Dose-Finding Study of S.Pneumoniae Whole Cell Vaccine Ads... | NCT02097472 | Trialant
NCT02097472
Sponsor
PATH
Status
Completed
Last Update Posted
Oct 10, 2019Actual
Enrollment
304Actual
Phase
Phase 1Phase 2
Conditions
Pneumonia, Pneumococcal
Interventions
PATH-wSP
Synflorix
Pentavac
Saline
Countries
Kenya
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT02097472
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
VAC-010
Secondary IDs
Not provided
Brief Title
Dose-Finding Study of S.Pneumoniae Whole Cell Vaccine Adsorbed to Alum (PATH-wSP) in Healthy Kenyan Adults and Toddlers
Official Title
A Dose-Finding Study to Assess the Safety, Tolerability, and Immunogenicity of Inactivated Streptococcus Pneumoniae Whole Cell Vaccine Formulated With Alum (PATH-wSP) in Healthy Kenyan Young Adults and PCV-Primed Toddlers
Acronym
Not provided
Organization
PATHOTHER
Status Module
Record Verification Date
Oct 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2014
Primary Completion Date
Dec 2015Actual
Completion Date
Dec 2015Actual
First Submitted Date
Mar 17, 2014
First Submission Date that Met QC Criteria
Mar 26, 2014
First Posted Date
Mar 27, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
May 7, 2018
Results First Submitted that Met QC Criteria
Jun 7, 2018
Results First Posted Date
Jun 12, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 1, 2019
Last Update Posted Date
Oct 10, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PATHOTHER
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Pneumonia, Pneumococcal
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
304Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Adult Cohort 1, PATH-wSP, 600 mcg
Experimental
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.
Biological: PATH-wSP
Adult Cohort 1, Saline
Placebo Comparator
A single injection of saline in one arm, followed 4 weeks later by a single injection of saline in the alternate arm.
Other: Saline
Adult Cohort 2, PATH-wSP, 1000 mcg
Experimental
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.
Biological: PATH-wSP
Adult Cohort 2, Saline
Placebo Comparator
A single injection of saline in one arm, followed 4 weeks later by a single injection of saline in the alternate arm.
Other: Saline
Toddler Cohort 1 PATH-wSP 300 mcg+Active control
Experimental
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.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PATH-wSP
Biological
Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum
Adult Cohort 1, PATH-wSP, 600 mcg
Adult Cohort 2, PATH-wSP, 1000 mcg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
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.
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
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.
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
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.
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
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.
Secondary Outcomes
Measure
Description
Time Frame
Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay
Measured with enzyme-linked immunosorbent assay (ELISA).
0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay
Other Outcomes
Measure
Description
Time Frame
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.
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.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
12 Months
Maximum Age
45 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Nekoye Otsyula, MD
Kenya Medical Research Institute/Walter Reed Project
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Kenya Medical Research Institute/Walter Reed Project
Kisumu
Nyanza
PO Box 54-40100
Kenya
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
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)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Adult Cohort 1: 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.
FG001
Adult Cohort 2: 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.
FG002
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.
FG003
Toddler Cohort 1: 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.
FG004
Toddler Cohort 1: 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.
FG005
Toddler Cohort 2: 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.
FG006
Toddler Cohort 2: 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.
FG007
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.
Periods
Title
Milestones
Reasons Not Completed
Received Vaccination 1
Type
Comment
Milestone Data
STARTED
FG00018 subjects
FG00118 subjects
FG00218 subjects
FG00350 subjects
FG00450 subjects
FG00550 subjects
FG00650 subjects
FG00750 subjects
COMPLETED
FG00018 subjects
FG00118 subjects
FG00218 subjects
FG00350 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Received Vaccination 2
Type
Comment
Milestone Data
STARTED
FG00018 subjects
FG00118 subjects
FG00218 subjects
FG003
Assessed for Immunogenicity
Type
Comment
Milestone Data
STARTED
FG00018 subjects
FG00118 subjects
FG00218 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.
BG001
Adult Cohort: PATH-wSP (1000 mcg)
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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.
Posted
Count of Participants
Participants
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
ID
Title
Description
OG000
PATH-wSP (600 mcg): Vaccination 1
A single injection of 600 mcg PATH-wSP in one arm
OG001
PATH-wSP (1000 mcg): Vaccination 1
A single injection of 1000 mcg PATH-wSP in one arm
Adverse Events Module
Frequency Threshold
5
Time Frame
4 weeks post-vaccination
Description
Subjects returned to the clinic 1 week post each vaccination and at 4 weeks after the final vaccination for assessment of solicited reactogenicity, targeted physical examination, vital signs, laboratory assessment, immunology testing, and evaluation for unsolicited AEs and concomitant medication use.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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.
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.
Biological: PATH-wSP
Other: Saline
Toddler Cohort 1: Active Control Only
Active Comparator
A single injection of saline 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 saline in the left thigh 8 weeks later.
Biological: Synflorix
Biological: Pentavac
Other: Saline
Toddler Cohort 2 PATH-wSP 600 mcg+Active control
Experimental
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.
Biological: PATH-wSP
Biological: Synflorix
Biological: Pentavac
Toddler Cohort 2 PATH-wSP 600 mcg+saline
Experimental
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.
Biological: PATH-wSP
Other: Saline
Toddler Cohort 2: Active Control Only
Active Comparator
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.
Biological: Synflorix
Biological: Pentavac
Other: Saline
Toddler Cohort 1 PATH-wSP 300 mcg+Active control
Toddler Cohort 1 PATH-wSP 300 mcg+Saline
Toddler Cohort 2 PATH-wSP 600 mcg+Active control
Toddler Cohort 2 PATH-wSP 600 mcg+saline
Synflorix
Biological
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
Toddler Cohort 1 PATH-wSP 300 mcg+Active control
Toddler Cohort 1: Active Control Only
Toddler Cohort 2 PATH-wSP 600 mcg+Active control
Toddler Cohort 2: Active Control Only
10-valent Pneumococcal Conjugate Vaccine (PCV10)
Pentavac
Biological
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.
Toddler Cohort 1 PATH-wSP 300 mcg+Active control
Toddler Cohort 1: Active Control Only
Toddler Cohort 2 PATH-wSP 600 mcg+Active control
Toddler Cohort 2: Active Control Only
Diptheria Pertussis Tetanus Hep B Haemophilus b Conjugate
Saline
Other
0.9% Sodium Chloride Injection, USP
Adult Cohort 1, Saline
Adult Cohort 2, Saline
Toddler Cohort 1 PATH-wSP 300 mcg+Saline
Toddler Cohort 1: Active Control Only
Toddler Cohort 2 PATH-wSP 600 mcg+saline
Toddler Cohort 2: Active Control Only
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
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
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
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.
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
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.
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
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
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
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).
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
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).
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
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).
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
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.
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
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).
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Measured with enzyme-linked immunosorbent assay (ELISA).
0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein
Measured using meso scale discovery (MSD).
0 days, 28 days (Dose 1) and 56 days (Dose 2)
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
Measured using Meso Scale Discovery (MSD) Assay
0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein
Measured using Meso Scale Discovery (MSD) Assay
0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein
Measured using Meso Scale Discovery (MSD) Assay
0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein
Measured using Meso Scale Discovery (MSD) Assay
0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein
MSD Assay
0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein
MSD Assay
0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein
MSD Assay
0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA
Measured using ELISA
0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA
Measured using ELISA
0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD
Measured using MSD
0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD
Measured using ELISA
0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein
Measured using MSD
0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein
Measured using MSD
0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein
Measured using MSD
0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein
Measured using MSD
0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein
Measured using MSD
0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein
Measured using MSD
0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein
Measured using MSD
0 days, 28 days (Dose 1) and 56 days (Dose 2)
Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA)
Measured using ELISA
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to PspA-Fam1 (ELISA)
Measured using ELISA
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to L460D Pneumococcal Protein (MSD)
Measured using MSD
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD)
Measured using MSD
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to PhtD Pneumococcal Protein
Measured using MSD
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to BCH0785 Pneumococcal Protein
Measured using MSD
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to StkP Pneumococcal Protein
Measured using MSD
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to PcpA Pneumococcal Protein
Measured using MSD
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to SPWCA Pneumococcal Protein
Measured using MSD
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to PiuA Pneumococcal Protein
Measured using MSD
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to PiaA Pneumococcal Protein
Measured using MSD
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
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).
0 days, 28 days (Dose 1) and 56 days (Dose 2)
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).
0 days, 28 days (Dose 1) and 56 days (Dose 2)
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.
12 weeks post vaccination 1
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.
12 weeks post vaccination 1
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.
12 weeks post vaccination 1
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.
12 weeks post vaccination 1
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.
12 weeks post vaccination 1
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.
12 weeks post vaccination 1
50 subjects
FG00550 subjects
FG00650 subjects
FG00750 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
50 subjects
FG00450 subjects
FG00550 subjects
FG00650 subjects
FG00750 subjects
COMPLETED
FG00018 subjects
FG00118 subjects
FG00218 subjects
FG00350 subjects
FG00450 subjects
FG00550 subjects
FG00649 subjects
FG00750 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
50 subjects
FG00450 subjects
FG00550 subjects
FG00649 subjects
FG00750 subjects
COMPLETED
FG00018 subjects
FG00118 subjects
FG00217 subjects
FG00348 subjects
FG00450 subjects
FG00548 subjects
FG00647 subjects
FG00749 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG0040 subjects
FG0052 subjects
FG0062 subjects
FG0071 subjects
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.
BG002
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.
BG003
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.
BG004
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.
BG005
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.
BG006
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.
BG007
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.
BG008
Total
Total of all reporting groups
18
BG00118
BG00218
BG00350
BG00450
BG00550
BG00650
BG00750
BG008304
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00026.94± 5.98
BG00128.56± 8.61
BG00230.39± 7.71
BG0031.10± 0.09
BG0041.09± 0.09
BG0051.11± 0.09
BG0061.13± 0.10
BG0071.09± 0.09
BG0085.99± 11.00
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG0015
BG0027
BG00332
BG00426
BG00523
BG00624
BG00723
BG008148
Male
BG00010
BG00113
BG00211
BG00318
BG004
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Kenya
Title
Measurements
BG00018
BG00118
BG00218
BG00350
BG00450
BG00550
BG00650
BG00750
BG008304
OG002
Saline: Vaccination 1
A single injection of saline in one arm.
OG003
PATH-wSP (600 mcg): Vaccination 2
Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection
OG004
PATH-wSP (1000 mcg): Vaccination 2
Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection
OG005
Saline: Vaccination 2
A single injection of saline in one arm, one month after initial injection
Units
Counts
Participants
OG00018
OG00118
OG00218
OG00318
OG00418
OG00518
Title
Denominators
Categories
Title
Measurements
No fatigue/malaise
OG00015
OG00115
OG00218
OG00316
OG00413
OG00515
Grade 1: no interference with activity
OG0003
OG0013
OG0020
OG0032
OG004
Grade 2: Some interference with activity
OG0000
OG0010
OG0020
OG0030
OG004
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.
Posted
Count of Participants
Participants
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
ID
Title
Description
OG000
PATH-wSP (600 mcg): Vaccination 1
A single injection of 600 mcg PATH-wSP in one arm
OG001
PATH-wSP (1000 mcg): Vaccination 1
A single injection of 1000 mcg PATH-wSP in one arm
OG002
Saline: Vaccination 1
A single injection of saline in one arm.
OG003
PATH-wSP (600 mcg): Vaccination 2
Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection
OG004
PATH-wSP (1000 mcg): Vaccination 2
Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection
OG005
Saline: Vaccination 2
A single injection of saline in one arm, one month after initial injection
Units
Counts
Participants
OG00018
OG00118
OG00218
OG003
Title
Denominators
Categories
Title
Measurements
No myalgia
OG00011
OG00116
OG00217
OG003
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.
Posted
Count of Participants
Participants
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
ID
Title
Description
OG000
PATH-wSP (600 mcg): Vaccination 1
A single injection of 600 mcg PATH-wSP in one arm
OG001
PATH-wSP (1000 mcg): Vaccination 1
A single injection of 1000 mcg PATH-wSP in one arm
OG002
Saline: Vaccination 1
A single injection of saline in one arm.
OG003
PATH-wSP (600 mcg): Vaccination 2
Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection
OG004
PATH-wSP (1000 mcg): Vaccination 2
Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection
OG005
Saline: Vaccination 2
A single injection of saline in one arm, one month after initial injection
Units
Counts
Participants
OG00018
OG00118
OG00218
OG003
Title
Denominators
Categories
Title
Measurements
No headache
OG00016
OG00112
OG00213
OG003
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.
Posted
Count of Participants
Participants
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
ID
Title
Description
OG000
PATH-wSP (600 mcg): Vaccination 1
A single injection of 600 mcg PATH-wSP in one arm
OG001
PATH-wSP (1000 mcg): Vaccination 1
A single injection of 1000 mcg PATH-wSP in one arm
OG002
Saline: Vaccination 1
A single injection of saline in one arm.
OG003
PATH-wSP (600 mcg): Vaccination 2
Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection
OG004
PATH-wSP (1000 mcg): Vaccination 2
Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection
OG005
Saline: Vaccination 2
A single injection of saline in one arm, one month after initial injection
Units
Counts
Participants
OG00018
OG00118
OG00218
OG003
Title
Denominators
Categories
Title
Measurements
No pain at injection site
OG0004
OG0013
OG00214
OG003
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.
Posted
Count of Participants
Participants
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
ID
Title
Description
OG000
PATH-wSP (600 mcg): Vaccination 1
A single injection of 600 mcg PATH-wSP in one arm
OG001
PATH-wSP (1000 mcg): Vaccination 1
A single injection of 1000 mcg PATH-wSP in one arm
OG002
Saline: Vaccination 1
A single injection of saline in one arm.
OG003
PATH-wSP (600 mcg): Vaccination 2
Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection
OG004
PATH-wSP (1000 mcg): Vaccination 2
Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection
OG005
Saline: Vaccination 2
A single injection of saline in one arm, one month after initial injection
Units
Counts
Participants
OG00018
OG00118
OG00218
OG003
Title
Denominators
Categories
Title
Measurements
No tenderness
OG0003
OG0014
OG00211
OG003
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
Posted
Count of Participants
Participants
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
ID
Title
Description
OG000
PATH-wSP (600 mcg): Vaccination 1
A single injection of 600 mcg PATH-wSP in one arm
OG001
PATH-wSP (1000 mcg): Vaccination 1
A single injection of 1000 mcg PATH-wSP in one arm
OG002
Saline: Vaccination 1
A single injection of saline in one arm.
OG003
PATH-wSP (600 mcg): Vaccination 2
Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection
OG004
PATH-wSP (1000 mcg): Vaccination 2
Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection
OG005
Saline: Vaccination 2
A single injection of saline in one arm, one month after initial injection
Units
Counts
Participants
OG00018
OG00118
OG00218
OG003
Title
Denominators
Categories
Title
Measurements
No induration/swelling
OG00013
OG00117
OG00217
OG003
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.
Posted
Count of Participants
Participants
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
ID
Title
Description
OG000
PATH-wSP (600 mcg): Vaccination 1
A single injection of 600 mcg PATH-wSP in one arm
OG001
PATH-wSP (1000 mcg): Vaccination 1
A single injection of 1000 mcg PATH-wSP in one arm
OG002
Saline: Vaccination 1
A single injection of saline in one arm.
OG003
PATH-wSP (600 mcg): Vaccination 2
Single injection of 600 mcg PATH-wSP in one arm, one month after initial injection
OG004
PATH-wSP (1000 mcg): Vaccination 2
Single injection of 1000 mcg PATH-wSP in one arm, one month after initial injection
OG005
Saline: Vaccination 2
A single injection of saline in one arm, one month after initial injection
Units
Counts
Participants
OG00018
OG00118
OG00218
OG003
Title
Denominators
Categories
Title
Measurements
No fever
OG00018
OG00118
OG00218
OG003
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.
Posted
Count of Participants
Participants
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
ID
Title
Description
OG000
PATH-wSP (300 mcg)+Active Control: Vaccination 1
A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG001
PATH-wSP (300 mcg)+Saline: Vaccination 1
Single injection of 1000 mcg PATH-wSP 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.
OG002
PATH-wSP (600 mcg)+Active Control: Vaccination 1
A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG003
PATH-wSP (600 mcg)+Saline: Vaccination 1
Single injection of 600 mcg PATH-wSP 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.
OG004
Active Control Only: Vaccination 1
A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG005
PATH-wSP (300 mcg): Vaccination 2
A single injection of PATH-wSP 300 mcg in the left thigh 8 weeks after the first vaccination of the same dosage
OG006
PATH-wSP (600 mcg): Vaccination 2
A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage
OG007
Saline: Vaccination 2
A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.
Units
Counts
Participants
OG00050
OG00150
OG00250
OG003
Title
Denominators
Categories
Title
Measurements
No fever
OG00026
OG00140
OG00231
OG003
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
Posted
Count of Participants
Participants
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
ID
Title
Description
OG000
PATH-wSP (300 mcg)+Active Control: Vaccination 1
A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG001
PATH-wSP (300 mcg)+Saline: Vaccination 1
Single injection of 1000 mcg PATH-wSP 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.
OG002
PATH-wSP (600 mcg)+Active Control: Vaccination 1
A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG003
PATH-wSP (600 mcg)+Saline: Vaccination 1
Single injection of 600 mcg PATH-wSP 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.
OG004
Active Control Only: Vaccination 1
A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG005
PATH-wSP (300 mcg): Vaccination 2
A single injection of PATH-wSP 300 mcg in the left thigh 8 weeks after the first vaccination of the same dosage
OG006
PATH-wSP (600 mcg): Vaccination 2
A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage
OG007
Saline: Vaccination 2
A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.
Units
Counts
Participants
OG00050
OG00150
OG00250
OG003
Title
Denominators
Categories
Title
Measurements
No cutaneous rash
OG00041
OG00144
OG00243
OG003
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).
Posted
Count of Participants
Participants
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
ID
Title
Description
OG000
PATH-wSP (300 mcg)+Active Control: Vaccination 1
A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG001
PATH-wSP (300 mcg)+Saline: Vaccination 1
Single injection of 1000 mcg PATH-wSP 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.
OG002
PATH-wSP (600 mcg)+Active Control: Vaccination 1
A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG003
PATH-wSP (600 mcg)+Saline: Vaccination 1
Single injection of 600 mcg PATH-wSP 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.
OG004
Active Control Only: Vaccination 1
A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG005
PATH-wSP (300 mcg): Vaccination 2
A single injection of PATH-wSP 300 mcg in the left thigh 8 weeks after the first vaccination of the same dosage
OG006
PATH-wSP (600 mcg): Vaccination 2
A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage
OG007
Saline: Vaccination 2
A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.
Units
Counts
Participants
OG00050
OG00150
OG00250
OG003
Title
Denominators
Categories
Title
Measurements
No irritability
OG00031
OG00146
OG00236
OG003
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).
Posted
Count of Participants
Participants
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
ID
Title
Description
OG000
PATH-wSP (300 mcg)+Active Control: Vaccination 1
A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG001
PATH-wSP (300 mcg)+Saline: Vaccination 1
Single injection of 1000 mcg PATH-wSP 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.
OG002
PATH-wSP (600 mcg)+Active Control: Vaccination 1
A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG003
PATH-wSP (600 mcg)+Saline: Vaccination 1
Single injection of 600 mcg PATH-wSP 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.
OG004
Active Control Only: Vaccination 1
A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG005
PATH-wSP (300 mcg): Vaccination 2
A single injection of PATH-wSP 300 mcg in the left thigh 8 weeks after the first vaccination of the same dosage
OG006
PATH-wSP (600 mcg): Vaccination 2
A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage
OG007
Saline: Vaccination 2
A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.
Units
Counts
Participants
OG00050
OG00150
OG00250
OG003
Title
Denominators
Categories
Title
Measurements
No drowsiness
OG00048
OG00149
OG00247
OG003
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).
Posted
Count of Participants
Participants
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
ID
Title
Description
OG000
PATH-wSP (300 mcg)+Active Control: Vaccination 1
A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG001
PATH-wSP (300 mcg)+Saline: Vaccination 1
Single injection of 1000 mcg PATH-wSP 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.
OG002
PATH-wSP (600 mcg)+Active Control: Vaccination 1
A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG003
PATH-wSP (600 mcg)+Saline: Vaccination 1
Single injection of 600 mcg PATH-wSP 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.
OG004
Active Control Only: Vaccination 1
A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG005
PATH-wSP (300 mcg): Vaccination 2
A single injection of PATH-wSP 300 mcg in the left thigh 8 weeks after the first vaccination of the same dosage
OG006
PATH-wSP (600 mcg): Vaccination 2
A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage
OG007
Saline: Vaccination 2
A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.
Units
Counts
Participants
OG00050
OG00150
OG00250
OG003
Title
Denominators
Categories
Title
Measurements
No loss of appetite
OG00032
OG00142
OG00230
OG003
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.
Posted
Count of Participants
Participants
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
ID
Title
Description
OG000
300 mcg PATH-wSP: Vaccination 1
A single injection of 300 mcg PATH-wSP in the left thigh at first vaccination (during which subjects also received either two saline injections, or or Synflorix and Pentavac injections, in the right thigh)
OG001
600 mcg PATH-wSP: Vaccination 1
A single injection of 600 mcg PATH-wSP in the left thigh (during which subjects also received either two saline injections, or or Synflorix and Pentavac injections, in the right thigh)
OG002
Active Control: Pentavac
A single injection of the active comparator vaccine Pentavac in the right thigh during the first vaccination.
OG003
Active Control: Synflorix
A single injection of the active comparator vaccine Synflorix in the right thigh during the first vaccination.
OG004
Active Control: Saline
One injection of saline in the left thigh during the first vaccination (during which subjects received Pentavac and Synflorix injections, but no PATH-wSP injections)
OG005
PATH-wSP (300 mcg): Vaccination 2
SA single injection of PATH-wSP 300 mcg in the left thigh 8 weeks after the first vaccination of the same dosage
OG006
PATH-wSP (600 mcg): Vaccination 2
A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage
OG007
Saline: Vaccination 2
A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.
Units
Counts
Participants
OG000100
OG001100
OG00250
OG003
Title
Denominators
Categories
Title
Measurements
No pain/tenderness at injection site
OG00033
OG00143
OG00217
OG003
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).
Posted
Count of Participants
Participants
up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
ID
Title
Description
OG000
300 mcg PATH-wSP: Vaccination 1
A single injection of 300 mcg PATH-wSP in the left thigh at first vaccination (during which subjects also received either two saline injections, or or Synflorix and Pentavac injections, in the right thigh)
OG001
600 mcg PATH-wSP: Vaccination 1
A single injection of 600 mcg PATH-wSP in the left thigh (during which subjects also received either two saline injections, or or Synflorix and Pentavac injections, in the right thigh)
OG002
Active Control: Pentavac
A single injection of the active comparator vaccine Pentavac in the right thigh during the first vaccination.
OG003
Active Control: Synflorix
A single injection of the active comparator vaccine Synflorix in the right thigh during the first vaccination.
OG004
Active Control: Saline
One injection of saline in the left thigh during the first vaccination (during which subjects received Pentavac and Synflorix injections, but no PATH-wSP injections)
OG005
PATH-wSP (300 mcg): Vaccination 2
SA single injection of PATH-wSP 300 mcg in the left thigh 8 weeks after the first vaccination of the same dosage
OG006
PATH-wSP (600 mcg): Vaccination 2
A single injection of PATH-wSP 600 mcg in the left thigh 8 weeks after the first vaccination of the same dosage
OG007
Saline: Vaccination 2
A single injection of saline in the left thigh 8 weeks after first vaccination visit of 2 active comparator vaccines (Synflorix and Pentavac) plus 1 saline injection.
Units
Counts
Participants
OG000100
OG001100
OG00250
OG003
Title
Denominators
Categories
Title
Measurements
No induration/swelling
OG00093
OG00198
OG00245
OG003
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay
Measured with enzyme-linked immunosorbent assay (ELISA).
Posted
Geometric Mean
90% Confidence Interval
titer
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG00018
OG00117
OG00216
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG0002083.27(1638.67 to 2648.49)
OG0011569.91(1102.09 to 2236.30)
OG0021998.33(1356.41 to 2944.02)
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay
Measured with enzyme-linked immunosorbent assay (ELISA).
Posted
Geometric Mean
90% Confidence Interval
titer
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG00018
OG00117
OG00217
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG0001899.32(1393.87 to 2588.06)
OG0012042.68(1679.25 to 2484.75)
OG0021793.44(1404.90 to 2289.43)
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein
Measured using meso scale discovery (MSD).
Insufficient sample
Posted
Geometric Mean
90% Confidence Interval
titer
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG00018
OG00118
OG00217
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG00018
ParticipantsOG00118
ParticipantsOG00217
ParticipantsOG003
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay
The number analyzed may differ between periods because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
titer
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG00018
OG00118
OG00217
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG00018
ParticipantsOG00118
ParticipantsOG00217
ParticipantsOG003
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein
Measured using Meso Scale Discovery (MSD) Assay
The number analyzed may differ between periods because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
titer
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG00018
OG00118
OG00217
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG00018
ParticipantsOG00118
ParticipantsOG00217
ParticipantsOG003
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein
Measured using Meso Scale Discovery (MSD) Assay
The number analyzed may differ between periods because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
titer
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG00018
OG00118
OG00217
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG00018
ParticipantsOG00118
ParticipantsOG00217
ParticipantsOG003
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein
Measured using Meso Scale Discovery (MSD) Assay
The number analyzed may differ between periods because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
titer
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG00018
OG00118
OG00217
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG00018
ParticipantsOG00118
ParticipantsOG00217
ParticipantsOG003
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein
Measured using Meso Scale Discovery (MSD) Assay
The number analyzed may differ between periods because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
titer
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG00018
OG00118
OG00217
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG00018
ParticipantsOG00118
ParticipantsOG00217
ParticipantsOG003
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein
MSD Assay
The number analyzed may differ between periods because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
titer
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG00018
OG00118
OG00217
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG00018
ParticipantsOG00118
ParticipantsOG00217
ParticipantsOG003
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein
MSD Assay
The number analyzed may differ between periods because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
titer
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG00018
OG00118
OG00217
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG00018
ParticipantsOG00118
ParticipantsOG00217
ParticipantsOG003
Secondary
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein
MSD Assay
The number analyzed may differ between periods because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
titer
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG00018
OG00118
OG00217
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG00018
ParticipantsOG00118
ParticipantsOG00217
ParticipantsOG003
Secondary
Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA
Measured using ELISA
The number analyzed may differ between periods because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
fold change
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00046
OG00147
OG00248
OG003
Title
Denominators
Categories
Post-vaccination 1
ParticipantsOG00046
ParticipantsOG00147
ParticipantsOG00248
ParticipantsOG003
Secondary
Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA
Measured using ELISA
The number analyzed may differ between periods because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
fold change
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00046
OG00147
OG00248
OG003
Title
Denominators
Categories
Post-vaccination 1
ParticipantsOG00046
ParticipantsOG00147
ParticipantsOG00248
ParticipantsOG003
Secondary
Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD
Measured using MSD
The number analyzed may differ between periods because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
fold change
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Post-vaccination 1
ParticipantsOG00048
ParticipantsOG00149
ParticipantsOG00248
ParticipantsOG003
Secondary
Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD
Measured using ELISA
The number analyzed may differ between periods because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
fold change
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Post-vaccination 1
ParticipantsOG00048
ParticipantsOG00149
ParticipantsOG00248
ParticipantsOG003
Secondary
Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein
Measured using MSD
The number analyzed may differ between periods because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
fold change
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Post-vaccination 1
ParticipantsOG00048
ParticipantsOG00149
ParticipantsOG00248
ParticipantsOG003
Secondary
Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein
Measured using MSD
The number analyzed may differ between periods because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
fold change
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Post-vaccination 1
ParticipantsOG00048
ParticipantsOG00149
ParticipantsOG00248
ParticipantsOG003
Secondary
Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein
Measured using MSD
The number analyzed may differ between periods because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
fold change
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Post-vaccination 1
ParticipantsOG00048
ParticipantsOG00149
ParticipantsOG00248
ParticipantsOG003
Secondary
Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein
Measured using MSD
The number analyzed may differ between periods because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
fold change
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Post-vaccination 1
ParticipantsOG00048
ParticipantsOG00149
ParticipantsOG00248
ParticipantsOG003
Secondary
Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein
Measured using MSD
The number analyzed may differ between periods because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
fold change
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Post-vaccination 1
ParticipantsOG00048
ParticipantsOG00149
ParticipantsOG00248
ParticipantsOG003
Secondary
Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein
Measured using MSD
The number analyzed may differ between periods because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
fold change
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Post-vaccination 1
ParticipantsOG00048
ParticipantsOG00149
ParticipantsOG00248
ParticipantsOG003
Secondary
Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein
Measured using MSD
The number analyzed may differ between periods because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
fold change
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Post-vaccination 1
ParticipantsOG00048
ParticipantsOG00149
ParticipantsOG00248
ParticipantsOG003
Secondary
Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA)
Measured using ELISA
Posted
Count of Participants
Participants
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
ID
Title
Description
OG000
PATH-wSP (300 mcg)+Active Control: Vaccination 1
A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG001
PATH-wSP (300 mcg)+Saline: Vaccination 1
Single injection of 300 mcg PATH-wSP 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.
OG002
PATH-wSP (600 mcg)+Active Control: Vaccination 1
A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG003
PATH-wSP (600 mcg)+Saline: Vaccination 1
Single injection of 600 mcg PATH-wSP 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.
OG004
Active Control Only: Vaccination 1
A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG005
PATH-wSP (300 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 300 mcg in the left thigh 8 weeks after the first vaccination of the same dosage plus two active control vaccines in the right thigh.
OG006
PATH-wSP (300 mcg)+Saline: Vaccination 2
Injection of PATH-wSP 300 mcg in the left thigh, 8 weeks after the first vaccination of the same plus a saline injection in the right thigh.
OG007
PATH-wSP (600 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 600 mcg in the left thigh, 8 weeks after the first vaccination of the same dosage and two active control vaccinations in the right thigh
OG008
PATH-wSP (600 mcg)+Saline: Vaccination 2
A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.
OG009
Active Control Only: Vaccination 2
A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
Units
Counts
Participants
OG00046
OG00147
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
<2-Fold
OG00028
OG00123
OG00232
OG003
Secondary
Fold Change in IgG Response to PspA-Fam1 (ELISA)
Measured using ELISA
Posted
Count of Participants
Participants
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
ID
Title
Description
OG000
PATH-wSP (300 mcg)+Active Control: Vaccination 1
A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG001
PATH-wSP (300 mcg)+Saline: Vaccination 1
Single injection of 300 mcg PATH-wSP 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.
OG002
PATH-wSP (600 mcg)+Active Control: Vaccination 1
A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG003
PATH-wSP (600 mcg)+Saline: Vaccination 1
Single injection of 600 mcg PATH-wSP 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.
OG004
Active Control Only: Vaccination 1
A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG005
PATH-wSP (300 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 300 mcg in the left thigh 8 weeks after the first vaccination of the same dosage plus two active control vaccines in the right thigh.
OG006
PATH-wSP (300 mcg)+Saline: Vaccination 2
Injection of PATH-wSP 300 mcg in the left thigh, 8 weeks after the first vaccination of the same plus a saline injection in the right thigh.
OG007
PATH-wSP (600 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 600 mcg in the left thigh, 8 weeks after the first vaccination of the same dosage and two active control vaccinations in the right thigh
OG008
PATH-wSP (600 mcg)+Saline: Vaccination 2
A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.
OG009
Active Control Only: Vaccination 2
A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
Units
Counts
Participants
OG00046
OG00147
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
<2-Fold
OG00036
OG00129
OG00242
OG003
Secondary
Fold Change in IgG Response to L460D Pneumococcal Protein (MSD)
Measured using MSD
Posted
Count of Participants
Participants
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
ID
Title
Description
OG000
PATH-wSP (300 mcg)+Active Control: Vaccination 1
A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG001
PATH-wSP (300 mcg)+Saline: Vaccination 1
Single injection of 300 mcg PATH-wSP 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.
OG002
PATH-wSP (600 mcg)+Active Control: Vaccination 1
A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG003
PATH-wSP (600 mcg)+Saline: Vaccination 1
Single injection of 600 mcg PATH-wSP 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.
OG004
Active Control Only: Vaccination 1
A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG005
PATH-wSP (300 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 300 mcg in the left thigh 8 weeks after the first vaccination of the same dosage plus two active control vaccines in the right thigh.
OG006
PATH-wSP (300 mcg)+Saline: Vaccination 2
Injection of PATH-wSP 300 mcg in the left thigh, 8 weeks after the first vaccination of the same plus a saline injection in the right thigh.
OG007
PATH-wSP (600 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 600 mcg in the left thigh, 8 weeks after the first vaccination of the same dosage and two active control vaccinations in the right thigh
OG008
PATH-wSP (600 mcg)+Saline: Vaccination 2
A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.
OG009
Active Control Only: Vaccination 2
A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
Units
Counts
Participants
OG00046
OG00147
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
<2-Fold
OG00037
OG00131
OG00243
OG003
Secondary
Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD)
Measured using MSD
Posted
Count of Participants
Participants
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
ID
Title
Description
OG000
PATH-wSP (300 mcg)+Active Control: Vaccination 1
A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG001
PATH-wSP (300 mcg)+Saline: Vaccination 1
Single injection of 300 mcg PATH-wSP 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.
OG002
PATH-wSP (600 mcg)+Active Control: Vaccination 1
A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG003
PATH-wSP (600 mcg)+Saline: Vaccination 1
Single injection of 600 mcg PATH-wSP 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.
OG004
Active Control Only: Vaccination 1
A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG005
PATH-wSP (300 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 300 mcg in the left thigh 8 weeks after the first vaccination of the same dosage plus two active control vaccines in the right thigh.
OG006
PATH-wSP (300 mcg)+Saline: Vaccination 2
Injection of PATH-wSP 300 mcg in the left thigh, 8 weeks after the first vaccination of the same plus a saline injection in the right thigh.
OG007
PATH-wSP (600 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 600 mcg in the left thigh, 8 weeks after the first vaccination of the same dosage and two active control vaccinations in the right thigh
OG008
PATH-wSP (600 mcg)+Saline: Vaccination 2
A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.
OG009
Active Control Only: Vaccination 2
A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
<2-Fold
OG00029
OG00126
OG00235
OG003
Secondary
Fold Change in IgG Response to PhtD Pneumococcal Protein
Measured using MSD
Posted
Count of Participants
Participants
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
ID
Title
Description
OG000
PATH-wSP (300 mcg)+Active Control: Vaccination 1
A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG001
PATH-wSP (300 mcg)+Saline: Vaccination 1
Single injection of 300 mcg PATH-wSP 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.
OG002
PATH-wSP (600 mcg)+Active Control: Vaccination 1
A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG003
PATH-wSP (600 mcg)+Saline: Vaccination 1
Single injection of 600 mcg PATH-wSP 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.
OG004
Active Control Only: Vaccination 1
A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG005
PATH-wSP (300 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 300 mcg in the left thigh 8 weeks after the first vaccination of the same dosage plus two active control vaccines in the right thigh.
OG006
PATH-wSP (300 mcg)+Saline: Vaccination 2
Injection of PATH-wSP 300 mcg in the left thigh, 8 weeks after the first vaccination of the same plus a saline injection in the right thigh.
OG007
PATH-wSP (600 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 600 mcg in the left thigh, 8 weeks after the first vaccination of the same dosage and two active control vaccinations in the right thigh
OG008
PATH-wSP (600 mcg)+Saline: Vaccination 2
A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.
OG009
Active Control Only: Vaccination 2
A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
<2-Fold
OG00037
OG00139
OG00243
OG003
Secondary
Fold Change in IgG Response to BCH0785 Pneumococcal Protein
Measured using MSD
Posted
Count of Participants
Participants
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
ID
Title
Description
OG000
PATH-wSP (300 mcg)+Active Control: Vaccination 1
A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG001
PATH-wSP (300 mcg)+Saline: Vaccination 1
Single injection of 300 mcg PATH-wSP 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.
OG002
PATH-wSP (600 mcg)+Active Control: Vaccination 1
A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG003
PATH-wSP (600 mcg)+Saline: Vaccination 1
Single injection of 600 mcg PATH-wSP 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.
OG004
Active Control Only: Vaccination 1
A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG005
PATH-wSP (300 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 300 mcg in the left thigh 8 weeks after the first vaccination of the same dosage plus two active control vaccines in the right thigh.
OG006
PATH-wSP (300 mcg)+Saline: Vaccination 2
Injection of PATH-wSP 300 mcg in the left thigh, 8 weeks after the first vaccination of the same plus a saline injection in the right thigh.
OG007
PATH-wSP (600 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 600 mcg in the left thigh, 8 weeks after the first vaccination of the same dosage and two active control vaccinations in the right thigh
OG008
PATH-wSP (600 mcg)+Saline: Vaccination 2
A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.
OG009
Active Control Only: Vaccination 2
A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
<2-Fold
OG00036
OG00135
OG00235
OG003
Secondary
Fold Change in IgG Response to StkP Pneumococcal Protein
Measured using MSD
Posted
Count of Participants
Participants
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
ID
Title
Description
OG000
PATH-wSP (300 mcg)+Active Control: Vaccination 1
A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG001
PATH-wSP (300 mcg)+Saline: Vaccination 1
Single injection of 300 mcg PATH-wSP 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.
OG002
PATH-wSP (600 mcg)+Active Control: Vaccination 1
A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG003
PATH-wSP (600 mcg)+Saline: Vaccination 1
Single injection of 600 mcg PATH-wSP 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.
OG004
Active Control Only: Vaccination 1
A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG005
PATH-wSP (300 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 300 mcg in the left thigh 8 weeks after the first vaccination of the same dosage plus two active control vaccines in the right thigh.
OG006
PATH-wSP (300 mcg)+Saline: Vaccination 2
Injection of PATH-wSP 300 mcg in the left thigh, 8 weeks after the first vaccination of the same plus a saline injection in the right thigh.
OG007
PATH-wSP (600 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 600 mcg in the left thigh, 8 weeks after the first vaccination of the same dosage and two active control vaccinations in the right thigh
OG008
PATH-wSP (600 mcg)+Saline: Vaccination 2
A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.
OG009
Active Control Only: Vaccination 2
A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
<2-Fold
OG00038
OG00135
OG00242
OG003
Secondary
Fold Change in IgG Response to PcpA Pneumococcal Protein
Measured using MSD
Posted
Count of Participants
Participants
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
ID
Title
Description
OG000
PATH-wSP (300 mcg)+Active Control: Vaccination 1
A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG001
PATH-wSP (300 mcg)+Saline: Vaccination 1
Single injection of 300 mcg PATH-wSP 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.
OG002
PATH-wSP (600 mcg)+Active Control: Vaccination 1
A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG003
PATH-wSP (600 mcg)+Saline: Vaccination 1
Single injection of 600 mcg PATH-wSP 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.
OG004
Active Control Only: Vaccination 1
A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG005
PATH-wSP (300 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 300 mcg in the left thigh 8 weeks after the first vaccination of the same dosage plus two active control vaccines in the right thigh.
OG006
PATH-wSP (300 mcg)+Saline: Vaccination 2
Injection of PATH-wSP 300 mcg in the left thigh, 8 weeks after the first vaccination of the same plus a saline injection in the right thigh.
OG007
PATH-wSP (600 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 600 mcg in the left thigh, 8 weeks after the first vaccination of the same dosage and two active control vaccinations in the right thigh
OG008
PATH-wSP (600 mcg)+Saline: Vaccination 2
A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.
OG009
Active Control Only: Vaccination 2
A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
<2-Fold
OG00037
OG00142
OG00240
OG003
Secondary
Fold Change in IgG Response to SPWCA Pneumococcal Protein
Measured using MSD
Posted
Count of Participants
Participants
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
ID
Title
Description
OG000
PATH-wSP (300 mcg)+Active Control: Vaccination 1
A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG001
PATH-wSP (300 mcg)+Saline: Vaccination 1
Single injection of 300 mcg PATH-wSP 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.
OG002
PATH-wSP (600 mcg)+Active Control: Vaccination 1
A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG003
PATH-wSP (600 mcg)+Saline: Vaccination 1
Single injection of 600 mcg PATH-wSP 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.
OG004
Active Control Only: Vaccination 1
A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG005
PATH-wSP (300 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 300 mcg in the left thigh 8 weeks after the first vaccination of the same dosage plus two active control vaccines in the right thigh.
OG006
PATH-wSP (300 mcg)+Saline: Vaccination 2
Injection of PATH-wSP 300 mcg in the left thigh, 8 weeks after the first vaccination of the same plus a saline injection in the right thigh.
OG007
PATH-wSP (600 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 600 mcg in the left thigh, 8 weeks after the first vaccination of the same dosage and two active control vaccinations in the right thigh
OG008
PATH-wSP (600 mcg)+Saline: Vaccination 2
A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.
OG009
Active Control Only: Vaccination 2
A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
<2-Fold
OG00045
OG00142
OG00242
OG003
Secondary
Fold Change in IgG Response to PiuA Pneumococcal Protein
Measured using MSD
Posted
Count of Participants
Participants
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
ID
Title
Description
OG000
PATH-wSP (300 mcg)+Active Control: Vaccination 1
A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG001
PATH-wSP (300 mcg)+Saline: Vaccination 1
Single injection of 300 mcg PATH-wSP 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.
OG002
PATH-wSP (600 mcg)+Active Control: Vaccination 1
A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG003
PATH-wSP (600 mcg)+Saline: Vaccination 1
Single injection of 600 mcg PATH-wSP 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.
OG004
Active Control Only: Vaccination 1
A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG005
PATH-wSP (300 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 300 mcg in the left thigh 8 weeks after the first vaccination of the same dosage plus two active control vaccines in the right thigh.
OG006
PATH-wSP (300 mcg)+Saline: Vaccination 2
Injection of PATH-wSP 300 mcg in the left thigh, 8 weeks after the first vaccination of the same plus a saline injection in the right thigh.
OG007
PATH-wSP (600 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 600 mcg in the left thigh, 8 weeks after the first vaccination of the same dosage and two active control vaccinations in the right thigh
OG008
PATH-wSP (600 mcg)+Saline: Vaccination 2
A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.
OG009
Active Control Only: Vaccination 2
A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
<2-Fold
OG00039
OG00135
OG00237
OG003
Secondary
Fold Change in IgG Response to PiaA Pneumococcal Protein
Measured using MSD
Posted
Count of Participants
Participants
28 days (post-vaccination 1) and 56 days (post-vaccination 2)
ID
Title
Description
OG000
PATH-wSP (300 mcg)+Active Control: Vaccination 1
A single injection of 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG001
PATH-wSP (300 mcg)+Saline: Vaccination 1
Single injection of 300 mcg PATH-wSP 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.
OG002
PATH-wSP (600 mcg)+Active Control: Vaccination 1
A single injection of 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG003
PATH-wSP (600 mcg)+Saline: Vaccination 1
Single injection of 600 mcg PATH-wSP 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.
OG004
Active Control Only: Vaccination 1
A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
OG005
PATH-wSP (300 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 300 mcg in the left thigh 8 weeks after the first vaccination of the same dosage plus two active control vaccines in the right thigh.
OG006
PATH-wSP (300 mcg)+Saline: Vaccination 2
Injection of PATH-wSP 300 mcg in the left thigh, 8 weeks after the first vaccination of the same plus a saline injection in the right thigh.
OG007
PATH-wSP (600 mcg)+Active Control: Vaccination 2
A single injection of PATH-wSP 600 mcg in the left thigh, 8 weeks after the first vaccination of the same dosage and two active control vaccinations in the right thigh
OG008
PATH-wSP (600 mcg)+Saline: Vaccination 2
A single injection of 600 mcg PATH-wSP in the left thigh, 8 weeks after receipt of vaccination of the same dosage and two saline injections in the right thigh.
OG009
Active Control Only: Vaccination 2
A single injection of saline in the left thigh, 8 weeks after the same saline injection plus a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh.
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
<2-Fold
OG00039
OG00136
OG00239
OG003
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).
Posted
Count of Participants
Participants
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
PATH-wSP (600 mcg): Baseline
Subjects receiving 600 mcg PATH-wSP: levels pre-vaccination
OG001
PATH-wSP (600 mcg): Vaccination 1
Subjects receiving 600 mcg PATH-wSP: levels after first vaccination
OG002
PATH-wSP (600 mcg): Vaccination 2
Subjects receiving 600 mcg PATH-wSP: levels after second vaccination
OG003
PATH-wSP (1000 mcg): Baseline
Subjects receiving 1000 mcg PATH-wSP: levels pre-vaccination
OG004
PATH-wSP (1000 mcg): Vaccination 1
Subjects receiving 1000 mcg PATH-wSP: levels after first vaccination
OG005
PATH-wSP (1000 mcg): Vaccination 2
Subjects receiving 1000 mcg PATH-wSP: levels after second vaccination
Subjects receiving saline placebo injection: levels after vaccination 1
OG008
Saline: Vaccination 2
Subjects receiving saline placebo injection: levels after vaccination 2
Units
Counts
Participants
OG00018
OG00118
OG00217
OG003
Title
Denominators
Categories
Title
Measurements
<1:20
OG0003
OG0013
OG0022
OG003
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).
Posted
Count of Participants
Participants
0 days, 28 days (Dose 1) and 56 days (Dose 2)
ID
Title
Description
OG000
PATH-wSP (300 mcg)+Active Control: Baseline
Subjects receiving 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination
OG001
PATH-wSP (300 mcg)+Active Control: Vaccination 1
Subjects receiving 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1
OG002
PATH-wSP (300 mcg)+Active Control: Vaccination 2
Subjects receiving 300 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
OG003
PATH-wSP (300 mcg)+Saline: Baseline
Subjects receiving 300 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: pre-vaccination
OG004
PATH-wSP (300 mcg)+Saline: Vaccination 1
Subjects receiving 300 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after vaccination 1
OG005
PATH-wSP (300 mcg)+Saline: Vaccination 2
Subjects receiving 300 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after vaccination 2
OG006
PATH-wSP (600 mcg)+Active Control: Baseline
Subjects receiving 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination
OG007
PATH-wSP (600 mcg)+Active Control: Vaccination 1
Subjects receiving 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1
OG008
PATH-wSP (600 mcg)+Active Control: Vaccination 2
Subjects receiving 600 mcg PATH-wSP in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
OG009
PATH-wSP (600 mcg)+Saline: Baseline
Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: pre-vaccination
OG010
PATH-wSP (600 mcg)+Saline: Vaccination 1
Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 1
OG011
PATH-wSP (600 mcg)+Saline: Vaccination 2
Subjects receiving 600 mcg PATH-wSP in the left thigh and two injections of saline placebo in the right thigh: after Vaccination 2
OG012
Active Control Only: Baseline
Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: pre-vaccination
OG013
Active Control Only: Vaccination 1
Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 1
OG014
Active Control Only: Vaccination 2
Subjects receiving saline placebo injection in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh: after vaccination 2
Units
Counts
Participants
OG00046
OG00146
OG00246
OG003
Title
Denominators
Categories
Title
Measurements
<1:20
OG00020
OG00119
OG00214
OG003
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.
The number analyzed may differ between proteins because of insufficient samples.
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.
OG001
Cohort 1: 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.
PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum
Saline: 0.9% Sodium Chloride Injection, USP
OG002
Cohort 1: Active Control Only
A single injection of saline 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 saline in the left thigh 8 weeks later.
OG003
Cohort 2 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.
OG004
Cohort 2: 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.
PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum
Saline: 0.9% Sodium Chloride Injection, USP
OG005
Cohort 2: 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.
Synflorix: 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
Pentavac: 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:
Units
Counts
Participants
OG00046
OG00147
OG00248
OG003
Title
Denominators
Categories
PnC-IgG-ELISA type 1
ParticipantsOG00046
ParticipantsOG00146
ParticipantsOG00248
ParticipantsOG003
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.
The number analyzed may differ between proteins because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
IU/mL
12 weeks post vaccination 1
ID
Title
Description
OG000
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.
OG001
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.
PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum
Saline: 0.9% Sodium Chloride Injection, USP
OG002
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.
OG003
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.
PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum
Saline: 0.9% Sodium Chloride Injection, USP
OG004
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.
Synflorix: 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
Pentavac: 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:
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
OG0007.73(6.38 to 9.36)
OG0010.25(0.20 to 0.32)
OG0027.71(6.48 to 9.19)
OG003
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.
The number analyzed may differ between proteins because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
mIU/mL
12 weeks post vaccination 1
ID
Title
Description
OG000
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.
OG001
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.
PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum
Saline: 0.9% Sodium Chloride Injection, USP
OG002
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.
OG003
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.
PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum
Saline: 0.9% Sodium Chloride Injection, USP
OG004
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.
Synflorix: 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
Pentavac: 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:
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
OG000784.78(532.71 to 11156.12)
OG001149.86(83.65 to 268.47)
OG002695.14(546.72 to 883.84)
OG003
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.
The number analyzed may differ between proteins because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
ug/mL
12 weeks post vaccination 1
ID
Title
Description
OG000
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.
OG001
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.
PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum
Saline: 0.9% Sodium Chloride Injection, USP
OG002
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.
OG003
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.
PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum
Saline: 0.9% Sodium Chloride Injection, USP
OG004
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.
Synflorix: 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
Pentavac: 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:
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
OG00041.05(29.61 to 56.92)
OG0011.68(1.20 to 2.34)
OG00239.06(30.70 to 49.68)
OG003
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.
The number analyzed may differ between proteins because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
IU/mL
12 weeks post vaccination 1
ID
Title
Description
OG000
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.
OG001
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.
PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum
Saline: 0.9% Sodium Chloride Injection, USP
OG002
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.
OG003
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.
PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum
Saline: 0.9% Sodium Chloride Injection, USP
OG004
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.
Synflorix: 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
Pentavac: 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:
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Pertussis FHA
Title
Measurements
OG00085.12(73.07 to 99.17)
OG0016.70(5.48 to 8.21)
OG00268.23(57.45 to 81.05)
OG003
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.
The number analyzed may differ between proteins because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
U/mL
12 weeks post vaccination 1
ID
Title
Description
OG000
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.
OG001
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.
PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum
Saline: 0.9% Sodium Chloride Injection, USP
OG002
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.
OG003
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.
PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum
Saline: 0.9% Sodium Chloride Injection, USP
OG004
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.
Synflorix: 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
Pentavac: 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:
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
OG000753.63(582.34 to 975.30)
OG00145.75(32.98 to 63.47)
OG002460.73(328.95 to 645.31)
OG003
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.
The number analyzed may differ between proteins because of insufficient samples.
Posted
Geometric Mean
90% Confidence Interval
IU/mL
12 weeks post vaccination 1
ID
Title
Description
OG000
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.
OG001
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.
PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum
Saline: 0.9% Sodium Chloride Injection, USP
OG002
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.
OG003
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.
PATH-wSP: Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum
Saline: 0.9% Sodium Chloride Injection, USP
OG004
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.
Synflorix: 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
Pentavac: 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:
Units
Counts
Participants
OG00048
OG00149
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
OG00021.83(18.94 to 25.17)
OG0011.15(0.93 to 1.43)
OG00221.64(19.01 to 24.62)
OG003
0
18
1
18
18
18
EG001
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.
0
18
1
18
16
18
EG002
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.
0
18
0
18
17
18
EG003
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.
1
50
6
50
50
50
EG004
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.
0
50
2
50
47
50
EG005
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.
0
50
2
50
48
50
EG006
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.
0
50
3
50
48
50
EG007
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.