Trial Outcomes & Findings for Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults (NCT NCT03541499)
NCT ID: NCT03541499
Last Updated: 2024-09-19
Results Overview
AESIs included medically attended wheezing events given the route of study product administration and the nature of the study product.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Day 1 through Day 29
Results posted on
2024-09-19
Participant Flow
The study population includes 50 healthy adults,18-49 years of age, inclusive, who meet all eligibility criteria. Participants were enrolled between 01NOV2018 and 06DEC2019.
Participant milestones
| Measure |
BPZE1 10^7 CFU by VaxINator
800 microliters (10\^7 CFU) of B. pertussis vaccine (BPZE1) administered intranasally with the VaxINator device on Day 1.
BPZE1: Lyophilized, live-attenuated Bordetella pertussis vaccine reconstituted with sterile water for injection (SWFI) and administered as a single intranasal dose of 10\^7 colony forming units (CFU).
|
BPZE1 10^9 CFU by VaxINator
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
BPZE1: Lyophilized, live-attenuated Bordetella pertussis vaccine reconstituted with sterile water for injection (SWFI) and administered as a single intranasal dose of 10\^9 colony forming units (CFU).
|
BPZE1 10^9 CFU by Syringe
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
BPZE1: Lyophilized, live-attenuated Bordetella pertussis vaccine reconstituted with sterile water for injection (SWFI) and administered as a single intranasal dose of 10\^9 colony forming units (CFU) .
|
Placebo by VaxINator
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
Placebo: The placebo consists of the same constituents in the same quantities as the BPZE1 investigational vaccines, absent the attenuated B. pertussis cells, reconstituted with sterile water for injection (SWFI).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
5
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
5
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults
Baseline characteristics by cohort
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30.3 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
29.1 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
30.2 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
30.9 years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
30.1 years
STANDARD_DEVIATION 9.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 29Population: The safety population consists of all participants who received the study vaccine and for whom any data on safety were available.
AESIs included medically attended wheezing events given the route of study product administration and the nature of the study product.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events of Special Interest (AESIs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 181Population: The safety population consists of all participants who received the study vaccine and for whom any data on safety were available.
NOCMCs are defined as new medical conditions, not present at the time of screening or enrollment, that require ongoing medical care and intervention.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Number of Participants Experiencing New Onset Chronic Medical Conditions (NOCMCs)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 181Population: The safety population consists of all participants who received the study vaccine and for whom any data on safety were available.
An adverse event was considered serious if, in the view of either the site principal investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect, or, when, based upon appropriate medical judgment they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 15Population: The safety population consists of all participants who received the study vaccine and for whom any data on safety were available.
The solicited local reactogenicity events included runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore/irritated throat, cough, and shortness of breath/wheezing.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Solicited Local Reactogenicity Adverse Events (AEs)
Stuffy nose/congestion
|
8 Participants
|
8 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants Experiencing Solicited Local Reactogenicity Adverse Events (AEs)
Nasal pain/irritation
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Solicited Local Reactogenicity Adverse Events (AEs)
Epistaxis
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Solicited Local Reactogenicity Adverse Events (AEs)
Sneezing
|
4 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Experiencing Solicited Local Reactogenicity Adverse Events (AEs)
Sinus pressure/pain
|
1 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Experiencing Solicited Local Reactogenicity Adverse Events (AEs)
Sore/irritated throat
|
4 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants Experiencing Solicited Local Reactogenicity Adverse Events (AEs)
Cough
|
6 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Experiencing Solicited Local Reactogenicity Adverse Events (AEs)
Shortness of breath/wheezing
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Solicited Local Reactogenicity Adverse Events (AEs)
Runny nose
|
6 Participants
|
7 Participants
|
2 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 15Population: The safety population consists of all participants who received the study vaccine and for whom any data on safety were available.
The solicited systemic reactogenicity events included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and rash/hypersensitivity.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Solicited Systemic Reactogenicity AEs
Fever
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Solicited Systemic Reactogenicity AEs
Feverishness
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Solicited Systemic Reactogenicity AEs
Fatigue (tiredness)
|
4 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants Experiencing Solicited Systemic Reactogenicity AEs
Malaise (general unwell feeling)
|
3 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Experiencing Solicited Systemic Reactogenicity AEs
Myalgia (body aches/muscular pain)
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Experiencing Solicited Systemic Reactogenicity AEs
Arthralgia (joint pain)
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Experiencing Solicited Systemic Reactogenicity AEs
Headache
|
5 Participants
|
9 Participants
|
2 Participants
|
8 Participants
|
|
Number of Participants Experiencing Solicited Systemic Reactogenicity AEs
Rash/hypersensitivity
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 29Population: The safety population consists of all participants who received the study vaccine and for whom any data on safety were available
Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Unsolicited non-serious AEs were documented and reported from the time of vaccination through Day 29.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Unsolicited Non-Serious AEs
|
3 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 15Population: The safety population consists of all participants who received the study vaccine and for whom any data on safety were available.
Solicited local reactogenicity events include runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore/irritated throat, cough, and shortness of breath/wheezing. They were graded as grade 1 (mild), grade 2 (moderate), or grade 3 (severe). Severe local events were those that required medical care or caused significant discomfort that prevented daily activity, including sore/irritated throat preventing eating or drinking and cough preventing sleep. Severe epistaxis events were bleeding events that required a medical encounter. Severe stuffy nose/congestion events caused the participant to be unable to breathe through the nose or to seek medical care.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Severe Solicited Local Reactogenicity Adverse Events
Sinus pressure/pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Severe Solicited Local Reactogenicity Adverse Events
Sneezing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Severe Solicited Local Reactogenicity Adverse Events
Sore/irritated throat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Severe Solicited Local Reactogenicity Adverse Events
Cough
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Severe Solicited Local Reactogenicity Adverse Events
Shortness of breath/wheezing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Severe Solicited Local Reactogenicity Adverse Events
Runny nose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Severe Solicited Local Reactogenicity Adverse Events
Stuffy nose/congestion
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Severe Solicited Local Reactogenicity Adverse Events
Nasal pain/irritation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Severe Solicited Local Reactogenicity Adverse Events
Epistaxis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 15Population: The safety population consists of all participants who received the study vaccine and for whom any data on safety were available.
Solicited systemic reactogenicity events include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and rash/hypersensitivity. They were graded as grade 1 (mild), grade 2 (moderate), and grade 3 (severe). For all symptoms except rash and fever, an event was considered severe if it caused significant interference and prevented daily activity. Severe rash/hypersensitivity events were those that caused generalized urticaria, anaphylaxis, or angioedema or localized urticaria that required medical encounter. Severe fever was a temperature exceeding 38.9°C.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Severe Solicited Systemic Reactogenicity AEs
Myalgia (body aches/muscular pain)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Severe Solicited Systemic Reactogenicity AEs
Arthralgia (joint pain)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Severe Solicited Systemic Reactogenicity AEs
Headache
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Severe Solicited Systemic Reactogenicity AEs
Rash/hypersensitivity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Severe Solicited Systemic Reactogenicity AEs
Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Severe Solicited Systemic Reactogenicity AEs
Feverishness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Severe Solicited Systemic Reactogenicity AEs
Fatigue (tiredness)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Severe Solicited Systemic Reactogenicity AEs
Malaise (general unwell feeling)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening, Day 29, Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to filamentous hemagglutinin (FHA) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL. The ratio of FHA-IgA to total mucosal IgA was computed for each participant at each time point, and the fold rise from baseline of this ratio was subsequently calculated for each participant. The geometric mean fold rise of the ratio was calculated for each study arm.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Fold Rise From Screening of the Ratio of Filamentous Hemagglutinin-specific IgA (FHA-IgA) to Total IgA by Nasal Aspirate
Day 29
|
1.2 fold rise
Interval 0.8 to 1.7
|
1.7 fold rise
Interval 1.0 to 3.0
|
0.3 fold rise
Interval 0.0 to 10.3
|
1 fold rise
Interval 0.7 to 1.6
|
|
Geometric Mean Fold Rise From Screening of the Ratio of Filamentous Hemagglutinin-specific IgA (FHA-IgA) to Total IgA by Nasal Aspirate
Day 181
|
0.8 fold rise
Interval 0.5 to 1.3
|
2 fold rise
Interval 1.2 to 3.3
|
0.4 fold rise
Interval 0.0 to 10.1
|
1.2 fold rise
Interval 0.7 to 2.1
|
SECONDARY outcome
Timeframe: Screening, Day 29, and Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to fimbriae 2/3 (FIM) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL. The ratio of FIM-IgA to total mucosal IgA was computed for each participant at each time point, and the fold rise from baseline of this ratio was subsequently calculated for each participant. The geometric mean fold rise of the ratio was calculated for each study arm.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Fold Rise From Screening of the Ratio of Fimbriae-Specific IgA (FIM-IgA) to Total IgA by Nasal Aspirate
Day 29
|
1.7 fold rise
Interval 0.7 to 3.8
|
6.2 fold rise
Interval 2.2 to 17.3
|
0.7 fold rise
Interval 0.0 to 36.3
|
0.6 fold rise
Interval 0.3 to 1.4
|
|
Geometric Mean Fold Rise From Screening of the Ratio of Fimbriae-Specific IgA (FIM-IgA) to Total IgA by Nasal Aspirate
Day 181
|
1.1 fold rise
Interval 0.6 to 1.9
|
6.7 fold rise
Interval 2.8 to 16.0
|
1 fold rise
Interval 0.1 to 18.9
|
0.8 fold rise
Interval 0.3 to 1.9
|
SECONDARY outcome
Timeframe: Screening, Day 29, and Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to pertactin (PRN) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL. The ratio of PRN-IgA to total mucosal IgA was computed for each participant at each time point, and the fold rise from baseline of this ratio was subsequently calculated for each participant. The geometric mean fold rise of the ratio was calculated for each study arm.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Fold Rise From Screening of the Ratio of Pertactin-Specific IgA (PRN-IgA) to Total IgA by Nasal Aspirate
Day 29
|
1.1 fold rise
Interval 0.8 to 1.5
|
3.3 fold rise
Interval 1.3 to 8.3
|
1.3 fold rise
Interval 0.1 to 27.0
|
0.8 fold rise
Interval 0.5 to 1.3
|
|
Geometric Mean Fold Rise From Screening of the Ratio of Pertactin-Specific IgA (PRN-IgA) to Total IgA by Nasal Aspirate
Day 181
|
1.1 fold rise
Interval 0.8 to 1.5
|
3.5 fold rise
Interval 1.4 to 8.8
|
3.3 fold rise
Interval 1.0 to 10.5
|
1 fold rise
Interval 0.5 to 1.9
|
SECONDARY outcome
Timeframe: Screening, Day 29, and Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to pertussis toxin (PT) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL. The ratio of PT-IgA to total mucosal IgA was computed for each participant at each time point, and the fold rise from baseline of this ratio was subsequently calculated for each participant. The geometric mean fold rise of the ratio was calculated for each study arm.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Fold Rise From Screening of the Ratio of Pertussis Toxin-Specific IgA (PT-IgA) to Total IgA by Nasal Aspirate
Day 29
|
0.9 fold rise
Interval 0.5 to 1.5
|
1.4 fold rise
Interval 0.8 to 2.5
|
0.9 fold rise
Interval 0.4 to 2.0
|
2.2 fold rise
Interval 1.4 to 3.5
|
|
Geometric Mean Fold Rise From Screening of the Ratio of Pertussis Toxin-Specific IgA (PT-IgA) to Total IgA by Nasal Aspirate
Day 181
|
1.3 fold rise
Interval 0.8 to 1.9
|
1.6 fold rise
Interval 0.9 to 2.6
|
1.6 fold rise
Interval 0.7 to 3.7
|
1.2 fold rise
Interval 0.7 to 2.2
|
SECONDARY outcome
Timeframe: Day 1, Day 15, Day 29, and Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to perform a bead-based assay to measure serum IgA and serum IgG levels (in ELISA units/mL) to filamentous hemagglutinin (FHA) pertussis antigen. The fold rise in FHA-IgA from baseline was calculated for each participant and the geometric mean of the fold rise was calculated for each study arm.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Fold Rise From Baseline Serum IgA and Serum IgG ELISA Titers to Filamentous Hemagglutinin (FHA)
IgA - Day 15
|
0.8 fold rise
Interval 0.4 to 1.4
|
1.3 fold rise
Interval 0.9 to 2.0
|
1.4 fold rise
Interval 0.7 to 2.8
|
1 fold rise
Interval 0.6 to 1.5
|
|
Geometric Mean Fold Rise From Baseline Serum IgA and Serum IgG ELISA Titers to Filamentous Hemagglutinin (FHA)
IgA - Day 29
|
1.4 fold rise
Interval 0.5 to 3.5
|
2.5 fold rise
Interval 1.3 to 4.6
|
3 fold rise
Interval 0.5 to 17.6
|
0.8 fold rise
Interval 0.6 to 1.1
|
|
Geometric Mean Fold Rise From Baseline Serum IgA and Serum IgG ELISA Titers to Filamentous Hemagglutinin (FHA)
IgA - Day 181
|
1.2 fold rise
Interval 0.5 to 3.2
|
2.1 fold rise
Interval 1.2 to 3.6
|
2.3 fold rise
Interval 0.5 to 10.0
|
1.1 fold rise
Interval 0.6 to 2.0
|
|
Geometric Mean Fold Rise From Baseline Serum IgA and Serum IgG ELISA Titers to Filamentous Hemagglutinin (FHA)
IgG - Day 15
|
1 fold rise
Interval 0.8 to 1.3
|
1.2 fold rise
Interval 0.8 to 1.7
|
0.8 fold rise
Interval 0.4 to 1.4
|
1.1 fold rise
Interval 0.9 to 1.4
|
|
Geometric Mean Fold Rise From Baseline Serum IgA and Serum IgG ELISA Titers to Filamentous Hemagglutinin (FHA)
IgG - Day 29
|
1.7 fold rise
Interval 0.8 to 3.8
|
1.5 fold rise
Interval 1.0 to 2.3
|
1.3 fold rise
Interval 0.4 to 4.2
|
0.9 fold rise
Interval 0.8 to 1.1
|
|
Geometric Mean Fold Rise From Baseline Serum IgA and Serum IgG ELISA Titers to Filamentous Hemagglutinin (FHA)
IgG - Day 181
|
1.8 fold rise
Interval 0.9 to 3.8
|
1.7 fold rise
Interval 1.1 to 2.5
|
1.2 fold rise
Interval 0.7 to 2.1
|
1 fold rise
Interval 0.7 to 1.4
|
SECONDARY outcome
Timeframe: Day 1, Day 15, Day 29, and Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to perform a bead-based assay to measure serum IgA levels and serum IgG levels (in ELISA units/mL) to fimbriae 2/3 (FIM) pertussis antigen. The fold rise in FIM-IgA and FIM-IgG from baseline was calculated for each participant and the geometric mean of the fold rise was calculated for each study arm.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Fimbriae 2/3 (FIM)
IgA - Day 15
|
1 fold rise
Interval 0.8 to 1.2
|
1.1 fold rise
Interval 0.6 to 1.8
|
1.1 fold rise
Interval 0.9 to 1.4
|
1 fold rise
Interval 0.8 to 1.2
|
|
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Fimbriae 2/3 (FIM)
IgA - Day 29
|
2.1 fold rise
Interval 0.8 to 5.4
|
2.2 fold rise
Interval 0.9 to 5.3
|
3.2 fold rise
Interval 0.4 to 26.8
|
0.7 fold rise
Interval 0.4 to 1.3
|
|
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Fimbriae 2/3 (FIM)
IgA - Day 181
|
1.4 fold rise
Interval 0.7 to 2.7
|
2 fold rise
Interval 0.9 to 4.7
|
2.3 fold rise
Interval 0.4 to 13.4
|
1.1 fold rise
Interval 0.8 to 1.5
|
|
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Fimbriae 2/3 (FIM)
IgG - Day 15
|
1.1 fold rise
Interval 0.9 to 1.3
|
1.5 fold rise
Interval 1.0 to 2.3
|
1 fold rise
Interval 0.6 to 1.6
|
1 fold rise
Interval 0.8 to 1.4
|
|
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Fimbriae 2/3 (FIM)
IgG - Day 29
|
1.6 fold rise
Interval 0.8 to 3.2
|
2.6 fold rise
Interval 1.3 to 5.3
|
1.2 fold rise
Interval 0.8 to 2.0
|
1 fold rise
Interval 0.9 to 1.2
|
|
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Fimbriae 2/3 (FIM)
IgG - Day 181
|
1.2 fold rise
Interval 0.9 to 1.6
|
2.8 fold rise
Interval 1.3 to 6.0
|
1.2 fold rise
Interval 1.0 to 1.6
|
0.9 fold rise
Interval 0.7 to 1.2
|
SECONDARY outcome
Timeframe: Day 1, Day 15, Day 29, and Day 181Population: The Immunogenicity Population includes all participants who have received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to perform a bead-based assay to measure serum IgA and serum IgG levels (in ELISA units/mL) to pertactin (PRN) pertussis antigen. The fold rise in PRN-IgA and PRN-IgG from baseline was calculated for each participant and the geometric mean of the fold rise was calculated for each study arm.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Pertactin (PRN)
IgG - Day 181
|
1.5 fold rise
Interval 0.5 to 4.2
|
2.5 fold rise
Interval 1.5 to 4.3
|
0.9 fold rise
Interval 0.3 to 2.3
|
0.9 fold rise
Interval 0.7 to 1.2
|
|
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Pertactin (PRN)
IgA - Day 15
|
0.7 fold rise
Interval 0.5 to 1.0
|
1.6 fold rise
Interval 1.2 to 2.3
|
1.1 fold rise
Interval 0.6 to 2.3
|
1.1 fold rise
Interval 0.8 to 1.5
|
|
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Pertactin (PRN)
IgA - Day 29
|
0.9 fold rise
Interval 0.4 to 1.8
|
3.2 fold rise
Interval 1.9 to 5.7
|
2.2 fold rise
Interval 0.6 to 8.1
|
1.1 fold rise
Interval 0.8 to 1.6
|
|
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Pertactin (PRN)
IgA - Day 181
|
0.9 fold rise
Interval 0.4 to 1.7
|
3.2 fold rise
Interval 2.1 to 4.9
|
1.5 fold rise
Interval 0.4 to 5.4
|
1.3 fold rise
Interval 0.9 to 1.8
|
|
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Pertactin (PRN)
IgG - Day 15
|
1 fold rise
Interval 0.7 to 1.4
|
1.5 fold rise
Interval 1.1 to 2.1
|
0.9 fold rise
Interval 0.5 to 1.4
|
1.1 fold rise
Interval 0.8 to 1.6
|
|
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Pertactin (PRN)
IgG - Day 29
|
1.7 fold rise
Interval 0.7 to 4.0
|
2.3 fold rise
Interval 1.3 to 4.3
|
1.2 fold rise
Interval 0.4 to 3.2
|
0.9 fold rise
Interval 0.7 to 1.1
|
SECONDARY outcome
Timeframe: Day 1, Day 15, Day 29, and Day 181Population: The Immunogenicity Population includes all participants who have received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to perform a bead-based assay to measure serum IgA and serum IgG levels (in ELISA units/mL) to pertussis toxin (PT) pertussis antigen. The fold rise in PT-IgA and PT-IgG from baseline was calculated for each participant and the geometric mean of the fold rise was calculated for each study arm.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Pertussis Toxin (PT)
IgG - Day 181
|
1.9 fold rise
Interval 0.7 to 5.3
|
1.4 fold rise
Interval 1.0 to 2.0
|
1.1 fold rise
Interval 0.4 to 3.0
|
0.9 fold rise
Interval 0.7 to 1.1
|
|
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Pertussis Toxin (PT)
IgA - Day 15
|
1.3 fold rise
Interval 0.8 to 2.1
|
1.9 fold rise
Interval 0.8 to 4.3
|
1 fold rise
Interval 0.5 to 1.9
|
1 fold rise
Interval 0.4 to 2.1
|
|
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Pertussis Toxin (PT)
IgA - Day 29
|
1.4 fold rise
Interval 0.7 to 2.8
|
1.9 fold rise
Interval 1.1 to 3.6
|
1.4 fold rise
Interval 0.3 to 6.6
|
1.2 fold rise
Interval 0.5 to 2.7
|
|
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Pertussis Toxin (PT)
IgA - Day 181
|
1 fold rise
Interval 0.5 to 2.2
|
1.8 fold rise
Interval 1.2 to 2.7
|
1 fold rise
Interval 0.3 to 3.2
|
1.4 fold rise
Interval 0.8 to 2.6
|
|
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Pertussis Toxin (PT)
IgG - Day 15
|
1.1 fold rise
Interval 0.8 to 1.4
|
1.2 fold rise
Interval 0.9 to 1.6
|
0.7 fold rise
Interval 0.4 to 1.3
|
1 fold rise
Interval 0.8 to 1.3
|
|
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Pertussis Toxin (PT)
IgG - Day 29
|
1.5 fold rise
Interval 0.6 to 3.9
|
1.4 fold rise
Interval 0.9 to 1.9
|
1.5 fold rise
Interval 0.3 to 7.8
|
1 fold rise
Interval 0.8 to 1.2
|
SECONDARY outcome
Timeframe: Day 1, Day 15, Day 29, and Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to measure serum IgA and serum IgG levels (in ELISA units/mL) to fimbriae 2/3 (FIM) pertussis antigen via a bead-based assay. The geometric mean FIM-IgA titer and FIM-IgG titer were calculated for each study arm.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Fimbriae 2/3
IgA - Day 15
|
3.27 titer
Interval 1.44 to 7.43
|
4.26 titer
Interval 2.05 to 8.89
|
2.04 titer
Interval 0.33 to 12.75
|
2.68 titer
Interval 1.06 to 6.77
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Fimbriae 2/3
IgG - Day 1
|
51.71 titer
Interval 21.47 to 124.54
|
15.98 titer
Interval 4.7 to 54.34
|
129.14 titer
Interval 33.05 to 504.51
|
24.48 titer
Interval 9.72 to 61.62
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Fimbriae 2/3
IgG - Day 15
|
56.73 titer
Interval 24.08 to 133.65
|
24.17 titer
Interval 8.59 to 68.04
|
129.80 titer
Interval 22.13 to 761.39
|
25.30 titer
Interval 9.27 to 69.07
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Fimbriae 2/3
IgG - Day 181
|
80.27 titer
Interval 28.79 to 223.77
|
45.32 titer
Interval 20.61 to 99.69
|
159.90 titer
Interval 50.19 to 509.41
|
21.84 titer
Interval 7.45 to 64.0
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Fimbriae 2/3
IgA - Day 1
|
3.40 titer
Interval 1.64 to 7.04
|
3.94 titer
Interval 1.99 to 7.82
|
1.85 titer
Interval 0.34 to 10.17
|
2.68 titer
Interval 1.12 to 6.44
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Fimbriae 2/3
IgA - Day 29
|
7.07 titer
Interval 2.3 to 21.73
|
8.84 titer
Interval 4.57 to 17.11
|
5.92 titer
Interval 1.17 to 29.86
|
1.79 titer
Interval 0.7 to 4.54
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Fimbriae 2/3
IgA - Day 181
|
5.30 titer
Interval 1.69 to 16.56
|
8.01 titer
Interval 4.35 to 14.76
|
4.29 titer
Interval 1.17 to 15.8
|
2.69 titer
Interval 1.08 to 6.7
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Fimbriae 2/3
IgG - Day 29
|
84.12 titer
Interval 33.2 to 213.14
|
41.30 titer
Interval 17.13 to 99.58
|
160.50 titer
Interval 39.43 to 653.35
|
24.35 titer
Interval 9.9 to 59.91
|
SECONDARY outcome
Timeframe: Day 1, Day 15, Day 29, and Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to measure serum IgA levels and serum IgG levels (in ELISA units/mL) to pertactin (PRN) pertussis antigen via a bead-based assay. The geometric mean PRN-IgA titer and PRN-IgG titer were calculated for each study arm.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Pertactin
IgA - Day 15
|
7.69 titer
Interval 3.62 to 16.33
|
6.21 titer
Interval 3.67 to 10.51
|
4.07 titer
Interval 0.29 to 56.22
|
3.22 titer
Interval 1.54 to 6.74
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Pertactin
IgA - Day 29
|
9.32 titer
Interval 3.8 to 22.87
|
12.38 titer
Interval 5.46 to 28.09
|
8.02 titer
Interval 0.8 to 80.35
|
3.19 titer
Interval 1.54 to 6.63
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Pertactin
IgG - Day 1
|
38.69 titer
Interval 17.89 to 83.67
|
17.68 titer
Interval 10.44 to 29.94
|
48.47 titer
Interval 10.3 to 228.02
|
8.81 titer
Interval 2.44 to 31.77
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Pertactin
IgG - Day 181
|
53.49 titer
Interval 24.22 to 118.15
|
44.92 titer
Interval 28.07 to 71.89
|
42.76 titer
Interval 9.37 to 195.09
|
11.36 titer
Interval 3.7 to 34.88
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Pertactin
IgA - Day 1
|
10.53 titer
Interval 5.78 to 19.18
|
3.82 titer
Interval 2.07 to 7.05
|
3.57 titer
Interval 0.36 to 35.49
|
2.88 titer
Interval 1.51 to 5.5
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Pertactin
IgA - Day 181
|
7.90 titer
Interval 3.37 to 18.5
|
12.19 titer
Interval 5.88 to 25.26
|
5.43 titer
Interval 0.82 to 35.95
|
4.10 titer
Interval 1.9 to 8.85
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Pertactin
IgG - Day 15
|
38.59 titer
Interval 20.87 to 71.36
|
26.42 titer
Interval 16.67 to 41.88
|
41.42 titer
Interval 13.35 to 128.47
|
9.58 titer
Interval 3.0 to 30.62
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Pertactin
IgG - Day 29
|
65.11 titer
Interval 35.36 to 119.9
|
41.07 titer
Interval 23.18 to 72.76
|
58.20 titer
Interval 23.31 to 145.33
|
7.63 titer
Interval 2.13 to 27.3
|
SECONDARY outcome
Timeframe: Day 1, Day 15, Day 29, and Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to measure serum IgA levels and serum IgG levels (in ELISA units/mL) to pertussis toxin (PT) pertussis antigen via a bead-based assay. The geometric mean PT-IgA titer and PT-IgG titer were calculated for each study arm.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Pertussis Toxin
IgG - Day 181
|
6.39 titer
Interval 2.6 to 15.7
|
5.67 titer
Interval 2.81 to 11.47
|
10.86 titer
Interval 1.67 to 70.71
|
3.09 titer
Interval 1.19 to 8.03
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Pertussis Toxin
IgA - Day 15
|
0.86 titer
Interval 0.45 to 1.65
|
0.92 titer
Interval 0.44 to 1.93
|
0.88 titer
Interval 0.24 to 3.16
|
0.80 titer
Interval 0.51 to 1.25
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Pertussis Toxin
IgA - Day 29
|
0.91 titer
Interval 0.47 to 1.77
|
0.95 titer
Interval 0.52 to 1.71
|
1.29 titer
Interval 0.3 to 5.47
|
0.99 titer
Interval 0.54 to 1.81
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Pertussis Toxin
IgA - Day 181
|
0.82 titer
Interval 0.41 to 1.62
|
0.86 titer
Interval 0.57 to 1.28
|
0.91 titer
Interval 0.21 to 3.92
|
1.28 titer
Interval 0.75 to 2.18
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Pertussis Toxin
IgG - Day 1
|
3.36 titer
Interval 1.73 to 6.53
|
4.00 titer
Interval 1.73 to 9.27
|
10.10 titer
Interval 1.33 to 76.89
|
3.41 titer
Interval 1.51 to 7.71
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Pertussis Toxin
IgG - Day 15
|
3.65 titer
Interval 1.82 to 7.3
|
4.77 titer
Interval 2.43 to 9.37
|
7.36 titer
Interval 1.47 to 36.78
|
3.38 titer
Interval 1.37 to 8.34
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Pertussis Toxin
IgG - Day 29
|
5.20 titer
Interval 2.25 to 12.05
|
5.41 titer
Interval 2.49 to 11.79
|
15.01 titer
Interval 2.52 to 89.24
|
3.42 titer
Interval 1.45 to 8.07
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Pertussis Toxin
IgA - Day 1
|
0.66 titer
Interval 0.38 to 1.15
|
0.48 titer
Interval 0.24 to 0.98
|
0.91 titer
Interval 0.15 to 5.53
|
0.82 titer
Interval 0.36 to 1.88
|
SECONDARY outcome
Timeframe: Day 15, Day 29, and Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to measure via a bead-based assay serum IgA and serum IgG levels (in ELISA units/mL) to pertussis toxin, filamentous hemagglutinin, pertactin, and fimbriae 2/3 pertussis antigens. Seroconversion was defined as at least a 2-fold rise in antigen-specific IgA or antigen-specific IgG levels post-baseline compared to baseline levels. The percentage of participants who seroconverted to at least one pertussis antigen at each and across immunogenicity timepoints (Day 15, Day 29, and Day 181) was calculated.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Seroconversion to One or More Pertussis Antigens as Measured by Serum IgA or Serum IgG Levels
Any Time Point
|
67 percentage of participants
Interval 38.4 to 88.2
|
100 percentage of participants
Interval 78.2 to 100.0
|
60 percentage of participants
Interval 14.7 to 94.7
|
73 percentage of participants
Interval 44.9 to 92.2
|
|
Percentage of Participants Achieving Seroconversion to One or More Pertussis Antigens as Measured by Serum IgA or Serum IgG Levels
Day 15
|
33 percentage of participants
Interval 11.8 to 61.6
|
67 percentage of participants
Interval 38.4 to 88.2
|
60 percentage of participants
Interval 14.7 to 94.7
|
40 percentage of participants
Interval 16.3 to 67.7
|
|
Percentage of Participants Achieving Seroconversion to One or More Pertussis Antigens as Measured by Serum IgA or Serum IgG Levels
Day 29
|
53 percentage of participants
Interval 26.6 to 78.7
|
93 percentage of participants
Interval 68.1 to 99.8
|
60 percentage of participants
Interval 14.7 to 94.7
|
47 percentage of participants
Interval 21.3 to 73.4
|
|
Percentage of Participants Achieving Seroconversion to One or More Pertussis Antigens as Measured by Serum IgA or Serum IgG Levels
Day 181
|
42 percentage of participants
Interval 15.2 to 72.3
|
93 percentage of participants
Interval 68.1 to 99.8
|
60 percentage of participants
Interval 14.7 to 94.7
|
57 percentage of participants
Interval 28.9 to 82.3
|
SECONDARY outcome
Timeframe: Day 15, Day 29, and Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to measure via a bead-based assay serum IgA and serum IgG levels (in ELISA units/mL) to pertussis toxin, filamentous hemagglutinin, pertactin, and fimbriae 2/3 pertussis antigens. Seroconversion was defined as at least a 2-fold rise in antigen-specific IgA levels or antigen-specific IgG levels post-baseline compared to baseline levels. The percentage of participants who seroconverted to at least two pertussis antigens at each and across all immunogenicity timepoints (Day 15, Day 29, and Day 181) was calculated.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Seroconversion to Two or More Pertussis Antigens as Measured by Serum IgA or Serum IgG Levels
Any Time Point
|
53 percentage of participants
Interval 26.6 to 78.7
|
73 percentage of participants
Interval 44.9 to 92.2
|
60 percentage of participants
Interval 14.7 to 94.7
|
53 percentage of participants
Interval 26.6 to 78.7
|
|
Percentage of Participants Achieving Seroconversion to Two or More Pertussis Antigens as Measured by Serum IgA or Serum IgG Levels
Day 15
|
7 percentage of participants
Interval 0.2 to 31.9
|
53 percentage of participants
Interval 26.6 to 78.7
|
20 percentage of participants
Interval 0.5 to 71.6
|
27 percentage of participants
Interval 7.8 to 55.1
|
|
Percentage of Participants Achieving Seroconversion to Two or More Pertussis Antigens as Measured by Serum IgA or Serum IgG Levels
Day 29
|
27 percentage of participants
Interval 7.8 to 55.1
|
73 percentage of participants
Interval 44.9 to 92.2
|
60 percentage of participants
Interval 14.7 to 94.7
|
20 percentage of participants
Interval 4.3 to 48.1
|
|
Percentage of Participants Achieving Seroconversion to Two or More Pertussis Antigens as Measured by Serum IgA or Serum IgG Levels
Day 181
|
25 percentage of participants
Interval 5.5 to 57.2
|
67 percentage of participants
Interval 38.4 to 88.2
|
60 percentage of participants
Interval 14.7 to 94.7
|
36 percentage of participants
Interval 12.8 to 64.9
|
SECONDARY outcome
Timeframe: Day 29 and Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to pertussis vaccine antigens via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL. The titer ratio of antigen-specific IgA to total mucosal IgA was computed for each participant at each time point, and the fold rise from baseline of this ratio was subsequently calculated for each participant. Seroconversion was defined as at least a 2-fold rise in antigen-specific titer ratios post-baseline compared to baseline titer ratios. The percentage of participants who seroconverted to at least one pertussis antigen at each and any immunogenicity timepoint was calculated.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Seroconversion to One or More Pertussis Antigens as Measured by the Ratio of Antigen-Specific Mucosal IgA Levels to Total Mucosal IgA Levels
Any Time Point
|
60 percentage of participants
Interval 32.3 to 83.7
|
93 percentage of participants
Interval 68.1 to 99.8
|
80 percentage of participants
Interval 28.4 to 99.5
|
80 percentage of participants
Interval 51.9 to 95.7
|
|
Percentage of Participants Achieving Seroconversion to One or More Pertussis Antigens as Measured by the Ratio of Antigen-Specific Mucosal IgA Levels to Total Mucosal IgA Levels
Day 29
|
53 percentage of participants
Interval 26.6 to 78.7
|
73 percentage of participants
Interval 44.9 to 92.2
|
60 percentage of participants
Interval 14.7 to 94.7
|
73 percentage of participants
Interval 44.9 to 92.2
|
|
Percentage of Participants Achieving Seroconversion to One or More Pertussis Antigens as Measured by the Ratio of Antigen-Specific Mucosal IgA Levels to Total Mucosal IgA Levels
Day 181
|
50 percentage of participants
Interval 21.1 to 78.9
|
93 percentage of participants
Interval 68.1 to 99.8
|
80 percentage of participants
Interval 28.4 to 99.5
|
50 percentage of participants
Interval 23.0 to 77.0
|
SECONDARY outcome
Timeframe: Day 29 and Day 46Population: The Per Protocol (PP) Population includes all participants in the immunogenicity population, excluding participants ineligible at baseline. Data is excluded from PP analyses from visits after major protocol deviations and study visits that occurred greater than 3 days out of window. Data from 1 participant was excluded from the BPZE1 10\^7 CFU by VaxINator group due to receipt of immunosuppressive therapy within 30 days of study vaccination.
Colonization of live B. pertussis organism was assessed from a nasopharyngeal swab performed 28 days after vaccine administration (Day 29) to ensure all participants were cleared of colonization. Standard microbiologic techniques were used to assess the presence of B. pertussis by culture. If any participants were positive for B. pertussis culture at Day 29, they were asked to return at Day 46 for a repeat culture. If the participant was not positive for B. pertussis at Day 29, no subsequent nasopharyngeal samples for culture were collected.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=14 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Detectable B. Pertussis From Nasopharyngeal Cultures
Day 29
|
0 percentage of participants
Interval 0.0 to 23.2
|
0 percentage of participants
Interval 0.0 to 21.8
|
0 percentage of participants
Interval 0.0 to 52.2
|
0 percentage of participants
Interval 0.0 to 21.8
|
SECONDARY outcome
Timeframe: Day 15, Day 29, and Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to measure via a bead-based assay serum IgA levels and serum IgG levels (in ELISA units/mL) to filamentous hemagglutinin (FHA) pertussis antigen. Seroconversion was defined as at least a 2-fold rise in antigen-specific IgA and IgG levels post-baseline compared to baseline levels. The percentage of participants who seroconverted to FHA-IgA and FHA-IgG at any and each immunogenicity timepoint (Day 15, Day 29, and Day 181) was calculated.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Seroconversion to Filamentous Hemagglutinin as Measured by Serum IgA and Serum IgG Levels
IgA - Any Time Point
|
20 percentage of participants
Interval 4.3 to 48.1
|
67 percentage of participants
Interval 38.4 to 88.2
|
60 percentage of participants
Interval 14.7 to 94.7
|
33 percentage of participants
Interval 11.8 to 61.6
|
|
Percentage of Participants Achieving Seroconversion to Filamentous Hemagglutinin as Measured by Serum IgA and Serum IgG Levels
IgA - Day 15
|
13 percentage of participants
Interval 1.7 to 40.5
|
20 percentage of participants
Interval 4.3 to 48.1
|
40 percentage of participants
Interval 5.3 to 85.3
|
7 percentage of participants
Interval 0.2 to 31.9
|
|
Percentage of Participants Achieving Seroconversion to Filamentous Hemagglutinin as Measured by Serum IgA and Serum IgG Levels
IgA - Day 29
|
13 percentage of participants
Interval 1.7 to 40.5
|
67 percentage of participants
Interval 38.4 to 88.2
|
60 percentage of participants
Interval 14.7 to 94.7
|
7 percentage of participants
Interval 0.2 to 31.9
|
|
Percentage of Participants Achieving Seroconversion to Filamentous Hemagglutinin as Measured by Serum IgA and Serum IgG Levels
IgA - Day 181
|
17 percentage of participants
Interval 2.1 to 48.4
|
40 percentage of participants
Interval 16.3 to 67.7
|
60 percentage of participants
Interval 14.7 to 94.7
|
21 percentage of participants
Interval 4.7 to 50.8
|
|
Percentage of Participants Achieving Seroconversion to Filamentous Hemagglutinin as Measured by Serum IgA and Serum IgG Levels
IgG - Any Time Point
|
47 percentage of participants
Interval 21.3 to 73.4
|
53 percentage of participants
Interval 26.6 to 78.7
|
40 percentage of participants
Interval 5.3 to 85.3
|
13 percentage of participants
Interval 1.7 to 40.5
|
|
Percentage of Participants Achieving Seroconversion to Filamentous Hemagglutinin as Measured by Serum IgA and Serum IgG Levels
IgG - Day 15
|
7 percentage of participants
Interval 0.2 to 31.9
|
7 percentage of participants
Interval 0.2 to 31.9
|
0 percentage of participants
Interval 0.0 to 52.2
|
7 percentage of participants
Interval 0.2 to 31.9
|
|
Percentage of Participants Achieving Seroconversion to Filamentous Hemagglutinin as Measured by Serum IgA and Serum IgG Levels
IgG - Day 29
|
33 percentage of participants
Interval 11.8 to 61.6
|
40 percentage of participants
Interval 16.3 to 67.7
|
40 percentage of participants
Interval 5.3 to 85.3
|
0 percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Achieving Seroconversion to Filamentous Hemagglutinin as Measured by Serum IgA and Serum IgG Levels
IgG - Day 181
|
33 percentage of participants
Interval 9.9 to 65.1
|
47 percentage of participants
Interval 21.3 to 73.4
|
20 percentage of participants
Interval 0.5 to 71.6
|
7 percentage of participants
Interval 0.2 to 33.9
|
SECONDARY outcome
Timeframe: Day 15, Day 29, and Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to measure via a bead-based assay serum IgA and serum IgG levels (in ELISA units/mL) to fimbriae 2/3 (FIM) pertussis antigen. Seroconversion was defined as at least a 2-fold rise in antigen-specific IgA levels and IgG levels post-baseline compared to baseline levels. The percentage of participants who seroconverted to FIM-IgA or FIM-IgG at any and each immunogenicity timepoint (Day 15, Day 29, or and Day 181) was calculated.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Seroconversion to Fimbriae 2/3 as Measured by Serum IgA and Serum IgG Levels
IgG - Any Time Point
|
20 percentage of participants
Interval 4.3 to 48.1
|
53 percentage of participants
Interval 26.6 to 78.7
|
0 percentage of participants
Interval 0.0 to 52.2
|
13 percentage of participants
Interval 1.7 to 40.5
|
|
Percentage of Participants Achieving Seroconversion to Fimbriae 2/3 as Measured by Serum IgA and Serum IgG Levels
IgA - Any Time Point
|
27 percentage of participants
Interval 7.8 to 55.1
|
53 percentage of participants
Interval 26.6 to 78.7
|
60 percentage of participants
Interval 14.7 to 94.7
|
7 percentage of participants
Interval 0.2 to 31.9
|
|
Percentage of Participants Achieving Seroconversion to Fimbriae 2/3 as Measured by Serum IgA and Serum IgG Levels
IgA - Day 15
|
0 percentage of participants
Interval 0.0 to 21.8
|
13 percentage of participants
Interval 1.7 to 40.5
|
0 percentage of participants
Interval 0.0 to 52.2
|
0 percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Achieving Seroconversion to Fimbriae 2/3 as Measured by Serum IgA and Serum IgG Levels
IgA - Day 29
|
27 percentage of participants
Interval 7.8 to 55.1
|
53 percentage of participants
Interval 26.6 to 78.7
|
60 percentage of participants
Interval 14.7 to 94.7
|
0 percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Achieving Seroconversion to Fimbriae 2/3 as Measured by Serum IgA and Serum IgG Levels
IgA - Day 181
|
8 percentage of participants
Interval 0.2 to 38.5
|
40 percentage of participants
Interval 16.3 to 67.7
|
40 percentage of participants
Interval 5.3 to 85.3
|
7 percentage of participants
Interval 0.2 to 33.9
|
|
Percentage of Participants Achieving Seroconversion to Fimbriae 2/3 as Measured by Serum IgA and Serum IgG Levels
IgG - Day 15
|
0 percentage of participants
Interval 0.0 to 21.8
|
20 percentage of participants
Interval 4.3 to 48.1
|
0 percentage of participants
Interval 0.0 to 52.2
|
13 percentage of participants
Interval 1.7 to 40.5
|
|
Percentage of Participants Achieving Seroconversion to Fimbriae 2/3 as Measured by Serum IgA and Serum IgG Levels
IgG - Day 29
|
20 percentage of participants
Interval 4.3 to 48.1
|
53 percentage of participants
Interval 26.6 to 78.7
|
0 percentage of participants
Interval 0.0 to 52.2
|
0 percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Achieving Seroconversion to Fimbriae 2/3 as Measured by Serum IgA and Serum IgG Levels
IgG - Day 181
|
17 percentage of participants
Interval 2.1 to 48.4
|
47 percentage of participants
Interval 21.3 to 73.4
|
0 percentage of participants
Interval 0.0 to 52.2
|
7 percentage of participants
Interval 0.2 to 33.9
|
SECONDARY outcome
Timeframe: Screening, Day 29, Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to filamentous hemagglutinin (FHA) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL. The ratio of FHA-IgA to total mucosal IgA was computed for each participant and the geometric mean of the ratio was calculated for each study arm.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Titer Ratio of Mucosal FHA-IgA to Total IgA by Nasal Aspirate
Screening
|
0.0154 Titer Ratio
Interval 0.0104 to 0.023
|
0.0133 Titer Ratio
Interval 0.0098 to 0.018
|
0.0251 Titer Ratio
Interval 0.0025 to 0.2497
|
0.0147 Titer Ratio
Interval 0.0093 to 0.0232
|
|
Geometric Mean Titer Ratio of Mucosal FHA-IgA to Total IgA by Nasal Aspirate
Day 29
|
0.0178 Titer Ratio
Interval 0.012 to 0.0264
|
0.0229 Titer Ratio
Interval 0.0141 to 0.0372
|
0.0069 Titer Ratio
Interval 0.0018 to 0.0271
|
0.0154 Titer Ratio
Interval 0.0092 to 0.0258
|
|
Geometric Mean Titer Ratio of Mucosal FHA-IgA to Total IgA by Nasal Aspirate
Day 181
|
0.011 Titer Ratio
Interval 0.0062 to 0.0195
|
0.0263 Titer Ratio
Interval 0.0155 to 0.0446
|
0.0109 Titer Ratio
Interval 0.0038 to 0.0313
|
0.0185 Titer Ratio
Interval 0.0102 to 0.0334
|
SECONDARY outcome
Timeframe: Screening, Day 29, Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to fimbriae 2/3 (FIM) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL. The ratio of FIM-IgA to total mucosal IgA was computed for each participant and the geometric mean of the ratio was calculated for each study arm.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Titer Ratio of Mucosal FIM-IgA to Total IgA by Nasal Aspirate
Day 29
|
0.0039 Titer Ratio
Interval 0.0017 to 0.009
|
0.0073 Titer Ratio
Interval 0.0038 to 0.0139
|
0.0052 Titer Ratio
Interval 0.0013 to 0.0216
|
0.0015 Titer Ratio
Interval 0.0006 to 0.0037
|
|
Geometric Mean Titer Ratio of Mucosal FIM-IgA to Total IgA by Nasal Aspirate
Screening
|
0.0023 Titer Ratio
Interval 0.001 to 0.0051
|
0.0012 Titer Ratio
Interval 0.0005 to 0.0025
|
0.0073 Titer Ratio
Interval 0.0005 to 0.1143
|
0.0023 Titer Ratio
Interval 0.001 to 0.005
|
|
Geometric Mean Titer Ratio of Mucosal FIM-IgA to Total IgA by Nasal Aspirate
Day 181
|
0.0021 Titer Ratio
Interval 0.0008 to 0.0057
|
0.0078 Titer Ratio
Interval 0.0044 to 0.0139
|
0.0074 Titer Ratio
Interval 0.0031 to 0.018
|
0.0017 Titer Ratio
Interval 0.0006 to 0.0047
|
SECONDARY outcome
Timeframe: Screening, Day 29, Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to pertactin (PRN) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL. The ratio of PRN-IgA to total mucosal IgA was computed for each participant and the geometric mean of the ratio was calculated for each study arm.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Titer Ratio of Mucosal PRN-IgA to Total IgA by Nasal Aspirate
Day 181
|
0.0157 Titer Ratio
Interval 0.0106 to 0.0233
|
0.0244 Titer Ratio
Interval 0.0099 to 0.0602
|
0.0207 Titer Ratio
Interval 0.0048 to 0.0892
|
0.0102 Titer Ratio
Interval 0.0051 to 0.0204
|
|
Geometric Mean Titer Ratio of Mucosal PRN-IgA to Total IgA by Nasal Aspirate
Screening
|
0.0167 Titer Ratio
Interval 0.0106 to 0.0263
|
0.007 Titer Ratio
Interval 0.0043 to 0.0115
|
0.0063 Titer Ratio
Interval 0.003 to 0.0133
|
0.0106 Titer Ratio
Interval 0.0052 to 0.0216
|
|
Geometric Mean Titer Ratio of Mucosal PRN-IgA to Total IgA by Nasal Aspirate
Day 29
|
0.0186 Titer Ratio
Interval 0.0117 to 0.0295
|
0.0231 Titer Ratio
Interval 0.0106 to 0.05
|
0.0083 Titer Ratio
Interval 0.0003 to 0.252
|
0.0087 Titer Ratio
Interval 0.0043 to 0.0175
|
SECONDARY outcome
Timeframe: Screening, Day 29, and Day 181Population: The Immunogenicity Population includes all participants who have received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to pertussis toxin (PT) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL. The ratio of PT-IgA to total mucosal IgA was computed for each participant and the geometric mean of the ratio was calculated for each study arm.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Titer Ratio of Mucosal PT-IgA to Total IgA by Nasal Aspirate
Screening
|
0.0014 Titer Ratio
Interval 0.0009 to 0.0022
|
0.0011 Titer Ratio
Interval 0.0007 to 0.0017
|
0.0021 Titer Ratio
Interval 0.0015 to 0.0028
|
0.0011 Titer Ratio
Interval 0.0007 to 0.0016
|
|
Geometric Mean Titer Ratio of Mucosal PT-IgA to Total IgA by Nasal Aspirate
Day 29
|
0.0013 Titer Ratio
Interval 0.0008 to 0.002
|
0.0015 Titer Ratio
Interval 0.0009 to 0.0026
|
0.0018 Titer Ratio
Interval 0.0008 to 0.0039
|
0.0024 Titer Ratio
Interval 0.0016 to 0.0036
|
|
Geometric Mean Titer Ratio of Mucosal PT-IgA to Total IgA by Nasal Aspirate
Day 181
|
0.0016 Titer Ratio
Interval 0.001 to 0.0024
|
0.0017 Titer Ratio
Interval 0.0009 to 0.0031
|
0.0033 Titer Ratio
Interval 0.0011 to 0.0098
|
0.0013 Titer Ratio
Interval 0.0008 to 0.0024
|
SECONDARY outcome
Timeframe: Day 1, Day 15, Day 29, and Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to measure serum IgA and serum IgG levels (in ELISA units/mL) to filamentous hemagglutinin (FHA) pertussis antigen via a bead-based assay. The geometric mean FHA-IgA titer and FHA-IgG titer were calculated for each study arm.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Filamentous Hemagglutinin
IgG - Day 15
|
19.99 Titer
Interval 8.16 to 48.93
|
23.19 Titer
Interval 16.0 to 33.62
|
12.78 Titer
Interval 1.54 to 105.88
|
14.14 Titer
Interval 7.1 to 28.14
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Filamentous Hemagglutinin
IgG - Day 29
|
33.49 Titer
Interval 16.56 to 67.72
|
29.4 Titer
Interval 21.17 to 40.84
|
20.9 Titer
Interval 2.9 to 150.52
|
11.96 Titer
Interval 6.15 to 23.38
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Filamentous Hemagglutinin
IgA - Day 1
|
3.83 Titer
Interval 1.4 to 10.48
|
3.54 Titer
Interval 1.61 to 7.8
|
1.21 Titer
Interval 0.25 to 5.95
|
2.71 Titer
Interval 1.49 to 4.96
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Filamentous Hemagglutinin
IgA - Day 15
|
3.06 Titer
Interval 1.29 to 7.29
|
4.66 Titer
Interval 2.12 to 10.24
|
1.75 Titer
Interval 0.58 to 5.29
|
2.62 Titer
Interval 1.5 to 4.55
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Filamentous Hemagglutinin
IgA - Day 29
|
5.27 Titer
Interval 2.46 to 11.29
|
8.67 Titer
Interval 4.3 to 17.51
|
3.68 Titer
Interval 1.2 to 11.28
|
2.21 Titer
Interval 1.08 to 4.53
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Filamentous Hemagglutinin
IgA - Day 181
|
5.13 Titer
Interval 2.12 to 12.39
|
7.52 Titer
Interval 3.57 to 15.85
|
2.81 Titer
Interval 1.73 to 4.58
|
3.3 Titer
Interval 1.66 to 6.57
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Filamentous Hemagglutinin
IgG - Day 1
|
19.59 Titer
Interval 8.04 to 47.69
|
19.65 Titer
Interval 11.27 to 34.27
|
16.59 Titer
Interval 2.33 to 118.01
|
12.81 Titer
Interval 7.06 to 23.25
|
|
Geometric Mean Titer by Serum IgA and Serum IgG to Filamentous Hemagglutinin
IgG - Day 181
|
32.73 Titer
Interval 15.49 to 69.17
|
32.92 Titer
Interval 24.18 to 44.83
|
19.62 Titer
Interval 2.79 to 101.57
|
13.84 Titer
Interval 6.22 to 30.8
|
SECONDARY outcome
Timeframe: Day 15, Day 29, and Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to measure via a bead-based assay serum IgA and serum IgG levels (in ELISA units/mL) to pertactin (PRN) pertussis antigen. Seroconversion was defined as at least a 2-fold rise in antigen-specific IgA and antigen-specific IgG levels post-baseline compared to baseline levels. The percentage of participants who seroconverted to PRN-IgA and PRN-IgG at any and each immunogenicity timepoint (Day 15, Day 29, or Day 181) were calculated.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Seroconversion to Pertactin as Measured by Serum IgA and Serum IgG Levels
IgA - Any Time Point
|
13 percentage of participants
Interval 1.7 to 40.5
|
80 percentage of participants
Interval 51.9 to 95.7
|
40 percentage of participants
Interval 5.3 to 85.3
|
53 percentage of participants
Interval 26.6 to 78.7
|
|
Percentage of Participants Achieving Seroconversion to Pertactin as Measured by Serum IgA and Serum IgG Levels
IgA - Day 15
|
0 percentage of participants
Interval 0.0 to 21.8
|
40 percentage of participants
Interval 16.3 to 67.7
|
20 percentage of participants
Interval 0.5 to 71.6
|
13 percentage of participants
Interval 1.7 to 40.5
|
|
Percentage of Participants Achieving Seroconversion to Pertactin as Measured by Serum IgA and Serum IgG Levels
IgA - Day 29
|
13 percentage of participants
Interval 1.7 to 40.5
|
67 percentage of participants
Interval 38.4 to 88.2
|
40 percentage of participants
Interval 5.3 to 85.3
|
20 percentage of participants
Interval 4.3 to 48.1
|
|
Percentage of Participants Achieving Seroconversion to Pertactin as Measured by Serum IgA and Serum IgG Levels
IgA - Day 181
|
17 percentage of participants
Interval 2.1 to 48.4
|
67 percentage of participants
Interval 38.4 to 88.2
|
40 percentage of participants
Interval 5.3 to 85.3
|
36 percentage of participants
Interval 12.8 to 64.9
|
|
Percentage of Participants Achieving Seroconversion to Pertactin as Measured by Serum IgA and Serum IgG Levels
IgG - Any Time Point
|
33 percentage of participants
Interval 11.8 to 61.6
|
47 percentage of participants
Interval 21.3 to 73.4
|
40 percentage of participants
Interval 5.3 to 85.3
|
20 percentage of participants
Interval 4.3 to 48.1
|
|
Percentage of Participants Achieving Seroconversion to Pertactin as Measured by Serum IgA and Serum IgG Levels
IgG - Day 15
|
7 percentage of participants
Interval 0.2 to 31.9
|
33 percentage of participants
Interval 11.8 to 61.6
|
0 percentage of participants
Interval 0.0 to 52.2
|
13 percentage of participants
Interval 1.7 to 40.5
|
|
Percentage of Participants Achieving Seroconversion to Pertactin as Measured by Serum IgA and Serum IgG Levels
IgG - Day 29
|
27 percentage of participants
Interval 7.8 to 55.1
|
40 percentage of participants
Interval 16.3 to 67.7
|
40 percentage of participants
Interval 5.3 to 85.3
|
7 percentage of participants
Interval 0.2 to 31.9
|
|
Percentage of Participants Achieving Seroconversion to Pertactin as Measured by Serum IgA and Serum IgG Levels
IgG - Day 181
|
25 percentage of participants
Interval 5.5 to 57.2
|
47 percentage of participants
Interval 21.3 to 73.4
|
0 percentage of participants
Interval 0.0 to 52.2
|
7 percentage of participants
Interval 0.2 to 33.9
|
SECONDARY outcome
Timeframe: Day 15, Day 29, and Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to measure via a bead-based assay serum IgA and serum IgG levels (in ELISA units/mL) to pertussis toxin (PT) antigen. Seroconversion was defined as at least a 2-fold rise in antigen-specific IgA/IgG levels post-baseline compared to baseline levels. The percentage of participants who seroconverted to PT-IgA and PT-IgG at any and each immunogenicity timepoint (Day 15, Day 29, or and Day 181) was calculated.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Seroconversion to Pertussis Toxin as Measured by Serum IgA and Serum IgG Levels
IgA - Any Time Point
|
53 percentage of participants
Interval 26.6 to 78.7
|
60 percentage of participants
Interval 32.3 to 83.7
|
20 percentage of participants
Interval 0.5 to 71.6
|
60 percentage of participants
Interval 32.3 to 83.7
|
|
Percentage of Participants Achieving Seroconversion to Pertussis Toxin as Measured by Serum IgA and Serum IgG Levels
IgA - Day 15
|
13 percentage of participants
Interval 1.7 to 40.5
|
47 percentage of participants
Interval 21.3 to 73.4
|
20 percentage of participants
Interval 0.5 to 71.6
|
33 percentage of participants
Interval 11.8 to 61.6
|
|
Percentage of Participants Achieving Seroconversion to Pertussis Toxin as Measured by Serum IgA and Serum IgG Levels
IgA - Day 29
|
33 percentage of participants
Interval 11.8 to 61.6
|
47 percentage of participants
Interval 21.3 to 73.4
|
20 percentage of participants
Interval 0.5 to 71.6
|
33 percentage of participants
Interval 11.8 to 61.6
|
|
Percentage of Participants Achieving Seroconversion to Pertussis Toxin as Measured by Serum IgA and Serum IgG Levels
IgA - Day 181
|
17 percentage of participants
Interval 2.1 to 48.4
|
47 percentage of participants
Interval 21.3 to 73.4
|
20 percentage of participants
Interval 0.5 to 71.6
|
50 percentage of participants
Interval 23.0 to 77.0
|
|
Percentage of Participants Achieving Seroconversion to Pertussis Toxin as Measured by Serum IgA and Serum IgG Levels
IgG - Any Time Point
|
27 percentage of participants
Interval 7.8 to 55.1
|
40 percentage of participants
Interval 16.3 to 67.7
|
20 percentage of participants
Interval 0.5 to 71.6
|
13 percentage of participants
Interval 1.7 to 40.5
|
|
Percentage of Participants Achieving Seroconversion to Pertussis Toxin as Measured by Serum IgA and Serum IgG Levels
IgG - Day 15
|
13 percentage of participants
Interval 1.7 to 40.5
|
13 percentage of participants
Interval 1.7 to 40.5
|
0 percentage of participants
Interval 0.0 to 52.2
|
7 percentage of participants
Interval 0.2 to 31.9
|
|
Percentage of Participants Achieving Seroconversion to Pertussis Toxin as Measured by Serum IgA and Serum IgG Levels
IgG - Day 29
|
13 percentage of participants
Interval 1.7 to 40.5
|
33 percentage of participants
Interval 11.8 to 61.6
|
20 percentage of participants
Interval 0.5 to 71.6
|
7 percentage of participants
Interval 0.2 to 31.9
|
|
Percentage of Participants Achieving Seroconversion to Pertussis Toxin as Measured by Serum IgA and Serum IgG Levels
IgG - Day 181
|
25 percentage of participants
Interval 5.5 to 57.2
|
20 percentage of participants
Interval 4.3 to 48.1
|
20 percentage of participants
Interval 0.5 to 71.6
|
0 percentage of participants
Interval 0.0 to 23.2
|
SECONDARY outcome
Timeframe: Day 29 and Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to filamentous hemagglutinin (FHA) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL. The titer ratio of antigen-specific IgA to total mucosal IgA was computed for each participant at each time point, and the fold rise from baseline of this ratio was subsequently calculated for each participant. Seroconversion was defined as at least a 2-fold rise in antigen-specific titer ratios post-baseline compared to baseline titer ratios. The percentage of participants who seroconverted FHA-IgA at each and any immunogenicity timepoint (Day 29 or Day 181) was calculated.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Seroconversion to Filamentous Hemagglutinin as Measured by Mucosal IgA Levels
Any Time Point
|
20 percentage of participants
Interval 4.3 to 48.1
|
67 percentage of participants
Interval 38.4 to 88.2
|
40 percentage of participants
Interval 5.3 to 85.3
|
40 percentage of participants
Interval 16.3 to 67.7
|
|
Percentage of Participants Achieving Seroconversion to Filamentous Hemagglutinin as Measured by Mucosal IgA Levels
Day 29
|
20 percentage of participants
Interval 4.3 to 48.1
|
47 percentage of participants
Interval 21.3 to 73.4
|
20 percentage of participants
Interval 0.5 to 71.6
|
7 percentage of participants
Interval 0.2 to 31.9
|
|
Percentage of Participants Achieving Seroconversion to Filamentous Hemagglutinin as Measured by Mucosal IgA Levels
Day 181
|
8 percentage of participants
Interval 0.2 to 38.5
|
53 percentage of participants
Interval 26.6 to 78.7
|
20 percentage of participants
Interval 0.5 to 71.6
|
43 percentage of participants
Interval 17.7 to 71.1
|
SECONDARY outcome
Timeframe: Day 29 and Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to fimbriae 2/3 (FIM) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL. The titer ratio of antigen-specific IgA to total mucosal IgA was computed for each participant at each time point, and the fold rise from baseline of this ratio was subsequently calculated for each participant. Seroconversion was defined as at least a 2-fold rise in antigen-specific titer ratios post-baseline compared to baseline titer ratios. The percentage of participants who seroconverted FIM-IgA at each and any immunogenicity timepoint (Day 29 and Day 181) was calculated.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Seroconversion to Fimbriae 2/3 as Measured by Mucosal IgA Levels
Any Time Point
|
27 percentage of participants
Interval 7.8 to 55.1
|
80 percentage of participants
Interval 51.9 to 95.7
|
60 percentage of participants
Interval 14.7 to 94.7
|
20 percentage of participants
Interval 4.3 to 48.1
|
|
Percentage of Participants Achieving Seroconversion to Fimbriae 2/3 as Measured by Mucosal IgA Levels
Day 29
|
27 percentage of participants
Interval 7.8 to 55.1
|
53 percentage of participants
Interval 26.6 to 78.7
|
40 percentage of participants
Interval 5.3 to 85.3
|
7 percentage of participants
Interval 0.2 to 31.9
|
|
Percentage of Participants Achieving Seroconversion to Fimbriae 2/3 as Measured by Mucosal IgA Levels
Day 181
|
8 percentage of participants
Interval 0.2 to 38.5
|
80 percentage of participants
Interval 51.9 to 95.7
|
60 percentage of participants
Interval 14.7 to 94.7
|
14 percentage of participants
Interval 1.8 to 42.8
|
SECONDARY outcome
Timeframe: Day 29 and Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to pertactin (PRN) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL. The titer ratio of antigen-specific IgA to total mucosal IgA was computed for each participant at each time point, and the fold rise from baseline of this ratio was subsequently calculated for each participant. Seroconversion was defined as at least a 2-fold rise in antigen-specific titer ratios post-baseline compared to baseline titer ratios. The percentage of participants who seroconverted PRN-IgA at each and any immunogenicity timepoint (Day 29 and Day 181) was calculated.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Seroconversion to Pertactin as Measured by Mucosal IgA Levels
Any Time Point
|
13 percentage of participants
Interval 1.7 to 40.5
|
53 percentage of participants
Interval 26.6 to 78.7
|
80 percentage of participants
Interval 28.4 to 99.5
|
20 percentage of participants
Interval 4.3 to 48.1
|
|
Percentage of Participants Achieving Seroconversion to Pertactin as Measured by Mucosal IgA Levels
Day 29
|
13 percentage of participants
Interval 1.7 to 40.5
|
40 percentage of participants
Interval 16.3 to 67.7
|
60 percentage of participants
Interval 14.7 to 94.7
|
13 percentage of participants
Interval 1.7 to 40.5
|
|
Percentage of Participants Achieving Seroconversion to Pertactin as Measured by Mucosal IgA Levels
Day 181
|
8 percentage of participants
Interval 0.2 to 38.5
|
47 percentage of participants
Interval 21.3 to 73.4
|
80 percentage of participants
Interval 28.4 to 99.5
|
21 percentage of participants
Interval 4.7 to 50.8
|
SECONDARY outcome
Timeframe: Day 29 and Day 181Population: The Immunogenicity Population includes all participants who received the study vaccination and contributed both pre-vaccination samples and either at least one post vaccination sample for humoral immunogenicity testing for which results were reported, or at least one post vaccination nasal sample for which results were reported.
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to pertussis toxin (PT) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL. The titer ratio of antigen-specific IgA to total mucosal IgA was calculated for each participant at each time point, and the fold rise from baseline of this ratio was subsequently calculated for each participant. Seroconversion was defined as at least a 2-fold rise in antigen-specific titer ratios post-baseline compared to baseline titer ratios. The percentage of participants who seroconverted PT-IgA at each immunogenicity timepoint (Day 29 and Day 181) was calculated.
Outcome measures
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 Participants
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 Participants
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 Participants
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Seroconversion to Pertussis Toxin as Measured by Mucosal IgA Levels
Any Time Point
|
40 percentage of participants
Interval 16.3 to 67.7
|
53 percentage of participants
Interval 26.6 to 78.7
|
20 percentage of participants
Interval 0.5 to 71.6
|
53 percentage of participants
Interval 26.6 to 78.7
|
|
Percentage of Participants Achieving Seroconversion to Pertussis Toxin as Measured by Mucosal IgA Levels
Day 29
|
13 percentage of participants
Interval 1.7 to 40.5
|
33 percentage of participants
Interval 11.8 to 61.6
|
0 percentage of participants
Interval 0.0 to 52.2
|
53 percentage of participants
Interval 26.6 to 78.7
|
|
Percentage of Participants Achieving Seroconversion to Pertussis Toxin as Measured by Mucosal IgA Levels
Day 181
|
42 percentage of participants
Interval 15.2 to 72.3
|
40 percentage of participants
Interval 16.3 to 67.7
|
20 percentage of participants
Interval 0.5 to 71.6
|
14 percentage of participants
Interval 1.8 to 42.8
|
Adverse Events
BPZE1 10^7 CFU by VaxINator
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
BPZE1 10^9 CFU by VaxINator
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
BPZE1 10^9 CFU by Syringe
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo by VaxINator
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BPZE1 10^7 CFU by VaxINator
n=15 participants at risk
800 microliters (10\^7 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by VaxINator
n=15 participants at risk
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1.
|
BPZE1 10^9 CFU by Syringe
n=5 participants at risk
800 microliters (10\^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1.
|
Placebo by VaxINator
n=15 participants at risk
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/5 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Eye disorders
Blepharitis
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
20.0%
1/5 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/5 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
General disorders
Fatigue
|
26.7%
4/15 • Number of events 4 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
26.7%
4/15 • Number of events 4 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
40.0%
2/5 • Number of events 2 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
33.3%
5/15 • Number of events 5 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
General disorders
Feeling hot
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
13.3%
2/15 • Number of events 2 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/5 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
General disorders
Malaise
|
20.0%
3/15 • Number of events 3 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
20.0%
3/15 • Number of events 3 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
20.0%
1/5 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
13.3%
2/15 • Number of events 2 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
General disorders
Pyrexia
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/5 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Infections and infestations
Acute sinusitis
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/5 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/5 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/5 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/5 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/5 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Investigations
Haemoglobin decreased
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/5 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
13.3%
2/15 • Number of events 2 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Investigations
Platelet count increased
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/5 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Investigations
White blood cell count increased
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/5 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
20.0%
3/15 • Number of events 3 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
20.0%
1/5 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
13.3%
2/15 • Number of events 2 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
20.0%
1/5 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/5 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Nervous system disorders
Headache
|
33.3%
5/15 • Number of events 5 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
60.0%
9/15 • Number of events 10 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
40.0%
2/5 • Number of events 2 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
53.3%
8/15 • Number of events 9 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
6/15 • Number of events 6 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
13.3%
2/15 • Number of events 2 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
40.0%
2/5 • Number of events 2 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
13.3%
2/15 • Number of events 2 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/5 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
53.3%
8/15 • Number of events 8 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
53.3%
8/15 • Number of events 8 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
40.0%
2/5 • Number of events 2 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
40.0%
6/15 • Number of events 6 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/5 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
26.7%
4/15 • Number of events 4 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
26.7%
4/15 • Number of events 4 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
40.0%
2/5 • Number of events 2 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
20.0%
3/15 • Number of events 4 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
26.7%
4/15 • Number of events 4 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/5 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
13.3%
2/15 • Number of events 2 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
40.0%
6/15 • Number of events 7 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
46.7%
7/15 • Number of events 7 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
40.0%
2/5 • Number of events 2 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
33.3%
5/15 • Number of events 6 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
26.7%
4/15 • Number of events 4 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
33.3%
5/15 • Number of events 5 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
20.0%
1/5 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
20.0%
3/15 • Number of events 3 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
13.3%
2/15 • Number of events 2 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/5 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Number of events 1 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/5 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
0.00%
0/15 • Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.
Reactogenicity assessments included an assessment of solicited adverse events which includes an assessment of mucosal reactions that include: runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore throat, cough, and shortness of breath, as well as systemic reactions that include fever, chills, fatigue, malaise, myalgia, arthralgia, headache, and hypersensitivity.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60