Pneumonia, Pneumococcal
Conditions
Brief summary
The purpose of this study is to assess the safety and tolerability of PATH-wSP, administered intramuscularly to healthy Kenyan adults and toddlers who have been primed with a pneumococcal conjugate vaccine (PCV). Additionally, the study will explore whether a measurable immune response is elicited when PATH-wSP is administered to healthy Kenyan adults and toddlers who have been primed with PCV.
Detailed description
S. pneumoniae whole cell vaccine (SPWCV) is a vaccine candidate made from whole, unencapsulated pneumococcal cells. S. pneumoniae whole cell antigen bulk was manufactured at Walter Reed Army Institute of Research from strain RM200 RX1E PdT ΔlytA and is inactivated with beta-propiolactone. Pneumolysin, a proven virulence factor, was genetically knocked out in SPWCV and replaced with pneumolysoid, a derivative carrying the toxin gene with 3 point mutations known to abolish both cytolytic activity and complement activation. When adsorbed to aluminum hydroxide (alum), SPWCV is utilized as the vaccine candidate Streptococcus pneumoniae whole cell vaccine with aluminum hydroxide adjuvant (PATH-wSP) for clinical investigation. PATH-wSP has been previously tested in adults in a Phase 1 trial in the US, in which doses of 100 to 600 μg were given to healthy young adults in a 3-vaccination series and showed a favorable safety, tolerability, and immunogenicity profile. This study was a dose escalation and age de-escalation study, and sequential cohorts of subjects were identified to allow safety evaluations of dosing and ages to occur progressively during the study. The following PATH-wSP cohorts were defined for adult and toddler subjects: * Adult Cohort 1: 600 μg PATH-wSP or saline * Adult Cohort 2: 1000 μg PATH-wSP or saline * Toddler Cohort 1: 300 μg PATH-wSP and/or active control vaccines * Toddler Cohort 2: 600 μg PATH-wSP and/or active control vaccines.
Interventions
BIOLOGICALPATH-wSP
Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum
BIOLOGICALSynflorix
1 dose (0.5 mL) contains: 1 μg of each of the following pneumococcal polysaccharide serotypes: 1, 5, 6B, 7F, 9V, 14, and 23 F And 3 μg of the following pneumococcal polysaccharide serotypes: 4, 18C and 19F. The serotypes are conjugated to either: protein D (derived from Non-Typeable Haemophilus influenzae) carrier protein, tetanus toxoid carrier protein or diphtheria toxoid carrier protein
BIOLOGICALPentavac
Each PFS contains 0.5 ml (single dose): Diphtheria Toxoid 20 Lf to 30 Lf Tetanus Toxoid 2.5 Lf to 10 Lf B. Pertussis 4 IU HBsAg (rDNA) 10 mcg Purified capsular HIB Polysaccharide (PRP) Conjugated to Tetanus Toxoid (carrier protein) 10 mcg Adsorbed on Aluminium Phosphate, AL+++ 1.25 mg Preservative: Thiomersal 0.005 % Dose: O.5ml by intramuscular injection.
OTHERSaline
0.9% Sodium Chloride Injection, USP
Sponsors
PATH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy young Kenyan adults between 18 to 45 years of age * Willing to provide written informed consent, able to understand comply with study requirements/procedures. * Adult female subjects surgically sterilized or with a negative serum pregnancy test on enrollment and prior to each vaccination. Adult females must be willing to avoid becoming pregnant over the duration of the study, and must agree to employ an effective form of birth control for the duration of the study. * Subjects willing to avoid consumption of herbal medication (including herbal medication taken by a mother, which may transmit to a toddler through breast milk) that could have effects on liver function or bleeding indices during the course of the study. * Healthy toddlers between 12 to 15 months of age who have completed their primary EPI vaccines. * Toddler's parent willing to provide written informed consent for subject, able to understand and comply with study requirements and procedures. * Not premature, had a birth weight of \>2.5 kg, and a weight-to-height Z score of ≥ -2 at the time of enrollment.
Exclusion criteria
* Use of any investigational or nonregistered drug within 90 days prior and during the course of study participation. * History of administration of any vaccine within 30 days prior to administration of study vaccine or planned vaccination during the course of study. * History of anaphylactic shock. * Positive test for malaria (blood film) at time of screening and when retested at Visit 1. * Immunosuppression or immunodeficiency, inclusive of human immunodeficiency virus, by medical history or by testing at screening. * Chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, or hematological functional abnormality or major congenital defects or illness that requires medical therapy, as deemed by medical history or clinical assessment. * Evidence of active hepatitis infection (B or C) by immunologic testing at screening. * 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 or may prevent the subject from completing the study follow-up. * An employee (or first degree relative of employee) of the Sponsor, the Clinical Research Organization, or any investigator or site personnel. * Any screening laboratory test result or vital sign measurement outside normal parameters and deemed by the clinician to be clinically significant, including a positive test for malaria. * Acute illness (moderate or severe) and/or fever (tympanic temperature \>38°C for adults and \>37.5°C for toddlers), or any acute and limited illness requiring medical treatment, including the use of antibiotics and treatment for parasites. * History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines. * Disorders that require chronic administration of 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; or anticipation of such administration during the study period. * Known disturbance of coagulation or other blood disorder in adult subject or in self/first degree relative of toddler subject; or receipt of anticoagulants in the past 3 weeks. * History of meningitis or seizures or any neurological disorder or major psychiatric disorder (adult). * Female subjects who are pregnant or breast-feeding. * Suspicion or recent history of alcohol or substance abuse. * Toddlers with evidence of congenital abnormality or developmental delay. * Toddlers with evidence of fetal alcohol syndrome or history of alcohol abuse in mother during pregnancy. * Toddlers exposed to HIV, born of an HIV infected mother, or who are HIV positive by either antibody or polymerase chain reaction testing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | up to 1 week following first vaccination (Day 7) or second vaccination (Day 35) | Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. |
| Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | up to 1 week following first vaccination (Day 7) or second vaccination (Day 35) | Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe). |
| Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | up to 1 week following first vaccination (Day 7) or second vaccination (Day 35) | Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Grade 2: includes diffuse macular/maculopapular/morbilliform rash |
| Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | up to 1 week following first vaccination (Day 7) or second vaccination (Day 35) | Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe). |
| Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | up to 1 week following first vaccination (Day 7) or second vaccination (Day 35) | Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. |
| Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | up to 1 week following first vaccination (Day 7) or second vaccination (Day 35) | Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe). |
| Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | up to 1 week following first vaccination (Day 7) or second vaccination (Day 35) | Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe). |
| Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination | up to 1 week following first vaccination (Day 7) or second vaccination (Day 35) | Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. |
| Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination | up to 1 week following first vaccination (Day 7) or second vaccination (Day 35) | Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. |
| Number/Percent of Adult Subjects Experiencing Headache Following Vaccination | up to 1 week following first vaccination (Day 7) or second vaccination (Day 35) | Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Grade 2 includes repeated use of non-narcotic pain reliever for more than 24 hours. |
| Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination | up to 1 week following first vaccination (Day 7) or second vaccination (Day 35) | Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Grade 2 includes use of non-narcotic pain reliever for more than 24 hours. |
| Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination | up to 1 week following first vaccination (Day 7) or second vaccination (Day 35) | Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. |
| Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination | up to 1 week following first vaccination (Day 7) or second vaccination (Day 35) | Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Grade 1: does not interfere with activity Grade 2: interferes with activity |
| Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination | up to 1 week following first vaccination (Day 7) or second vaccination (Day 35) | Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | Measured using MSD |
| Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | Measured using ELISA |
| Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | Measured using MSD |
| Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | Measured using MSD |
| Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | Measured using MSD |
| Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | Measured using MSD |
| Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | Measured using MSD |
| Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | Measured using MSD |
| Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | Measured using MSD |
| Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) | 28 days (post-vaccination 1) and 56 days (post-vaccination 2) | Measured using ELISA |
| Fold Change in IgG Response to PspA-Fam1 (ELISA) | 28 days (post-vaccination 1) and 56 days (post-vaccination 2) | Measured using ELISA |
| Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | 28 days (post-vaccination 1) and 56 days (post-vaccination 2) | Measured using MSD |
| Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | 28 days (post-vaccination 1) and 56 days (post-vaccination 2) | Measured using MSD |
| Fold Change in IgG Response to PhtD Pneumococcal Protein | 28 days (post-vaccination 1) and 56 days (post-vaccination 2) | Measured using MSD |
| Fold Change in IgG Response to BCH0785 Pneumococcal Protein | 28 days (post-vaccination 1) and 56 days (post-vaccination 2) | Measured using MSD |
| Fold Change in IgG Response to PcpA Pneumococcal Protein | 28 days (post-vaccination 1) and 56 days (post-vaccination 2) | Measured using MSD |
| Fold Change in IgG Response to SPWCA Pneumococcal Protein | 28 days (post-vaccination 1) and 56 days (post-vaccination 2) | Measured using MSD |
| Fold Change in IgG Response to PiuA Pneumococcal Protein | 28 days (post-vaccination 1) and 56 days (post-vaccination 2) | Measured using MSD |
| Fold Change in IgG Response to PiaA Pneumococcal Protein | 28 days (post-vaccination 1) and 56 days (post-vaccination 2) | Measured using MSD |
| Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | Functional antibody responses to Ply (pneumolysin) were assessed using a toxin neutralization assay based on the ability of antibodies to neutralize wild-type Ply-induced lysis of rabbit red blood cells. Briefly, serial 2-fold dilutions (starting at 1/5 dilution) of human serum samples were added together with wild-type Ply in 96-well plates. Rabbit red blood cells were then added and following incubation supernatants removed and transferred to new 96-well plates and absorbance measured at 540 nm using a spectrophotometer plate reader. The mean A450 nm blank value was subtracted by 10% to obtain the Plate Specific Cut Point for each plate. Each sample was categorized as negative (\<1/20) or positive (with titer between 1/20 and 1/320). |
| Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | Functional antibody responses to Ply (pneumolysin) were assessed using a toxin neutralization assay based on the ability of antibodies to neutralize wild-type Ply-induced lysis of rabbit red blood cells. Briefly, serial 2-fold dilutions (starting at 1/5 dilution) of human serum samples were added together with wild-type Ply in 96-well plates. Rabbit red blood cells were then added and following incubation supernatants removed and transferred to new 96-well plates and absorbance measured at 540 nm using a spectrophotometer plate reader. The mean A450 nm blank value was subtracted by 10% to obtain the Plate Specific Cut Point for each plate. Each sample was categorized as negative (\<1/20) or positive (with titer between 1/20 and 1/320). |
| Fold Change in IgG Response to StkP Pneumococcal Protein | 28 days (post-vaccination 1) and 56 days (post-vaccination 2) | Measured using MSD |
| Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | Measured with enzyme-linked immunosorbent assay (ELISA). |
| Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | Measured with enzyme-linked immunosorbent assay (ELISA). |
| Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | Measured using meso scale discovery (MSD). |
| Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | — |
| Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | Measured using Meso Scale Discovery (MSD) Assay |
| Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | Measured using Meso Scale Discovery (MSD) Assay |
| Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | Measured using Meso Scale Discovery (MSD) Assay |
| Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | Measured using Meso Scale Discovery (MSD) Assay |
| Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | MSD Assay |
| Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | MSD Assay |
| Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | MSD Assay |
| Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | Measured using ELISA |
| Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA | 0 days, 28 days (Dose 1) and 56 days (Dose 2) | Measured using ELISA |
Other
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | 12 weeks (Cohort 1) and 4 weeks (Cohort 2) post-vaccination 1 | GMCs of these IgG proteins were measured to assess potential interference of PATH-wSP with 10-valent pneumococcal conjugate vaccine (Synflorix). GMCs of Cohort 1 were measured at a different time point than those in Cohort 2, so results are presented separately. |
| Geometric Mean Concentration (GMC) Ratio of Tetanus Booster Immune Response Among Toddler Subjects | 12 weeks post vaccination 1 | GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose. |
| Geometric Mean Concentration (GMC) Ratio of Pertussis Fimbriae Immune Response Among Toddler Subjects | 12 weeks post vaccination 1 | GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose. |
| Geometric Mean Concentration (GMC) Ratio of Pertussis FHA and Pertussis Toxin Immune Response Among Toddler Subjects | 12 weeks post vaccination 1 | GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose. |
| Geometric Mean Concentration (GMC) Ratio of Haemophilus Influenzae Type b (Hib) Booster Immune Response Among Toddler Subjects | 12 weeks post vaccination 1 | GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose. |
| Geometric Mean Concentration (GMC) Ratio of Hepatitis B Booster Immune Response Among Toddler Subjects | 12 weeks post vaccination 1 | GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose. |
| Geometric Mean Concentration (GMC) Ratio of Diptheria Booster Immune Response Among Toddler Subjects | 12 weeks post vaccination 1 | GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose. |
Countries
Kenya
Participant flow
Recruitment details
Recruitment period: approximately 12 months Site: Single center at Kenya Medical Research Institute/Walter Reed Project (KEMRI/WRP) Kombewa Clinical Research Center (CRC)
Participants by arm
| Arm | Count |
|---|---|
| Adult Cohort: PATH-wSP (600 mcg) A single injection of 600 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 600 mcg PATH-wSP in the alternate arm. | 18 |
| Adult Cohort: PATH-wSP (1000 mcg) A single injection of 1000 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 1000 mcg PATH-wSP in the alternate arm. | 18 |
| Adult Cohort: Saline A single injection of saline in one arm, followed 4 weeks later by a single injection of saline in the alternate arm. | 18 |
| Toddler Cohort: PATH-wSP (300 mcg)+Active Control A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later. | 50 |
| Toddler Cohort: PATH-wSP (300 mcg)+Saline A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later. | 50 |
| Toddler Cohort: PATH-wSP (600 mcg)+Active Control A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later. | 50 |
| Toddler Cohort: PATH-wSP (600 mcg)+Saline A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later. | 50 |
| Toddler Cohort: Active Control Only A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines in the right thigh. These 3 injections are followed by a single injection of saline in the left thigh 8 weeks later. | 50 |
| Total | 304 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Received Vaccination 2 | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Adult Cohort: PATH-wSP (600 mcg) | Adult Cohort: PATH-wSP (1000 mcg) | Adult Cohort: Saline | Toddler Cohort: PATH-wSP (300 mcg)+Active Control | Toddler Cohort: PATH-wSP (300 mcg)+Saline | Toddler Cohort: PATH-wSP (600 mcg)+Active Control | Toddler Cohort: PATH-wSP (600 mcg)+Saline | Toddler Cohort: Active Control Only | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 26.94 years STANDARD_DEVIATION 5.98 | 28.56 years STANDARD_DEVIATION 8.61 | 30.39 years STANDARD_DEVIATION 7.71 | 1.10 years STANDARD_DEVIATION 0.09 | 1.09 years STANDARD_DEVIATION 0.09 | 1.11 years STANDARD_DEVIATION 0.09 | 1.13 years STANDARD_DEVIATION 0.1 | 1.09 years STANDARD_DEVIATION 0.09 | 5.99 years STANDARD_DEVIATION 11 |
| Region of Enrollment Kenya | 18 Participants | 18 Participants | 18 Participants | 50 Participants | 50 Participants | 50 Participants | 50 Participants | 50 Participants | 304 Participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 7 Participants | 32 Participants | 26 Participants | 23 Participants | 24 Participants | 23 Participants | 148 Participants |
| Sex: Female, Male Male | 10 Participants | 13 Participants | 11 Participants | 18 Participants | 24 Participants | 27 Participants | 26 Participants | 27 Participants | 156 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 | 0 / 18 | 1 / 50 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 18 / 18 | 16 / 18 | 17 / 18 | 50 / 50 | 47 / 50 | 48 / 50 | 48 / 50 | 48 / 50 |
| serious Total, serious adverse events | 1 / 18 | 1 / 18 | 0 / 18 | 6 / 50 | 2 / 50 | 2 / 50 | 3 / 50 | 2 / 50 |
Outcome results
Primary
Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination | Grade 1: no interference with activity | 3 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination | No fatigue/malaise | 15 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination | Grade 2: Some interference with activity | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination | Grade 1: no interference with activity | 3 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination | No fatigue/malaise | 15 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination | Grade 2: Some interference with activity | 0 Participants |
| Saline: Vaccination 1 | Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination | Grade 1: no interference with activity | 0 Participants |
| Saline: Vaccination 1 | Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination | No fatigue/malaise | 18 Participants |
| Saline: Vaccination 1 | Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination | Grade 2: Some interference with activity | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination | Grade 1: no interference with activity | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination | No fatigue/malaise | 16 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination | Grade 2: Some interference with activity | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination | Grade 1: no interference with activity | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination | No fatigue/malaise | 13 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination | Grade 2: Some interference with activity | 3 Participants |
| Saline: Vaccination 2 | Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination | No fatigue/malaise | 15 Participants |
| Saline: Vaccination 2 | Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination | Grade 2: Some interference with activity | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination | Grade 1: no interference with activity | 3 Participants |
Primary
Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination | No fever | 18 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination | Grade 3: ≥39.0 to ≤40.0 degrees Celsius | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination | No fever | 18 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination | Grade 3: ≥39.0 to ≤40.0 degrees Celsius | 0 Participants |
| Saline: Vaccination 1 | Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination | No fever | 18 Participants |
| Saline: Vaccination 1 | Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination | Grade 3: ≥39.0 to ≤40.0 degrees Celsius | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination | No fever | 18 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination | Grade 3: ≥39.0 to ≤40.0 degrees Celsius | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination | No fever | 17 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination | Grade 3: ≥39.0 to ≤40.0 degrees Celsius | 1 Participants |
| Saline: Vaccination 2 | Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination | No fever | 18 Participants |
| Saline: Vaccination 2 | Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination | Grade 3: ≥39.0 to ≤40.0 degrees Celsius | 0 Participants |
Primary
Number/Percent of Adult Subjects Experiencing Headache Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Grade 2 includes repeated use of non-narcotic pain reliever for more than 24 hours.
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Headache Following Vaccination | Grade 1: no interference with activity | 1 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Headache Following Vaccination | No headache | 16 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Headache Following Vaccination | Grade 2: Some interference with activity | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Headache Following Vaccination | Grade 1: no interference with activity | 6 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Headache Following Vaccination | No headache | 12 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Headache Following Vaccination | Grade 2: Some interference with activity | 0 Participants |
| Saline: Vaccination 1 | Number/Percent of Adult Subjects Experiencing Headache Following Vaccination | Grade 1: no interference with activity | 5 Participants |
| Saline: Vaccination 1 | Number/Percent of Adult Subjects Experiencing Headache Following Vaccination | No headache | 13 Participants |
| Saline: Vaccination 1 | Number/Percent of Adult Subjects Experiencing Headache Following Vaccination | Grade 2: Some interference with activity | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Headache Following Vaccination | Grade 1: no interference with activity | 3 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Headache Following Vaccination | No headache | 15 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Headache Following Vaccination | Grade 2: Some interference with activity | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Headache Following Vaccination | Grade 1: no interference with activity | 6 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Headache Following Vaccination | No headache | 11 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Headache Following Vaccination | Grade 2: Some interference with activity | 1 Participants |
| Saline: Vaccination 2 | Number/Percent of Adult Subjects Experiencing Headache Following Vaccination | No headache | 12 Participants |
| Saline: Vaccination 2 | Number/Percent of Adult Subjects Experiencing Headache Following Vaccination | Grade 2: Some interference with activity | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Adult Subjects Experiencing Headache Following Vaccination | Grade 1: no interference with activity | 6 Participants |
Primary
Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Grade 1: does not interfere with activity Grade 2: interferes with activity
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination | Grade 1: 2.5-5cm | 4 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination | No induration/swelling | 13 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination | Grade 2: 5.1-10cm | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination | Grade 1: 2.5-5cm | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination | No induration/swelling | 17 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination | Grade 2: 5.1-10cm | 0 Participants |
| Saline: Vaccination 1 | Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination | Grade 1: 2.5-5cm | 1 Participants |
| Saline: Vaccination 1 | Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination | No induration/swelling | 17 Participants |
| Saline: Vaccination 1 | Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination | Grade 2: 5.1-10cm | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination | Grade 1: 2.5-5cm | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination | No induration/swelling | 18 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination | Grade 2: 5.1-10cm | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination | Grade 1: 2.5-5cm | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination | No induration/swelling | 16 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination | Grade 2: 5.1-10cm | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination | No induration/swelling | 18 Participants |
| Saline: Vaccination 2 | Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination | Grade 2: 5.1-10cm | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination | Grade 1: 2.5-5cm | 0 Participants |
Primary
Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination | Grade 1: no interference with activity | 6 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination | No myalgia | 11 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination | Grade 2: Some interference with activity | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination | Grade 1: no interference with activity | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination | No myalgia | 16 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination | Grade 2: Some interference with activity | 1 Participants |
| Saline: Vaccination 1 | Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination | Grade 1: no interference with activity | 1 Participants |
| Saline: Vaccination 1 | Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination | No myalgia | 17 Participants |
| Saline: Vaccination 1 | Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination | Grade 2: Some interference with activity | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination | Grade 1: no interference with activity | 3 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination | No myalgia | 15 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination | Grade 2: Some interference with activity | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination | Grade 1: no interference with activity | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination | No myalgia | 16 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination | Grade 2: Some interference with activity | 1 Participants |
| Saline: Vaccination 2 | Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination | No myalgia | 15 Participants |
| Saline: Vaccination 2 | Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination | Grade 2: Some interference with activity | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination | Grade 1: no interference with activity | 3 Participants |
Primary
Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Grade 2 includes use of non-narcotic pain reliever for more than 24 hours.
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination | Grade 1: no interference with activity | 11 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination | No pain at injection site | 4 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination | Grade 2: Some interference limiting limb use | 3 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination | Grade 1: no interference with activity | 13 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination | No pain at injection site | 3 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination | Grade 2: Some interference limiting limb use | 2 Participants |
| Saline: Vaccination 1 | Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination | Grade 1: no interference with activity | 4 Participants |
| Saline: Vaccination 1 | Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination | No pain at injection site | 14 Participants |
| Saline: Vaccination 1 | Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination | Grade 2: Some interference limiting limb use | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination | Grade 1: no interference with activity | 8 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination | No pain at injection site | 9 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination | Grade 2: Some interference limiting limb use | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination | Grade 1: no interference with activity | 11 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination | No pain at injection site | 5 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination | Grade 2: Some interference limiting limb use | 2 Participants |
| Saline: Vaccination 2 | Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination | No pain at injection site | 16 Participants |
| Saline: Vaccination 2 | Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination | Grade 2: Some interference limiting limb use | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination | Grade 1: no interference with activity | 2 Participants |
Primary
Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination | Grade 1: no interference with activity | 12 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination | No tenderness | 3 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination | Grade 2: pain limiting limb use | 3 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination | Grade 1: no interference with activity | 12 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination | No tenderness | 4 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination | Grade 2: pain limiting limb use | 2 Participants |
| Saline: Vaccination 1 | Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination | Grade 1: no interference with activity | 7 Participants |
| Saline: Vaccination 1 | Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination | No tenderness | 11 Participants |
| Saline: Vaccination 1 | Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination | Grade 2: pain limiting limb use | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination | Grade 1: no interference with activity | 10 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination | No tenderness | 7 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination | Grade 2: pain limiting limb use | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination | Grade 1: no interference with activity | 8 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination | No tenderness | 7 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination | Grade 2: pain limiting limb use | 3 Participants |
| Saline: Vaccination 2 | Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination | No tenderness | 16 Participants |
| Saline: Vaccination 2 | Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination | Grade 2: pain limiting limb use | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination | Grade 1: no interference with activity | 2 Participants |
Primary
Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Grade 2: includes diffuse macular/maculopapular/morbilliform rash
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | No cutaneous rash | 41 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | Grade 2: Diffuse rash or target lesions | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | Grade 1: localized macular rash | 7 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | Grade 2: Diffuse rash or target lesions | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | Grade 1: localized macular rash | 4 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | No cutaneous rash | 44 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | Grade 2: Diffuse rash or target lesions | 2 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | No cutaneous rash | 43 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | Grade 1: localized macular rash | 5 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | No cutaneous rash | 39 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | Grade 1: localized macular rash | 6 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | Grade 2: Diffuse rash or target lesions | 5 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | Grade 1: localized macular rash | 8 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | No cutaneous rash | 40 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | Grade 2: Diffuse rash or target lesions | 2 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | Grade 1: localized macular rash | 9 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | No cutaneous rash | 83 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | Grade 2: Diffuse rash or target lesions | 3 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | Grade 1: localized macular rash | 16 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | No cutaneous rash | 72 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | Grade 2: Diffuse rash or target lesions | 6 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | No cutaneous rash | 38 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | Grade 1: localized macular rash | 7 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination | Grade 2: Diffuse rash or target lesions | 3 Participants |
Primary
Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | No drowsiness | 48 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | Grade 2: interferes with normal activity | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | Grade 1: drowsiness easily tolerated | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | Grade 2: interferes with normal activity | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | Grade 1: drowsiness easily tolerated | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | No drowsiness | 49 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | Grade 2: interferes with normal activity | 1 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | No drowsiness | 47 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | Grade 1: drowsiness easily tolerated | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | No drowsiness | 50 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | Grade 1: drowsiness easily tolerated | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | Grade 2: interferes with normal activity | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | Grade 1: drowsiness easily tolerated | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | No drowsiness | 50 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | Grade 2: interferes with normal activity | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | Grade 1: drowsiness easily tolerated | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | No drowsiness | 95 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | Grade 2: interferes with normal activity | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | Grade 1: drowsiness easily tolerated | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | No drowsiness | 94 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | Grade 2: interferes with normal activity | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | No drowsiness | 47 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | Grade 1: drowsiness easily tolerated | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination | Grade 2: interferes with normal activity | 1 Participants |
Primary
Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | No fever | 26 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 4: >40.0 deg. Celsius | 1 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 3: ≥39.1 to ≤40.0 deg. Celsius | 3 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 2: ≥38.1 to ≤39.0 deg. Celsius | 9 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 1: ≥37.5 to ≤38.0 deg. Celsius | 11 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 1: ≥37.5 to ≤38.0 deg. Celsius | 6 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 3: ≥39.1 to ≤40.0 deg. Celsius | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 4: >40.0 deg. Celsius | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 2: ≥38.1 to ≤39.0 deg. Celsius | 3 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | No fever | 40 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 1: ≥37.5 to ≤38.0 deg. Celsius | 13 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 4: >40.0 deg. Celsius | 0 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | No fever | 31 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 3: ≥39.1 to ≤40.0 deg. Celsius | 3 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 2: ≥38.1 to ≤39.0 deg. Celsius | 3 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 2: ≥38.1 to ≤39.0 deg. Celsius | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 4: >40.0 deg. Celsius | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | No fever | 42 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 1: ≥37.5 to ≤38.0 deg. Celsius | 4 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 3: ≥39.1 to ≤40.0 deg. Celsius | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 2: ≥38.1 to ≤39.0 deg. Celsius | 3 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | No fever | 37 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 1: ≥37.5 to ≤38.0 deg. Celsius | 9 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 3: ≥39.1 to ≤40.0 deg. Celsius | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 4: >40.0 deg. Celsius | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 2: ≥38.1 to ≤39.0 deg. Celsius | 2 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 3: ≥39.1 to ≤40.0 deg. Celsius | 1 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 1: ≥37.5 to ≤38.0 deg. Celsius | 5 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | No fever | 87 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 4: >40.0 deg. Celsius | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 2: ≥38.1 to ≤39.0 deg. Celsius | 5 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | No fever | 78 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 1: ≥37.5 to ≤38.0 deg. Celsius | 11 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 4: >40.0 deg. Celsius | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 3: ≥39.1 to ≤40.0 deg. Celsius | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 4: >40.0 deg. Celsius | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 3: ≥39.1 to ≤40.0 deg. Celsius | 2 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | No fever | 42 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 2: ≥38.1 to ≤39.0 deg. Celsius | 2 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination | Grade 1: ≥37.5 to ≤38.0 deg. Celsius | 2 Participants |
Primary
Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | No induration/swelling | 93 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | G2: Induration OR edema ≥2.5cm but <50% surface ar | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | Grade 1: Induration or edema <2.5cm | 5 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | G2: Induration OR edema ≥2.5cm but <50% surface ar | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | Grade 1: Induration or edema <2.5cm | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | No induration/swelling | 98 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | G2: Induration OR edema ≥2.5cm but <50% surface ar | 1 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | No induration/swelling | 45 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | Grade 1: Induration or edema <2.5cm | 4 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | No induration/swelling | 48 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | Grade 1: Induration or edema <2.5cm | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | G2: Induration OR edema ≥2.5cm but <50% surface ar | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | Grade 1: Induration or edema <2.5cm | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | No induration/swelling | 49 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | G2: Induration OR edema ≥2.5cm but <50% surface ar | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | Grade 1: Induration or edema <2.5cm | 2 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | No induration/swelling | 93 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | G2: Induration OR edema ≥2.5cm but <50% surface ar | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | Grade 1: Induration or edema <2.5cm | 5 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | No induration/swelling | 89 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | G2: Induration OR edema ≥2.5cm but <50% surface ar | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | No induration/swelling | 47 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | Grade 1: Induration or edema <2.5cm | 1 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination | G2: Induration OR edema ≥2.5cm but <50% surface ar | 0 Participants |
Primary
Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | No irritability | 31 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | Grade 2: crying>usual/interferes w/normal activity | 3 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | Grade 1: crying >usual/normal activity | 16 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | Grade 2: crying>usual/interferes w/normal activity | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | Grade 1: crying >usual/normal activity | 4 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | No irritability | 46 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | Grade 2: crying>usual/interferes w/normal activity | 5 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | No irritability | 36 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | Grade 1: crying >usual/normal activity | 9 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | No irritability | 49 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | Grade 1: crying >usual/normal activity | 1 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | Grade 2: crying>usual/interferes w/normal activity | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | Grade 1: crying >usual/normal activity | 9 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | No irritability | 40 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | Grade 2: crying>usual/interferes w/normal activity | 1 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | Grade 1: crying >usual/normal activity | 4 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | No irritability | 90 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | Grade 2: crying>usual/interferes w/normal activity | 1 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | Grade 1: crying >usual/normal activity | 5 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | No irritability | 89 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | Grade 2: crying>usual/interferes w/normal activity | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | No irritability | 47 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | Grade 1: crying >usual/normal activity | 1 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination | Grade 2: crying>usual/interferes w/normal activity | 0 Participants |
Primary
Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | No loss of appetite | 32 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | Grade 1: eating <usual/normal activity | 17 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | Gr. 2: eating <usual/interferes w/ normal activity | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | Grade 1: eating <usual/normal activity | 7 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | No loss of appetite | 42 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | Gr. 2: eating <usual/interferes w/ normal activity | 1 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | Grade 1: eating <usual/normal activity | 19 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | Gr. 2: eating <usual/interferes w/ normal activity | 1 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | No loss of appetite | 30 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | No loss of appetite | 47 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | Gr. 2: eating <usual/interferes w/ normal activity | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | Grade 1: eating <usual/normal activity | 3 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | Gr. 2: eating <usual/interferes w/ normal activity | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | No loss of appetite | 31 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | Grade 1: eating <usual/normal activity | 19 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | No loss of appetite | 85 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | Gr. 2: eating <usual/interferes w/ normal activity | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | Grade 1: eating <usual/normal activity | 10 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | No loss of appetite | 88 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | Grade 1: eating <usual/normal activity | 6 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | Gr. 2: eating <usual/interferes w/ normal activity | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | Gr. 2: eating <usual/interferes w/ normal activity | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | No loss of appetite | 45 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination | Grade 1: eating <usual/normal activity | 3 Participants |
Primary
Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | No pain/tenderness at injection site | 33 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | Grade 2: cries/protests to touch | 6 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | Grade 1: minor reactions to touch | 61 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | Grade 2: cries/protests to touch | 5 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | Grade 1: minor reactions to touch | 52 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | No pain/tenderness at injection site | 43 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | Grade 2: cries/protests to touch | 1 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | No pain/tenderness at injection site | 17 Participants |
| Saline: Vaccination 1 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | Grade 1: minor reactions to touch | 32 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | No pain/tenderness at injection site | 21 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | Grade 1: minor reactions to touch | 28 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | Grade 2: cries/protests to touch | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | Grade 1: minor reactions to touch | 30 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | No pain/tenderness at injection site | 20 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | Grade 2: cries/protests to touch | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | Grade 1: minor reactions to touch | 22 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | No pain/tenderness at injection site | 72 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | Grade 2: cries/protests to touch | 1 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | Grade 1: minor reactions to touch | 13 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | No pain/tenderness at injection site | 81 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | Grade 2: cries/protests to touch | 0 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | No pain/tenderness at injection site | 42 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | Grade 1: minor reactions to touch | 6 Participants |
| Saline: Vaccination 2 | Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination | Grade 2: cries/protests to touch | 0 Participants |
Secondary
Fold Change in IgG Response to BCH0785 Pneumococcal Protein
Measured using MSD
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | <2-Fold | 36 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥2-Fold, <3-Fold | 9 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥3-Fold, <4-Fold | 1 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥4-Fold | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥2-Fold, <3-Fold | 11 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | <2-Fold | 35 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥4-Fold | 3 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥3-Fold, <4-Fold | 0 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥2-Fold, <3-Fold | 8 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | <2-Fold | 35 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥3-Fold, <4-Fold | 0 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥4-Fold | 5 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | <2-Fold | 36 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥2-Fold, <3-Fold | 6 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥3-Fold, <4-Fold | 4 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥4-Fold | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥3-Fold, <4-Fold | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥2-Fold, <3-Fold | 4 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥4-Fold | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | <2-Fold | 42 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥3-Fold, <4-Fold | 5 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥2-Fold, <3-Fold | 7 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | <2-Fold | 31 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥4-Fold | 3 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥2-Fold, <3-Fold | 8 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥3-Fold, <4-Fold | 6 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥4-Fold | 6 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | <2-Fold | 27 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | <2-Fold | 26 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥4-Fold | 6 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥2-Fold, <3-Fold | 14 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥3-Fold, <4-Fold | 2 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥4-Fold | 8 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | <2-Fold | 20 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥3-Fold, <4-Fold | 1 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥2-Fold, <3-Fold | 17 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥3-Fold, <4-Fold | 1 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | <2-Fold | 32 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥4-Fold | 4 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to BCH0785 Pneumococcal Protein | ≥2-Fold, <3-Fold | 11 Participants |
Secondary
Fold Change in IgG Response to L460D Pneumococcal Protein (MSD)
Measured using MSD
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | <2-Fold | 37 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥2-Fold, <3-Fold | 8 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥4-Fold | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥3-Fold, <4-Fold | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥2-Fold, <3-Fold | 9 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | <2-Fold | 31 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥4-Fold | 3 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥3-Fold, <4-Fold | 4 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥2-Fold, <3-Fold | 4 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | <2-Fold | 43 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥4-Fold | 0 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥3-Fold, <4-Fold | 1 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | <2-Fold | 26 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥2-Fold, <3-Fold | 13 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥3-Fold, <4-Fold | 3 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥4-Fold | 5 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥3-Fold, <4-Fold | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥2-Fold, <3-Fold | 5 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥4-Fold | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | <2-Fold | 39 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | <2-Fold | 23 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥2-Fold, <3-Fold | 18 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥3-Fold, <4-Fold | 0 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥4-Fold | 5 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥2-Fold, <3-Fold | 14 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥3-Fold, <4-Fold | 4 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | <2-Fold | 23 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥4-Fold | 6 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥3-Fold, <4-Fold | 3 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥4-Fold | 9 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥2-Fold, <3-Fold | 18 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | <2-Fold | 18 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥3-Fold, <4-Fold | 6 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥2-Fold, <3-Fold | 22 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | <2-Fold | 6 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥4-Fold | 12 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | <2-Fold | 38 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥3-Fold, <4-Fold | 1 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥4-Fold | 1 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to L460D Pneumococcal Protein (MSD) | ≥2-Fold, <3-Fold | 8 Participants |
Secondary
Fold Change in IgG Response to PcpA Pneumococcal Protein
Measured using MSD
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PcpA Pneumococcal Protein | <2-Fold | 37 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥2-Fold, <3-Fold | 7 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥3-Fold, <4-Fold | 1 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥4-Fold | 3 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥2-Fold, <3-Fold | 3 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PcpA Pneumococcal Protein | <2-Fold | 42 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥4-Fold | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥3-Fold, <4-Fold | 3 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥2-Fold, <3-Fold | 4 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PcpA Pneumococcal Protein | <2-Fold | 40 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥3-Fold, <4-Fold | 0 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥4-Fold | 4 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | <2-Fold | 39 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥2-Fold, <3-Fold | 5 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥3-Fold, <4-Fold | 1 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥4-Fold | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥3-Fold, <4-Fold | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥2-Fold, <3-Fold | 10 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥4-Fold | 6 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | <2-Fold | 33 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥3-Fold, <4-Fold | 2 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥2-Fold, <3-Fold | 9 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | <2-Fold | 30 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥4-Fold | 5 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥2-Fold, <3-Fold | 7 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥3-Fold, <4-Fold | 3 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥4-Fold | 5 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | <2-Fold | 32 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | <2-Fold | 35 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥4-Fold | 3 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥2-Fold, <3-Fold | 7 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥3-Fold, <4-Fold | 3 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥4-Fold | 8 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | <2-Fold | 26 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥3-Fold, <4-Fold | 3 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥2-Fold, <3-Fold | 9 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥3-Fold, <4-Fold | 1 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | <2-Fold | 23 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥4-Fold | 9 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PcpA Pneumococcal Protein | ≥2-Fold, <3-Fold | 15 Participants |
Secondary
Fold Change in IgG Response to PhtD Pneumococcal Protein
Measured using MSD
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PhtD Pneumococcal Protein | <2-Fold | 37 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥2-Fold, <3-Fold | 8 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥3-Fold, <4-Fold | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥4-Fold | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥2-Fold, <3-Fold | 7 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PhtD Pneumococcal Protein | <2-Fold | 39 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥4-Fold | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥3-Fold, <4-Fold | 2 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥2-Fold, <3-Fold | 3 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PhtD Pneumococcal Protein | <2-Fold | 43 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥3-Fold, <4-Fold | 0 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥4-Fold | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | <2-Fold | 34 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥2-Fold, <3-Fold | 7 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥3-Fold, <4-Fold | 5 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥4-Fold | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥3-Fold, <4-Fold | 3 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥2-Fold, <3-Fold | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥4-Fold | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | <2-Fold | 42 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥3-Fold, <4-Fold | 6 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥2-Fold, <3-Fold | 18 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | <2-Fold | 20 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥4-Fold | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥2-Fold, <3-Fold | 18 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥3-Fold, <4-Fold | 1 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥4-Fold | 8 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | <2-Fold | 20 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | <2-Fold | 22 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥4-Fold | 7 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥2-Fold, <3-Fold | 15 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥3-Fold, <4-Fold | 4 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥4-Fold | 8 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | <2-Fold | 20 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥3-Fold, <4-Fold | 3 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥2-Fold, <3-Fold | 15 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥3-Fold, <4-Fold | 4 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | <2-Fold | 26 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥4-Fold | 3 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PhtD Pneumococcal Protein | ≥2-Fold, <3-Fold | 15 Participants |
Secondary
Fold Change in IgG Response to PiaA Pneumococcal Protein
Measured using MSD
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥2-Fold, <3-Fold | 7 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥4-Fold | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥3-Fold, <4-Fold | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PiaA Pneumococcal Protein | <2-Fold | 39 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥3-Fold, <4-Fold | 3 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PiaA Pneumococcal Protein | <2-Fold | 36 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥4-Fold | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥2-Fold, <3-Fold | 8 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥4-Fold | 1 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PiaA Pneumococcal Protein | <2-Fold | 39 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥2-Fold, <3-Fold | 6 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥3-Fold, <4-Fold | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥2-Fold, <3-Fold | 8 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥3-Fold, <4-Fold | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥4-Fold | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | <2-Fold | 35 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥3-Fold, <4-Fold | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥4-Fold | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥2-Fold, <3-Fold | 4 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | <2-Fold | 41 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥4-Fold | 5 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥3-Fold, <4-Fold | 4 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥2-Fold, <3-Fold | 12 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | <2-Fold | 25 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥4-Fold | 6 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | <2-Fold | 25 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥2-Fold, <3-Fold | 12 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥3-Fold, <4-Fold | 4 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥3-Fold, <4-Fold | 2 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥2-Fold, <3-Fold | 18 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | <2-Fold | 22 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥4-Fold | 6 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥2-Fold, <3-Fold | 13 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | <2-Fold | 24 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥3-Fold, <4-Fold | 4 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥4-Fold | 5 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | <2-Fold | 32 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥2-Fold, <3-Fold | 8 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥4-Fold | 5 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PiaA Pneumococcal Protein | ≥3-Fold, <4-Fold | 3 Participants |
Secondary
Fold Change in IgG Response to PiuA Pneumococcal Protein
Measured using MSD
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PiuA Pneumococcal Protein | <2-Fold | 39 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥2-Fold, <3-Fold | 5 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥3-Fold, <4-Fold | 3 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥4-Fold | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥2-Fold, <3-Fold | 7 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PiuA Pneumococcal Protein | <2-Fold | 35 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥4-Fold | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥3-Fold, <4-Fold | 5 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥2-Fold, <3-Fold | 6 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PiuA Pneumococcal Protein | <2-Fold | 37 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥3-Fold, <4-Fold | 2 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥4-Fold | 3 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | <2-Fold | 37 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥2-Fold, <3-Fold | 9 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥3-Fold, <4-Fold | 1 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥4-Fold | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥3-Fold, <4-Fold | 3 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥2-Fold, <3-Fold | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥4-Fold | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | <2-Fold | 46 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥3-Fold, <4-Fold | 3 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥2-Fold, <3-Fold | 11 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | <2-Fold | 30 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥4-Fold | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥2-Fold, <3-Fold | 14 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥3-Fold, <4-Fold | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥4-Fold | 4 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | <2-Fold | 27 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | <2-Fold | 23 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥4-Fold | 7 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥2-Fold, <3-Fold | 18 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥3-Fold, <4-Fold | 0 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥4-Fold | 6 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | <2-Fold | 24 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥3-Fold, <4-Fold | 2 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥2-Fold, <3-Fold | 14 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥3-Fold, <4-Fold | 2 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | <2-Fold | 39 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥4-Fold | 2 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PiuA Pneumococcal Protein | ≥2-Fold, <3-Fold | 5 Participants |
Secondary
Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA)
Measured using ELISA
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) | <2-Fold | 28 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) | ≥2-Fold | 18 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) | <2-Fold | 23 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) | ≥2-Fold | 24 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) | <2-Fold | 32 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) | ≥2-Fold | 16 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) | <2-Fold | 16 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) | ≥2-Fold | 31 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) | ≥2-Fold | 12 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) | <2-Fold | 36 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) | ≥2-Fold | 28 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) | <2-Fold | 18 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) | ≥2-Fold | 33 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) | <2-Fold | 14 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) | <2-Fold | 20 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) | ≥2-Fold | 28 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) | <2-Fold | 14 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) | ≥2-Fold | 31 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) | <2-Fold | 34 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA) | ≥2-Fold | 14 Participants |
Secondary
Fold Change in IgG Response to PspA-Fam1 (ELISA)
Measured using ELISA
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PspA-Fam1 (ELISA) | <2-Fold | 36 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PspA-Fam1 (ELISA) | ≥2-Fold | 10 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PspA-Fam1 (ELISA) | <2-Fold | 29 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PspA-Fam1 (ELISA) | ≥2-Fold | 18 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PspA-Fam1 (ELISA) | <2-Fold | 42 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PspA-Fam1 (ELISA) | ≥2-Fold | 6 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 (ELISA) | <2-Fold | 29 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 (ELISA) | ≥2-Fold | 18 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 (ELISA) | ≥2-Fold | 4 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 (ELISA) | <2-Fold | 44 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 (ELISA) | ≥2-Fold | 16 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 (ELISA) | <2-Fold | 30 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 (ELISA) | ≥2-Fold | 19 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 (ELISA) | <2-Fold | 28 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 (ELISA) | <2-Fold | 31 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 (ELISA) | ≥2-Fold | 17 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 (ELISA) | <2-Fold | 25 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 (ELISA) | ≥2-Fold | 21 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 (ELISA) | <2-Fold | 34 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 (ELISA) | ≥2-Fold | 14 Participants |
Secondary
Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD)
Measured using MSD
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | <2-Fold | 29 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥2-Fold, <3-Fold | 12 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥3-Fold, <4-Fold | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥4-Fold | 5 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥2-Fold, <3-Fold | 11 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | <2-Fold | 26 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥4-Fold | 5 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥3-Fold, <4-Fold | 7 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥2-Fold, <3-Fold | 8 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | <2-Fold | 35 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥3-Fold, <4-Fold | 1 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥4-Fold | 4 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | <2-Fold | 18 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥2-Fold, <3-Fold | 15 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥3-Fold, <4-Fold | 5 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥4-Fold | 9 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥3-Fold, <4-Fold | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥2-Fold, <3-Fold | 6 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥4-Fold | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | <2-Fold | 40 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥3-Fold, <4-Fold | 5 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥2-Fold, <3-Fold | 16 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | <2-Fold | 16 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥4-Fold | 9 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥2-Fold, <3-Fold | 21 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥3-Fold, <4-Fold | 1 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥4-Fold | 9 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | <2-Fold | 16 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | <2-Fold | 20 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥4-Fold | 9 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥2-Fold, <3-Fold | 15 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥3-Fold, <4-Fold | 4 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥4-Fold | 16 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | <2-Fold | 4 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥3-Fold, <4-Fold | 5 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥2-Fold, <3-Fold | 21 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥3-Fold, <4-Fold | 3 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | <2-Fold | 30 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥4-Fold | 4 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD) | ≥2-Fold, <3-Fold | 11 Participants |
Secondary
Fold Change in IgG Response to SPWCA Pneumococcal Protein
Measured using MSD
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | <2-Fold | 45 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥2-Fold, <3-Fold | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥3-Fold, <4-Fold | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥4-Fold | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥2-Fold, <3-Fold | 6 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | <2-Fold | 42 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥4-Fold | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥3-Fold, <4-Fold | 1 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥2-Fold, <3-Fold | 4 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | <2-Fold | 42 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥3-Fold, <4-Fold | 0 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥4-Fold | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | <2-Fold | 45 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥2-Fold, <3-Fold | 1 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥3-Fold, <4-Fold | 1 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥4-Fold | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥3-Fold, <4-Fold | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥2-Fold, <3-Fold | 4 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥4-Fold | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | <2-Fold | 44 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥3-Fold, <4-Fold | 1 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥2-Fold, <3-Fold | 6 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | <2-Fold | 38 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥4-Fold | 1 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥2-Fold, <3-Fold | 6 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥3-Fold, <4-Fold | 1 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥4-Fold | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | <2-Fold | 40 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | <2-Fold | 36 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥4-Fold | 1 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥2-Fold, <3-Fold | 10 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥3-Fold, <4-Fold | 1 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥4-Fold | 3 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | <2-Fold | 31 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥3-Fold, <4-Fold | 0 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥2-Fold, <3-Fold | 12 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥3-Fold, <4-Fold | 0 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | <2-Fold | 41 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥4-Fold | 1 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to SPWCA Pneumococcal Protein | ≥2-Fold, <3-Fold | 6 Participants |
Secondary
Fold Change in IgG Response to StkP Pneumococcal Protein
Measured using MSD
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to StkP Pneumococcal Protein | <2-Fold | 38 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥2-Fold, <3-Fold | 6 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥3-Fold, <4-Fold | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥4-Fold | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥2-Fold, <3-Fold | 9 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to StkP Pneumococcal Protein | <2-Fold | 35 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥4-Fold | 5 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥3-Fold, <4-Fold | 0 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥2-Fold, <3-Fold | 4 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to StkP Pneumococcal Protein | <2-Fold | 42 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥3-Fold, <4-Fold | 0 Participants |
| Saline: Vaccination 1 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥4-Fold | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | <2-Fold | 38 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥2-Fold, <3-Fold | 7 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥3-Fold, <4-Fold | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥4-Fold | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥3-Fold, <4-Fold | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥2-Fold, <3-Fold | 6 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥4-Fold | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | <2-Fold | 41 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥3-Fold, <4-Fold | 3 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥2-Fold, <3-Fold | 16 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | <2-Fold | 22 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥4-Fold | 5 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥2-Fold, <3-Fold | 15 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥3-Fold, <4-Fold | 4 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥4-Fold | 7 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | <2-Fold | 21 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | <2-Fold | 22 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥4-Fold | 8 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥2-Fold, <3-Fold | 18 Participants |
| Saline: Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥3-Fold, <4-Fold | 0 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥4-Fold | 4 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | <2-Fold | 24 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥3-Fold, <4-Fold | 4 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥2-Fold, <3-Fold | 14 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥3-Fold, <4-Fold | 2 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | <2-Fold | 35 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥4-Fold | 2 Participants |
| Active Control Only: Vaccination 2 | Fold Change in IgG Response to StkP Pneumococcal Protein | ≥2-Fold, <3-Fold | 9 Participants |
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein
Measured using Meso Scale Discovery (MSD) Assay
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Population: The number analyzed may differ between periods because of insufficient samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Baseline | 1566.50 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 2 | 1808.37 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 1 | 1665.26 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 2 | 1713.83 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 1 | 1367.52 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Baseline | 1145.05 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 2 | 1340.75 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Baseline | 1236.11 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 1 | 1224.22 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Baseline | 400.58 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 1 | 504.49 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 2 | 561.60 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 1 | 364.39 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Baseline | 271.66 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 2 | 480.18 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 1 | 373.57 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Baseline | 281.66 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 2 | 470.01 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 1 | 526.34 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Baseline | 372.53 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 2 | 716.82 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Baseline | 288.13 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 1 | 328.03 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 2 | 394.37 titer |
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein
Measured using meso scale discovery (MSD).
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Population: Insufficient sample
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Baseline | 861.27 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Post-vaccination 2 | 1391.66 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Post-vaccination 1 | 1127.59 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Post-vaccination 2 | 1410.11 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Post-vaccination 1 | 998.09 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Baseline | 820.92 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Post-vaccination 2 | 963.25 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Baseline | 908.51 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Post-vaccination 1 | 886.15 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Baseline | 263.85 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Post-vaccination 1 | 329.38 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Post-vaccination 2 | 462.54 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Post-vaccination 1 | 328.35 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Baseline | 210.15 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Post-vaccination 2 | 408.40 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Post-vaccination 1 | 386.92 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Baseline | 309.74 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Post-vaccination 2 | 631.63 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Post-vaccination 1 | 602.20 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Baseline | 331.08 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Post-vaccination 2 | 803.61 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Baseline | 216.45 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Post-vaccination 1 | 247.77 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein | Post-vaccination 2 | 279.43 titer |
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein
Measured using Meso Scale Discovery (MSD) Assay
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Population: The number analyzed may differ between periods because of insufficient samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Baseline | 1677.20 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 2 | 1497.72 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 1 | 1523.84 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 2 | 950.83 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 1 | 904.99 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Baseline | 1016.49 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 2 | 1728.30 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Baseline | 1436.97 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 1 | 1461.34 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Baseline | 316.39 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 1 | 354.49 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 2 | 375.72 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 1 | 327.75 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Baseline | 350.52 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 2 | 342.08 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 1 | 473.66 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Baseline | 355.69 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 2 | 441.77 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 1 | 344.10 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Baseline | 356.24 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 2 | 434.85 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Baseline | 254.77 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 1 | 297.33 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 2 | 392.99 titer |
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein
Measured using Meso Scale Discovery (MSD) Assay
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Population: The number analyzed may differ between periods because of insufficient samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Baseline | 841.63 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 2 | 890.67 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 1 | 839.14 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 2 | 982.10 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 1 | 868.55 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Baseline | 784.56 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 2 | 872.62 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Baseline | 775.26 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 1 | 775.29 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Baseline | 426.11 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 1 | 563.55 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 2 | 804.59 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 1 | 491.70 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Baseline | 403.13 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 2 | 704.46 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 1 | 577.47 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Baseline | 466.20 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 2 | 767.31 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 1 | 654.21 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Baseline | 497.28 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 2 | 1074.36 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Baseline | 434.86 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 1 | 513.83 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 2 | 679.80 titer |
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein
MSD Assay
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Population: The number analyzed may differ between periods because of insufficient samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Baseline | 1933.77 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 2 | 2471.44 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 1 | 2299.24 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 2 | 2875.72 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 1 | 2396.09 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Baseline | 2027.06 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 2 | 2218.47 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Baseline | 1897.23 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 1 | 1853.17 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Baseline | 650.98 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 1 | 759.91 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 2 | 926.53 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 1 | 622.89 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Baseline | 503.78 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 2 | 833.02 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 1 | 721.16 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Baseline | 609.28 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 2 | 880.18 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 1 | 1197.63 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Baseline | 892.24 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 2 | 1493.50 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Baseline | 542.93 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 1 | 602.56 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 2 | 750.60 titer |
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein
MSD Assay
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Population: The number analyzed may differ between periods because of insufficient samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Baseline | 1401.11 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 2 | 1582.79 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 1 | 1471.39 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 2 | 1898.28 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 1 | 1668.22 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Baseline | 1524.31 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 2 | 1769.43 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Baseline | 1625.92 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 1 | 1603.96 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Baseline | 677.28 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 1 | 837.32 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 2 | 937.83 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 1 | 732.41 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Baseline | 575.24 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 2 | 815.05 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 1 | 702.78 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Baseline | 556.30 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 2 | 961.01 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 1 | 860.69 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Baseline | 679.07 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 2 | 1108.83 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Baseline | 601.79 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 1 | 671.40 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 2 | 763.13 titer |
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay
Measured with enzyme-linked immunosorbent assay (ELISA).
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Baseline | 2083.27 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Post-vaccination 2 | 3752.62 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Post-vaccination 1 | 2619.99 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Post-vaccination 2 | 2933.71 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Post-vaccination 1 | 2394.59 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Baseline | 1569.91 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Post-vaccination 2 | 1961.47 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Baseline | 1998.33 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Post-vaccination 1 | 1945.09 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Baseline | 400.00 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Post-vaccination 1 | 516.79 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Post-vaccination 2 | 800.00 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Post-vaccination 1 | 506.45 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Baseline | 311.30 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Post-vaccination 2 | 732.25 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Post-vaccination 1 | 897.97 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Baseline | 755.10 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Post-vaccination 2 | 1510.20 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Post-vaccination 1 | 1647.90 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Baseline | 848.61 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Post-vaccination 2 | 2211.06 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Baseline | 455.52 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Post-vaccination 1 | 489.62 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay | Post-vaccination 2 | 526.28 titer |
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay
Measured with enzyme-linked immunosorbent assay (ELISA).
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Baseline | 1899.32 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Post-vaccination 2 | 3192.07 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Post-vaccination 1 | 2425.50 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Post-vaccination 2 | 3901.23 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Post-vaccination 1 | 3083.33 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Baseline | 2042.68 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Post-vaccination 2 | 2031.31 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Baseline | 1793.44 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Post-vaccination 1 | 1922.47 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Baseline | 410.23 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Post-vaccination 1 | 565.40 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Post-vaccination 2 | 724.42 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Post-vaccination 1 | 557.07 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Baseline | 361.41 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Post-vaccination 2 | 541.73 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Post-vaccination 1 | 637.63 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Baseline | 550.02 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Post-vaccination 2 | 889.48 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Post-vaccination 1 | 1126.67 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Baseline | 674.04 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Post-vaccination 2 | 1264.22 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Baseline | 456.64 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Post-vaccination 1 | 417.09 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay | Post-vaccination 2 | 487.03 titer |
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Population: The number analyzed may differ between periods because of insufficient samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Baseline | 2124.32 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Post-vaccination 2 | 3469.35 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Post-vaccination 1 | 3149.80 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Post-vaccination 2 | 4607.95 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Post-vaccination 1 | 3442.17 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Baseline | 2129.61 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Post-vaccination 2 | 2323.41 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Baseline | 2049.33 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Post-vaccination 1 | 2105.22 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Baseline | 175.80 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Post-vaccination 1 | 283.38 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Post-vaccination 2 | 367.01 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Post-vaccination 1 | 294.98 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Baseline | 174.35 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Post-vaccination 2 | 338.19 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Post-vaccination 1 | 272.19 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Baseline | 202.89 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Post-vaccination 2 | 371.56 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Post-vaccination 1 | 420.45 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Baseline | 217.24 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Post-vaccination 2 | 518.77 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Baseline | 177.29 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Post-vaccination 1 | 167.21 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay | Post-vaccination 2 | 186.84 titer |
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein
MSD Assay
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Population: The number analyzed may differ between periods because of insufficient samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Baseline | 1707.99 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 2 | 1709.46 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 1 | 1660.20 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 2 | 1685.31 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 1 | 1359.27 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Baseline | 1398.09 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 2 | 1493.37 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Baseline | 1321.49 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 1 | 1263.81 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Baseline | 664.34 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 1 | 778.54 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 2 | 844.62 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 1 | 717.62 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Baseline | 632.54 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 2 | 764.02 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 1 | 728.65 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Baseline | 615.81 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 2 | 820.14 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 1 | 771.90 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Baseline | 665.59 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 2 | 939.58 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Baseline | 652.61 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 1 | 682.37 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 2 | 765.74 titer |
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein
Measured using Meso Scale Discovery (MSD) Assay
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Population: The number analyzed may differ between periods because of insufficient samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Baseline | 1406.04 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 2 | 1753.89 titer |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 1 | 1632.87 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 2 | 1620.05 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 1 | 1311.45 titer |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Baseline | 1140.55 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 2 | 1430.78 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Baseline | 1263.61 titer |
| Saline: Vaccination 1 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 1 | 1308.29 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Baseline | 204.58 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 1 | 278.64 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 2 | 351.25 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 1 | 164.27 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Baseline | 130.62 titer |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 2 | 230.51 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 1 | 187.67 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Baseline | 157.58 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 2 | 273.84 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 1 | 295.14 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Baseline | 229.15 titer |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 2 | 396.24 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Baseline | 161.89 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 1 | 180.93 titer |
| Saline: Vaccination 2 | Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 2 | 217.32 titer |
Secondary
Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein
Measured using MSD
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Population: The number analyzed may differ between periods because of insufficient samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 1 | 1.26 fold change |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 2 | 1.36 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 1 | 1.30 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 2 | 1.70 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 1 | 1.33 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 2 | 1.67 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 2 | 1.93 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 1 | 1.41 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 1 | 1.14 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein | Post-vaccination 2 | 1.31 fold change |
Secondary
Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein
Measured using MSD
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Population: The number analyzed may differ between periods because of insufficient samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 1 | 1.12 fold change |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 2 | 1.17 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 1 | 0.95 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 2 | 1.07 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 1 | 1.33 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 2 | 1.24 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 2 | 1.17 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 1 | 0.97 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 1 | 1.17 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein | Post-vaccination 2 | 1.43 fold change |
Secondary
Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein
Measured using MSD
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Population: The number analyzed may differ between periods because of insufficient samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 1 | 1.32 fold change |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 2 | 1.79 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 1 | 1.25 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 2 | 1.90 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 1 | 1.24 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 2 | 1.65 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 2 | 2.10 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 1 | 1.32 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 1 | 1.18 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein | Post-vaccination 2 | 1.60 fold change |
Secondary
Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein
Measured using MSD
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Population: The number analyzed may differ between periods because of insufficient samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 1 | 1.17 fold change |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 2 | 1.40 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 1 | 1.23 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 2 | 1.69 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 1 | 1.18 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 2 | 1.44 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 2 | 1.66 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 1 | 1.34 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 1 | 1.11 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein | Post-vaccination 2 | 1.34 fold change |
Secondary
Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein
Measured using MSD
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Population: The number analyzed may differ between periods because of insufficient samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 1 | 1.24 fold change |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 2 | 1.35 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 1 | 1.26 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 2 | 1.45 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 1 | 1.26 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 2 | 1.73 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 2 | 1.64 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 1 | 1.27 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 1 | 1.12 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein | Post-vaccination 2 | 1.24 fold change |
Secondary
Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA
Measured using ELISA
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Population: The number analyzed may differ between periods because of insufficient samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA | Post-vaccination 1 | 1.29 fold change |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA | Post-vaccination 2 | 2.00 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA | Post-vaccination 1 | 1.63 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA | Post-vaccination 2 | 2.35 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA | Post-vaccination 1 | 1.19 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA | Post-vaccination 2 | 2.00 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA | Post-vaccination 2 | 2.48 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA | Post-vaccination 1 | 1.94 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA | Post-vaccination 1 | 1.07 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA | Post-vaccination 2 | 1.16 fold change |
Secondary
Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD
Measured using MSD
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Population: The number analyzed may differ between periods because of insufficient samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD | Post-vaccination 1 | 1.25 fold change |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD | Post-vaccination 2 | 1.72 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD | Post-vaccination 1 | 1.56 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD | Post-vaccination 2 | 1.96 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD | Post-vaccination 1 | 1.25 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD | Post-vaccination 2 | 2.04 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD | Post-vaccination 2 | 2.40 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD | Post-vaccination 1 | 1.82 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD | Post-vaccination 1 | 1.14 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD | Post-vaccination 2 | 1.28 fold change |
Secondary
Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA
Measured using ELISA
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Population: The number analyzed may differ between periods because of insufficient samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA | Post-vaccination 1 | 1.38 fold change |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA | Post-vaccination 2 | 1.77 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA | Post-vaccination 1 | 1.54 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA | Post-vaccination 2 | 1.50 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA | Post-vaccination 1 | 1.16 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA | Post-vaccination 2 | 1.62 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA | Post-vaccination 2 | 1.83 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA | Post-vaccination 1 | 1.67 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA | Post-vaccination 1 | 0.91 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA | Post-vaccination 2 | 1.07 fold change |
Secondary
Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD
Measured using ELISA
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Population: The number analyzed may differ between periods because of insufficient samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD | Post-vaccination 1 | 1.61 fold change |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD | Post-vaccination 2 | 2.09 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD | Post-vaccination 1 | 1.74 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD | Post-vaccination 2 | 1.97 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD | Post-vaccination 1 | 1.34 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD | Post-vaccination 2 | 1.83 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD | Post-vaccination 2 | 2.38 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD | Post-vaccination 1 | 1.94 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD | Post-vaccination 1 | 0.94 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD | Post-vaccination 2 | 1.03 fold change |
Secondary
Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein
Measured using MSD
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Population: The number analyzed may differ between periods because of insufficient samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 1 | 1.17 fold change |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 2 | 1.26 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 1 | 1.14 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 2 | 1.23 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 1 | 1.18 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 2 | 1.33 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 2 | 1.43 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 1 | 1.16 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 1 | 1.05 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein | Post-vaccination 2 | 1.17 fold change |
Secondary
Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein
Measured using MSD
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Population: The number analyzed may differ between periods because of insufficient samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 1 | 1.36 fold change |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 2 | 1.69 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 1 | 1.26 fold change |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 2 | 1.79 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 1 | 1.19 fold change |
| Saline: Vaccination 1 | Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 2 | 1.74 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 2 | 1.67 fold change |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 1 | 1.29 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 1 | 1.12 fold change |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein | Post-vaccination 2 | 1.29 fold change |
Secondary
Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin
Functional antibody responses to Ply (pneumolysin) were assessed using a toxin neutralization assay based on the ability of antibodies to neutralize wild-type Ply-induced lysis of rabbit red blood cells. Briefly, serial 2-fold dilutions (starting at 1/5 dilution) of human serum samples were added together with wild-type Ply in 96-well plates. Rabbit red blood cells were then added and following incubation supernatants removed and transferred to new 96-well plates and absorbance measured at 540 nm using a spectrophotometer plate reader. The mean A450 nm blank value was subtracted by 10% to obtain the Plate Specific Cut Point for each plate. Each sample was categorized as negative (\<1/20) or positive (with titer between 1/20 and 1/320).
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 5 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 3 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 7 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 3 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 4 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 5 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 5 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 3 Participants |
| Saline: Vaccination 1 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 4 Participants |
| Saline: Vaccination 1 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 2 Participants |
| Saline: Vaccination 1 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 3 Participants |
| Saline: Vaccination 1 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 2 Participants |
| Saline: Vaccination 1 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 6 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 5 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 7 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 5 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 3 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 8 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 5 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 0 Participants |
| Saline: Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 3 Participants |
| Saline: Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 3 Participants |
| Saline: Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 8 Participants |
| Saline: Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 4 Participants |
| Saline: Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 5 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 10 Participants |
| Saline: Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 7 Participants |
| Saline: Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 7 Participants |
| Saline: Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 0 Participants |
| Saline: Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 3 Participants |
| Saline: Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 0 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 0 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 0 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 7 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 6 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 4 Participants |
Secondary
Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin
Functional antibody responses to Ply (pneumolysin) were assessed using a toxin neutralization assay based on the ability of antibodies to neutralize wild-type Ply-induced lysis of rabbit red blood cells. Briefly, serial 2-fold dilutions (starting at 1/5 dilution) of human serum samples were added together with wild-type Ply in 96-well plates. Rabbit red blood cells were then added and following incubation supernatants removed and transferred to new 96-well plates and absorbance measured at 540 nm using a spectrophotometer plate reader. The mean A450 nm blank value was subtracted by 10% to obtain the Plate Specific Cut Point for each plate. Each sample was categorized as negative (\<1/20) or positive (with titer between 1/20 and 1/320).
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 10 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 1 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:320 | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 11 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 20 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 19 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:320 | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 9 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 8 Participants |
| PATH-wSP (1000 mcg): Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 8 Participants |
| Saline: Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 14 Participants |
| Saline: Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:320 | 1 Participants |
| Saline: Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 9 Participants |
| Saline: Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 10 Participants |
| Saline: Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 8 Participants |
| Saline: Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 4 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 15 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 18 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 5 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:320 | 1 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 8 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 0 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 5 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 10 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:320 | 1 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 15 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 2 Participants |
| PATH-wSP (1000 mcg): Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 14 Participants |
| Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 10 Participants |
| Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:320 | 0 Participants |
| Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 11 Participants |
| Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 14 Participants |
| Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 7 Participants |
| Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 5 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 13 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 13 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 2 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:320 | 0 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 17 Participants |
| PATH-wSP (600 mcg): Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 3 Participants |
| Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 1 Participants |
| Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 14 Participants |
| Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 13 Participants |
| Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 14 Participants |
| Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 5 Participants |
| Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:320 | 1 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 3 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 6 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:320 | 2 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 11 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 16 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 10 Participants |
| Active Control Only: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 12 Participants |
| Active Control Only: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 14 Participants |
| Active Control Only: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 6 Participants |
| Active Control Only: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:320 | 0 Participants |
| Active Control Only: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 14 Participants |
| Active Control Only: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 1 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:320 | 1 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 12 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 7 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 6 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 10 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 11 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 6 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 13 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 13 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 5 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 6 Participants |
| PATH-wSP (600 mcg)+Saline: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:320 | 3 Participants |
| Active Control Only: Baseline | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 1 Participants |
| Active Control Only: Baseline | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 27 Participants |
| Active Control Only: Baseline | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 4 Participants |
| Active Control Only: Baseline | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 6 Participants |
| Active Control Only: Baseline | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 10 Participants |
| Active Control Only: Baseline | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:320 | 0 Participants |
| Active Control Only: Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:320 | 0 Participants |
| Active Control Only: Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 13 Participants |
| Active Control Only: Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 3 Participants |
| Active Control Only: Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 11 Participants |
| Active Control Only: Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 0 Participants |
| Active Control Only: Vaccination 1 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 21 Participants |
| Active Control Only: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | <1:20 | 19 Participants |
| Active Control Only: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:40 | 6 Participants |
| Active Control Only: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:20 | 17 Participants |
| Active Control Only: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:80 | 5 Participants |
| Active Control Only: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:320 | 1 Participants |
| Active Control Only: Vaccination 2 | Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin | 1:160 | 0 Participants |
Other Pre-specified
Geometric Mean Concentration (GMC) Ratio of Diptheria Booster Immune Response Among Toddler Subjects
GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.
Time frame: 12 weeks post vaccination 1
Population: The number analyzed may differ between proteins because of insufficient samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentration (GMC) Ratio of Diptheria Booster Immune Response Among Toddler Subjects | 7.73 IU/mL |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentration (GMC) Ratio of Diptheria Booster Immune Response Among Toddler Subjects | 0.25 IU/mL |
| Saline: Vaccination 1 | Geometric Mean Concentration (GMC) Ratio of Diptheria Booster Immune Response Among Toddler Subjects | 7.71 IU/mL |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentration (GMC) Ratio of Diptheria Booster Immune Response Among Toddler Subjects | 0.27 IU/mL |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentration (GMC) Ratio of Diptheria Booster Immune Response Among Toddler Subjects | 9.39 IU/mL |
Other Pre-specified
Geometric Mean Concentration (GMC) Ratio of Haemophilus Influenzae Type b (Hib) Booster Immune Response Among Toddler Subjects
GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.
Time frame: 12 weeks post vaccination 1
Population: The number analyzed may differ between proteins because of insufficient samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentration (GMC) Ratio of Haemophilus Influenzae Type b (Hib) Booster Immune Response Among Toddler Subjects | 41.05 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentration (GMC) Ratio of Haemophilus Influenzae Type b (Hib) Booster Immune Response Among Toddler Subjects | 1.68 ug/mL |
| Saline: Vaccination 1 | Geometric Mean Concentration (GMC) Ratio of Haemophilus Influenzae Type b (Hib) Booster Immune Response Among Toddler Subjects | 39.06 ug/mL |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentration (GMC) Ratio of Haemophilus Influenzae Type b (Hib) Booster Immune Response Among Toddler Subjects | 1.23 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentration (GMC) Ratio of Haemophilus Influenzae Type b (Hib) Booster Immune Response Among Toddler Subjects | 37.45 ug/mL |
Other Pre-specified
Geometric Mean Concentration (GMC) Ratio of Hepatitis B Booster Immune Response Among Toddler Subjects
GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.
Time frame: 12 weeks post vaccination 1
Population: The number analyzed may differ between proteins because of insufficient samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentration (GMC) Ratio of Hepatitis B Booster Immune Response Among Toddler Subjects | 784.78 mIU/mL |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentration (GMC) Ratio of Hepatitis B Booster Immune Response Among Toddler Subjects | 149.86 mIU/mL |
| Saline: Vaccination 1 | Geometric Mean Concentration (GMC) Ratio of Hepatitis B Booster Immune Response Among Toddler Subjects | 695.14 mIU/mL |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentration (GMC) Ratio of Hepatitis B Booster Immune Response Among Toddler Subjects | 135.79 mIU/mL |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentration (GMC) Ratio of Hepatitis B Booster Immune Response Among Toddler Subjects | 815.39 mIU/mL |
Other Pre-specified
Geometric Mean Concentration (GMC) Ratio of Pertussis FHA and Pertussis Toxin Immune Response Among Toddler Subjects
GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.
Time frame: 12 weeks post vaccination 1
Population: The number analyzed may differ between proteins because of insufficient samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentration (GMC) Ratio of Pertussis FHA and Pertussis Toxin Immune Response Among Toddler Subjects | Pertussis FHA | 85.12 IU/mL |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentration (GMC) Ratio of Pertussis FHA and Pertussis Toxin Immune Response Among Toddler Subjects | Pertussis Toxin | 145.11 IU/mL |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentration (GMC) Ratio of Pertussis FHA and Pertussis Toxin Immune Response Among Toddler Subjects | Pertussis FHA | 6.70 IU/mL |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentration (GMC) Ratio of Pertussis FHA and Pertussis Toxin Immune Response Among Toddler Subjects | Pertussis Toxin | 19.38 IU/mL |
| Saline: Vaccination 1 | Geometric Mean Concentration (GMC) Ratio of Pertussis FHA and Pertussis Toxin Immune Response Among Toddler Subjects | Pertussis FHA | 68.23 IU/mL |
| Saline: Vaccination 1 | Geometric Mean Concentration (GMC) Ratio of Pertussis FHA and Pertussis Toxin Immune Response Among Toddler Subjects | Pertussis Toxin | 131.23 IU/mL |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentration (GMC) Ratio of Pertussis FHA and Pertussis Toxin Immune Response Among Toddler Subjects | Pertussis Toxin | 18.79 IU/mL |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentration (GMC) Ratio of Pertussis FHA and Pertussis Toxin Immune Response Among Toddler Subjects | Pertussis FHA | 10.47 IU/mL |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentration (GMC) Ratio of Pertussis FHA and Pertussis Toxin Immune Response Among Toddler Subjects | Pertussis FHA | 90.65 IU/mL |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentration (GMC) Ratio of Pertussis FHA and Pertussis Toxin Immune Response Among Toddler Subjects | Pertussis Toxin | 124.39 IU/mL |
Other Pre-specified
Geometric Mean Concentration (GMC) Ratio of Pertussis Fimbriae Immune Response Among Toddler Subjects
GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.
Time frame: 12 weeks post vaccination 1
Population: The number analyzed may differ between proteins because of insufficient samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentration (GMC) Ratio of Pertussis Fimbriae Immune Response Among Toddler Subjects | 753.63 U/mL |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentration (GMC) Ratio of Pertussis Fimbriae Immune Response Among Toddler Subjects | 45.75 U/mL |
| Saline: Vaccination 1 | Geometric Mean Concentration (GMC) Ratio of Pertussis Fimbriae Immune Response Among Toddler Subjects | 460.73 U/mL |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentration (GMC) Ratio of Pertussis Fimbriae Immune Response Among Toddler Subjects | 37.99 U/mL |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentration (GMC) Ratio of Pertussis Fimbriae Immune Response Among Toddler Subjects | 503.25 U/mL |
Other Pre-specified
Geometric Mean Concentration (GMC) Ratio of Tetanus Booster Immune Response Among Toddler Subjects
GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.
Time frame: 12 weeks post vaccination 1
Population: The number analyzed may differ between proteins because of insufficient samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentration (GMC) Ratio of Tetanus Booster Immune Response Among Toddler Subjects | 21.83 IU/mL |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentration (GMC) Ratio of Tetanus Booster Immune Response Among Toddler Subjects | 1.15 IU/mL |
| Saline: Vaccination 1 | Geometric Mean Concentration (GMC) Ratio of Tetanus Booster Immune Response Among Toddler Subjects | 21.64 IU/mL |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentration (GMC) Ratio of Tetanus Booster Immune Response Among Toddler Subjects | 1.27 IU/mL |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentration (GMC) Ratio of Tetanus Booster Immune Response Among Toddler Subjects | 21.92 IU/mL |
Other Pre-specified
Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects
GMCs of these IgG proteins were measured to assess potential interference of PATH-wSP with 10-valent pneumococcal conjugate vaccine (Synflorix). GMCs of Cohort 1 were measured at a different time point than those in Cohort 2, so results are presented separately.
Time frame: 12 weeks (Cohort 1) and 4 weeks (Cohort 2) post-vaccination 1
Population: The number analyzed may differ between proteins because of insufficient samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 6B | 1.60 ug/mL |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 5 | 0.38 ug/mL |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 23F | 0.98 ug/mL |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 19F | 4.62 ug/mL |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 18C | 1.51 ug/mL |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 14 | 3.16 ug/mL |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 4 | 1.22 ug/mL |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 1 | 0.87 ug/mL |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 9V | 0.77 ug/mL |
| PATH-wSP (600 mcg): Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 7F | 1.79 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 4 | 0.28 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 1 | 0.18 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 5 | 0.17 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 6B | 0.69 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 7F | 0.60 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 9V | 0.26 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 14 | 0.63 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 18C | 0.28 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 19F | 1.48 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 23F | 0.27 ug/mL |
| Saline: Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 6B | 4.28 ug/mL |
| Saline: Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 18C | 3.52 ug/mL |
| Saline: Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 1 | 3.09 ug/mL |
| Saline: Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 7F | 4.32 ug/mL |
| Saline: Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 5 | 0.77 ug/mL |
| Saline: Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 4 | 3.41 ug/mL |
| Saline: Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 9V | 2.03 ug/mL |
| Saline: Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 19F | 10.93 ug/mL |
| Saline: Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 23F | 2.76 ug/mL |
| Saline: Vaccination 1 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 14 | 8.62 ug/mL |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 14 | 1.02 ug/mL |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 18C | 0.33 ug/mL |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 4 | 0.36 ug/mL |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 23F | 0.28 ug/mL |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 19F | 1.50 ug/mL |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 1 | 0.25 ug/mL |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 9V | 0.29 ug/mL |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 7F | 0.72 ug/mL |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 6B | 0.95 ug/mL |
| PATH-wSP (600 mcg): Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 5 | 0.19 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 14 | 3.20 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 6B | 2.19 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 7F | 1.36 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 9V | 0.71 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 1 | 0.83 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 18C | 1.31 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 23F | 0.97 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 19F | 4.76 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 5 | 0.44 ug/mL |
| PATH-wSP (1000 mcg): Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 4 | 1.15 ug/mL |
| Saline: Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 9V | 1.57 ug/mL |
| Saline: Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 23F | 3.50 ug/mL |
| Saline: Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 4 | 2.59 ug/mL |
| Saline: Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 5 | 0.77 ug/mL |
| Saline: Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 7F | 3.57 ug/mL |
| Saline: Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 14 | 7.40 ug/mL |
| Saline: Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 6B | 3.68 ug/mL |
| Saline: Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 18C | 3.05 ug/mL |
| Saline: Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 1 | 2.47 ug/mL |
| Saline: Vaccination 2 | Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects | PnC-IgG-ELISA type 19F | 7.59 ug/mL |