Healthy
Conditions
Brief summary
The purpose of this study is to evaluate the safety/reactogenicity of the ExPEC4V clinical trial material (CTM) after the first vaccination and to evaluate the immunogenicity of the ExPEC4V CTM, as measured by the enzyme-linked immunosorbent assay (ELISA), 14 days after the first vaccination (on Day 15).
Interventions
BIOLOGICALExPEC4V
Participants will receive ExPEC4V vaccine as an IM injection on Days 1 and 181.
BIOLOGICALPlacebo
Participants will receive placebo as an IM injection on Days 1 and 181.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants who provides written informed consent and signs the informed consent form (ICF) indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study * Participant is medically stable as confirmed by documented medical history, physical examination and vital signs. Participant may have underlying illnesses such as hypertension, diabetes, or ischemic heart disease, as long as their symptoms/signs are medically controlled. If he/she is on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination * Participant must have a body mass index (BMI) of less than or equal to (\<=)35.0 kilogram per square meter (kg/m\^2) * Contraceptive (birth control) use by woman should be consistent with local regulations regarding the acceptable methods of contraception for participant participating in clinical studies * All females of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) at pregnancy test on Visit 1 (pre-vaccination) and Visit 4 (prior to the second vaccination)
Exclusion criteria
* Participant with contraindication to intramuscular (IM) injections and blood draws, for example, bleeding disorders * Participant with known allergies, hypersensitivity, or intolerance to ExPEC4V or its excipients * Participant with abnormal function of the immune system resulting from: a) clinical conditions (for example, autoimmune disease or immunodeficiency); b) chronic or recurrent use of systemic corticosteroids; c) administration of antineoplastic and immunomodulating agents or radiotherapy * Participant has a history of neoplastic disease (excluding non-melanoma skin cancer or carcinoma in situ of the cervix that was successfully treated) within the past 1 year or a history of any hematological malignancy * Participant with history of acute polyneuropathy (for example, Guillain-Barre syndrome) * Participant who has a history of an underlying clinically significant acute or (uncontrolled) chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ELISA Geometric Mean Ratio (GMR) for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 | Day 15/Day 1 | IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMR for serotypes O1A, O2, O6A and O25B (Day 15/Day 1) was reported. |
| Percentage of Participants With Solicited Local Adverse Events (AEs) After First Vaccination | 14 days after first vaccination (Day 1 to Day 15) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited local AEs were precisely defined local events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. |
| Percentage of Participants With Solicited Systemic Adverse Events After First Vaccination | 14 days after first vaccination (Day 1 to Day 15) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited systemic AEs were precisely defined systemic events that participants were specifically asked about and which were noted by participants in the diary. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever. |
| Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15 | Day 15 | Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by ELISA at Day 15 were reported. |
| Percentage of Participants With Unsolicited Adverse Events After First Vaccination | 29 days after first vaccination (Day 1 to Day 30) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary. |
| Number of Participants With Serious Adverse Events (SAEs) After First Vaccination | Up to Day 180 | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product. |
| Enzyme-linked Immunosorbent Assay (ELISA) Geometric Mean Titers (GMTs) for Serotypes O1A, O2, O6A and O25B at Day 1 | Day 1 | Immunoglobulin G (IgG) antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Day 1 were reported. |
| ELISA GMTs for Serotypes O1A, O2, O6A and O25B at Day 15 | Day 15 | IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Day 15 were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Day 181/Day 1 and Day 195/Day 1 | IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMR for serotypes O1A, O2, O6A and O25B (Day 181/Day 1 and Day 195/Day 1) was reported. |
| Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Days 181 and 195 | Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by ELISA at Days 181 and 195 were reported. |
| Percentage of Participants With Solicited Local Adverse Events After Second Vaccination | 14 days after second vaccination (Day 181 to Day 195) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited local AEs were precisely defined local events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. |
| OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Day 181/Day 1 and Day 195/Day 1 | Specific functional antibacterial antibodies were measured by OPKA. GMR for serotypes O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 were reported. |
| Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Days 181 and 195 | Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by OPKA at Days 181 and 195 were reported. |
| OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195 | Days 181 and 195 | Specific functional antibacterial antibodies were measured by OPKA. GMTs for serotypes O1A, O2, O6A and O25B at Days 181 and 195 were reported. |
| Percentage of Participants With Solicited Systemic Adverse Events After Second Vaccination | 14 days after second vaccination (Day 181 to Day 195) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited systemic AEs were precisely defined systemic events that participants were specifically asked about and which were noted by participants in the diary. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever. |
| Percentage of Participants With Unsolicited Adverse Events After Second Vaccination | 29 days after second vaccination (Day 181 to Day 210) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary. |
| Number of Participants With Serious Adverse Events After Second Vaccination | Day 181 until Day 360 | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product. |
| Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15 | Days 1 and 15 | Specific functional antibacterial antibodies were measured by OPKA. GMTs for serotypes O1A, O2, O6A and O25B at Days 1 and 15 were reported. |
| OPKA GMR for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 | Day 15/Day 1 | Specific functional antibacterial antibodies were measured by OPKA. GMR for serotypes O1A, O2, O6A and O25B (Day 15/Day 1) was reported. |
| Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15 | Day 15 | Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by OPKA at Day 15 were reported. |
| ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195 | Days 181 and 195 | IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A, O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Days 181 and 195 were reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ExPEC4V Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181. | 75 |
| Placebo Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181. | 25 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | ExPEC4V | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 55.7 years STANDARD_DEVIATION 18.86 | 56.4 years STANDARD_DEVIATION 17.56 | 55.9 years STANDARD_DEVIATION 18.45 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 69 Participants | 23 Participants | 92 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 2 Participants | 8 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 7 Participants | 2 Participants | 9 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 61 Participants | 21 Participants | 82 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 63 Participants | 22 Participants | 85 Participants |
| Region of Enrollment UNITED STATES | 75 Participants | 25 Participants | 100 Participants |
| Sex: Female, Male Female | 39 Participants | 13 Participants | 52 Participants |
| Sex: Female, Male Male | 36 Participants | 12 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 25 |
| other Total, other adverse events | 54 / 75 | 17 / 25 |
| serious Total, serious adverse events | 2 / 75 | 1 / 25 |
Outcome results
Primary
ELISA Geometric Mean Ratio (GMR) for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1
IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMR for serotypes O1A, O2, O6A and O25B (Day 15/Day 1) was reported.
Time frame: Day 15/Day 1
Population: The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ExPEC4V | ELISA Geometric Mean Ratio (GMR) for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 | Serotype O1A | 5.22 Ratio |
| ExPEC4V | ELISA Geometric Mean Ratio (GMR) for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 | Serotype O2 | 12.06 Ratio |
| ExPEC4V | ELISA Geometric Mean Ratio (GMR) for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 | Serotype O6A | 8.61 Ratio |
| ExPEC4V | ELISA Geometric Mean Ratio (GMR) for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 | Serotype O25B | 12.02 Ratio |
| Placebo | ELISA Geometric Mean Ratio (GMR) for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 | Serotype O25B | 0.87 Ratio |
| Placebo | ELISA Geometric Mean Ratio (GMR) for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 | Serotype O1A | 0.91 Ratio |
| Placebo | ELISA Geometric Mean Ratio (GMR) for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 | Serotype O6A | 0.94 Ratio |
| Placebo | ELISA Geometric Mean Ratio (GMR) for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 | Serotype O2 | 0.89 Ratio |
Primary
ELISA GMTs for Serotypes O1A, O2, O6A and O25B at Day 15
IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Day 15 were reported.
Time frame: Day 15
Population: The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ExPEC4V | ELISA GMTs for Serotypes O1A, O2, O6A and O25B at Day 15 | Serotype O1A | 17030.3 Titer |
| ExPEC4V | ELISA GMTs for Serotypes O1A, O2, O6A and O25B at Day 15 | Serotype O2 | 44704.8 Titer |
| ExPEC4V | ELISA GMTs for Serotypes O1A, O2, O6A and O25B at Day 15 | Serotype O6A | 8206.6 Titer |
| ExPEC4V | ELISA GMTs for Serotypes O1A, O2, O6A and O25B at Day 15 | Serotype O25B | 6132.4 Titer |
| Placebo | ELISA GMTs for Serotypes O1A, O2, O6A and O25B at Day 15 | Serotype O25B | 467.1 Titer |
| Placebo | ELISA GMTs for Serotypes O1A, O2, O6A and O25B at Day 15 | Serotype O1A | 2838.2 Titer |
| Placebo | ELISA GMTs for Serotypes O1A, O2, O6A and O25B at Day 15 | Serotype O6A | 746.2 Titer |
| Placebo | ELISA GMTs for Serotypes O1A, O2, O6A and O25B at Day 15 | Serotype O2 | 3761.6 Titer |
Primary
Enzyme-linked Immunosorbent Assay (ELISA) Geometric Mean Titers (GMTs) for Serotypes O1A, O2, O6A and O25B at Day 1
Immunoglobulin G (IgG) antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Day 1 were reported.
Time frame: Day 1
Population: The per-protocol immunogenicity (PPI) analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ExPEC4V | Enzyme-linked Immunosorbent Assay (ELISA) Geometric Mean Titers (GMTs) for Serotypes O1A, O2, O6A and O25B at Day 1 | Serotype O1A | 3177.8 Titer |
| ExPEC4V | Enzyme-linked Immunosorbent Assay (ELISA) Geometric Mean Titers (GMTs) for Serotypes O1A, O2, O6A and O25B at Day 1 | Serotype O2 | 3598.1 Titer |
| ExPEC4V | Enzyme-linked Immunosorbent Assay (ELISA) Geometric Mean Titers (GMTs) for Serotypes O1A, O2, O6A and O25B at Day 1 | Serotype O6A | 864.6 Titer |
| ExPEC4V | Enzyme-linked Immunosorbent Assay (ELISA) Geometric Mean Titers (GMTs) for Serotypes O1A, O2, O6A and O25B at Day 1 | Serotype O25B | 375.3 Titer |
| Placebo | Enzyme-linked Immunosorbent Assay (ELISA) Geometric Mean Titers (GMTs) for Serotypes O1A, O2, O6A and O25B at Day 1 | Serotype O25B | 550.8 Titer |
| Placebo | Enzyme-linked Immunosorbent Assay (ELISA) Geometric Mean Titers (GMTs) for Serotypes O1A, O2, O6A and O25B at Day 1 | Serotype O1A | 3113.7 Titer |
| Placebo | Enzyme-linked Immunosorbent Assay (ELISA) Geometric Mean Titers (GMTs) for Serotypes O1A, O2, O6A and O25B at Day 1 | Serotype O6A | 817.9 Titer |
| Placebo | Enzyme-linked Immunosorbent Assay (ELISA) Geometric Mean Titers (GMTs) for Serotypes O1A, O2, O6A and O25B at Day 1 | Serotype O2 | 4127.3 Titer |
Primary
Number of Participants With Serious Adverse Events (SAEs) After First Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.
Time frame: Up to Day 180
Population: The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ExPEC4V | Number of Participants With Serious Adverse Events (SAEs) After First Vaccination | 1 Participants |
| Placebo | Number of Participants With Serious Adverse Events (SAEs) After First Vaccination | 1 Participants |
Primary
Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15
Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by ELISA at Day 15 were reported.
Time frame: Day 15
Population: The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15 | Serotype O1A: ELISA 2-fold | 82.2 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15 | Serotype O1A: ELISA 4-fold | 57.5 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15 | Serotype O2: ELISA 2-fold | 91.8 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15 | Serotype O2: ELISA 4-fold | 83.6 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15 | Serotype O6A: ELISA 2-fold | 84.9 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15 | Serotype O6A: ELISA 4-fold | 75.3 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15 | Serotype O25B: ELISA 2-fold | 89.0 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15 | Serotype O25B: ELISA 4-fold | 75.3 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15 | Serotype O25B: ELISA 4-fold | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15 | Serotype O1A: ELISA 2-fold | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15 | Serotype O6A: ELISA 2-fold | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15 | Serotype O1A: ELISA 4-fold | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15 | Serotype O25B: ELISA 2-fold | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15 | Serotype O2: ELISA 2-fold | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15 | Serotype O6A: ELISA 4-fold | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15 | Serotype O2: ELISA 4-fold | 0.0 Percentage of participants |
Primary
Percentage of Participants With Solicited Local Adverse Events (AEs) After First Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited local AEs were precisely defined local events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration.
Time frame: 14 days after first vaccination (Day 1 to Day 15)
Population: The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ExPEC4V | Percentage of Participants With Solicited Local Adverse Events (AEs) After First Vaccination | 38.7 Percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Adverse Events (AEs) After First Vaccination | 20.0 Percentage of participants |
Primary
Percentage of Participants With Solicited Systemic Adverse Events After First Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited systemic AEs were precisely defined systemic events that participants were specifically asked about and which were noted by participants in the diary. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.
Time frame: 14 days after first vaccination (Day 1 to Day 15)
Population: The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ExPEC4V | Percentage of Participants With Solicited Systemic Adverse Events After First Vaccination | 49.3 Percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events After First Vaccination | 20.0 Percentage of participants |
Primary
Percentage of Participants With Unsolicited Adverse Events After First Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.
Time frame: 29 days after first vaccination (Day 1 to Day 30)
Population: The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ExPEC4V | Percentage of Participants With Unsolicited Adverse Events After First Vaccination | 30.7 Percentage of participants |
| Placebo | Percentage of Participants With Unsolicited Adverse Events After First Vaccination | 32.0 Percentage of participants |
Secondary
ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1
IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMR for serotypes O1A, O2, O6A and O25B (Day 181/Day 1 and Day 195/Day 1) was reported.
Time frame: Day 181/Day 1 and Day 195/Day 1
Population: Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ExPEC4V | ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O1A: Day 181/Day 1 | 3.30 Ratio |
| ExPEC4V | ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O1A: Day 195/Day 1 | 4.42 Ratio |
| ExPEC4V | ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O2: Day 181/Day 1 | 7.78 Ratio |
| ExPEC4V | ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O2: Day 195/Day 1 | 9.88 Ratio |
| ExPEC4V | ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O6A: Day 181/Day 1 | 4.85 Ratio |
| ExPEC4V | ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O6A: Day 195/Day 1 | 8.22 Ratio |
| ExPEC4V | ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O25B: Day 181/Day 1 | 4.39 Ratio |
| ExPEC4V | ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O25B: Day 195/Day 1 | 8.51 Ratio |
| Placebo | ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O25B: Day 195/Day 1 | 0.97 Ratio |
| Placebo | ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O1A: Day 181/Day 1 | 1.04 Ratio |
| Placebo | ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O6A: Day 181/Day 1 | 1.20 Ratio |
| Placebo | ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O1A: Day 195/Day 1 | 1.03 Ratio |
| Placebo | ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O25B: Day 181/Day 1 | 0.98 Ratio |
| Placebo | ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O2: Day 181/Day 1 | 1.22 Ratio |
| Placebo | ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O6A: Day 195/Day 1 | 1.22 Ratio |
| Placebo | ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O2: Day 195/Day 1 | 1.20 Ratio |
Secondary
ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195
IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A, O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Days 181 and 195 were reported.
Time frame: Days 181 and 195
Population: Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ExPEC4V | ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195 | Serotype O1A: Day 181 | 10445.0 Titer |
| ExPEC4V | ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195 | Serotype O1A: Day 195 | 14347.1 Titer |
| ExPEC4V | ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195 | Serotype O2: Day 181 | 27748.0 Titer |
| ExPEC4V | ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195 | Serotype O2: Day 195 | 34841.7 Titer |
| ExPEC4V | ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195 | Serotype O6A: Day 181 | 4658.9 Titer |
| ExPEC4V | ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195 | Serotype O6A: Day 195 | 7716.8 Titer |
| ExPEC4V | ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195 | Serotype O25B: Day 181 | 2089.0 Titer |
| ExPEC4V | ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195 | Serotype O25B: Day 195 | 4212.3 Titer |
| Placebo | ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195 | Serotype O25B: Day 195 | 532.1 Titer |
| Placebo | ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195 | Serotype O1A: Day 181 | 3245.8 Titer |
| Placebo | ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195 | Serotype O6A: Day 181 | 1014.4 Titer |
| Placebo | ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195 | Serotype O1A: Day 195 | 3214.6 Titer |
| Placebo | ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195 | Serotype O25B: Day 181 | 541.1 Titer |
| Placebo | ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195 | Serotype O2: Day 181 | 5187.8 Titer |
| Placebo | ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195 | Serotype O6A: Day 195 | 1057.8 Titer |
| Placebo | ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195 | Serotype O2: Day 195 | 5252.6 Titer |
Secondary
Number of Participants With Serious Adverse Events After Second Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.
Time frame: Day 181 until Day 360
Population: The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ExPEC4V | Number of Participants With Serious Adverse Events After Second Vaccination | 1 Participants |
| Placebo | Number of Participants With Serious Adverse Events After Second Vaccination | 0 Participants |
Secondary
OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1
Specific functional antibacterial antibodies were measured by OPKA. GMR for serotypes O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 were reported.
Time frame: Day 181/Day 1 and Day 195/Day 1
Population: Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ExPEC4V | OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O1A: Day 181/Day 1 | 1.77 Ratio |
| ExPEC4V | OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O1A: Day 195/Day 1 | 2.27 Ratio |
| ExPEC4V | OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O2: Day 181/Day 1 | 4.98 Ratio |
| ExPEC4V | OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O2: Day 195/Day 1 | 5.97 Ratio |
| ExPEC4V | OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O6A: Day 181/Day 1 | 1.25 Ratio |
| ExPEC4V | OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O6A: Day 195/Day 1 | 1.77 Ratio |
| ExPEC4V | OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O25B: Day 181/Day 1 | 1.30 Ratio |
| ExPEC4V | OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O25B: Day 195/Day 1 | 1.89 Ratio |
| Placebo | OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O25B: Day 195/Day 1 | 0.95 Ratio |
| Placebo | OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O1A: Day 181/Day 1 | 0.94 Ratio |
| Placebo | OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O6A: Day 181/Day 1 | 0.83 Ratio |
| Placebo | OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O1A: Day 195/Day 1 | 0.93 Ratio |
| Placebo | OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O25B: Day 181/Day 1 | 0.99 Ratio |
| Placebo | OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O2: Day 181/Day 1 | 0.82 Ratio |
| Placebo | OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O6A: Day 195/Day 1 | 0.84 Ratio |
| Placebo | OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 | Serotype O2: Day 195/Day 1 | 0.79 Ratio |
Secondary
OPKA GMR for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1
Specific functional antibacterial antibodies were measured by OPKA. GMR for serotypes O1A, O2, O6A and O25B (Day 15/Day 1) was reported.
Time frame: Day 15/Day 1
Population: The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ExPEC4V | OPKA GMR for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 | Serotype O1A | 3.47 Ratio |
| ExPEC4V | OPKA GMR for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 | Serotype O2 | 10.78 Ratio |
| ExPEC4V | OPKA GMR for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 | Serotype O6A | 2.49 Ratio |
| ExPEC4V | OPKA GMR for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 | Serotype O25B | 2.37 Ratio |
| Placebo | OPKA GMR for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 | Serotype O25B | 0.87 Ratio |
| Placebo | OPKA GMR for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 | Serotype O1A | 0.98 Ratio |
| Placebo | OPKA GMR for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 | Serotype O6A | 1.23 Ratio |
| Placebo | OPKA GMR for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 | Serotype O2 | 0.84 Ratio |
Secondary
OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195
Specific functional antibacterial antibodies were measured by OPKA. GMTs for serotypes O1A, O2, O6A and O25B at Days 181 and 195 were reported.
Time frame: Days 181 and 195
Population: Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ExPEC4V | OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195 | Serotype O1A: Day 181 | 313.9 Titer |
| ExPEC4V | OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195 | Serotype O1A: Day 195 | 431.1 Titer |
| ExPEC4V | OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195 | Serotype O2: Day 181 | 1145.3 Titer |
| ExPEC4V | OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195 | Serotype O2: Day 195 | 1366.2 Titer |
| ExPEC4V | OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195 | Serotype O6A: Day 181 | 372.3 Titer |
| ExPEC4V | OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195 | Serotype O6A: Day 195 | 555.8 Titer |
| ExPEC4V | OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195 | Serotype O25B: Day 181 | 96.6 Titer |
| ExPEC4V | OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195 | Serotype O25B: Day 195 | 145.2 Titer |
| Placebo | OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195 | Serotype O25B: Day 195 | 55.0 Titer |
| Placebo | OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195 | Serotype O1A: Day 181 | 153.1 Titer |
| Placebo | OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195 | Serotype O6A: Day 181 | 324.0 Titer |
| Placebo | OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195 | Serotype O1A: Day 195 | 151.3 Titer |
| Placebo | OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195 | Serotype O25B: Day 181 | 57.3 Titer |
| Placebo | OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195 | Serotype O2: Day 181 | 228.9 Titer |
| Placebo | OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195 | Serotype O6A: Day 195 | 328.0 Titer |
| Placebo | OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195 | Serotype O2: Day 195 | 220.5 Titer |
Secondary
Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15
Specific functional antibacterial antibodies were measured by OPKA. GMTs for serotypes O1A, O2, O6A and O25B at Days 1 and 15 were reported.
Time frame: Days 1 and 15
Population: The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ExPEC4V | Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15 | Serotype O1A: Day 1 | 156.8 Titer |
| ExPEC4V | Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15 | Serotype O1A: Day 15 | 735.6 Titer |
| ExPEC4V | Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15 | Serotype O2: Day 1 | 207.2 Titer |
| ExPEC4V | Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15 | Serotype O2: Day 15 | 2667.3 Titer |
| ExPEC4V | Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15 | Serotype O6A: Day 1 | 304.8 Titer |
| ExPEC4V | Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15 | Serotype O6A: Day 15 | 802.4 Titer |
| ExPEC4V | Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15 | Serotype O25B: Day 1 | 68.8 Titer |
| ExPEC4V | Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15 | Serotype O25B: Day 15 | 188.9 Titer |
| Placebo | Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15 | Serotype O25B: Day 15 | 51.9 Titer |
| Placebo | Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15 | Serotype O1A: Day 1 | 173.0 Titer |
| Placebo | Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15 | Serotype O6A: Day 1 | 380.7 Titer |
| Placebo | Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15 | Serotype O1A: Day 15 | 165.3 Titer |
| Placebo | Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15 | Serotype O25B: Day 1 | 59.3 Titer |
| Placebo | Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15 | Serotype O2: Day 1 | 295.0 Titer |
| Placebo | Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15 | Serotype O6A: Day 15 | 468.5 Titer |
| Placebo | Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15 | Serotype O2: Day 15 | 241.8 Titer |
Secondary
Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195
Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by ELISA at Days 181 and 195 were reported.
Time frame: Days 181 and 195
Population: Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O1A: ELISA 2-fold: Day 181 | 64.2 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O1A: ELISA 2-fold: Day 195 | 81.3 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O1A: ELISA 4-fold: Day 181 | 37.3 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O1A: ELISA 4-fold: Day 195 | 57.8 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O2: ELISA 2-fold: Day 181 | 85.1 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O2: ELISA 2-fold: Day 195 | 95.3 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O2: ELISA 4-fold: Day 181 | 73.1 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O2: ELISA 4-fold: Day 195 | 82.8 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O6A: ELISA 2-fold: Day 181 | 79.1 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O6A: ELISA 2-fold: Day 195 | 95.3 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O6A: ELISA 4-fold: Day 181 | 59.7 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O6A: ELISA 4-fold: Day 195 | 78.1 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O25B: ELISA 2-fold: Day 181 | 65.7 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O25B: ELISA 2-fold: Day 195 | 85.9 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O25B: ELISA 4-fold: Day 181 | 43.3 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O25B: ELISA 4-fold: Day 195 | 67.2 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O25B: ELISA 4-fold: Day 195 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O1A: ELISA 2-fold: Day 181 | 4.2 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O6A: ELISA 2-fold: Day 181 | 8.3 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O1A: ELISA 2-fold: Day 195 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O25B: ELISA 2-fold: Day 181 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O1A: ELISA 4-fold: Day 181 | 0.00 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O6A: ELISA 2-fold: Day 195 | 8.3 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O1A: ELISA 4-fold: Day 195 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O25B: ELISA 4-fold: Day 181 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O2: ELISA 2-fold: Day 181 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O6A: ELISA 4-fold: Day 181 | 4.2 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O2: ELISA 2-fold: Day 195 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O25B: ELISA 2-fold: Day 195 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O2: ELISA 4-fold: Day 181 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O6A: ELISA 4-fold: Day 195 | 4.2 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 | Serotype O2: ELISA 4-fold: Day 195 | 0.0 Percentage of participants |
Secondary
Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15
Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by OPKA at Day 15 were reported.
Time frame: Day 15
Population: The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15 | Serotype O1A: OPKA 2-fold | 64.4 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15 | Serotype O1A: OPKA 4-fold | 41.1 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15 | Serotype O2: OPKA 2-fold | 86.3 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15 | Serotype O2: OPKA 4-fold | 72.6 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15 | Serotype O6A: OPKA 2-fold | 46.6 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15 | Serotype O6A: OPKA 4-fold | 23.3 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15 | Serotype O25B: OPKA 2-fold | 46.6 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15 | Serotype O25B: OPKA 4-fold | 21.9 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15 | Serotype O25B: OPKA 4-fold | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15 | Serotype O1A: OPKA 2-fold | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15 | Serotype O6A: OPKA 2-fold | 8.3 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15 | Serotype O1A: OPKA 4-fold | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15 | Serotype O25B: OPKA 2-fold | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15 | Serotype O2: OPKA 2-fold | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15 | Serotype O6A: OPKA 4-fold | 8.3 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15 | Serotype O2: OPKA 4-fold | 0.0 Percentage of participants |
Secondary
Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195
Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by OPKA at Days 181 and 195 were reported.
Time frame: Days 181 and 195
Population: Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O1A: OPKA 2-fold: Day 181 | 38.8 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O6A: OPKA 2-fold: Day 181 | 20.9 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O2: OPKA 2-fold: Day 181 | 76.1 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O6A: OPKA 2-fold: Day 195 | 34.4 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O1A: OPKA 4-fold: Day 181 | 14.9 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O6A: OPKA 4-fold: Day 181 | 9.0 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O2: OPKA 2-fold: Day 195 | 84.4 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O6A: OPKA 4-fold: Day 195 | 15.6 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O1A: OPKA 2-fold: Day 195 | 54.7 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O25B: OPKA 2-fold: Day 181 | 14.9 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O2: OPKA 4-fold: Day 181 | 58.2 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O25B: OPKA 2-fold: Day 195 | 37.5 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O1A: OPKA 4-fold: Day 195 | 31.3 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O2: OPKA 4-fold: Day 195 | 62.5 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O25B: OPKA 4-fold: Day 195 | 17.2 Percentage of participants |
| ExPEC4V | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O25B: OPKA 4-fold: Day 181 | 4.5 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O25B: OPKA 4-fold: Day 195 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O1A: OPKA 2-fold: Day 181 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O1A: OPKA 2-fold: Day 195 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O1A: OPKA 4-fold: Day 181 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O1A: OPKA 4-fold: Day 195 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O2: OPKA 2-fold: Day 181 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O2: OPKA 2-fold: Day 195 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O2: OPKA 4-fold: Day 181 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O2: OPKA 4-fold: Day 195 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O6A: OPKA 2-fold: Day 181 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O6A: OPKA 2-fold: Day 195 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O6A: OPKA 4-fold: Day 181 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O6A: OPKA 4-fold: Day 195 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O25B: OPKA 2-fold: Day 181 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O25B: OPKA 2-fold: Day 195 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 | Serotype O25B: OPKA 4-fold: Day 181 | 0.0 Percentage of participants |
Secondary
Percentage of Participants With Solicited Local Adverse Events After Second Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited local AEs were precisely defined local events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration.
Time frame: 14 days after second vaccination (Day 181 to Day 195)
Population: The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ExPEC4V | Percentage of Participants With Solicited Local Adverse Events After Second Vaccination | 45.6 Percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Adverse Events After Second Vaccination | 4.2 Percentage of participants |
Secondary
Percentage of Participants With Solicited Systemic Adverse Events After Second Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited systemic AEs were precisely defined systemic events that participants were specifically asked about and which were noted by participants in the diary. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.
Time frame: 14 days after second vaccination (Day 181 to Day 195)
Population: The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ExPEC4V | Percentage of Participants With Solicited Systemic Adverse Events After Second Vaccination | 48.5 Percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events After Second Vaccination | 29.2 Percentage of participants |
Secondary
Percentage of Participants With Unsolicited Adverse Events After Second Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.
Time frame: 29 days after second vaccination (Day 181 to Day 210)
Population: The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ExPEC4V | Percentage of Participants With Unsolicited Adverse Events After Second Vaccination | 11.8 Percentage of participants |
| Placebo | Percentage of Participants With Unsolicited Adverse Events After Second Vaccination | 8.3 Percentage of participants |