Pneumonia
Conditions
Keywords
Vaccine
Brief summary
This study aimed to determine whether PATH-wSP, a vaccine against a germ that causes pneumonia, is safe and induces immune responses in adults and toddlers. The study vaccine was compared to placebo. First adults received 2 injections of a lower dose of the vaccine or placebo, 28 days apart. Since the lower dose was considered safe, a higher dose was tested. Once the safety was established in adults the lower and higher dose was tested in toddlers, starting with the lower dose and then the higher dose.
Detailed description
S. pneumoniae whole cell vaccine (SPWCV) is a vaccine candidate made from whole unencapsulated pneumococcal cells and adsorbed to aluminum hydroxide adjuvant (Alum). After adsorption of the Alum to SPWCV, the vaccine is referred to as PATH-wSP. PATH-wSP has been previously tested in Phase 1/2 studies in healthy US adults (VAC-002), and in healthy Kenyan adults and toddlers (VAC-010) and showed a favorable safety, tolerability, and immunogenicity profile. The SPWCV and Alum used in previous Phase 1/2 trials were supplied separately in a two-vial configuration; the SPWCV was manufactured at Walter Reed Army Institute of Research and the Alum at Instituto Butantan. A single-vial formulation of PATH wSP, an adsorbed suspension of SPWCV and Alum, has now been manufactured by PT Bio Farma, Indonesia. The purpose of this study was to assess the safety and tolerability of this new formulation.
Interventions
BIOLOGICALPATH-wSP
Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide
BIOLOGICALPlacebo
Normal Saline
Sponsors
PATH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults who are 18 to 40 years old, or toddlers who are 12 to 19 months old. * Must provide voluntary written/thumb-printed informed consent * Must comply with study requirements and procedures. * Must have an identifiable place of residence to allow home visits, and a consistent means of telephone contact * Must be resident in the study area with no plans to travel outside the study area during the study * Must be willing to not take herbal or other local traditional medications within 28 days of randomization and during the course of the study * Adult female subjects must have a negative serum pregnancy test at screening and urine pregnancy test prior to each vaccination * Toddlers must have been born full-term, and have a mid-upper arm circumference \> 11.5 cm at the time of enrollment. * Toddlers must have completed their Kenyan infant EPI schedule through 9 months including 1 birth dose of BCG, 3 doses of DTwPHibHep, 3 doses of OPV (birth dose is not required), 3 doses of PCV, and 1 dose of measles vaccine
Exclusion criteria
* Use of any investigational or nonregistered drug within 90 days of enrollment * Use of any potentially hepatotoxic drug * Receipt of any licensed vaccine within 14 days of administration of study vaccine. * Chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, or hematological functional abnormality or major congenital defects or illness that requires medical therapy, based on medical history or clinical assessment * History of anaphylactic shock * History of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines * History of immunosuppression or immunodeficiency, inclusive of human immunodeficiency virus (HIV) infection by medical history (including that of an enrolled toddler's mother) or by HIV testing at screening * Evidence of active hepatitis infection (B or C) by serologic testing at screening. * Any screening laboratory test (chemistry or hematology) or vital sign measurement with toxicity grade ≥ 1 * Acute illness (moderate or severe) and/or fever (axillary temperature ≥ 37.5°C) * Positive test for malaria (blood film) at screening that remains positive post treatment when retested prior to vaccination * Disorders that require chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within the past 6 months prior to the administration of the study vaccine. * Administration of immunoglobulins and/or any blood products within the 6 months preceding enrollment in the study * Known disturbance of coagulation or other blood disorder (e.g., thalassemia, sickle cell disease, thrombocytopenia, disorders of the lymphocytes, severe anemia at birth) in adult subject or in self/first-degree relative of toddler subject; or receipt of anticoagulants in the past three weeks (aspirin as needed and nonsteroidal anti-inflammatory drugs are acceptable) * History of meningitis, seizures or any neurological disorder (all participants) or major psychiatric disorder (adults) * Any medical or social condition that in the opinion of the investigator will interfere with the study objectives or pose a risk to the study subject * An employee (or first-degree relative of employee) of the Sponsor, the CRO, or any investigator or site personnel * Female adult subjects who are pregnant or breast-feeding * Adults with a recent history (within the past year) of alcohol or substance abuse. * Toddlers who have already received a pentavalent booster (following the primary series). * Toddlers with a family history of suspected primary immunodeficiency in first-degree relative. * Toddlers who had a sibling die of likely sudden infant death syndrome (SIDS) or die suddenly and without apparent other cause or preceding illness in the first year of life. * Toddlers with evidence of a clinically significant congenital abnormality as judged by the PI. * Toddlers with evidence of fetal alcohol syndrome or maternal history of alcohol abuse during pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | 112 days | Only treatment-emergent adverse events (TEAEs) were included in the analysis; adverse events (AEs) that were not TEAEs were to have been listed. |
| Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | 7 days after the second dose (Day 35) | Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, headache, axillary fever/temperature, fatigue/malaise, and arthralgia/myalgia. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the principal investigator (PI) for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity. |
| Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | 7 days after the first dose (Day 7) | Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, axillary fever/temperature, drowsiness, irritability, and decreased appetite. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the PI for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity. Grade 0 is equivalent to no event. |
| Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | 7 days after the second dose (Day 35) | Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, axillary fever/temperature, drowsiness, irritability, and decreased appetite. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the PI for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity. Grade 0 is equivalent to no event. |
| Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | 7 days after the first dose (Day 7) | Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, headache, axillary fever/temperature, fatigue/malaise, and arthralgia/myalgia. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the principal investigator (PI) for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity. Grade 0 is equivalent to no event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | Baseline and 12 weeks after vaccination 2 (Day 0 and Day 112) | Between baseline and 28 days after vaccination 2. Proteins were measured on the Meso Scale Discovery (MSD) platform using an an electrochemiluminescence detection assay. |
| Number of Subjects With Immunoglobulin G (IgG) Seroresponse | Baseline and 12 weeks after vaccination 2 (Day 0 and Day 112) | Between baseline and 28 days after vaccination 2. Proteins were measured on the Meso Scale Discovery (MSD) platform using an an electrochemiluminescence detection assay. |
| Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | Baseline and 12 weeks after vaccination 2 (Day 0 and Day 112) | Proteins were measured on the Meso Scale Discovery (MSD) platform using an an electrochemiluminescence detection assay. Units were arbitrary. |
Countries
Kenya
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adult 0.6mg PATH-wSP Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses
PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide | 12 |
| Adult 1.0 mg PATH-wSP Two 1 mg doses of PATH-wSP with a 28 day interval between doses
PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide | 12 |
| Adult Placebo Low Dose Two injections of normal saline with a 28 day interval between injections
Placebo: Normal Saline | 12 |
| Adult Placebo High Dose Two injections of normal saline with a 28 day interval between injections
Placebo: Normal Saline | 12 |
| Toddler 0.6mg PATH-wSP Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses
PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide | 50 |
| Toddler 1.0 mg PATH-wSP Two 1 mg doses of PATH-wSP with a 28 day interval between doses
PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide | 50 |
| Toddler Placebo Low Dose Two injections of normal saline with a 28 day interval between injections
Placebo: Normal Saline | 50 |
| Toddler Placebo High Dose Two injections of normal saline with a 28 day interval between injections
Placebo: Normal Saline | 50 |
| Total | 248 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Had Immunology Data | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Received Vaccination 2 | Adverse Event | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Received Vaccination 2 | Physician Decision | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Received Vaccination 2 | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Adult 1.0 mg PATH-wSP | Total | Toddler Placebo High Dose | Toddler Placebo Low Dose | Toddler 1.0 mg PATH-wSP | Toddler 0.6mg PATH-wSP | Adult 0.6mg PATH-wSP | Adult Placebo High Dose | Adult Placebo Low Dose |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 30.8 years STANDARD_DEVIATION 5.51 | 6.6 years STANDARD_DEVIATION 11.1 | 1.4 years STANDARD_DEVIATION 0.21 | 1.3 years STANDARD_DEVIATION 0.21 | 1.4 years STANDARD_DEVIATION 0.19 | 1.4 years STANDARD_DEVIATION 0.25 | 25.7 years STANDARD_DEVIATION 7.04 | 27.6 years STANDARD_DEVIATION 6.78 | 29.5 years STANDARD_DEVIATION 6.74 |
| Ethnic Group Chonyi | 8 Participants | 197 Participants | 42 Participants | 40 Participants | 45 Participants | 38 Participants | 11 Participants | 7 Participants | 6 Participants |
| Ethnic Group Giriama | 2 Participants | 37 Participants | 5 Participants | 9 Participants | 5 Participants | 9 Participants | 1 Participants | 2 Participants | 4 Participants |
| Ethnic Group Luo | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnic Group Other | 2 Participants | 13 Participants | 3 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 3 Participants | 2 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 | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 248 Participants | 50 Participants | 50 Participants | 50 Participants | 50 Participants | 12 Participants | 12 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 5 Participants | 125 Participants | 24 Participants | 31 Participants | 29 Participants | 23 Participants | 4 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Male | 7 Participants | 123 Participants | 26 Participants | 19 Participants | 21 Participants | 27 Participants | 8 Participants | 8 Participants | 7 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 24 | 0 / 50 | 0 / 50 | 0 / 100 |
| other Total, other adverse events | 9 / 12 | 9 / 12 | 20 / 24 | 45 / 50 | 44 / 50 | 87 / 100 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 24 | 2 / 50 | 1 / 50 | 5 / 100 |
Outcome results
Primary
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1
Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, headache, axillary fever/temperature, fatigue/malaise, and arthralgia/myalgia. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the principal investigator (PI) for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity. Grade 0 is equivalent to no event.
Time frame: 7 days after the first dose (Day 7)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Swelling/Hardness at injection site | Grade 1 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Arthralgia | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Fatigue/Malaise | Grade 2 | 1 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Cutaneous Rash | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Arthralgia | Grade 2 | 1 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Fatigue/Malaise | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Cutaneous Rash | Grade 1 | 1 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Arthralgia | Grade 1 | 1 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Myalgia | Grade 0 | 10 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Cutaneous Rash | Grade 0 | 11 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Arthralgia | Grade 0 | 10 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Myalgia | Grade 1 | 1 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Headache | Grade 0 | 11 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Myalgia | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Myalgia | Grade 2 | 1 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Swelling/Hardness at injection site | Grade 0 | 12 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Headache | Grade 1 | 1 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Swelling/Hardness at injection site | Grade 2 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Pain at Injection Site | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Headache | Grade 2 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Pain at Injection Site | Grade 2 | 1 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Headache | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Cutaneous Rash | Grade 2 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Pain at Injection Site | Grade 1 | 9 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Fatigue/Malaise | Grade 0 | 9 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Swelling/Hardness at injection site | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Pain at Injection Site | Grade 0 | 2 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Fatigue/Malaise | Grade 1 | 2 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Swelling/Hardness at injection site | Grade 0 | 10 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Cutaneous Rash | Grade 0 | 12 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Headache | Grade 0 | 8 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Headache | Grade 2 | 1 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Cutaneous Rash | Grade 1 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Cutaneous Rash | Grade 2 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Cutaneous Rash | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Headache | Grade 1 | 3 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Headache | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Fatigue/Malaise | Grade 0 | 8 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Fatigue/Malaise | Grade 1 | 3 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Fatigue/Malaise | Grade 2 | 1 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Fatigue/Malaise | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Myalgia | Grade 0 | 8 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Myalgia | Grade 1 | 4 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Myalgia | Grade 2 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Myalgia | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Arthralgia | Grade 0 | 9 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Arthralgia | Grade 1 | 2 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Arthralgia | Grade 2 | 1 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Arthralgia | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Pain at Injection Site | Grade 0 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Pain at Injection Site | Grade 1 | 9 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Pain at Injection Site | Grade 2 | 2 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Pain at Injection Site | Grade 3 | 1 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Swelling/Hardness at injection site | Grade 1 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Swelling/Hardness at injection site | Grade 2 | 2 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Swelling/Hardness at injection site | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Arthralgia | Grade 2 | 1 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Fatigue/Malaise | Grade 1 | 2 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Cutaneous Rash | Grade 0 | 22 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Arthralgia | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Fatigue/Malaise | Grade 0 | 21 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Swelling/Hardness at injection site | Grade 1 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Pain at Injection Site | Grade 0 | 17 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Headache | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Cutaneous Rash | Grade 1 | 1 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Pain at Injection Site | Grade 1 | 7 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Headache | Grade 2 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Swelling/Hardness at injection site | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Pain at Injection Site | Grade 2 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Headache | Grade 1 | 5 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Swelling/Hardness at injection site | Grade 2 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Pain at Injection Site | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Myalgia | Grade 2 | 1 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Myalgia | Grade 1 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Headache | Grade 0 | 19 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Myalgia | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Myalgia | Grade 0 | 23 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Cutaneous Rash | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Arthralgia | Grade 0 | 23 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Fatigue/Malaise | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Swelling/Hardness at injection site | Grade 0 | 24 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Arthralgia | Grade 1 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Fatigue/Malaise | Grade 2 | 1 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 | Cutaneous Rash | Grade 2 | 1 Participants |
Primary
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2
Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, headache, axillary fever/temperature, fatigue/malaise, and arthralgia/myalgia. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the principal investigator (PI) for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity.
Time frame: 7 days after the second dose (Day 35)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Headache | Grade 1 | 1 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Pain at Injection Site | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Swelling/Hardness at injection site | Grade 0 | 11 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Swelling/Hardness at injection site | Grade 1 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Cutaneous Rash | Grade 0 | 11 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Cutaneous Rash | Grade 1 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Cutaneous Rash | Grade 2 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Cutaneous Rash | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Headache | Grade 0 | 10 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Swelling/Hardness at injection site | Grade 2 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Swelling/Hardness at injection site | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Temperature | Grade 0 | 10 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Temperature | Grade 1 | 1 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Temperature | Grade 2 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Temperature | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Headache | Grade 2 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Headache | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Fatigue/Malaise | Grade 0 | 9 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Fatigue/Malaise | Grade 1 | 1 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Fatigue/Malaise | Grade 2 | 1 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Fatigue/Malaise | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Myalgia | Grade 0 | 10 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Myalgia | Grade 1 | 1 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Myalgia | Grade 2 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Myalgia | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Arthralgia | Grade 0 | 7 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Arthralgia | Grade 1 | 4 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Arthralgia | Grade 2 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Arthralgia | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Pain at Injection Site | Grade 0 | 4 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Pain at Injection Site | Grade 1 | 7 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Pain at Injection Site | Grade 2 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Pain at Injection Site | Grade 1 | 8 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Temperature | Grade 2 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Pain at Injection Site | Grade 0 | 2 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Pain at Injection Site | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Headache | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Myalgia | Grade 0 | 10 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Swelling/Hardness at injection site | Grade 0 | 10 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Temperature | Grade 0 | 10 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Arthralgia | Grade 1 | 1 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Fatigue/Malaise | Grade 0 | 9 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Cutaneous Rash | Grade 0 | 11 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Arthralgia | Grade 0 | 9 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Myalgia | Grade 1 | 1 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Cutaneous Rash | Grade 1 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Temperature | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Fatigue/Malaise | Grade 1 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Cutaneous Rash | Grade 2 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Temperature | Grade 1 | 1 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Arthralgia | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Cutaneous Rash | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Headache | Grade 2 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Myalgia | Grade 2 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Headache | Grade 0 | 10 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Fatigue/Malaise | Grade 2 | 2 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Pain at Injection Site | Grade 2 | 1 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Headache | Grade 1 | 1 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Swelling/Hardness at injection site | Grade 1 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Myalgia | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Arthralgia | Grade 2 | 1 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Swelling/Hardness at injection site | Grade 2 | 1 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Fatigue/Malaise | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Swelling/Hardness at injection site | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Arthralgia | Grade 3 | 1 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Swelling/Hardness at injection site | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Temperature | Grade 0 | 24 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Myalgia | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Temperature | Grade 1 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Temperature | Grade 2 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Temperature | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Headache | Grade 1 | 5 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Arthralgia | Grade 0 | 22 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Headache | Grade 2 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Headache | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Fatigue/Malaise | Grade 0 | 22 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Arthralgia | Grade 1 | 1 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Fatigue/Malaise | Grade 1 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Pain at Injection Site | Grade 0 | 15 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Fatigue/Malaise | Grade 2 | 1 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Fatigue/Malaise | Grade 3 | 1 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Pain at Injection Site | Grade 2 | 1 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Arthralgia | Grade 2 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Pain at Injection Site | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Swelling/Hardness at injection site | Grade 0 | 24 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Myalgia | Grade 0 | 24 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Pain at Injection Site | Grade 1 | 8 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Cutaneous Rash | Grade 0 | 22 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Cutaneous Rash | Grade 1 | 2 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Myalgia | Grade 1 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Cutaneous Rash | Grade 2 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Cutaneous Rash | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Headache | Grade 0 | 19 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Swelling/Hardness at injection site | Grade 1 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Myalgia | Grade 2 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 | Swelling/Hardness at injection site | Grade 2 | 0 Participants |
Primary
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1
Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, axillary fever/temperature, drowsiness, irritability, and decreased appetite. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the PI for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity. Grade 0 is equivalent to no event.
Time frame: 7 days after the first dose (Day 7)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Irritability | Grade 0 | 42 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Temperature | Grade 0 | 43 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Temperature | Grade 1 | 5 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Temperature | Grade 2 | 2 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Temperature | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Cutaneous Rash | Grade 0 | 46 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Cutaneous Rash | Grade 1 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Cutaneous Rash | Grade 2 | 4 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Cutaneous Rash | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Irritability | Grade 1 | 7 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Irritability | Grade 2 | 1 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Irritability | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Drowsiness | Grade 0 | 50 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Drowsiness | Grade 1 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Drowsiness | Grade 2 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Drowsiness | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Loss of appetite | Grade 0 | 41 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Loss of appetite | Grade 1 | 9 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Loss of appetite | Grade 2 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Loss of appetite | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Tenderness at injection site | Grade 0 | 29 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Tenderness at injection site | Grade 1 | 18 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Tenderness at injection site | Grade 2 | 3 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Tenderness at injection site | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Redness at injection site | Grade 0 | 48 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Redness at injection site | Grade 1 | 2 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Redness at injection site | Grade 2 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Redness at injection site | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Swelling/hardness at injection site | Grade 0 | 46 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Swelling/hardness at injection site | Grade 1 | 4 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Swelling/hardness at injection site | Grade 2 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Swelling/hardness at injection site | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Tenderness at injection site | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Irritability | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Redness at injection site | Grade 1 | 4 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Drowsiness | Grade 0 | 49 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Drowsiness | Grade 1 | 1 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Swelling/hardness at injection site | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Drowsiness | Grade 2 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Redness at injection site | Grade 2 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Drowsiness | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Loss of appetite | Grade 0 | 48 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Swelling/hardness at injection site | Grade 2 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Loss of appetite | Grade 1 | 2 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Redness at injection site | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Loss of appetite | Grade 2 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Loss of appetite | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Tenderness at injection site | Grade 0 | 41 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Swelling/hardness at injection site | Grade 0 | 45 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Tenderness at injection site | Grade 1 | 8 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Temperature | Grade 0 | 47 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Temperature | Grade 1 | 2 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Tenderness at injection site | Grade 2 | 1 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Temperature | Grade 2 | 1 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Temperature | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Cutaneous Rash | Grade 0 | 44 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Cutaneous Rash | Grade 1 | 4 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Cutaneous Rash | Grade 2 | 2 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Swelling/hardness at injection site | Grade 1 | 5 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Cutaneous Rash | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Irritability | Grade 0 | 45 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Redness at injection site | Grade 0 | 46 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Irritability | Grade 1 | 5 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Irritability | Grade 2 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Cutaneous Rash | Grade 1 | 7 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Swelling/hardness at injection site | Grade 1 | 1 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Tenderness at injection site | Grade 1 | 6 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Irritability | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Tenderness at injection site | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Temperature | Grade 0 | 93 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Drowsiness | Grade 0 | 98 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Redness at injection site | Grade 1 | 6 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Swelling/hardness at injection site | Grade 0 | 99 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Drowsiness | Grade 1 | 2 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Redness at injection site | Grade 0 | 94 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Temperature | Grade 1 | 6 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Drowsiness | Grade 2 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Cutaneous Rash | Grade 2 | 2 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Irritability | Grade 0 | 97 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Drowsiness | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Redness at injection site | Grade 2 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Tenderness at injection site | Grade 2 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Loss of appetite | Grade 0 | 95 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Irritability | Grade 1 | 3 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Temperature | Grade 3 | 1 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Loss of appetite | Grade 1 | 5 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Swelling/hardness at injection site | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Cutaneous Rash | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Loss of appetite | Grade 2 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Redness at injection site | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Cutaneous Rash | Grade 0 | 91 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Loss of appetite | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Swelling/hardness at injection site | Grade 2 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Irritability | Grade 2 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Tenderness at injection site | Grade 0 | 94 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 | Temperature | Grade 2 | 0 Participants |
Primary
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2
Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, axillary fever/temperature, drowsiness, irritability, and decreased appetite. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the PI for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity. Grade 0 is equivalent to no event.
Time frame: 7 days after the second dose (Day 35)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Temperature | Grade 0 | 42 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Temperature | Grade 1 | 5 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Temperature | Grade 2 | 3 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Temperature | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Cutaneous Rash | Grade 0 | 45 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Cutaneous Rash | Grade 1 | 4 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Cutaneous Rash | Grade 2 | 1 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Cutaneous Rash | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Irritability | Grade 0 | 30 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Irritability | Grade 1 | 18 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Irritability | Grade 2 | 2 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Irritability | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Drowsiness | Grade 0 | 48 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Drowsiness | Grade 1 | 2 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Drowsiness | Grade 2 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Drowsiness | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Loss of appetite | Grade 0 | 36 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Loss of appetite | Grade 1 | 10 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Loss of appetite | Grade 2 | 4 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Loss of appetite | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Tenderness at injection site | Grade 0 | 30 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Tenderness at injection site | Grade 1 | 13 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Tenderness at injection site | Grade 2 | 6 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Tenderness at injection site | Grade 3 | 1 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Redness at injection site | Grade 0 | 46 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Redness at injection site | Grade 1 | 4 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Redness at injection site | Grade 2 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Redness at injection site | Grade 3 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Swelling/hardness at injection site | Grade 0 | 47 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Swelling/hardness at injection site | Grade 1 | 0 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Swelling/hardness at injection site | Grade 2 | 3 Participants |
| Adult 0.6mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Swelling/hardness at injection site | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Tenderness at injection site | Grade 1 | 12 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Temperature | Grade 0 | 41 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Loss of appetite | Grade 0 | 36 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Drowsiness | Grade 0 | 49 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Temperature | Grade 1 | 6 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Swelling/hardness at injection site | Grade 2 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Loss of appetite | Grade 1 | 14 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Temperature | Grade 2 | 2 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Swelling/hardness at injection site | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Tenderness at injection site | Grade 2 | 2 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Temperature | Grade 3 | 1 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Redness at injection site | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Loss of appetite | Grade 2 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Cutaneous Rash | Grade 0 | 46 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Drowsiness | Grade 2 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Irritability | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Cutaneous Rash | Grade 1 | 4 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Loss of appetite | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Tenderness at injection site | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Cutaneous Rash | Grade 2 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Redness at injection site | Grade 2 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Drowsiness | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Redness at injection site | Grade 1 | 1 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Cutaneous Rash | Grade 3 | 0 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Tenderness at injection site | Grade 0 | 36 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Swelling/hardness at injection site | Grade 1 | 4 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Irritability | Grade 0 | 32 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Drowsiness | Grade 1 | 1 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Redness at injection site | Grade 0 | 49 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Irritability | Grade 1 | 17 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Swelling/hardness at injection site | Grade 0 | 46 Participants |
| Adult 1.0 mg PATH-wSP | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Irritability | Grade 2 | 1 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Redness at injection site | Grade 0 | 97 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Irritability | Grade 2 | 3 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Swelling/hardness at injection site | Grade 1 | 4 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Irritability | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Drowsiness | Grade 0 | 89 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Redness at injection site | Grade 1 | 3 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Drowsiness | Grade 1 | 9 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Drowsiness | Grade 2 | 2 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Drowsiness | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Redness at injection site | Grade 2 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Loss of appetite | Grade 0 | 78 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Loss of appetite | Grade 1 | 20 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Loss of appetite | Grade 2 | 2 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Redness at injection site | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Loss of appetite | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Swelling/hardness at injection site | Grade 2 | 3 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Tenderness at injection site | Grade 0 | 75 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Temperature | Grade 0 | 80 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Tenderness at injection site | Grade 1 | 21 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Temperature | Grade 1 | 11 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Swelling/hardness at injection site | Grade 0 | 93 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Temperature | Grade 2 | 8 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Temperature | Grade 3 | 1 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Tenderness at injection site | Grade 2 | 2 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Cutaneous Rash | Grade 0 | 93 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Swelling/hardness at injection site | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Cutaneous Rash | Grade 1 | 6 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Cutaneous Rash | Grade 2 | 1 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Tenderness at injection site | Grade 3 | 2 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Cutaneous Rash | Grade 3 | 0 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Irritability | Grade 0 | 61 Participants |
| Adult Placebo | Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 | Irritability | Grade 1 | 36 Participants |
Primary
Number of Adverse Events (AE), by Relation to Vaccine and Seriousness
Only treatment-emergent adverse events (TEAEs) were included in the analysis; adverse events (AEs) that were not TEAEs were to have been listed.
Time frame: 112 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult 0.6mg PATH-wSP | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Serious : Related | 0 adverse events |
| Adult 0.6mg PATH-wSP | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Non-serious : Not related | 18 adverse events |
| Adult 0.6mg PATH-wSP | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Non-serious : Related | 0 adverse events |
| Adult 0.6mg PATH-wSP | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Serious : Not related | 0 adverse events |
| Adult 1.0 mg PATH-wSP | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Non-serious : Not related | 21 adverse events |
| Adult 1.0 mg PATH-wSP | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Serious : Not related | 0 adverse events |
| Adult 1.0 mg PATH-wSP | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Serious : Related | 0 adverse events |
| Adult 1.0 mg PATH-wSP | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Non-serious : Related | 0 adverse events |
| Adult Placebo | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Serious : Related | 0 adverse events |
| Adult Placebo | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Non-serious : Related | 0 adverse events |
| Adult Placebo | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Serious : Not related | 0 adverse events |
| Adult Placebo | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Non-serious : Not related | 39 adverse events |
| Adult Placebo High Dose | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Non-serious : Not related | 148 adverse events |
| Adult Placebo High Dose | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Serious : Not related | 3 adverse events |
| Adult Placebo High Dose | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Non-serious : Related | 0 adverse events |
| Adult Placebo High Dose | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Serious : Related | 0 adverse events |
| Toddler 0.6mg PATH-wSP | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Serious : Not related | 2 adverse events |
| Toddler 0.6mg PATH-wSP | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Serious : Related | 0 adverse events |
| Toddler 0.6mg PATH-wSP | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Non-serious : Related | 2 adverse events |
| Toddler 0.6mg PATH-wSP | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Non-serious : Not related | 80 adverse events |
| Toddler 1.0 mg PATH-wSP | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Non-serious : Not related | 253 adverse events |
| Toddler 1.0 mg PATH-wSP | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Serious : Related | 2 adverse events |
| Toddler 1.0 mg PATH-wSP | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Serious : Not related | 3 adverse events |
| Toddler 1.0 mg PATH-wSP | Number of Adverse Events (AE), by Relation to Vaccine and Seriousness | Non-serious : Related | 1 adverse events |
Secondary
Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins
Proteins were measured on the Meso Scale Discovery (MSD) platform using an an electrochemiluminescence detection assay. Units were arbitrary.
Time frame: Baseline and 12 weeks after vaccination 2 (Day 0 and Day 112)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | BCH0785: Post-vaccination 2 | 713.5 arbitrary units |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | BCH0785: Baseline | 593.8 arbitrary units |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PhtD: Post-vaccination 2 | 842.5 arbitrary units |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiaA: Baseline | 1313.4 arbitrary units |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | L460D: Post-vaccination 2 | 1004.1 arbitrary units |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiuA: Post-vaccination 2 | 1001.9 arbitrary units |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiuA: Baseline | 659.7 arbitrary units |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | SPWCV: Post-vaccination 2 | 1042.2 arbitrary units |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PspA-Fam1: Baseline | 1555.7 arbitrary units |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | L460D: Baseline | 642.5 arbitrary units |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | SPWCV: Baseline | 938.2 arbitrary units |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PcpA: Post-vaccination 2 | 1094.6 arbitrary units |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PspA-Fam1: Post-vaccination 2 | 3344.5 arbitrary units |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PcpA: Baseline | 1099.7 arbitrary units |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | StkP: Post-vaccination 2 | 701.1 arbitrary units |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | StkP: Baseline | 524.6 arbitrary units |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PhtD: Baseline | 736.6 arbitrary units |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiaA: Post-vaccination 2 | 1768.8 arbitrary units |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PhtD: Baseline | 942.3 arbitrary units |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | BCH0785: Baseline | 562.3 arbitrary units |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | SPWCV: Baseline | 886.3 arbitrary units |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PhtD: Post-vaccination 2 | 923.3 arbitrary units |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | StkP: Post-vaccination 2 | 1209.4 arbitrary units |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiaA: Baseline | 1462.5 arbitrary units |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PcpA: Post-vaccination 2 | 820.8 arbitrary units |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiuA: Post-vaccination 2 | 1049.7 arbitrary units |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | BCH0785: Post-vaccination 2 | 640.6 arbitrary units |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | L460D: Post-vaccination 2 | 1294.2 arbitrary units |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | L460D: Baseline | 804.6 arbitrary units |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PcpA: Baseline | 967 arbitrary units |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiuA: Baseline | 796.1 arbitrary units |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | StkP: Baseline | 917.6 arbitrary units |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | SPWCV: Post-vaccination 2 | 954.9 arbitrary units |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PspA-Fam1: Post-vaccination 2 | 2684.4 arbitrary units |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiaA: Post-vaccination 2 | 1802.5 arbitrary units |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PspA-Fam1: Baseline | 1342.1 arbitrary units |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PspA-Fam1: Baseline | 2145.3 arbitrary units |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | L460D: Baseline | 614.4 arbitrary units |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | L460D: Post-vaccination 2 | 620.3 arbitrary units |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PspA-Fam1: Post-vaccination 2 | 2071.8 arbitrary units |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PhtD: Baseline | 655.7 arbitrary units |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PhtD: Post-vaccination 2 | 663.8 arbitrary units |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | BCH0785: Baseline | 1214.5 arbitrary units |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | BCH0785: Post-vaccination 2 | 1205 arbitrary units |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | StkP: Baseline | 1270.6 arbitrary units |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | StkP: Post-vaccination 2 | 1329.5 arbitrary units |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PcpA: Baseline | 1240.7 arbitrary units |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PcpA: Post-vaccination 2 | 1259.7 arbitrary units |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | SPWCV: Baseline | 893.5 arbitrary units |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | SPWCV: Post-vaccination 2 | 930.6 arbitrary units |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiuA: Baseline | 1554.8 arbitrary units |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiuA: Post-vaccination 2 | 1540.4 arbitrary units |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiaA: Baseline | 1620.3 arbitrary units |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiaA: Post-vaccination 2 | 1540 arbitrary units |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiaA: Baseline | 1611.4 arbitrary units |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiuA: Post-vaccination 2 | 1214.3 arbitrary units |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiuA: Baseline | 1223.9 arbitrary units |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PhtD: Baseline | 619.5 arbitrary units |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | L460D: Post-vaccination 2 | 943.0 arbitrary units |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | StkP: Baseline | 973.3 arbitrary units |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | StkP: Post-vaccination 2 | 907.7 arbitrary units |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | BCH0785: Post-vaccination 2 | 747.9 arbitrary units |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PspA-Fam1: Post-vaccination 2 | 2588.5 arbitrary units |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PcpA: Baseline | 1053.8 arbitrary units |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PhtD: Post-vaccination 2 | 592 arbitrary units |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | L460D: Baseline | 1022.3 arbitrary units |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PcpA: Post-vaccination 2 | 972.3 arbitrary units |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PspA-Fam1: Baseline | 2837.2 arbitrary units |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | SPWCV: Baseline | 742 arbitrary units |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | BCH0785: Baseline | 790.1 arbitrary units |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiaA: Post-vaccination 2 | 1638.8 arbitrary units |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | SPWCV: Post-vaccination 2 | 698.9 arbitrary units |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PhtD: Post-vaccination 2 | 870.3 arbitrary units |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | L460D: Baseline | 267.7 arbitrary units |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PhtD: Baseline | 671.3 arbitrary units |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | BCH0785: Baseline | 287.4 arbitrary units |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiuA: Post-vaccination 2 | 1091.9 arbitrary units |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | L460D: Post-vaccination 2 | 422.1 arbitrary units |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiaA: Post-vaccination 2 | 743.6 arbitrary units |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PcpA: Post-vaccination 2 | 611.3 arbitrary units |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiuA: Baseline | 811.6 arbitrary units |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PcpA: Baseline | 505.8 arbitrary units |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PspA-Fam1: Baseline | 197 arbitrary units |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | BCH0785: Post-vaccination 2 | 398 arbitrary units |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | SPWCV: Baseline | 495.2 arbitrary units |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | SPWCV: Post-vaccination 2 | 636.8 arbitrary units |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | StkP: Baseline | 192 arbitrary units |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | StkP: Post-vaccination 2 | 346 arbitrary units |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PspA-Fam1: Post-vaccination 2 | 326.2 arbitrary units |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiaA: Baseline | 560.6 arbitrary units |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | SPWCV: Baseline | 544.9 arbitrary units |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PhtD: Baseline | 713.2 arbitrary units |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | StkP: Post-vaccination 2 | 409 arbitrary units |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiuA: Post-vaccination 2 | 1343.2 arbitrary units |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PhtD: Post-vaccination 2 | 1064.5 arbitrary units |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | L460D: Baseline | 326.8 arbitrary units |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PcpA: Baseline | 431.9 arbitrary units |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | BCH0785: Post-vaccination 2 | 627.8 arbitrary units |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PspA-Fam1: Baseline | 358 arbitrary units |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PspA-Fam1: Post-vaccination 2 | 593.8 arbitrary units |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | SPWCV: Post-vaccination 2 | 688.8 arbitrary units |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | L460D: Post-vaccination 2 | 563.6 arbitrary units |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiuA: Baseline | 917.7 arbitrary units |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PcpA: Post-vaccination 2 | 580.6 arbitrary units |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiaA: Post-vaccination 2 | 904.3 arbitrary units |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | BCH0785: Baseline | 389.3 arbitrary units |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | StkP: Baseline | 218.9 arbitrary units |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiaA: Baseline | 662.8 arbitrary units |
| Toddler Placebo Low Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | SPWCV: Post-vaccination 2 | 562.1 arbitrary units |
| Toddler Placebo Low Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | BCH0785: Post-vaccination 2 | 301.8 arbitrary units |
| Toddler Placebo Low Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PspA-Fam1: Post-vaccination 2 | 315.1 arbitrary units |
| Toddler Placebo Low Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiaA: Baseline | 571.4 arbitrary units |
| Toddler Placebo Low Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | StkP: Baseline | 153.6 arbitrary units |
| Toddler Placebo Low Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | StkP: Post-vaccination 2 | 199.1 arbitrary units |
| Toddler Placebo Low Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PcpA: Baseline | 635.4 arbitrary units |
| Toddler Placebo Low Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PspA-Fam1: Baseline | 230.3 arbitrary units |
| Toddler Placebo Low Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PcpA: Post-vaccination 2 | 778.3 arbitrary units |
| Toddler Placebo Low Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | SPWCV: Baseline | 488.3 arbitrary units |
| Toddler Placebo Low Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | L460D: Post-vaccination 2 | 262.3 arbitrary units |
| Toddler Placebo Low Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | BCH0785: Baseline | 237.1 arbitrary units |
| Toddler Placebo Low Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiuA: Baseline | 665.4 arbitrary units |
| Toddler Placebo Low Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiuA: Post-vaccination 2 | 809 arbitrary units |
| Toddler Placebo Low Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | L460D: Baseline | 197.4 arbitrary units |
| Toddler Placebo Low Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiaA: Post-vaccination 2 | 647.6 arbitrary units |
| Toddler Placebo Low Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PhtD: Post-vaccination 2 | 776.3 arbitrary units |
| Toddler Placebo Low Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PhtD: Baseline | 644.1 arbitrary units |
| Toddler Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiaA: Baseline | 626.5 arbitrary units |
| Toddler Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiuA: Post-vaccination 2 | 899 arbitrary units |
| Toddler Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | StkP: Baseline | 197 arbitrary units |
| Toddler Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiaA: Post-vaccination 2 | 640.5 arbitrary units |
| Toddler Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PspA-Fam1: Post-vaccination 2 | 560.4 arbitrary units |
| Toddler Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PhtD: Baseline | 775.8 arbitrary units |
| Toddler Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PcpA: Post-vaccination 2 | 737.5 arbitrary units |
| Toddler Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PcpA: Baseline | 506.1 arbitrary units |
| Toddler Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PspA-Fam1: Baseline | 414.4 arbitrary units |
| Toddler Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | StkP: Post-vaccination 2 | 211.6 arbitrary units |
| Toddler Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | BCH0785: Post-vaccination 2 | 367.4 arbitrary units |
| Toddler Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PhtD: Post-vaccination 2 | 922.7 arbitrary units |
| Toddler Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | BCH0785: Baseline | 346.6 arbitrary units |
| Toddler Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | L460D: Baseline | 330.6 arbitrary units |
| Toddler Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | PiuA: Baseline | 888 arbitrary units |
| Toddler Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | SPWCV: Post-vaccination 2 | 654.5 arbitrary units |
| Toddler Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | L460D: Post-vaccination 2 | 389.6 arbitrary units |
| Toddler Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins | SPWCV: Baseline | 590.8 arbitrary units |
Secondary
Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins
Between baseline and 28 days after vaccination 2. Proteins were measured on the Meso Scale Discovery (MSD) platform using an an electrochemiluminescence detection assay.
Time frame: Baseline and 12 weeks after vaccination 2 (Day 0 and Day 112)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PiuA | 1.52 fold change |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PiaA | 1.35 fold change |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PhtD | 1.14 fold change |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PcpA | 1.00 fold change |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | SPWCV | 1.11 fold change |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | StkP | 1.34 fold change |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PspA-Fam1 | 2.15 fold change |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | L460D | 1.56 fold change |
| Adult 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | BCH0785 | 1.20 fold change |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PiaA | 1.23 fold change |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PcpA | 0.85 fold change |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PspA-Fam1 | 2.00 fold change |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PhtD | 0.98 fold change |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | L460D | 1.61 fold change |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PiuA | 1.32 fold change |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | BCH0785 | 1.14 fold change |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | SPWCV | 1.08 fold change |
| Adult 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | StkP | 1.32 fold change |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PspA-Fam1 | 0.94 fold change |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PcpA | 0.97 fold change |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | BCH0785 | 0.97 fold change |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PiuA | 0.99 fold change |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PiaA | 0.98 fold change |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PhtD | 0.98 fold change |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | SPWCV | 0.99 fold change |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | StkP | 0.99 fold change |
| Adult Placebo | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | L460D | 0.97 fold change |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PcpA | 1.21 fold change |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | L460D | 1.58 fold change |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PspA-Fam1 | 1.66 fold change |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PhtD | 1.30 fold change |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | BCH0785 | 1.38 fold change |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | StkP | 1.80 fold change |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | SPWCV | 1.29 fold change |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PiuA | 1.35 fold change |
| Adult Placebo High Dose | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PiaA | 1.33 fold change |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | StkP | 1.87 fold change |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | BCH0785 | 1.87 fold change |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | SPWCV | 1.26 fold change |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PhtD | 1.49 fold change |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PiaA | 1.36 fold change |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PiuA | 1.46 fold change |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PspA-Fam1 | 1.66 fold change |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | L460D | 1.72 fold change |
| Toddler 0.6mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PcpA | 1.34 fold change |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | L460D | 1.25 fold change |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | BCH0785 | 1.18 fold change |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PcpA | 1.34 fold change |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PiaA | 1.08 fold change |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PiuA | 1.11 fold change |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | SPWCV | 1.12 fold change |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PhtD | 1.20 fold change |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | StkP | 1.18 fold change |
| Toddler 1.0 mg PATH-wSP | Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins | PspA-Fam1 | 1.36 fold change |
Secondary
Number of Subjects With Immunoglobulin G (IgG) Seroresponse
Between baseline and 28 days after vaccination 2. Proteins were measured on the Meso Scale Discovery (MSD) platform using an an electrochemiluminescence detection assay.
Time frame: Baseline and 12 weeks after vaccination 2 (Day 0 and Day 112)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | <2 fold rise | 9 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | Between 3 and 4 fold rise | 0 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | <2 fold rise | 11 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | ≥4 fold rise | 0 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | Between 2 and 3 fold rise | 2 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | Between 2 and 3 fold rise | 1 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | Between 3 and 4 fold rise | 0 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | ≥4 fold rise | 3 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | Between 2 and 3 fold rise | 0 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | Between 3 and 4 fold rise | 0 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | ≥4 fold rise | 0 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | ≥4 fold rise | 0 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | ≥4 fold rise | 0 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | Between 2 and 3 fold rise | 0 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | <2 fold rise | 11 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | Between 3 and 4 fold rise | 0 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | Between 3 and 4 fold rise | 1 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | Between 2 and 3 fold rise | 2 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | Between 2 and 3 fold rise | 0 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | Between 3 and 4 fold rise | 0 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | Between 3 and 4 fold rise | 0 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | <2 fold rise | 9 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | Between 3 and 4 fold rise | 0 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | ≥4 fold rise | 0 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | ≥4 fold rise | 0 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | <2 fold rise | 6 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | ≥4 fold rise | 0 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | Between 2 and 3 fold rise | 0 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | <2 fold rise | 11 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | Between 2 and 3 fold rise | 2 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | <2 fold rise | 9 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | Between 2 and 3 fold rise | 2 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | ≥4 fold rise | 0 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | Between 3 and 4 fold rise | 0 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | <2 fold rise | 11 Participants |
| Adult 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | <2 fold rise | 9 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | <2 fold rise | 9 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | Between 3 and 4 fold rise | 0 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | ≥4 fold rise | 0 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | ≥4 fold rise | 0 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | ≥4 fold rise | 1 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | <2 fold rise | 11 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | Between 3 and 4 fold rise | 0 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | Between 2 and 3 fold rise | 0 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | Between 2 and 3 fold rise | 1 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | Between 2 and 3 fold rise | 0 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | ≥4 fold rise | 0 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | <2 fold rise | 10 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | Between 3 and 4 fold rise | 0 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | ≥4 fold rise | 0 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | ≥4 fold rise | 2 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | Between 2 and 3 fold rise | 0 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | <2 fold rise | 11 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | <2 fold rise | 9 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | Between 3 and 4 fold rise | 0 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | Between 2 and 3 fold rise | 0 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | Between 2 and 3 fold rise | 2 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | Between 3 and 4 fold rise | 0 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | ≥4 fold rise | 0 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | <2 fold rise | 9 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | <2 fold rise | 10 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | Between 3 and 4 fold rise | 2 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | ≥4 fold rise | 0 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | Between 2 and 3 fold rise | 1 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | Between 3 and 4 fold rise | 0 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | Between 3 and 4 fold rise | 0 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | ≥4 fold rise | 0 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | Between 3 and 4 fold rise | 0 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | Between 2 and 3 fold rise | 0 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | <2 fold rise | 10 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | <2 fold rise | 11 Participants |
| Adult 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | Between 2 and 3 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | ≥4 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | <2 fold rise | 24 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | ≥4 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | <2 fold rise | 24 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | <2 fold rise | 24 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | Between 2 and 3 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | ≥4 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | <2 fold rise | 24 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | <2 fold rise | 24 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | ≥4 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | Between 2 and 3 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | Between 2 and 3 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | Between 3 and 4 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | Between 3 and 4 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | ≥4 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | Between 2 and 3 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | <2 fold rise | 24 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | Between 3 and 4 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | <2 fold rise | 24 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | <2 fold rise | 24 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | Between 3 and 4 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | Between 3 and 4 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | Between 2 and 3 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | Between 2 and 3 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | Between 2 and 3 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | Between 2 and 3 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | ≥4 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | ≥4 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | Between 3 and 4 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | Between 3 and 4 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | ≥4 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | <2 fold rise | 24 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | Between 3 and 4 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | Between 3 and 4 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | ≥4 fold rise | 0 Participants |
| Adult Placebo | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | Between 2 and 3 fold rise | 0 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | Between 3 and 4 fold rise | 3 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | <2 fold rise | 34 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | Between 2 and 3 fold rise | 12 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | Between 3 and 4 fold rise | 2 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | ≥4 fold rise | 2 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | <2 fold rise | 31 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | Between 2 and 3 fold rise | 11 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | Between 3 and 4 fold rise | 5 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | ≥4 fold rise | 3 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | ≥4 fold rise | 8 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | <2 fold rise | 37 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | Between 2 and 3 fold rise | 11 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | Between 3 and 4 fold rise | 2 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | ≥4 fold rise | 0 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | <2 fold rise | 36 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | Between 2 and 3 fold rise | 7 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | Between 3 and 4 fold rise | 4 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | ≥4 fold rise | 3 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | <2 fold rise | 25 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | Between 2 and 3 fold rise | 16 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | Between 3 and 4 fold rise | 1 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | <2 fold rise | 44 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | Between 2 and 3 fold rise | 1 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | ≥4 fold rise | 2 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | <2 fold rise | 43 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | Between 2 and 3 fold rise | 6 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | Between 3 and 4 fold rise | 0 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | ≥4 fold rise | 1 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | <2 fold rise | 40 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | Between 2 and 3 fold rise | 6 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | Between 3 and 4 fold rise | 0 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | ≥4 fold rise | 4 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | <2 fold rise | 43 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | Between 2 and 3 fold rise | 3 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | Between 3 and 4 fold rise | 1 Participants |
| Adult Placebo High Dose | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | ≥4 fold rise | 3 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | ≥4 fold rise | 5 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | <2 fold rise | 39 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | Between 2 and 3 fold rise | 2 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | Between 2 and 3 fold rise | 11 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | Between 3 and 4 fold rise | 3 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | <2 fold rise | 33 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | ≥4 fold rise | 4 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | ≥4 fold rise | 2 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | Between 3 and 4 fold rise | 3 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | ≥4 fold rise | 1 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | ≥4 fold rise | 3 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | <2 fold rise | 45 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | Between 3 and 4 fold rise | 4 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | Between 2 and 3 fold rise | 12 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | ≥4 fold rise | 0 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | <2 fold rise | 33 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | <2 fold rise | 38 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | ≥4 fold rise | 6 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | <2 fold rise | 30 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | Between 3 and 4 fold rise | 4 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | ≥4 fold rise | 4 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | <2 fold rise | 37 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | Between 2 and 3 fold rise | 5 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | Between 2 and 3 fold rise | 6 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | Between 2 and 3 fold rise | 7 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | Between 3 and 4 fold rise | 6 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | <2 fold rise | 33 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | <2 fold rise | 27 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | Between 3 and 4 fold rise | 5 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | Between 2 and 3 fold rise | 4 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | Between 3 and 4 fold rise | 1 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | Between 3 and 4 fold rise | 5 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | Between 2 and 3 fold rise | 6 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | Between 3 and 4 fold rise | 1 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | ≥4 fold rise | 4 Participants |
| Toddler 0.6mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | Between 2 and 3 fold rise | 12 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | ≥4 fold rise | 9 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | <2 fold rise | 78 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | Between 3 and 4 fold rise | 6 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | <2 fold rise | 95 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | ≥4 fold rise | 6 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | Between 3 and 4 fold rise | 5 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | Between 2 and 3 fold rise | 3 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | Between 2 and 3 fold rise | 6 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | Between 2 and 3 fold rise | 13 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | Between 3 and 4 fold rise | 0 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | BCH0785 | <2 fold rise | 81 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | SPWCV | ≥4 fold rise | 0 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | ≥4 fold rise | 1 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | Between 3 and 4 fold rise | 2 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | <2 fold rise | 82 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | Between 2 and 3 fold rise | 17 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | Between 3 and 4 fold rise | 4 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | Between 2 and 3 fold rise | 11 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PhtD | <2 fold rise | 78 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | ≥4 fold rise | 18 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | Between 3 and 4 fold rise | 4 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | Between 3 and 4 fold rise | 2 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | <2 fold rise | 78 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiuA | ≥4 fold rise | 1 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | Between 2 and 3 fold rise | 6 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PspA-Fam1 | <2 fold rise | 72 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | <2 fold rise | 89 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | L460D | ≥4 fold rise | 1 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | ≥4 fold rise | 2 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | Between 2 and 3 fold rise | 13 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | <2 fold rise | 69 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | ≥4 fold rise | 2 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PcpA | Between 3 and 4 fold rise | 7 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | Between 3 and 4 fold rise | 3 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | StkP | Between 2 and 3 fold rise | 15 Participants |
| Toddler 1.0 mg PATH-wSP | Number of Subjects With Immunoglobulin G (IgG) Seroresponse | PiaA | Between 2 and 3 fold rise | 3 Participants |