in Analysis Set)
|
Boostrix IM Prime, BPZE1 (10^7) Boost
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
(10\^7 Safety Lead-in Analysis Set)
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
3
|
7
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
1
|
3
|
0
|
0
|
0
|
|
Overall Study
Other: early termination, telemedicine visits
|
4
|
1
|
1
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Study of BPZE1 Intranasal Pertussis Vaccine (Administered Via VaxINator(TM)), Prime + Boost, in Healthy Adults
Baseline characteristics by cohort
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
n=92 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
(10\^9 ITT Analysis Set)
|
BPZE1 Intranasal Prime, Placebo Boost
n=92 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
(10\^9 ITT Analysis Set)
|
Boostrix IM Prime, BPZE1 Boost
n=46 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
(10\^9 ITT Analysis Set)
|
Boostrix IM Prime, Placebo Boost
n=50 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
(10\^9 ITT Analysis Set)
|
BPZE1 (10^7) Intranasal Prime, BPZE1 (10^7) Boost
n=8 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
(10\^7 Safety Lead-in Analysis Set)
|
BPZE1 (10^7) Intranasal Prime, Placebo Boost
n=8 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
(10\^7 Safety Lead-in Analysis Set)
|
Boostrix IM Prime, BPZE1 (10^7) Boost
n=4 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
(10\^7 Safety Lead-in Analysis Set)
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.6 years
STANDARD_DEVIATION 9.0 • n=93 Participants
|
35.2 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
34.6 years
STANDARD_DEVIATION 9.0 • n=27 Participants
|
34.2 years
STANDARD_DEVIATION 9.9 • n=483 Participants
|
31.6 years
STANDARD_DEVIATION 10.3 • n=36 Participants
|
34.6 years
STANDARD_DEVIATION 8.7 • n=10 Participants
|
35.5 years
STANDARD_DEVIATION 12.0 • n=115 Participants
|
35.0 years
STANDARD_DEVIATION 9.1 • n=40 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
27 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
165 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
135 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
42 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
77 Participants
n=93 Participants
|
81 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
43 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
258 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
8 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
61 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
70 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
41 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
223 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
|
Body Mass Index (BMI)
|
28.0 kg/m^2
STANDARD_DEVIATION 5.4 • n=93 Participants
|
28.1 kg/m^2
STANDARD_DEVIATION 5.6 • n=4 Participants
|
27.7 kg/m^2
STANDARD_DEVIATION 5.0 • n=27 Participants
|
27.2 kg/m^2
STANDARD_DEVIATION 5.0 • n=483 Participants
|
26.7 kg/m^2
STANDARD_DEVIATION 7.7 • n=36 Participants
|
31.1 kg/m^2
STANDARD_DEVIATION 7.0 • n=10 Participants
|
29.6 kg/m^2
STANDARD_DEVIATION 7.3 • n=115 Participants
|
27.9 kg/m^2
STANDARD_DEVIATION 5.3 • n=40 Participants
|
PRIMARY outcome
Timeframe: Days 29 and 113Population: 10\^9 Immunogenicity Analysis Set. The overall number of participants analyzed includes participants with nonmissing values. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
Number of participants who achieve mucosal seroconversion (IgA) against at least 1 anti-pertussis antibody for whole cell extract (WCE), pertussis toxin (PT), filamentous hemagglutinin (FHA), or pertactin (PRN) on Day 29 or Day 113. Mucosal seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value was below the detection limits of the assay).
Outcome measures
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
n=84 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
BPZE1 Intranasal Prime, Placebo Boost
n=94 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, BPZE1 Boost
n=42 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, Placebo Boost
n=45 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
|---|---|---|---|---|
|
Number of Participants With Nasal Mucosal Seroconversion (Immunoglobulin A [IgA])
|
79 Participants
|
89 Participants
|
38 Participants
|
42 Participants
|
PRIMARY outcome
Timeframe: Through 7 Days Following Day 1 VaccinationPopulation: 10\^9 Safety Analysis Set. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
Number of participants with Solicited AEs (nasal/respiratory reactogenicity events) by Grade - Any Day Grade 1 through 3 and Grade 3. Grading of reactogenicity is defined per protocol as Grade 1 (mild), Grade 2 (moderate), and Grade 3 (severe) AEs.
Outcome measures
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
n=87 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
BPZE1 Intranasal Prime, Placebo Boost
n=96 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, BPZE1 Boost
n=46 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, Placebo Boost
n=50 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
|---|---|---|---|---|
|
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Sneezing - Any Day Grade 3
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Sinus Pressure/Pain - Any Day Grade 1 through 3
|
12 participants
|
19 participants
|
5 participants
|
10 participants
|
|
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Runny Nose - Any Day Grade 1 through 3
|
25 participants
|
41 participants
|
17 participants
|
16 participants
|
|
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Runny Nose - Any Day Grade 3
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Stuffy Nose/Congestion - Any Day Grade 1 through 3
|
27 participants
|
44 participants
|
19 participants
|
15 participants
|
|
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Stuffy Nose/Congestion - Any Day Grade 3
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Nasal Pain/Irritation - Any Day Grade 1 through 3
|
10 participants
|
13 participants
|
7 participants
|
7 participants
|
|
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Nasal Pain/Irritation - Any Day Grade 3
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Epistaxis - Any Day Grade 1 through 3
|
1 participants
|
5 participants
|
2 participants
|
1 participants
|
|
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Epistaxis - Any Day Grade 3
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Sneezing - Any Day Grade 1 through 3
|
25 participants
|
35 participants
|
15 participants
|
13 participants
|
|
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Sinus Pressure/Pain - Any Day Grade 3
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Sore/Irritated Throat - Any Day Grade 1 through 3
|
22 participants
|
29 participants
|
8 participants
|
10 participants
|
|
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Sore/Irritated Throat - Any Day Grade 3
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Cough - Any Day Grade 1 through 3
|
11 participants
|
18 participants
|
10 participants
|
9 participants
|
|
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Cough - Any Day Grade 3
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Shortness of Breath/Wheezing - Any Day Grade 1 through 3
|
1 participants
|
7 participants
|
2 participants
|
3 participants
|
|
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Shortness of Breath/Wheezing - Any Day Grade 3
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Through 7 Days Following Day 1 VaccinationPopulation: 10\^9 Safety Analysis Set. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
Number of participants with Solicited AEs (local reactogenicity events) by Grade - Any Day Grade 1 through 4 and Grade 3 and 4. Grading of reactogenicity is defined per protocol as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (potentially life-threatening) AEs.
Outcome measures
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
n=87 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
BPZE1 Intranasal Prime, Placebo Boost
n=96 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, BPZE1 Boost
n=46 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, Placebo Boost
n=50 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
|---|---|---|---|---|
|
Safety - Number of Participants With Local Solicited AEs
Pain - Any Day Grade 1 Through 4
|
8 participants
|
7 participants
|
22 participants
|
27 participants
|
|
Safety - Number of Participants With Local Solicited AEs
Pain - Any Day Grade 3 and 4
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety - Number of Participants With Local Solicited AEs
Tenderness - Any Day Grade 1 Through 4
|
15 participants
|
13 participants
|
28 participants
|
30 participants
|
|
Safety - Number of Participants With Local Solicited AEs
Tenderness - Any Day Grade 3 and 4
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety - Number of Participants With Local Solicited AEs
Erythema/Redness - Any Day Grade 1 Through 4
|
0 participants
|
2 participants
|
1 participants
|
2 participants
|
|
Safety - Number of Participants With Local Solicited AEs
Erythema/Redness - Any Day Grade 3 and 4
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety - Number of Participants With Local Solicited AEs
Induration/Swelling - Any Day Grade 1 Through 4
|
0 participants
|
0 participants
|
4 participants
|
2 participants
|
|
Safety - Number of Participants With Local Solicited AEs
Induration/Swelling - Any Day Grade 3 and 4
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Through 7 Days Following Day 1 VaccinationPopulation: 10\^9 Safety Analysis Set. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
Number of participants with Solicited AEs (systemic reactogenicity events) by Grade - Any Day Grade 1 through 3 and Grade 3. Grading of reactogenicity is defined per protocol as Grade 1 (mild), Grade 2 (moderate), and Grade 3 (severe) AEs.
Outcome measures
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
n=87 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
BPZE1 Intranasal Prime, Placebo Boost
n=96 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, BPZE1 Boost
n=46 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, Placebo Boost
n=50 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
|---|---|---|---|---|
|
Safety - Number of Participants With Systemic Solicited AEs
Rash/Hypersensitivity - Any Day Grade 1 through 3
|
0 participants
|
4 participants
|
0 participants
|
1 participants
|
|
Safety - Number of Participants With Systemic Solicited AEs
Fever - Any Day Grade 1 through 3
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Safety - Number of Participants With Systemic Solicited AEs
Fever - Any Day Grade 3
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Safety - Number of Participants With Systemic Solicited AEs
Fatigue (Tiredness) - Any Day Grade 1 through 3
|
27 participants
|
35 participants
|
9 participants
|
12 participants
|
|
Safety - Number of Participants With Systemic Solicited AEs
Fatigue (Tiredness) - Any Day Grade 3
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Safety - Number of Participants With Systemic Solicited AEs
Malaise (General Unwell Feeling) - Any Day Grade 1 through 3
|
13 participants
|
25 participants
|
6 participants
|
8 participants
|
|
Safety - Number of Participants With Systemic Solicited AEs
Malaise (General Unwell Feeling) - Any Day Grade 3
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Safety - Number of Participants With Systemic Solicited AEs
Myalgia (Body Aches/Muscular Pain) - Any Day Grade 1 through 3
|
8 participants
|
19 participants
|
4 participants
|
8 participants
|
|
Safety - Number of Participants With Systemic Solicited AEs
Myalgia (Body Aches/Muscular Pain) - Any Day Grade 3
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Safety - Number of Participants With Systemic Solicited AEs
Arthralgia (Joint Pain) - Any Day Grade 1 through 3
|
5 participants
|
7 participants
|
1 participants
|
4 participants
|
|
Safety - Number of Participants With Systemic Solicited AEs
Arthralgia (Joint Pain) - Any Day Grade 3
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety - Number of Participants With Systemic Solicited AEs
Headache - Any Day Grade 1 through 3
|
31 participants
|
37 participants
|
13 participants
|
22 participants
|
|
Safety - Number of Participants With Systemic Solicited AEs
Headache - Any Day Grade 3
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Safety - Number of Participants With Systemic Solicited AEs
Rash/Hypersensitivity - Any Day Grade 3
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Days 8 and 92Population: Safety Lead-in Participants vaccinated with BPZE1 10\^7 CFU for Prime (Day 1) and/or Boost (Day 85)
Number of participants in the safety lead-in cohort with Grade 2 through 4 laboratory abnormalities: Serum Chemistry - Bilirubin, Creatinine, ALT, AST; WBC, Hemoglobin, Prothrombin time, Partial Thromboplastin Time. Grading of laboratory results is defined per protocol as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threatening) laboratory abnormalities (DHHS 2007).
Outcome measures
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
n=8 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
BPZE1 Intranasal Prime, Placebo Boost
n=8 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, BPZE1 Boost
n=4 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, Placebo Boost
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
|---|---|---|---|---|
|
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
Prothrombin Time Increase by Factor Day 92
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
Bilirubin Increase Day 8
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
Bilirubin Increase Day 92
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
Creatinine Day 8
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
Creatinine Day 92
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
ALT Day 8
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
ALT Day 92
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
AST Day 8
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
AST Day 92
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
WBC decrease Day 8
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
WBC decrease Day 92
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
WBC Increase Day 8
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
WBC Increase Day 92
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
Hemoglobin Day 8
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
Hemoglobin Day 92
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
Platelets Decrease Day 8
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
Platelets Decrease Day 92
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
Prothrombin Time Increase by Factor Day 8
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
Partial Thromboplastin Time Increase by Factor Day 8
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
Partial Thromboplastin Time Increase by Factor Day 92
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: 10\^9 Immunogenicity Analysis Set. The number analyzed includes participants with nonmissing values. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
Number of participants who achieve seroconversion (serum IgG) against 1 or more pertussis antigens (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\], pertactin \[PRN\], or whole cell extract \[WCE\]) on Days 29, 85, 113, 169, and/or 254. Systemic seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value fell below the detection limits of the assay).
Outcome measures
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
n=85 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
BPZE1 Intranasal Prime, Placebo Boost
n=94 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, BPZE1 Boost
n=43 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, Placebo Boost
n=45 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
|---|---|---|---|---|
|
Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints
At least 1 of WCE, PT, FHA, PRN: Any of Days 29, 85, or 113
|
63 Participants
|
71 Participants
|
41 Participants
|
45 Participants
|
|
Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints
At least 1 of WCE, PT, FHA, PRN: Either Day 169 or Day 254
|
54 Participants
|
59 Participants
|
33 Participants
|
32 Participants
|
|
Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints
WCE: Either Day 29 or Day 113
|
45 Participants
|
41 Participants
|
28 Participants
|
32 Participants
|
|
Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints
PT, FHA, PRN: Either Day 29 or Day 113
|
19 Participants
|
16 Participants
|
28 Participants
|
28 Participants
|
|
Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints
At least 2 of WCE, PT, FHA, OR PRN: Any of Days 29, 85, or 113
|
46 Participants
|
50 Participants
|
37 Participants
|
41 Participants
|
|
Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints
At least 2 of WCE, PT, FHA, OR PRN: Either Day 169 or Day Day 254
|
40 Participants
|
41 Participants
|
32 Participants
|
28 Participants
|
|
Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints
Boosting Achieved on Day 113 (over Day 85) Against WCE
|
8 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 9 MonthsPopulation: 10\^9 Immunogenicity Analysis Set. The number analyzed includes participants with nonmissing values. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
Number of participants who achieve seroconversion (serum IgA) against 1 or more pertussis antigens (PT, FHA, PRN) on Days 29, 85, 113, 169, and/or 254. Systemic seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value fell below the detection limits of the assay).
Outcome measures
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
n=85 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
BPZE1 Intranasal Prime, Placebo Boost
n=94 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, BPZE1 Boost
n=43 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, Placebo Boost
n=45 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
|---|---|---|---|---|
|
Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints
Against at least 1 of PT, FHA, or PRN: Any of Days 29, 85, or 113
|
64 Participants
|
71 Participants
|
40 Participants
|
41 Participants
|
|
Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints
Against at least 1 of PT, FHA, or PRN: Either day 169 or Day 254
|
55 Participants
|
58 Participants
|
32 Participants
|
29 Participants
|
|
Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints
Against PT, FHA, and PRN: Either Day 29 or Day 113
|
23 Participants
|
29 Participants
|
18 Participants
|
9 Participants
|
|
Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints
Against at least 2 of PT, FHA, or PRN: Each Day 29, 85, or 113
|
25 Participants
|
28 Participants
|
14 Participants
|
13 Participants
|
|
Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints
Against at least 2 of PT, FHA, or PRN: Any of Days 29, 85, or 113
|
50 Participants
|
49 Participants
|
28 Participants
|
30 Participants
|
|
Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints
Against at least 2 of PT, FHA, or PRN: Either Day 169 or Day 254
|
41 Participants
|
30 Participants
|
24 Participants
|
14 Participants
|
|
Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints
Boosting Achieved on Day 113 (over Day 85) against PT
|
3 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints
Boosting Achieved on Day 113 (over Day 85) against FHA
|
6 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints
Boosting Achieved on Day 113 (over Day 85) against PRN
|
13 Participants
|
4 Participants
|
8 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 29 and 85Population: 10\^9 Immunogenicity Analysis Set. The Day 29 and Day 85 GMFR values are for the pooled BPZE1 group (BPZE1/BPZE1 and BPZE1/placebo) and pooled Boostrix group (Boostrix/BPZE1 and Boostrix/placebo), since these Days were prior to the Day 85 challenge/boost. The number analyzed includes participants with nonmissing values.
Systemic Immunogenicity: Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Day 29 and Day 85 over baseline (Day 1)
Outcome measures
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
n=179 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
BPZE1 Intranasal Prime, Placebo Boost
n=88 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, BPZE1 Boost
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, Placebo Boost
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
|---|---|---|---|---|
|
Systemic Immunogenicity - Summary of Geometric Mean Fold Rises (GMFRs) of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point
GMFR WCE Day 29
|
1.80 Ratio
Interval 1.63 to 2.0
|
3.06 Ratio
Interval 2.57 to 3.64
|
—
|
—
|
|
Systemic Immunogenicity - Summary of Geometric Mean Fold Rises (GMFRs) of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point
GMFR WCE Day 85
|
1.76 Ratio
Interval 1.59 to 1.94
|
2.30 Ratio
Interval 1.94 to 2.72
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 113, 169 and 254Population: 10\^9 Immunogenicity Analysis Set. The number analyzed includes participants with nonmissing values. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
Systemic Immunogenicity: Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Days 113, 169, and 254 over baseline (Day 1)
Outcome measures
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
n=85 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
BPZE1 Intranasal Prime, Placebo Boost
n=94 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, BPZE1 Boost
n=43 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, Placebo Boost
n=45 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
|---|---|---|---|---|
|
Systemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point
GMFR WCE Day 113
|
2.10 Ratio
Interval 1.79 to 2.48
|
1.64 Ratio
Interval 1.42 to 1.89
|
2.73 Ratio
Interval 2.01 to 3.71
|
2.04 Ratio
Interval 1.63 to 2.56
|
|
Systemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point
GMFR WCE Day 169
|
1.85 Ratio
Interval 1.57 to 2.18
|
1.54 Ratio
Interval 1.34 to 1.78
|
2.32 Ratio
Interval 1.67 to 3.22
|
1.62 Ratio
Interval 1.33 to 1.98
|
|
Systemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point
GMFR WCE Day 254
|
1.66 Ratio
Interval 1.41 to 1.96
|
1.43 Ratio
Interval 1.26 to 1.61
|
1.99 Ratio
Interval 1.52 to 2.59
|
1.37 Ratio
Interval 1.12 to 1.66
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: 10\^9 Immunogenicity Analysis Set. The number analyzed includes participants with nonmissing values. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
Number of participants who achieve seroconversion against any pertussis specific antigen (PT, PRN, FHA, or WCE) in nasal secretions (S-IgA). Mucosal seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value was below the detection limits of the assay).
Outcome measures
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
n=85 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
BPZE1 Intranasal Prime, Placebo Boost
n=94 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, BPZE1 Boost
n=43 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, Placebo Boost
n=45 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
|---|---|---|---|---|
|
Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints
Against at least 1 of WCE, PT, FHA, or PRN: Any of Days 29, 78, or 113
|
75 Participants
|
84 Participants
|
33 Participants
|
27 Participants
|
|
Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints
Against at least 1 of WCE, PT, FHA, or PRN: Either Day 169 or Day 254
|
66 Participants
|
63 Participants
|
30 Participants
|
13 Participants
|
|
Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints
Against WCE: Either Day 29 or Day 113
|
54 Participants
|
64 Participants
|
21 Participants
|
11 Participants
|
|
Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints
Against PT, FHA, PRN: Either Day 29 or Day 113
|
23 Participants
|
14 Participants
|
5 Participants
|
2 Participants
|
|
Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints
Against at least 2 of WCE, PT, FHA, or PRN: Any of Days 29, 78, or 113
|
64 Participants
|
70 Participants
|
23 Participants
|
11 Participants
|
|
Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints
Against at least 2 of WCE, PT, FHA, or PRN: Either Day 169 or Day 254
|
47 Participants
|
43 Participants
|
17 Participants
|
3 Participants
|
|
Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints
Boosting achieved on Day 113 (over Day 78) against WCE
|
23 Participants
|
7 Participants
|
11 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Days 29 and 78Population: 10\^9 Immunogenicity Analysis Set. The Day 29 and Day 78 GMFR values are for the pooled BPZE1 group (BPZE1/BPZE1 + BPZE1/placebo) and pooled Boostrix group (Boostrix/BPZE1 + Boostrix/placebo), since these Days are prior to the Day 85 challenge/boost. The number analyzed includes participants with nonmissing values.
Mucosal Immunogenicity: Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Day 29 and Day 78 over baseline (Day 1)
Outcome measures
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
n=179 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
BPZE1 Intranasal Prime, Placebo Boost
n=88 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, BPZE1 Boost
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, Placebo Boost
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
|---|---|---|---|---|
|
Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point
GMFR WCE Day 29
|
2.22 Ratio
Interval 1.94 to 2.54
|
1.07 Ratio
Interval 0.92 to 1.24
|
—
|
—
|
|
Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point
GMFR WCE Day 78
|
2.10 Ratio
Interval 1.84 to 2.39
|
1.04 Ratio
Interval 0.89 to 1.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 113, 169, 254Population: 10\^9 Immunogenicity Analysis Set. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received. The number analyzed includes participants with nonmissing values.
Mucosal Immunogenicity: Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Day 113, Day 169, and Day 254 over baseline (Day 1)
Outcome measures
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
n=85 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
BPZE1 Intranasal Prime, Placebo Boost
n=94 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, BPZE1 Boost
n=43 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, Placebo Boost
n=45 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
|---|---|---|---|---|
|
Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point
GMFR WCE Day 113
|
2.96 Ratio
Interval 2.35 to 3.75
|
2.04 Ratio
Interval 1.71 to 2.43
|
1.91 Ratio
Interval 1.53 to 2.37
|
1.15 Ratio
Interval 0.94 to 1.39
|
|
Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point
GMFR WCE Day 169
|
2.23 Ratio
Interval 1.8 to 2.77
|
1.57 Ratio
Interval 1.33 to 1.86
|
1.75 Ratio
Interval 1.39 to 2.19
|
0.82 Ratio
Interval 0.67 to 0.99
|
|
Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point
GMFR WCE Day 254
|
1.73 Ratio
Interval 1.39 to 2.15
|
1.45 Ratio
Interval 1.22 to 1.72
|
1.26 Ratio
Interval 1.02 to 1.55
|
0.82 Ratio
Interval 0.68 to 0.99
|
SECONDARY outcome
Timeframe: Days 92, 96, 113Population: 10\^9 Immunogenicity Analysis Set. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received. The number analyzed includes participants with nonmissing values.
Number of participants with positive B. pertussis by bacterial culture of nasal sample on any of Days 92, 96, and 113 (colonization)
Outcome measures
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
n=80 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
BPZE1 Intranasal Prime, Placebo Boost
n=91 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, BPZE1 Boost
n=40 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, Placebo Boost
n=41 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
|---|---|---|---|---|
|
Colonization - Summary of Colonization for B. Pertussis Bacterial Culture From Nasal Sample by Timepoint
|
8 Participants
|
0 Participants
|
28 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 1 through 29Population: 10\^9 Safety Analysis Set. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
Number of participants with Unsolicited AEs collected Day 1 to Day 29 by Medical Dictionary for Regulatory Activities (MedDRA) classification. Threshold is greater than or equal to 5% of participants.
Outcome measures
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
n=87 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
BPZE1 Intranasal Prime, Placebo Boost
n=96 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, BPZE1 Boost
n=46 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, Placebo Boost
n=50 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
|---|---|---|---|---|
|
Safety - Number of Participants With Unsolicited AEs
Headache
|
5 Participants
|
7 Participants
|
0 Participants
|
1 Participants
|
|
Safety - Number of Participants With Unsolicited AEs
Nasal congestion
|
5 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Safety - Number of Participants With Unsolicited AEs
Rhinorrhoea
|
5 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Safety - Number of Participants With Unsolicited AEs
Sneezing
|
6 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Days 85 through 113Population: 10\^9 Safety Analysis Set. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
Number of participants with Unsolicited AEs Day 85 through Day 113 by MedDRA classification. Threshold is greater than or equal to 5% of participants.
Outcome measures
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
n=87 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
BPZE1 Intranasal Prime, Placebo Boost
n=96 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, BPZE1 Boost
n=46 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, Placebo Boost
n=50 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
|---|---|---|---|---|
|
Safety - Number of Participants With Unsolicited AEs
Upper respiratory tract infection
|
4 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
|
Safety - Number of Participants With Unsolicited AEs
Nasal congestion
|
1 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Days 1 to 84Population: 10\^9 Safety Analysis Set. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
Number of participants with Serious AEs collected on Day 1 through Day 84 by MedDRA classification.
Outcome measures
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
n=87 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
BPZE1 Intranasal Prime, Placebo Boost
n=96 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, BPZE1 Boost
n=46 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, Placebo Boost
n=50 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
|---|---|---|---|---|
|
Safety - Number of Participants With Serious AEs
Bacterial sepsis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Number of Participants With Serious AEs
Cellulitis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Number of Participants With Serious AEs
Post procedural haemorrhage
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Number of Participants With Serious AEs
Hyperglycaemia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 85 to 113Population: 10\^9 Safety Analysis Set. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
Number of participants with Serious AEs collected on Day 85 through Day 113 by MedDRA classification.
Outcome measures
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
n=87 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
BPZE1 Intranasal Prime, Placebo Boost
n=96 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, BPZE1 Boost
n=46 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, Placebo Boost
n=50 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
|---|---|---|---|---|
|
Safety - Number of Participants With Serious AEs
Diabetic metabolic decompensation
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Number of Participants With Serious AEs
Other
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 114 to 254 (end of study)Population: 10\^9 Safety Analysis Set. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
Number of participants with Serious AEs collected on Day 114 through Day 254 by MedDRA classification.
Outcome measures
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
n=87 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
BPZE1 Intranasal Prime, Placebo Boost
n=96 Participants
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, BPZE1 Boost
n=46 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
|
Boostrix IM Prime, Placebo Boost
n=50 Participants
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
|
|---|---|---|---|---|
|
Safety - Number of Participants With Serious AEs
Obesity
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety - Number of Participants With Serious AEs
Other
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
BPZE1 Intranasal Prime, BPZE1 Boost
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
BPZE1 Intranasal Prime, Placebo Boost
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Boostrix IM Prime, BPZE1 Boost
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Boostrix IM Prime, Placebo Boost
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
BPZE1 (10^7) Intranasal Prime, BPZE1 (10^7) Boost
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BPZE1 (10^7) Intranasal Prime, Placebo Boost
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Boostrix IM Prime, BPZE1 (10^7) Boost
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
n=87 participants at risk
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day85. (10\^9 Safety Analysis Set)
|
BPZE1 Intranasal Prime, Placebo Boost
n=96 participants at risk
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85. (10\^9 Safety Analysis Set)
|
Boostrix IM Prime, BPZE1 Boost
n=46 participants at risk
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85. (10\^9 Safety Analysis Set)
|
Boostrix IM Prime, Placebo Boost
n=50 participants at risk
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85. (10\^9 Safety Analysis Set)
|
BPZE1 (10^7) Intranasal Prime, BPZE1 (10^7) Boost
n=8 participants at risk
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
(10\^7 Safety Lead-in Analysis Set)
|
BPZE1 (10^7) Intranasal Prime, Placebo Boost
n=8 participants at risk
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
(10\^7 Safety Lead-in Analysis Set)
|
Boostrix IM Prime, BPZE1 (10^7) Boost
n=4 participants at risk
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
(10\^7 Safety Lead-in Analysis Set)
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
1.0%
1/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
1.0%
1/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.1%
1/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
1.0%
1/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
1.0%
1/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
2.2%
1/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
Other adverse events
| Measure |
BPZE1 Intranasal Prime, BPZE1 Boost
n=87 participants at risk
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day85. (10\^9 Safety Analysis Set)
|
BPZE1 Intranasal Prime, Placebo Boost
n=96 participants at risk
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85. (10\^9 Safety Analysis Set)
|
Boostrix IM Prime, BPZE1 Boost
n=46 participants at risk
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85. (10\^9 Safety Analysis Set)
|
Boostrix IM Prime, Placebo Boost
n=50 participants at risk
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85. (10\^9 Safety Analysis Set)
|
BPZE1 (10^7) Intranasal Prime, BPZE1 (10^7) Boost
n=8 participants at risk
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
(10\^7 Safety Lead-in Analysis Set)
|
BPZE1 (10^7) Intranasal Prime, Placebo Boost
n=8 participants at risk
Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
(10\^7 Safety Lead-in Analysis Set)
|
Boostrix IM Prime, BPZE1 (10^7) Boost
n=4 participants at risk
Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
(10\^7 Safety Lead-in Analysis Set)
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
5.7%
5/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
7.3%
7/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
2.0%
1/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.1%
1/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
6.2%
6/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
8.7%
4/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
8.0%
4/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
12.5%
1/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.7%
5/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
3.1%
3/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
4.3%
2/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
4.0%
2/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
6.9%
6/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
2.1%
2/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
4.3%
2/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
2.0%
1/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.6%
4/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
5.2%
5/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
2.2%
1/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
8.0%
4/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
12.5%
1/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
Investigations
Coagulation test abnormal
|
0.00%
0/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
12.5%
1/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.1%
1/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
12.5%
1/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
25.0%
1/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.1%
1/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
2.0%
1/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
12.5%
1/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
2.1%
2/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
2.2%
1/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
12.5%
1/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
12.5%
1/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
12.5%
1/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
1.0%
1/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
12.5%
1/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
General disorders
Malaise
|
0.00%
0/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
2.1%
2/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
12.5%
1/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
12.5%
1/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
12.5%
1/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
2.2%
1/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
2.0%
1/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
12.5%
1/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/87 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
1.0%
1/96 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/46 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/50 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
12.5%
1/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/8 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
0.00%
0/4 • Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study)
10\^7 and 10\^9 Safety Analysis Set (includes 10\^9 Safety Analysis Set \[n=279\] and Safety Lead-in Cohort of participants who received BPZE1 10\^7 CFU \[n=20\]). Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Protocol Section 10.9: After study completion, data may be considered for reporting at scientific meeting/publication in scientific journal. In these cases, sponsor will be responsible for these activities to determine how the manuscript is written/edited, number/order of authors, publication for submission, etc. Sponsor has final approval over all issues. Data are property of sponsor and cannot be published without prior authorization, but data/publication thereof will not be unduly withheld.
- Publication restrictions are in place
Restriction type: OTHER