Pertussis, Whooping Cough
Conditions
Keywords
pertussis, Bordetella infection, Gram-negative bacterial infection, Respiratory tract infection, Whooping cough, Infection, Respiratory tract disease, Vaccine, Immunological factors, Physiological effects of drugs
Brief summary
This study evaluates the safety and immunogenicity of the BPZE1 live attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares a single (prime) BPZE1 dose or BPZE1 2-dose (prime + boost) to a single (prime) Boostrix or Boostrix prime + BPZE1 boost.
Detailed description
This study evaluates the safety and immunogenicity of the BPZE1 live attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares a single (prime) BPZE1 dose or BPZE1 2-dose (prime + boost) to a single (prime) Boostrix or Boostrix prime + BPZE1 boost. This is a multi-center, randomized, placebo-controlled, and observer blinded trial in healthy adults with a 6 month safety follow-up after the last vaccination.
Interventions
COMBINATION_PRODUCTBPZE1 pertussis vaccine and VaxINator(TM) Atomization Device
Live attenuated pertussis vaccine administered via the VaxINator(TM) atomization device
Sponsors
PPD Development, LP
ILiAD Biotechnologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Is a male or nonpregnant female 18 to 50 years of age, inclusive, on Day 1 (primary vaccination). 2. Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements. 3. Female subjects must be nonpregnant and nonlactating and meet 1 of the following criteria: 1. Postmenopausal (defined as 12 consecutive months with no menses without an alternative medical cause or documented plasma follicle-stimulating hormone level in the postmenopausal range); 2. Surgically sterile (ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy). NOTE: These procedures and laboratory test results must be confirmed by physical examination, or by subject recall of specific date and hospital/facility of procedure, or by medical documentation of said procedure. 3. Is of childbearing potential (defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal), agrees to be heterosexually inactive from at least 21 days prior to enrollment and through 3 months after the boosting vaccination or agrees to consistently use any of the following methods of contraception from at least 21 days prior to enrollment and through 3 months after the boosting vaccination: i. Condoms (male or female) with spermicide ii. Diaphragm with spermicide iii. Cervical cap with spermicide iv. Intrauterine device v. Oral or patch contraceptives vi. Norplant®, Depo-Provera®, or other FDA approved contraceptive method that is designed to protect against pregnancy. NOTE: Periodic abstinence (eg, calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception. 4. Has a stable health status as assessed by the investigator, as established by physical examination, vital sign measurements, and medical history. 5. Has access to a consistent and reliable means of telephone contact, which may be in the home, workplace, or by personal mobile electronic device. 6. Is able to understand and comply with planned study procedures. 7. Lives a reasonable distance from the clinical site to be able to travel to and from the clinical site for follow-up visits and agrees to go to the clinical site for evaluation (or provide medical record access if evaluated elsewhere) in the event of an AE. 8. Agrees to stay in contact with the clinical site for the duration of the study, has no current plans to move from the study area, and provides updated contact information as necessary.
Exclusion criteria
1. History of being vaccinated in the past 5 years against pertussis. 2. Any significant past reaction to any component of Boostrix (at the discretion of the investigator). 3. Subject reported diagnosis of pertussis in the past 10 years (must be laboratory confirmed or physician diagnosed from medical records). 4. Vital signs by FDA toxicity scoring \>1 (may be repeated once during the screening period to allow for inclusion and the most recent measurement taken at baseline). 5. Chronic illness being treated actively and with evidence of recent intervention for worsening or fluctuating symptoms (at the discretion of the investigator). 6. The subject has a history of active cancer (malignancy) in the last 10 years (exception is subjects with adequately treated non melanomatous skin carcinoma, who may participate in the study). 7. Current use of any smoking products and unwillingness to refrain from the use of any smoking products from screening through 28 days after the boosting vaccination. 8. Use of narcotic drugs, evidenced by urine toxicology screen or a history of drug/alcohol abuse within the past 2 years. 9. Has donated blood or suffered from blood loss of more than 450 mL (1 unit of blood) within 60 days prior to screening or donated plasma within 14 days prior to screening. 10. Receipt of immunoglobulin, blood-derived products, systemic corticosteroids, or other immunosuppressant drugs within 90 days prior to Day 1. 11. Asthma, obstructive nasal canal, recurrent or acute sinusitis or other chronic respiratory problems inclusive of the diagnosis of any significant pulmonary disease. 12. History of nasal surgery or Bell's palsy. 13. Use of repeated nasal sprays, Neti pot, routine nasal washing within the past 1 month (more than 2 times per week). Subjects must agree to refrain from use of any of these modalities through Day 113. 14. A temporary exclusion to vaccinate if acute respiratory tract infection or rhinorrhea or temperature \>100.4°F (no symptoms for 3 days prior to vaccination day). Subjects may be vaccinated if they stay within the vaccination window (screening \[30 days\] or at the time of the booster \[10 days\]). NOTE: If a subject exceeds the screening window, they must be reconsented and screening must be reinitiated. 15. Use of corticosteroids in the respiratory tract (eg, nasal steroids, inhaled steroids) within 30 days prior to Day 1. 16. Receipt of a licensed vaccine within the last 30 days prior to Day 1 or planned vaccination during the active study conduct through Day 113. In the case of seasonal influenza, vaccination should not be withheld and is not contraindicated for subject participation. However, vaccination should be planned outside of a 30 day pre- and 30 day post vaccination window whenever possible. 17. Known hypersensitivity to any component of the study vaccines. 18. Participation in any other clinical trial for the testing of an unlicensed product during the previous 6 months or planned during the study conduct. 19. Inability to adhere to the protocol, including plans to move from the area. 20. Personal history or family (first degree) history of congenital or hereditary immunodeficiency. 21. Past or present infection with human immunodeficiency virus, hepatitis B, or hepatitis C by screening test. 22. Any autoimmune or immunodeficiency disease/condition (inherited or iatrogenic). 23. Any neurological disease or history of significant neurological disorder (eg, meningitis, seizures, multiple sclerosis, vasculitis, migraines, Guillain-Barré syndrome \[genetic/congenital or acquired\]). 24. Any medical condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might affect the safety of the individual, (eg, major depression or history of suicidal attempt). 25. Toxicity grading \>1 for screening laboratory test results for kidney, hepatic, and hematologic values (may be repeated once during the screening period to allow for inclusion and the most recent measurement taken at baseline). See Table 13 2 for specifically designated parameters. 26. Body mass index \<17 kg/m2 or \>40 kg/m2. 27. Frequent contact with children less than 1 year of age (parent, childcare worker, nurse, etc.) or residence in the same household as persons with known immunodeficiency including persons on immunosuppressant therapy. 28. Study team member or first-degree relative of study team member.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Nasal Mucosal Seroconversion (Immunoglobulin A [IgA]) | Days 29 and 113 | Number of participants who achieve mucosal seroconversion (IgA) against at least 1 anti-pertussis antibody for whole cell extract (WCE), pertussis toxin (PT), filamentous hemagglutinin (FHA), or pertactin (PRN) on Day 29 or Day 113. Mucosal seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value was below the detection limits of the assay). |
| Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Through 7 Days Following Day 1 Vaccination | Number of participants with Solicited AEs (nasal/respiratory reactogenicity events) by Grade - Any Day Grade 1 through 3 and Grade 3. Grading of reactogenicity is defined per protocol as Grade 1 (mild), Grade 2 (moderate), and Grade 3 (severe) AEs. |
| Safety - Number of Participants With Local Solicited AEs | Through 7 Days Following Day 1 Vaccination | Number of participants with Solicited AEs (local reactogenicity events) by Grade - Any Day Grade 1 through 4 and Grade 3 and 4. Grading of reactogenicity is defined per protocol as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (potentially life-threatening) AEs. |
| Safety - Number of Participants With Systemic Solicited AEs | Through 7 Days Following Day 1 Vaccination | Number of participants with Solicited AEs (systemic reactogenicity events) by Grade - Any Day Grade 1 through 3 and Grade 3. Grading of reactogenicity is defined per protocol as Grade 1 (mild), Grade 2 (moderate), and Grade 3 (severe) AEs. |
| Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Days 8 and 92 | Number of participants in the safety lead-in cohort with Grade 2 through 4 laboratory abnormalities: Serum Chemistry - Bilirubin, Creatinine, ALT, AST; WBC, Hemoglobin, Prothrombin time, Partial Thromboplastin Time. Grading of laboratory results is defined per protocol as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threatening) laboratory abnormalities (DHHS 2007). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point | Days 29 and 78 | Mucosal Immunogenicity: Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Day 29 and Day 78 over baseline (Day 1) |
| Colonization - Summary of Colonization for B. Pertussis Bacterial Culture From Nasal Sample by Timepoint | Days 92, 96, 113 | Number of participants with positive B. pertussis by bacterial culture of nasal sample on any of Days 92, 96, and 113 (colonization) |
| Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | 9 months | Number of participants who achieve seroconversion (serum IgG) against 1 or more pertussis antigens (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\], pertactin \[PRN\], or whole cell extract \[WCE\]) on Days 29, 85, 113, 169, and/or 254. Systemic seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value fell below the detection limits of the assay). |
| Safety - Number of Participants With Serious AEs | Days 1 to 84 | Number of participants with Serious AEs collected on Day 1 through Day 84 by MedDRA classification. |
| Safety - Number of Participants With Unsolicited AEs | Days 1 through 29 | Number of participants with Unsolicited AEs collected Day 1 to Day 29 by Medical Dictionary for Regulatory Activities (MedDRA) classification. Threshold is greater than or equal to 5% of participants. |
| Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | 9 Months | Number of participants who achieve seroconversion (serum IgA) against 1 or more pertussis antigens (PT, FHA, PRN) on Days 29, 85, 113, 169, and/or 254. Systemic seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value fell below the detection limits of the assay). |
| Systemic Immunogenicity - Summary of Geometric Mean Fold Rises (GMFRs) of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point | Days 29 and 85 | Systemic Immunogenicity: Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Day 29 and Day 85 over baseline (Day 1) |
| Systemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point | Days 113, 169 and 254 | Systemic Immunogenicity: Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Days 113, 169, and 254 over baseline (Day 1) |
| Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | 9 months | Number of participants who achieve seroconversion against any pertussis specific antigen (PT, PRN, FHA, or WCE) in nasal secretions (S-IgA). Mucosal seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value was below the detection limits of the assay). |
Countries
United States
Participant flow
Recruitment details
Period 1 (Day 1): Prime; Period 2 (Day 85): Boost 300 participants: * 20 received BPZE1 10\^7 CFU as a Safety Lead-in cohort (Prime/Boost: BPZE1/BPZE1 \[n=8\]; BPZE1/Placebo \[n=8\]; Boostrix/BPZE1 \[n=4\]). Safety Lead-in cohort used for one secondary endpoint (abnormal laboratory) and Safety. * 280 in 10\^9 ITT Analysis Set (Prime/Boost: BPZE 10\^9/BPZE1 10\^9 \[n=92\]; BPZE1 10\^9/Placebo \[n=92\]; Boostrix/BPZE1 10\^9 \[n=46\], and Boostrix/Placebo \[n=50\]).
Participants by arm
| Arm | Count |
|---|---|
| BPZE1 Intranasal Prime, BPZE1 Boost Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
(10\^9 ITT Analysis Set) | 92 |
| BPZE1 Intranasal Prime, Placebo Boost Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
(10\^9 ITT Analysis Set) | 92 |
| Boostrix IM Prime, BPZE1 Boost Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
(10\^9 ITT Analysis Set) | 46 |
| Boostrix IM Prime, Placebo Boost Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
(10\^9 ITT Analysis Set) | 50 |
| BPZE1 (10^7) Intranasal Prime, BPZE1 (10^7) Boost Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
(10\^7 Safety Lead-in Analysis Set) | 8 |
| BPZE1 (10^7) Intranasal Prime, Placebo Boost Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of IM placebo on Day 1. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device on Day 85.
(10\^7 Safety Lead-in Analysis Set) | 8 |
| Boostrix IM Prime, BPZE1 (10^7) Boost Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of IM Boostrix (aP vaccine comparator) on Day 1. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device on Day 85.
(10\^7 Safety Lead-in Analysis Set) | 4 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 5 | 3 | 7 | 1 | 0 | 0 |
| Overall Study | Other: early termination, telemedicine visits | 4 | 1 | 1 | 0 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 1 | 1 | 3 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | BPZE1 (10^7) Intranasal Prime, Placebo Boost | Boostrix IM Prime, BPZE1 (10^7) Boost | Total | BPZE1 Intranasal Prime, BPZE1 Boost | BPZE1 (10^7) Intranasal Prime, BPZE1 (10^7) Boost | Boostrix IM Prime, Placebo Boost | Boostrix IM Prime, BPZE1 Boost | BPZE1 Intranasal Prime, Placebo Boost |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 34.6 years STANDARD_DEVIATION 8.7 | 35.5 years STANDARD_DEVIATION 12 | 35.0 years STANDARD_DEVIATION 9.1 | 35.6 years STANDARD_DEVIATION 9 | 31.6 years STANDARD_DEVIATION 10.3 | 34.2 years STANDARD_DEVIATION 9.9 | 34.6 years STANDARD_DEVIATION 9 | 35.2 years STANDARD_DEVIATION 8.8 |
| Body Mass Index (BMI) | 31.1 kg/m^2 STANDARD_DEVIATION 7 | 29.6 kg/m^2 STANDARD_DEVIATION 7.3 | 27.9 kg/m^2 STANDARD_DEVIATION 5.3 | 28.0 kg/m^2 STANDARD_DEVIATION 5.4 | 26.7 kg/m^2 STANDARD_DEVIATION 7.7 | 27.2 kg/m^2 STANDARD_DEVIATION 5 | 27.7 kg/m^2 STANDARD_DEVIATION 5 | 28.1 kg/m^2 STANDARD_DEVIATION 5.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 42 Participants | 15 Participants | 0 Participants | 7 Participants | 8 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 4 Participants | 258 Participants | 77 Participants | 8 Participants | 43 Participants | 38 Participants | 81 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 8 Participants | 1 Participants | 0 Participants | 1 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 61 Participants | 19 Participants | 0 Participants | 8 Participants | 9 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 2 Participants | 223 Participants | 70 Participants | 7 Participants | 41 Participants | 31 Participants | 65 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 165 Participants | 56 Participants | 3 Participants | 27 Participants | 26 Participants | 46 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 135 Participants | 36 Participants | 5 Participants | 23 Participants | 20 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 87 | 0 / 96 | 0 / 46 | 0 / 50 | 0 / 8 | 0 / 8 | 0 / 4 |
| other Total, other adverse events | 25 / 87 | 26 / 96 | 14 / 46 | 12 / 50 | 3 / 8 | 2 / 8 | 1 / 4 |
| serious Total, serious adverse events | 1 / 87 | 3 / 96 | 1 / 46 | 0 / 50 | 0 / 8 | 0 / 8 | 0 / 4 |
Outcome results
Primary
Number of Participants With Nasal Mucosal Seroconversion (Immunoglobulin A [IgA])
Number of participants who achieve mucosal seroconversion (IgA) against at least 1 anti-pertussis antibody for whole cell extract (WCE), pertussis toxin (PT), filamentous hemagglutinin (FHA), or pertactin (PRN) on Day 29 or Day 113. Mucosal seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value was below the detection limits of the assay).
Time frame: Days 29 and 113
Population: 10\^9 Immunogenicity Analysis Set. The overall number of participants analyzed includes participants with nonmissing values. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BPZE1 Intranasal Prime, BPZE1 Boost | Number of Participants With Nasal Mucosal Seroconversion (Immunoglobulin A [IgA]) | 79 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Number of Participants With Nasal Mucosal Seroconversion (Immunoglobulin A [IgA]) | 89 Participants |
| Boostrix IM Prime, BPZE1 Boost | Number of Participants With Nasal Mucosal Seroconversion (Immunoglobulin A [IgA]) | 38 Participants |
| Boostrix IM Prime, Placebo Boost | Number of Participants With Nasal Mucosal Seroconversion (Immunoglobulin A [IgA]) | 42 Participants |
Primary
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
Number of participants in the safety lead-in cohort with Grade 2 through 4 laboratory abnormalities: Serum Chemistry - Bilirubin, Creatinine, ALT, AST; WBC, Hemoglobin, Prothrombin time, Partial Thromboplastin Time. Grading of laboratory results is defined per protocol as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threatening) laboratory abnormalities (DHHS 2007).
Time frame: Days 8 and 92
Population: Safety Lead-in Participants vaccinated with BPZE1 10\^7 CFU for Prime (Day 1) and/or Boost (Day 85)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | WBC Increase Day 92 | 0 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | ALT Day 8 | 0 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Partial Thromboplastin Time Increase by Factor Day 8 | 0 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Platelets Decrease Day 92 | 0 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | WBC Increase Day 8 | 0 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | AST Day 8 | 0 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | ALT Day 92 | 0 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Prothrombin Time Increase by Factor Day 8 | 2 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | WBC decrease Day 92 | 0 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | WBC decrease Day 8 | 0 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Partial Thromboplastin Time Increase by Factor Day 92 | 0 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Bilirubin Increase Day 8 | 1 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Prothrombin Time Increase by Factor Day 92 | 0 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Platelets Decrease Day 8 | 0 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Bilirubin Increase Day 92 | 0 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Hemoglobin Day 92 | 0 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Creatinine Day 8 | 0 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | AST Day 92 | 0 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Hemoglobin Day 8 | 0 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Creatinine Day 92 | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Platelets Decrease Day 8 | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Creatinine Day 92 | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | WBC Increase Day 92 | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Hemoglobin Day 92 | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Bilirubin Increase Day 8 | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Creatinine Day 8 | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | ALT Day 8 | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | ALT Day 92 | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | AST Day 8 | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | AST Day 92 | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | WBC decrease Day 8 | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | WBC decrease Day 92 | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | WBC Increase Day 8 | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Hemoglobin Day 8 | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Bilirubin Increase Day 92 | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Platelets Decrease Day 92 | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Prothrombin Time Increase by Factor Day 8 | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Prothrombin Time Increase by Factor Day 92 | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Partial Thromboplastin Time Increase by Factor Day 8 | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Partial Thromboplastin Time Increase by Factor Day 92 | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Partial Thromboplastin Time Increase by Factor Day 8 | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Hemoglobin Day 8 | 1 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Bilirubin Increase Day 92 | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Hemoglobin Day 92 | 1 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Bilirubin Increase Day 8 | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Prothrombin Time Increase by Factor Day 92 | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Platelets Decrease Day 8 | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | WBC Increase Day 92 | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | ALT Day 8 | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Platelets Decrease Day 92 | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Partial Thromboplastin Time Increase by Factor Day 92 | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | WBC decrease Day 8 | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | AST Day 92 | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Prothrombin Time Increase by Factor Day 8 | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | WBC decrease Day 92 | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | ALT Day 92 | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | AST Day 8 | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | WBC Increase Day 8 | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Creatinine Day 92 | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In) | Creatinine Day 8 | 0 Participants |
Primary
Safety - Number of Participants With Local Solicited AEs
Number of participants with Solicited AEs (local reactogenicity events) by Grade - Any Day Grade 1 through 4 and Grade 3 and 4. Grading of reactogenicity is defined per protocol as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (potentially life-threatening) AEs.
Time frame: Through 7 Days Following Day 1 Vaccination
Population: 10\^9 Safety Analysis Set. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Local Solicited AEs | Erythema/Redness - Any Day Grade 1 Through 4 | 0 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Local Solicited AEs | Induration/Swelling - Any Day Grade 1 Through 4 | 0 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Local Solicited AEs | Erythema/Redness - Any Day Grade 3 and 4 | 0 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Local Solicited AEs | Induration/Swelling - Any Day Grade 3 and 4 | 0 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Local Solicited AEs | Tenderness - Any Day Grade 1 Through 4 | 15 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Local Solicited AEs | Pain - Any Day Grade 1 Through 4 | 8 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Local Solicited AEs | Pain - Any Day Grade 3 and 4 | 0 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Local Solicited AEs | Tenderness - Any Day Grade 3 and 4 | 0 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Local Solicited AEs | Induration/Swelling - Any Day Grade 3 and 4 | 0 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Local Solicited AEs | Pain - Any Day Grade 1 Through 4 | 7 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Local Solicited AEs | Erythema/Redness - Any Day Grade 1 Through 4 | 2 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Local Solicited AEs | Tenderness - Any Day Grade 3 and 4 | 0 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Local Solicited AEs | Pain - Any Day Grade 3 and 4 | 0 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Local Solicited AEs | Erythema/Redness - Any Day Grade 3 and 4 | 0 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Local Solicited AEs | Tenderness - Any Day Grade 1 Through 4 | 13 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Local Solicited AEs | Induration/Swelling - Any Day Grade 1 Through 4 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Local Solicited AEs | Erythema/Redness - Any Day Grade 3 and 4 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Local Solicited AEs | Induration/Swelling - Any Day Grade 3 and 4 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Local Solicited AEs | Pain - Any Day Grade 1 Through 4 | 22 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Local Solicited AEs | Tenderness - Any Day Grade 1 Through 4 | 28 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Local Solicited AEs | Erythema/Redness - Any Day Grade 1 Through 4 | 1 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Local Solicited AEs | Tenderness - Any Day Grade 3 and 4 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Local Solicited AEs | Induration/Swelling - Any Day Grade 1 Through 4 | 4 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Local Solicited AEs | Pain - Any Day Grade 3 and 4 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Local Solicited AEs | Induration/Swelling - Any Day Grade 3 and 4 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Local Solicited AEs | Erythema/Redness - Any Day Grade 3 and 4 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Local Solicited AEs | Pain - Any Day Grade 1 Through 4 | 27 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Local Solicited AEs | Pain - Any Day Grade 3 and 4 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Local Solicited AEs | Tenderness - Any Day Grade 1 Through 4 | 30 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Local Solicited AEs | Tenderness - Any Day Grade 3 and 4 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Local Solicited AEs | Erythema/Redness - Any Day Grade 1 Through 4 | 2 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Local Solicited AEs | Induration/Swelling - Any Day Grade 1 Through 4 | 2 participants |
Primary
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Number of participants with Solicited AEs (nasal/respiratory reactogenicity events) by Grade - Any Day Grade 1 through 3 and Grade 3. Grading of reactogenicity is defined per protocol as Grade 1 (mild), Grade 2 (moderate), and Grade 3 (severe) AEs.
Time frame: Through 7 Days Following Day 1 Vaccination
Population: 10\^9 Safety Analysis Set. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sore/Irritated Throat - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Cough - Any Day Grade 1 through 3 | 11 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Cough - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Stuffy Nose/Congestion - Any Day Grade 1 through 3 | 27 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Shortness of Breath/Wheezing - Any Day Grade 1 through 3 | 1 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Shortness of Breath/Wheezing - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Runny Nose - Any Day Grade 1 through 3 | 25 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Nasal Pain/Irritation - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Stuffy Nose/Congestion - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Nasal Pain/Irritation - Any Day Grade 1 through 3 | 10 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Epistaxis - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Epistaxis - Any Day Grade 1 through 3 | 1 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sneezing - Any Day Grade 1 through 3 | 25 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sneezing - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sinus Pressure/Pain - Any Day Grade 1 through 3 | 12 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sinus Pressure/Pain - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sore/Irritated Throat - Any Day Grade 1 through 3 | 22 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Runny Nose - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Runny Nose - Any Day Grade 1 through 3 | 41 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sore/Irritated Throat - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sore/Irritated Throat - Any Day Grade 1 through 3 | 29 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Runny Nose - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Nasal Pain/Irritation - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Cough - Any Day Grade 1 through 3 | 18 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sinus Pressure/Pain - Any Day Grade 1 through 3 | 19 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sneezing - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sneezing - Any Day Grade 1 through 3 | 35 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Cough - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sinus Pressure/Pain - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Epistaxis - Any Day Grade 1 through 3 | 5 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Shortness of Breath/Wheezing - Any Day Grade 1 through 3 | 7 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Stuffy Nose/Congestion - Any Day Grade 1 through 3 | 44 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Nasal Pain/Irritation - Any Day Grade 1 through 3 | 13 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Shortness of Breath/Wheezing - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Epistaxis - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Stuffy Nose/Congestion - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sore/Irritated Throat - Any Day Grade 1 through 3 | 8 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sinus Pressure/Pain - Any Day Grade 1 through 3 | 5 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Stuffy Nose/Congestion - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Epistaxis - Any Day Grade 1 through 3 | 2 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Shortness of Breath/Wheezing - Any Day Grade 1 through 3 | 2 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Nasal Pain/Irritation - Any Day Grade 1 through 3 | 7 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Nasal Pain/Irritation - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sneezing - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Epistaxis - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sore/Irritated Throat - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sinus Pressure/Pain - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Cough - Any Day Grade 1 through 3 | 10 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Runny Nose - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Cough - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sneezing - Any Day Grade 1 through 3 | 15 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Runny Nose - Any Day Grade 1 through 3 | 17 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Shortness of Breath/Wheezing - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Stuffy Nose/Congestion - Any Day Grade 1 through 3 | 19 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Shortness of Breath/Wheezing - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sneezing - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Runny Nose - Any Day Grade 1 through 3 | 16 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Runny Nose - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Stuffy Nose/Congestion - Any Day Grade 1 through 3 | 15 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Stuffy Nose/Congestion - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Nasal Pain/Irritation - Any Day Grade 1 through 3 | 7 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Nasal Pain/Irritation - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Epistaxis - Any Day Grade 1 through 3 | 1 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Epistaxis - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sneezing - Any Day Grade 1 through 3 | 13 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sinus Pressure/Pain - Any Day Grade 1 through 3 | 10 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sinus Pressure/Pain - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sore/Irritated Throat - Any Day Grade 1 through 3 | 10 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Sore/Irritated Throat - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Cough - Any Day Grade 1 through 3 | 9 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Cough - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs) | Shortness of Breath/Wheezing - Any Day Grade 1 through 3 | 3 participants |
Primary
Safety - Number of Participants With Systemic Solicited AEs
Number of participants with Solicited AEs (systemic reactogenicity events) by Grade - Any Day Grade 1 through 3 and Grade 3. Grading of reactogenicity is defined per protocol as Grade 1 (mild), Grade 2 (moderate), and Grade 3 (severe) AEs.
Time frame: Through 7 Days Following Day 1 Vaccination
Population: 10\^9 Safety Analysis Set. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Fever - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Fatigue (Tiredness) - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Myalgia (Body Aches/Muscular Pain) - Any Day Grade 1 through 3 | 8 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Myalgia (Body Aches/Muscular Pain) - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Arthralgia (Joint Pain) - Any Day Grade 1 through 3 | 5 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Headache - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Fever - Any Day Grade 1 through 3 | 0 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Fatigue (Tiredness) - Any Day Grade 1 through 3 | 27 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Malaise (General Unwell Feeling) - Any Day Grade 1 through 3 | 13 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Malaise (General Unwell Feeling) - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Arthralgia (Joint Pain) - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Headache - Any Day Grade 1 through 3 | 31 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Rash/Hypersensitivity - Any Day Grade 1 through 3 | 0 participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Rash/Hypersensitivity - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Fever - Any Day Grade 3 | 1 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Fatigue (Tiredness) - Any Day Grade 1 through 3 | 35 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Headache - Any Day Grade 1 through 3 | 37 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Arthralgia (Joint Pain) - Any Day Grade 3 | 0 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Malaise (General Unwell Feeling) - Any Day Grade 3 | 1 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Rash/Hypersensitivity - Any Day Grade 1 through 3 | 4 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Malaise (General Unwell Feeling) - Any Day Grade 1 through 3 | 25 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Myalgia (Body Aches/Muscular Pain) - Any Day Grade 3 | 1 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Arthralgia (Joint Pain) - Any Day Grade 1 through 3 | 7 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Fever - Any Day Grade 1 through 3 | 1 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Headache - Any Day Grade 3 | 1 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Myalgia (Body Aches/Muscular Pain) - Any Day Grade 1 through 3 | 19 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Rash/Hypersensitivity - Any Day Grade 3 | 1 participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Fatigue (Tiredness) - Any Day Grade 3 | 1 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Fatigue (Tiredness) - Any Day Grade 1 through 3 | 9 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Arthralgia (Joint Pain) - Any Day Grade 1 through 3 | 1 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Headache - Any Day Grade 1 through 3 | 13 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Rash/Hypersensitivity - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Headache - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Fever - Any Day Grade 1 through 3 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Fever - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Malaise (General Unwell Feeling) - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Myalgia (Body Aches/Muscular Pain) - Any Day Grade 1 through 3 | 4 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Rash/Hypersensitivity - Any Day Grade 1 through 3 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Arthralgia (Joint Pain) - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Fatigue (Tiredness) - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Malaise (General Unwell Feeling) - Any Day Grade 1 through 3 | 6 participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Systemic Solicited AEs | Myalgia (Body Aches/Muscular Pain) - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Fatigue (Tiredness) - Any Day Grade 1 through 3 | 12 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Headache - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Rash/Hypersensitivity - Any Day Grade 1 through 3 | 1 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Fever - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Headache - Any Day Grade 1 through 3 | 22 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Myalgia (Body Aches/Muscular Pain) - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Malaise (General Unwell Feeling) - Any Day Grade 1 through 3 | 8 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Rash/Hypersensitivity - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Fatigue (Tiredness) - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Malaise (General Unwell Feeling) - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Arthralgia (Joint Pain) - Any Day Grade 3 | 0 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Myalgia (Body Aches/Muscular Pain) - Any Day Grade 1 through 3 | 8 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Arthralgia (Joint Pain) - Any Day Grade 1 through 3 | 4 participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Systemic Solicited AEs | Fever - Any Day Grade 1 through 3 | 0 participants |
Secondary
Colonization - Summary of Colonization for B. Pertussis Bacterial Culture From Nasal Sample by Timepoint
Number of participants with positive B. pertussis by bacterial culture of nasal sample on any of Days 92, 96, and 113 (colonization)
Time frame: Days 92, 96, 113
Population: 10\^9 Immunogenicity Analysis Set. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received. The number analyzed includes participants with nonmissing values.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BPZE1 Intranasal Prime, BPZE1 Boost | Colonization - Summary of Colonization for B. Pertussis Bacterial Culture From Nasal Sample by Timepoint | 8 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Colonization - Summary of Colonization for B. Pertussis Bacterial Culture From Nasal Sample by Timepoint | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Colonization - Summary of Colonization for B. Pertussis Bacterial Culture From Nasal Sample by Timepoint | 28 Participants |
| Boostrix IM Prime, Placebo Boost | Colonization - Summary of Colonization for B. Pertussis Bacterial Culture From Nasal Sample by Timepoint | 0 Participants |
Secondary
Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point
Mucosal Immunogenicity: Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Day 113, Day 169, and Day 254 over baseline (Day 1)
Time frame: Days 113, 169, 254
Population: 10\^9 Immunogenicity Analysis Set. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received. The number analyzed includes participants with nonmissing values.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BPZE1 Intranasal Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 113 | 2.96 Ratio |
| BPZE1 Intranasal Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 169 | 2.23 Ratio |
| BPZE1 Intranasal Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 254 | 1.73 Ratio |
| BPZE1 Intranasal Prime, Placebo Boost | Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 113 | 2.04 Ratio |
| BPZE1 Intranasal Prime, Placebo Boost | Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 169 | 1.57 Ratio |
| BPZE1 Intranasal Prime, Placebo Boost | Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 254 | 1.45 Ratio |
| Boostrix IM Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 254 | 1.26 Ratio |
| Boostrix IM Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 169 | 1.75 Ratio |
| Boostrix IM Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 113 | 1.91 Ratio |
| Boostrix IM Prime, Placebo Boost | Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 254 | 0.82 Ratio |
| Boostrix IM Prime, Placebo Boost | Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 169 | 0.82 Ratio |
| Boostrix IM Prime, Placebo Boost | Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 113 | 1.15 Ratio |
Secondary
Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point
Mucosal Immunogenicity: Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Day 29 and Day 78 over baseline (Day 1)
Time frame: Days 29 and 78
Population: 10\^9 Immunogenicity Analysis Set. The Day 29 and Day 78 GMFR values are for the pooled BPZE1 group (BPZE1/BPZE1 + BPZE1/placebo) and pooled Boostrix group (Boostrix/BPZE1 + Boostrix/placebo), since these Days are prior to the Day 85 challenge/boost. The number analyzed includes participants with nonmissing values.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BPZE1 Intranasal Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 29 | 2.22 Ratio |
| BPZE1 Intranasal Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 78 | 2.10 Ratio |
| BPZE1 Intranasal Prime, Placebo Boost | Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 78 | 1.04 Ratio |
| BPZE1 Intranasal Prime, Placebo Boost | Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 29 | 1.07 Ratio |
Secondary
Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints
Number of participants who achieve seroconversion against any pertussis specific antigen (PT, PRN, FHA, or WCE) in nasal secretions (S-IgA). Mucosal seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value was below the detection limits of the assay).
Time frame: 9 months
Population: 10\^9 Immunogenicity Analysis Set. The number analyzed includes participants with nonmissing values. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BPZE1 Intranasal Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against PT, FHA, PRN: Either Day 29 or Day 113 | 23 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against at least 2 of WCE, PT, FHA, or PRN: Any of Days 29, 78, or 113 | 64 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Boosting achieved on Day 113 (over Day 78) against WCE | 23 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against at least 1 of WCE, PT, FHA, or PRN: Either Day 169 or Day 254 | 66 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against WCE: Either Day 29 or Day 113 | 54 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against at least 1 of WCE, PT, FHA, or PRN: Any of Days 29, 78, or 113 | 75 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against at least 2 of WCE, PT, FHA, or PRN: Either Day 169 or Day 254 | 47 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against at least 1 of WCE, PT, FHA, or PRN: Either Day 169 or Day 254 | 63 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against PT, FHA, PRN: Either Day 29 or Day 113 | 14 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against at least 1 of WCE, PT, FHA, or PRN: Any of Days 29, 78, or 113 | 84 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against at least 2 of WCE, PT, FHA, or PRN: Any of Days 29, 78, or 113 | 70 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Boosting achieved on Day 113 (over Day 78) against WCE | 7 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against at least 2 of WCE, PT, FHA, or PRN: Either Day 169 or Day 254 | 43 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against WCE: Either Day 29 or Day 113 | 64 Participants |
| Boostrix IM Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against at least 1 of WCE, PT, FHA, or PRN: Any of Days 29, 78, or 113 | 33 Participants |
| Boostrix IM Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against at least 2 of WCE, PT, FHA, or PRN: Any of Days 29, 78, or 113 | 23 Participants |
| Boostrix IM Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against at least 1 of WCE, PT, FHA, or PRN: Either Day 169 or Day 254 | 30 Participants |
| Boostrix IM Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against WCE: Either Day 29 or Day 113 | 21 Participants |
| Boostrix IM Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against PT, FHA, PRN: Either Day 29 or Day 113 | 5 Participants |
| Boostrix IM Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against at least 2 of WCE, PT, FHA, or PRN: Either Day 169 or Day 254 | 17 Participants |
| Boostrix IM Prime, BPZE1 Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Boosting achieved on Day 113 (over Day 78) against WCE | 11 Participants |
| Boostrix IM Prime, Placebo Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against at least 1 of WCE, PT, FHA, or PRN: Either Day 169 or Day 254 | 13 Participants |
| Boostrix IM Prime, Placebo Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Boosting achieved on Day 113 (over Day 78) against WCE | 6 Participants |
| Boostrix IM Prime, Placebo Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against at least 2 of WCE, PT, FHA, or PRN: Either Day 169 or Day 254 | 3 Participants |
| Boostrix IM Prime, Placebo Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against at least 1 of WCE, PT, FHA, or PRN: Any of Days 29, 78, or 113 | 27 Participants |
| Boostrix IM Prime, Placebo Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against at least 2 of WCE, PT, FHA, or PRN: Any of Days 29, 78, or 113 | 11 Participants |
| Boostrix IM Prime, Placebo Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against PT, FHA, PRN: Either Day 29 or Day 113 | 2 Participants |
| Boostrix IM Prime, Placebo Boost | Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints | Against WCE: Either Day 29 or Day 113 | 11 Participants |
Secondary
Safety - Number of Participants With Serious AEs
Number of participants with Serious AEs collected on Day 1 through Day 84 by MedDRA classification.
Time frame: Days 1 to 84
Population: 10\^9 Safety Analysis Set. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Serious AEs | Post procedural haemorrhage | 1 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Serious AEs | Cellulitis | 0 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Serious AEs | Bacterial sepsis | 0 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Serious AEs | Hyperglycaemia | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Serious AEs | Post procedural haemorrhage | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Serious AEs | Hyperglycaemia | 1 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Serious AEs | Cellulitis | 1 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Serious AEs | Bacterial sepsis | 1 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Serious AEs | Post procedural haemorrhage | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Serious AEs | Bacterial sepsis | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Serious AEs | Hyperglycaemia | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Serious AEs | Cellulitis | 0 Participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Serious AEs | Cellulitis | 0 Participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Serious AEs | Bacterial sepsis | 0 Participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Serious AEs | Hyperglycaemia | 0 Participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Serious AEs | Post procedural haemorrhage | 0 Participants |
Secondary
Safety - Number of Participants With Serious AEs
Number of participants with Serious AEs collected on Day 114 through Day 254 by MedDRA classification.
Time frame: Days 114 to 254 (end of study)
Population: 10\^9 Safety Analysis Set. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Serious AEs | Obesity | 0 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Serious AEs | Other | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Serious AEs | Other | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Serious AEs | Obesity | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Serious AEs | Obesity | 1 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Serious AEs | Other | 0 Participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Serious AEs | Obesity | 0 Participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Serious AEs | Other | 0 Participants |
Secondary
Safety - Number of Participants With Serious AEs
Number of participants with Serious AEs collected on Day 85 through Day 113 by MedDRA classification.
Time frame: Days 85 to 113
Population: 10\^9 Safety Analysis Set. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Serious AEs | Other | 0 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Serious AEs | Diabetic metabolic decompensation | 0 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Serious AEs | Diabetic metabolic decompensation | 1 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Serious AEs | Other | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Serious AEs | Other | 0 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Serious AEs | Diabetic metabolic decompensation | 0 Participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Serious AEs | Diabetic metabolic decompensation | 0 Participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Serious AEs | Other | 0 Participants |
Secondary
Safety - Number of Participants With Unsolicited AEs
Number of participants with Unsolicited AEs collected Day 1 to Day 29 by Medical Dictionary for Regulatory Activities (MedDRA) classification. Threshold is greater than or equal to 5% of participants.
Time frame: Days 1 through 29
Population: 10\^9 Safety Analysis Set. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Unsolicited AEs | Rhinorrhoea | 5 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Unsolicited AEs | Nasal congestion | 5 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Unsolicited AEs | Sneezing | 6 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Unsolicited AEs | Headache | 5 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Unsolicited AEs | Nasal congestion | 4 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Unsolicited AEs | Sneezing | 2 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Unsolicited AEs | Headache | 7 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Unsolicited AEs | Rhinorrhoea | 3 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Unsolicited AEs | Sneezing | 2 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Unsolicited AEs | Nasal congestion | 3 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Unsolicited AEs | Rhinorrhoea | 2 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Unsolicited AEs | Headache | 0 Participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Unsolicited AEs | Sneezing | 1 Participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Unsolicited AEs | Headache | 1 Participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Unsolicited AEs | Rhinorrhoea | 2 Participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Unsolicited AEs | Nasal congestion | 3 Participants |
Secondary
Safety - Number of Participants With Unsolicited AEs
Number of participants with Unsolicited AEs Day 85 through Day 113 by MedDRA classification. Threshold is greater than or equal to 5% of participants.
Time frame: Days 85 through 113
Population: 10\^9 Safety Analysis Set. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Unsolicited AEs | Upper respiratory tract infection | 4 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Safety - Number of Participants With Unsolicited AEs | Nasal congestion | 1 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Unsolicited AEs | Upper respiratory tract infection | 5 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Safety - Number of Participants With Unsolicited AEs | Nasal congestion | 6 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Unsolicited AEs | Nasal congestion | 4 Participants |
| Boostrix IM Prime, BPZE1 Boost | Safety - Number of Participants With Unsolicited AEs | Upper respiratory tract infection | 0 Participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Unsolicited AEs | Upper respiratory tract infection | 4 Participants |
| Boostrix IM Prime, Placebo Boost | Safety - Number of Participants With Unsolicited AEs | Nasal congestion | 4 Participants |
Secondary
Systemic Immunogenicity - Summary of Geometric Mean Fold Rises (GMFRs) of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point
Systemic Immunogenicity: Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Day 29 and Day 85 over baseline (Day 1)
Time frame: Days 29 and 85
Population: 10\^9 Immunogenicity Analysis Set. The Day 29 and Day 85 GMFR values are for the pooled BPZE1 group (BPZE1/BPZE1 and BPZE1/placebo) and pooled Boostrix group (Boostrix/BPZE1 and Boostrix/placebo), since these Days were prior to the Day 85 challenge/boost. The number analyzed includes participants with nonmissing values.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BPZE1 Intranasal Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Geometric Mean Fold Rises (GMFRs) of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 29 | 1.80 Ratio |
| BPZE1 Intranasal Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Geometric Mean Fold Rises (GMFRs) of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 85 | 1.76 Ratio |
| BPZE1 Intranasal Prime, Placebo Boost | Systemic Immunogenicity - Summary of Geometric Mean Fold Rises (GMFRs) of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 29 | 3.06 Ratio |
| BPZE1 Intranasal Prime, Placebo Boost | Systemic Immunogenicity - Summary of Geometric Mean Fold Rises (GMFRs) of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 85 | 2.30 Ratio |
Secondary
Systemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point
Systemic Immunogenicity: Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Days 113, 169, and 254 over baseline (Day 1)
Time frame: Days 113, 169 and 254
Population: 10\^9 Immunogenicity Analysis Set. The number analyzed includes participants with nonmissing values. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BPZE1 Intranasal Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 254 | 1.66 Ratio |
| BPZE1 Intranasal Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 169 | 1.85 Ratio |
| BPZE1 Intranasal Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 113 | 2.10 Ratio |
| BPZE1 Intranasal Prime, Placebo Boost | Systemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 254 | 1.43 Ratio |
| BPZE1 Intranasal Prime, Placebo Boost | Systemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 169 | 1.54 Ratio |
| BPZE1 Intranasal Prime, Placebo Boost | Systemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 113 | 1.64 Ratio |
| Boostrix IM Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 113 | 2.73 Ratio |
| Boostrix IM Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 254 | 1.99 Ratio |
| Boostrix IM Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 169 | 2.32 Ratio |
| Boostrix IM Prime, Placebo Boost | Systemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 169 | 1.62 Ratio |
| Boostrix IM Prime, Placebo Boost | Systemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 254 | 1.37 Ratio |
| Boostrix IM Prime, Placebo Boost | Systemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point | GMFR WCE Day 113 | 2.04 Ratio |
Secondary
Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints
Number of participants who achieve seroconversion (serum IgA) against 1 or more pertussis antigens (PT, FHA, PRN) on Days 29, 85, 113, 169, and/or 254. Systemic seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value fell below the detection limits of the assay).
Time frame: 9 Months
Population: 10\^9 Immunogenicity Analysis Set. The number analyzed includes participants with nonmissing values. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BPZE1 Intranasal Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against at least 1 of PT, FHA, or PRN: Any of Days 29, 85, or 113 | 64 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Boosting Achieved on Day 113 (over Day 85) against PT | 3 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against at least 2 of PT, FHA, or PRN: Each Day 29, 85, or 113 | 25 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against PT, FHA, and PRN: Either Day 29 or Day 113 | 23 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against at least 1 of PT, FHA, or PRN: Either day 169 or Day 254 | 55 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Boosting Achieved on Day 113 (over Day 85) against PRN | 13 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against at least 2 of PT, FHA, or PRN: Either Day 169 or Day 254 | 41 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Boosting Achieved on Day 113 (over Day 85) against FHA | 6 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against at least 2 of PT, FHA, or PRN: Any of Days 29, 85, or 113 | 50 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against at least 2 of PT, FHA, or PRN: Each Day 29, 85, or 113 | 28 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against at least 1 of PT, FHA, or PRN: Either day 169 or Day 254 | 58 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against at least 2 of PT, FHA, or PRN: Any of Days 29, 85, or 113 | 49 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against at least 2 of PT, FHA, or PRN: Either Day 169 or Day 254 | 30 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against at least 1 of PT, FHA, or PRN: Any of Days 29, 85, or 113 | 71 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against PT, FHA, and PRN: Either Day 29 or Day 113 | 29 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Boosting Achieved on Day 113 (over Day 85) against PT | 2 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Boosting Achieved on Day 113 (over Day 85) against FHA | 4 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Boosting Achieved on Day 113 (over Day 85) against PRN | 4 Participants |
| Boostrix IM Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Boosting Achieved on Day 113 (over Day 85) against PT | 4 Participants |
| Boostrix IM Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against at least 2 of PT, FHA, or PRN: Each Day 29, 85, or 113 | 14 Participants |
| Boostrix IM Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against at least 2 of PT, FHA, or PRN: Either Day 169 or Day 254 | 24 Participants |
| Boostrix IM Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against at least 2 of PT, FHA, or PRN: Any of Days 29, 85, or 113 | 28 Participants |
| Boostrix IM Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against PT, FHA, and PRN: Either Day 29 or Day 113 | 18 Participants |
| Boostrix IM Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Boosting Achieved on Day 113 (over Day 85) against PRN | 8 Participants |
| Boostrix IM Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Boosting Achieved on Day 113 (over Day 85) against FHA | 3 Participants |
| Boostrix IM Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against at least 1 of PT, FHA, or PRN: Either day 169 or Day 254 | 32 Participants |
| Boostrix IM Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against at least 1 of PT, FHA, or PRN: Any of Days 29, 85, or 113 | 40 Participants |
| Boostrix IM Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Boosting Achieved on Day 113 (over Day 85) against PT | 0 Participants |
| Boostrix IM Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Boosting Achieved on Day 113 (over Day 85) against FHA | 1 Participants |
| Boostrix IM Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against at least 2 of PT, FHA, or PRN: Each Day 29, 85, or 113 | 13 Participants |
| Boostrix IM Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against at least 1 of PT, FHA, or PRN: Either day 169 or Day 254 | 29 Participants |
| Boostrix IM Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against at least 2 of PT, FHA, or PRN: Any of Days 29, 85, or 113 | 30 Participants |
| Boostrix IM Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against at least 1 of PT, FHA, or PRN: Any of Days 29, 85, or 113 | 41 Participants |
| Boostrix IM Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against at least 2 of PT, FHA, or PRN: Either Day 169 or Day 254 | 14 Participants |
| Boostrix IM Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Against PT, FHA, and PRN: Either Day 29 or Day 113 | 9 Participants |
| Boostrix IM Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints | Boosting Achieved on Day 113 (over Day 85) against PRN | 0 Participants |
Secondary
Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints
Number of participants who achieve seroconversion (serum IgG) against 1 or more pertussis antigens (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\], pertactin \[PRN\], or whole cell extract \[WCE\]) on Days 29, 85, 113, 169, and/or 254. Systemic seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value fell below the detection limits of the assay).
Time frame: 9 months
Population: 10\^9 Immunogenicity Analysis Set. The number analyzed includes participants with nonmissing values. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BPZE1 Intranasal Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | PT, FHA, PRN: Either Day 29 or Day 113 | 19 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | WCE: Either Day 29 or Day 113 | 45 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | At least 2 of WCE, PT, FHA, OR PRN: Either Day 169 or Day Day 254 | 40 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | At least 1 of WCE, PT, FHA, PRN: Any of Days 29, 85, or 113 | 63 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | At least 2 of WCE, PT, FHA, OR PRN: Any of Days 29, 85, or 113 | 46 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | At least 1 of WCE, PT, FHA, PRN: Either Day 169 or Day 254 | 54 Participants |
| BPZE1 Intranasal Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | Boosting Achieved on Day 113 (over Day 85) Against WCE | 8 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | At least 1 of WCE, PT, FHA, PRN: Any of Days 29, 85, or 113 | 71 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | At least 1 of WCE, PT, FHA, PRN: Either Day 169 or Day 254 | 59 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | WCE: Either Day 29 or Day 113 | 41 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | PT, FHA, PRN: Either Day 29 or Day 113 | 16 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | At least 2 of WCE, PT, FHA, OR PRN: Any of Days 29, 85, or 113 | 50 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | At least 2 of WCE, PT, FHA, OR PRN: Either Day 169 or Day Day 254 | 41 Participants |
| BPZE1 Intranasal Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | Boosting Achieved on Day 113 (over Day 85) Against WCE | 4 Participants |
| Boostrix IM Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | At least 1 of WCE, PT, FHA, PRN: Any of Days 29, 85, or 113 | 41 Participants |
| Boostrix IM Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | Boosting Achieved on Day 113 (over Day 85) Against WCE | 4 Participants |
| Boostrix IM Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | At least 2 of WCE, PT, FHA, OR PRN: Any of Days 29, 85, or 113 | 37 Participants |
| Boostrix IM Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | At least 2 of WCE, PT, FHA, OR PRN: Either Day 169 or Day Day 254 | 32 Participants |
| Boostrix IM Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | WCE: Either Day 29 or Day 113 | 28 Participants |
| Boostrix IM Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | PT, FHA, PRN: Either Day 29 or Day 113 | 28 Participants |
| Boostrix IM Prime, BPZE1 Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | At least 1 of WCE, PT, FHA, PRN: Either Day 169 or Day 254 | 33 Participants |
| Boostrix IM Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | Boosting Achieved on Day 113 (over Day 85) Against WCE | 2 Participants |
| Boostrix IM Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | PT, FHA, PRN: Either Day 29 or Day 113 | 28 Participants |
| Boostrix IM Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | At least 1 of WCE, PT, FHA, PRN: Any of Days 29, 85, or 113 | 45 Participants |
| Boostrix IM Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | At least 2 of WCE, PT, FHA, OR PRN: Any of Days 29, 85, or 113 | 41 Participants |
| Boostrix IM Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | At least 2 of WCE, PT, FHA, OR PRN: Either Day 169 or Day Day 254 | 28 Participants |
| Boostrix IM Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | At least 1 of WCE, PT, FHA, PRN: Either Day 169 or Day 254 | 32 Participants |
| Boostrix IM Prime, Placebo Boost | Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints | WCE: Either Day 29 or Day 113 | 32 Participants |