Trial Outcomes & Findings for Nasopharyngeal Carriage Study in Healthy Kenyan Toddlers (NCT NCT02146365)
NCT ID: NCT02146365
Last Updated: 2020-02-17
Results Overview
The prevalence of Streptococcus pneumoniae (SPn) in the nasopharynx was measured by the number (and percentage) of participants positive for SPn detected by quantitative polymerase chain reaction (qPCR) from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only plus non-interventional participants enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only plus non-interventional participants enrolled during Cohort 2
Recruitment status
COMPLETED
Target enrollment
297 participants
Primary outcome timeframe
Week 0, Week 12, Week 16, Week 20, Week 32
Results posted on
2020-02-17
Participant Flow
This study enrolled healthy Kenyan toddlers who participated in the randomized control trial VAC-010 (NCT02097472) whose parents provided consent to participate in VAC-011. In addition, 50 healthy toddlers who did not participate in the VAC-010 study were enrolled from the community as a pneumococcal conjugate vaccine (PCV)-primed-only open cohort.
Participants were enrolled sequentially into Cohort 1 (PATH-wSP 300 µg or control) and Cohort 2 (PATH-wSP 600 µg or control).
Participant milestones
| Measure |
PATH-wSP 300 µg + Booster
Toddlers who enrolled in Cohort 1 of Study VAC-010 and received 300 µg PATH-wSP plus the two booster vaccines (Synflorix and Pentavac) followed by a 2nd injection of 300 µg PATH-wSP 8 weeks later.
|
PATH-wSP 300 µg Only
Toddlers who enrolled in Cohort 1 of Study VAC-010 and received 300 µg PATH-wSP and 2 saline injections followed by a 2nd injection of 300 µg PATH-wSP 8 weeks later.
|
PATH-wSP 600 µg + Booster
Toddlers who enrolled in Cohort 2 of Study VAC-010 and received 600 µg PATH-wSP plus the two booster vaccines (Synflorix and Pentavac) followed by a 2nd injection of 600 µg PATH-wSP 8 weeks later.
|
PATH-wSP 600 µg Only
Toddlers who enrolled in Cohort 2 of Study VAC-010 and received 600 µg PATH-wSP and 2 saline injections followed by a 2nd injection of 600 µg PATH-wSP 8 weeks later.
|
Booster Only (300 µg)
Toddlers who enrolled in Cohort 1 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
Booster Only (600 µg)
Toddlers who enrolled in Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention (300 µg)
Toddlers who enrolled during Cohort 1 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
No Intervention (600 µg)
Toddlers who enrolled during Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
49
|
50
|
50
|
24
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
45
|
45
|
43
|
41
|
22
|
24
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
7
|
9
|
2
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
PATH-wSP 300 µg + Booster
Toddlers who enrolled in Cohort 1 of Study VAC-010 and received 300 µg PATH-wSP plus the two booster vaccines (Synflorix and Pentavac) followed by a 2nd injection of 300 µg PATH-wSP 8 weeks later.
|
PATH-wSP 300 µg Only
Toddlers who enrolled in Cohort 1 of Study VAC-010 and received 300 µg PATH-wSP and 2 saline injections followed by a 2nd injection of 300 µg PATH-wSP 8 weeks later.
|
PATH-wSP 600 µg + Booster
Toddlers who enrolled in Cohort 2 of Study VAC-010 and received 600 µg PATH-wSP plus the two booster vaccines (Synflorix and Pentavac) followed by a 2nd injection of 600 µg PATH-wSP 8 weeks later.
|
PATH-wSP 600 µg Only
Toddlers who enrolled in Cohort 2 of Study VAC-010 and received 600 µg PATH-wSP and 2 saline injections followed by a 2nd injection of 600 µg PATH-wSP 8 weeks later.
|
Booster Only (300 µg)
Toddlers who enrolled in Cohort 1 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
Booster Only (600 µg)
Toddlers who enrolled in Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention (300 µg)
Toddlers who enrolled during Cohort 1 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
No Intervention (600 µg)
Toddlers who enrolled during Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
3
|
3
|
1
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
5
|
1
|
0
|
0
|
0
|
|
Overall Study
Unable to Comply with Protocol
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
1
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Nasopharyngeal Carriage Study in Healthy Kenyan Toddlers
Baseline characteristics by cohort
| Measure |
PATH-wSP 300 µg + Booster
n=49 Participants
Toddlers who enrolled in Cohort 1 of Study VAC-010 and received 300 µg PATH-wSP plus the two booster vaccines (Synflorix and Pentavac) followed by a 2nd injection of 300 µg PATH-wSP 8 weeks later.
|
PATH-wSP 300 µg Only
n=49 Participants
Toddlers who enrolled in Cohort 1 of Study VAC-010 and received 300 µg PATH-wSP and 2 saline injections followed by a 2nd injection of 300 µg PATH-wSP 8 weeks later.
|
PATH-wSP 600 µg + Booster
n=50 Participants
Toddlers who enrolled in Cohort 2 of Study VAC-010 and received 600 µg PATH-wSP plus the two booster vaccines (Synflorix and Pentavac) followed by a 2nd injection of 600 µg PATH-wSP 8 weeks later.
|
PATH-wSP 600 µg Only
n=50 Participants
Toddlers who enrolled in Cohort 2 of Study VAC-010 and received 600 µg PATH-wSP and 2 saline injections followed by a 2nd injection of 600 µg PATH-wSP 8 weeks later.
|
Booster Only (Both Cohorts)
n=49 Participants
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
n=50 Participants
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
Total
n=297 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
13.2 months
STANDARD_DEVIATION 1.1 • n=5 Participants
|
13.0 months
STANDARD_DEVIATION 1.1 • n=7 Participants
|
13.3 months
STANDARD_DEVIATION 1.1 • n=5 Participants
|
13.5 months
STANDARD_DEVIATION 1.2 • n=4 Participants
|
13.1 months
STANDARD_DEVIATION 1.0 • n=21 Participants
|
13.3 months
STANDARD_DEVIATION 1.2 • n=10 Participants
|
13.2 months
STANDARD_DEVIATION 1.1 • n=115 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
31 Participants
n=10 Participants
|
157 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
140 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Luhya
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Luo
|
45 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
48 Participants
n=10 Participants
|
274 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: The Nasopharyngeal Carriage (NPC) population included enrolled participants with at least one post-enrollment swab measurement not associated with a protocol violation that may have interfered with the assessment of NPC outcomes. VAC-010 participants who did not receive both vaccinations were excluded.
The prevalence of Streptococcus pneumoniae (SPn) in the nasopharynx was measured by the number (and percentage) of participants positive for SPn detected by quantitative polymerase chain reaction (qPCR) from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only plus non-interventional participants enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only plus non-interventional participants enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=91 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=47 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=94 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=50 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Prevalence of Streptococcus Pneumoniae in Nasopharynx
Visit 1 (Week 0)
|
76 Participants
|
43 Participants
|
86 Participants
|
46 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae in Nasopharynx
Visit 2 (Week 12)
|
77 Participants
|
44 Participants
|
80 Participants
|
47 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae in Nasopharynx
Visit 4 (Week 20)
|
85 Participants
|
43 Participants
|
81 Participants
|
44 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae in Nasopharynx
Visit 3 (Week 16)
|
85 Participants
|
43 Participants
|
81 Participants
|
45 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae in Nasopharynx
Visit 5 (Week 32)
|
81 Participants
|
43 Participants
|
71 Participants
|
43 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: The Nasopharyngeal Carriage (NPC) population with available LytA data at each time point
The density of Streptococcus pneumoniae (SPn) in the nasopharynx was measured by the number of autolysin (LytA) gene copies detected by quantitative polymerase chain reaction (qPCR) from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=79 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=43 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=85 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=49 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Density of Streptococcus Pneumoniae in the Nasopharynx
Visit 2 (Week 12)
|
14.0 log LytA copies
Interval 12.9 to 14.9
|
13.0 log LytA copies
Interval 11.3 to 14.3
|
16.4 log LytA copies
Interval 15.6 to 17.2
|
15.9 log LytA copies
Interval 14.7 to 17.4
|
—
|
—
|
|
Density of Streptococcus Pneumoniae in the Nasopharynx
Visit 3 (Week 16)
|
14.7 log LytA copies
Interval 14.0 to 15.2
|
14.5 log LytA copies
Interval 13.6 to 15.7
|
16.8 log LytA copies
Interval 16.0 to 17.3
|
16.5 log LytA copies
Interval 15.2 to 17.5
|
—
|
—
|
|
Density of Streptococcus Pneumoniae in the Nasopharynx
Visit 4 (Week 20)
|
15.1 log LytA copies
Interval 14.4 to 15.8
|
14.0 log LytA copies
Interval 13.1 to 15.2
|
15.5 log LytA copies
Interval 14.6 to 16.3
|
15.1 log LytA copies
Interval 14.1 to 16.2
|
—
|
—
|
|
Density of Streptococcus Pneumoniae in the Nasopharynx
Visit 5 (Week 32)
|
16.8 log LytA copies
Interval 16.2 to 17.3
|
14.9 log LytA copies
Interval 14.5 to 16.0
|
14.9 log LytA copies
Interval 14.1 to 15.7
|
14.8 log LytA copies
Interval 14.0 to 15.9
|
—
|
—
|
|
Density of Streptococcus Pneumoniae in the Nasopharynx
Visit 1 (Week 0)
|
13.5 log LytA copies
Interval 12.4 to 14.6
|
12.5 log LytA copies
Interval 11.7 to 14.4
|
13.9 log LytA copies
Interval 13.2 to 14.5
|
13.8 log LytA copies
Interval 12.9 to 14.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0), 4 weeks post-vaccination 2 (Week 12), and 6 months post-vaccination 2 (Week 32).Population: The Immunogenicity (IG) population includes participants enrolled in Study VAC-010 with at least one usable value in the VAC-011 immunogenicity data set. VAC-010 participants who did not receive both vaccinations were excluded.
Immunogenicity was evaluated based on the following assays: 1. Immunoglobulin (IgG) response to pneumolysoid \[L460D\] and pneumococcal surface protein A family 1 \[PspA-Fam1\] was measured by enzyme-linked immunosorbent assay (ELISA). 2. IgG response to the following pneumococcal proteins was measured using the Meso Scale Discovery (MSD) platform: * L460D * PspA-Fam1 * Pneumococcal histidine triad D (PhtD) * Boston Children's Hospital protein 785 (BCH0785) * Serine threonine kinase protein (StkP) * Pneumococcal choline-binding protein A (PcpA) * Streptococcus pneumonia whole cell antigen (SPWCA) * Pneumococcal iron uptake protein A (PiuA) * Pneumococcal iron acquisition protein A (PiaA)
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=43 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=40 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=38 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=35 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
n=38 Participants
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PhtD: 4 weeks post-Vaccination 2
|
847.28 titer
Interval 636.32 to 1128.18
|
773.24 titer
Interval 610.73 to 979.01
|
702.42 titer
Interval 512.66 to 962.4
|
1174.38 titer
Interval 910.85 to 1514.14
|
575.56 titer
Interval 423.05 to 783.05
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
Pneumolysoid (L460D): Baseline
|
381.12 titer
Interval 272.73 to 532.58
|
330.58 titer
Interval 218.99 to 499.03
|
785.54 titer
Interval 546.78 to 1128.56
|
832.32 titer
Interval 561.77 to 1233.19
|
497.88 titer
Interval 329.88 to 751.44
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
Pneumolysoid (L460D): 4 weeks post-Vaccination 2
|
813.00 titer
Interval 560.96 to 1178.29
|
786.26 titer
Interval 539.05 to 1146.83
|
1600 titer
Interval 1130.57 to 2264.35
|
2330.97 titer
Interval 1571.0 to 3457.66
|
545.42 titer
Interval 377.42 to 788.21
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
Pneumolysoid (L460D): 6 months post-Vaccination 2
|
1069.31 titer
Interval 739.69 to 1545.8
|
1212.57 titer
Interval 894.84 to 1643.12
|
1372.33 titer
Interval 1021.16 to 1844.25
|
1697.94 titer
Interval 1224.11 to 2355.18
|
1051.76 titer
Interval 757.13 to 1461.05
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PspA-Fam1 (ELISA): Baseline
|
397.94 titer
Interval 284.0 to 557.59
|
382.99 titer
Interval 277.26 to 529.05
|
602.57 titer
Interval 450.01 to 806.85
|
725.31 titer
Interval 533.27 to 986.52
|
513.79 titer
Interval 388.35 to 679.75
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PspA-Fam1 (ELISA): 4 weeks post-Vaccination 2
|
720.33 titer
Interval 551.98 to 940.03
|
571.29 titer
Interval 418.14 to 780.55
|
870.53 titer
Interval 672.36 to 1127.1
|
1409.82 titer
Interval 979.31 to 2029.6
|
514.81 titer
Interval 362.75 to 730.63
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PspA-Fam1 (ELISA): 6 months post-Vaccination 2
|
873.74 titer
Interval 618.19 to 1234.94
|
824.96 titer
Interval 558.84 to 1217.81
|
762.72 titer
Interval 555.97 to 1046.35
|
1239.01 titer
Interval 892.62 to 1719.83
|
796.22 titer
Interval 557.37 to 1137.42
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
L460D: Baseline
|
261.25 titer
Interval 199.66 to 341.84
|
234.51 titer
Interval 171.83 to 320.05
|
314.86 titer
Interval 240.39 to 412.41
|
346.26 titer
Interval 273.01 to 439.16
|
241.08 titer
Interval 187.27 to 310.35
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
L460D: 4 weeks post-Vaccination 2
|
460.91 titer
Interval 344.59 to 616.5
|
440.19 titer
Interval 335.66 to 577.28
|
622.67 titer
Interval 484.23 to 800.7
|
917.86 titer
Interval 696.84 to 1208.97
|
303.90 titer
Interval 234.88 to 393.22
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
L460D: 6 months post-Vaccination 2
|
499.10 titer
Interval 373.82 to 666.36
|
525.38 titer
Interval 413.09 to 668.18
|
508.30 titer
Interval 384.86 to 671.33
|
701.06 titer
Interval 551.11 to 891.8
|
380.59 titer
Interval 294.18 to 492.39
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PspA-Fam1 (MSD): Baseline
|
172.25 titer
Interval 116.1 to 255.57
|
195.25 titer
Interval 128.65 to 296.33
|
219.55 titer
Interval 151.45 to 318.27
|
231.28 titer
Interval 156.45 to 341.9
|
218.24 titer
Interval 153.16 to 310.99
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PspA-Fam1 (MSD): 4 weeks post-Vaccination 2
|
368.08 titer
Interval 261.0 to 519.08
|
357.83 titer
Interval 242.6 to 527.79
|
349.00 titer
Interval 254.08 to 479.38
|
609.24 titer
Interval 406.57 to 912.93
|
213.82 titer
Interval 137.75 to 331.91
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PspA-Fam1 (MSD): 6 months post-Vaccination 2
|
303.31 titer
Interval 208.18 to 441.91
|
339.07 titer
Interval 220.62 to 521.1
|
362.35 titer
Interval 264.93 to 495.58
|
548.93 titer
Interval 383.92 to 784.84
|
317.09 titer
Interval 213.51 to 470.92
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PhtD: Baseline
|
464.43 titer
Interval 335.55 to 642.8
|
456.19 titer
Interval 339.35 to 613.26
|
464.52 titer
Interval 315.74 to 683.42
|
555.72 titer
Interval 415.87 to 742.6
|
377.18 titer
Interval 272.45 to 522.17
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PhtD: 6 months post-Vaccination 2
|
1128.66 titer
Interval 851.33 to 1496.33
|
1163.21 titer
Interval 946.47 to 1429.57
|
926.31 titer
Interval 692.19 to 1239.6
|
1282.89 titer
Interval 975.69 to 1686.81
|
890.03 titer
Interval 659.09 to 1201.88
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
BCH0785: Baseline
|
401.04 titer
Interval 289.77 to 555.05
|
322.75 titer
Interval 239.06 to 435.74
|
267.80 titer
Interval 187.61 to 382.28
|
371.19 titer
Interval 258.34 to 533.31
|
314.85 titer
Interval 213.23 to 464.88
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
BCH0785: 4 weeks post-Vaccination 2
|
555.25 titer
Interval 396.67 to 777.24
|
514.90 titer
Interval 400.37 to 662.18
|
411.22 titer
Interval 297.25 to 568.88
|
761.38 titer
Interval 541.86 to 1069.83
|
397.66 titer
Interval 280.8 to 563.15
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
BCH0785: 6 months post-Vaccination 2
|
539.24 titer
Interval 406.71 to 714.95
|
602.44 titer
Interval 472.33 to 768.4
|
385.46 titer
Interval 279.12 to 532.3
|
726.43 titer
Interval 542.87 to 972.06
|
460.80 titer
Interval 327.57 to 648.21
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
StkP: Baseline
|
193.50 titer
Interval 135.62 to 276.08
|
142.90 titer
Interval 107.04 to 190.79
|
163.30 titer
Interval 110.56 to 241.2
|
246.51 titer
Interval 170.96 to 355.45
|
191.77 titer
Interval 136.54 to 269.35
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
StkP: 4 weeks post-Vaccination 2
|
334.14 titer
Interval 238.9 to 467.33
|
240.51 titer
Interval 190.85 to 303.1
|
253.15 titer
Interval 181.99 to 352.13
|
444.83 titer
Interval 322.88 to 612.84
|
235.29 titer
Interval 169.75 to 326.15
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
StkP: 6 months post-Vaccination 2
|
304.48 titer
Interval 219.27 to 422.8
|
331.73 titer
Interval 262.02 to 420.0
|
278.27 titer
Interval 197.74 to 391.6
|
470.92 titer
Interval 345.08 to 642.66
|
305.51 titer
Interval 214.28 to 435.58
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PcpA: Baseline
|
320.15 titer
Interval 199.08 to 514.86
|
369.58 titer
Interval 213.36 to 640.18
|
307.97 titer
Interval 160.95 to 589.28
|
464.90 titer
Interval 278.23 to 776.8
|
302.03 titer
Interval 177.98 to 512.53
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PcpA: 4 weeks post-Vaccination 2
|
383.75 titer
Interval 237.14 to 620.99
|
358.39 titer
Interval 218.41 to 588.08
|
387.80 titer
Interval 216.85 to 693.5
|
527.74 titer
Interval 303.33 to 918.2
|
351.00 titer
Interval 194.02 to 635.0
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PcpA: 6 months post-Vaccination 2
|
631.99 titer
Interval 394.03 to 1013.67
|
681.06 titer
Interval 470.01 to 986.87
|
633.57 titer
Interval 400.16 to 1003.12
|
779.77 titer
Interval 499.74 to 1216.72
|
558.79 titer
Interval 338.9 to 921.36
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
SPWCA: Baseline
|
676.76 titer
Interval 584.1 to 784.1
|
665.77 titer
Interval 575.42 to 770.3
|
630.23 titer
Interval 527.12 to 753.5
|
669.91 titer
Interval 590.27 to 760.29
|
660.13 titer
Interval 575.51 to 757.18
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
SPWCA: 4 weeks post-Vaccination 2
|
852.45 titer
Interval 735.87 to 987.5
|
782.09 titer
Interval 701.14 to 872.38
|
815.92 titer
Interval 722.01 to 922.06
|
965.60 titer
Interval 817.61 to 1140.38
|
762.31 titer
Interval 663.45 to 875.89
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
SPWCA: 6 months post-Vaccination 2
|
849.99 titer
Interval 730.32 to 989.27
|
908.71 titer
Interval 797.98 to 1034.8
|
828.46 titer
Interval 718.93 to 954.67
|
1020.25 titer
Interval 895.7 to 1162.12
|
700.71 titer
Interval 595.24 to 824.86
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PiuA: Baseline
|
685.69 titer
Interval 530.35 to 886.53
|
631.45 titer
Interval 489.14 to 815.17
|
585.28 titer
Interval 451.15 to 759.3
|
697.84 titer
Interval 521.35 to 934.08
|
608.91 titer
Interval 457.96 to 809.6
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PiuA: 4 weeks post-Vaccination 2
|
938.09 titer
Interval 717.5 to 1226.49
|
867.54 titer
Interval 693.68 to 1084.98
|
925.23 titer
Interval 758.38 to 1128.79
|
1164.80 titer
Interval 894.83 to 1516.2
|
743.11 titer
Interval 574.02 to 962.0
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PiuA: 6 months post-Vaccination 2
|
1035.89 titer
Interval 806.39 to 1330.7
|
1274.26 titer
Interval 989.51 to 1640.94
|
998.07 titer
Interval 795.24 to 1252.64
|
1188.92 titer
Interval 927.29 to 1524.37
|
923.97 titer
Interval 665.8 to 1282.27
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PiaA: Baseline
|
650.37 titer
Interval 494.57 to 855.26
|
560.35 titer
Interval 406.33 to 772.74
|
604.16 titer
Interval 453.7 to 804.5
|
886.79 titer
Interval 678.57 to 1158.92
|
606.15 titer
Interval 472.84 to 777.05
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PiaA: 4 weeks post-Vaccination 2
|
930.90 titer
Interval 705.04 to 1229.1
|
851.40 titer
Interval 651.29 to 1113.01
|
788.37 titer
Interval 626.08 to 992.72
|
1574.97 titer
Interval 1207.4 to 2054.43
|
805.26 titer
Interval 605.9 to 1070.23
|
—
|
|
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PiaA: 6 months post-Vaccination
|
1014.92 titer
Interval 782.79 to 1315.88
|
1055.71 titer
Interval 782.89 to 1423.6
|
732.05 titer
Interval 556.8 to 962.48
|
1428.92 titer
Interval 1120.44 to 1822.33
|
816.56 titer
Interval 605.56 to 1101.08
|
—
|
SECONDARY outcome
Timeframe: Week 32Population: Immunogenicity population
Data reported are the geometric mean concentration at 6 months post-vaccination 2 (Week 32) for each PATH-wSP group divided by the Booster (Synflorix and Pentavax)-only group (N=38). Immunogenicity was evaluated based on the following assays: 1. Immunoglobulin (IgG) response to pneumolysoid (L460D) and pneumococcal surface protein A family 1 (PspA-Fam1) was measured by enzyme-linked immunosorbent assay (ELISA). 2. IgG response to the following pneumococcal proteins was measured using the Meso Scale Discovery (MSD) platform: * L460D * PspA-Fam1 * Pneumococcal histidine triad D (PhtD) * Boston Children's Hospital protein 785 (BCH0785) * Serine threonine kinase protein (StkP) * Pneumococcal choline-binding protein A (PcpA) * Streptococcus pneumonia whole cell antigen (SPWCA) * Pneumococcal iron uptake protein A (PiuA) * Pneumococcal iron acquisition protein A (PiaA)
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=43 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=40 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=38 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=35 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group
Pneumolysoid (L460D)
|
1.02 ratio
Interval 0.62 to 1.67
|
1.15 ratio
Interval 0.74 to 1.79
|
1.30 ratio
Interval 0.84 to 2.02
|
1.61 ratio
Interval 1.02 to 2.55
|
—
|
—
|
|
Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group
PspA-Fam1 (ELISA)
|
1.10 ratio
Interval 0.67 to 1.79
|
1.04 ratio
Interval 0.61 to 1.75
|
0.96 ratio
Interval 0.6 to 1.53
|
1.56 ratio
Interval 0.96 to 2.52
|
—
|
—
|
|
Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group
L460D
|
1.31 ratio
Interval 0.89 to 1.93
|
1.38 ratio
Interval 0.98 to 1.95
|
1.34 ratio
Interval 0.92 to 1.94
|
1.84 ratio
Interval 1.3 to 2.61
|
—
|
—
|
|
Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group
PspA-Fam1 (MSD)
|
0.96 ratio
Interval 0.56 to 1.64
|
1.07 ratio
Interval 0.6 to 1.91
|
1.14 ratio
Interval 0.69 to 1.88
|
1.73 ratio
Interval 1.02 to 2.94
|
—
|
—
|
|
Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group
PhtD
|
1.27 ratio
Interval 0.84 to 1.91
|
1.31 ratio
Interval 0.91 to 1.87
|
1.04 ratio
Interval 0.69 to 1.88
|
1.44 ratio
Interval 0.96 to 2.16
|
—
|
—
|
|
Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group
BCH0785
|
1.17 ratio
Interval 0.76 to 1.81
|
1.31 ratio
Interval 0.87 to 1.97
|
0.84 ratio
Interval 0.53 to 1.33
|
1.58 ratio
Interval 1.01 to 2.46
|
—
|
—
|
|
Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group
StkP
|
1.00 ratio
Interval 0.62 to 1.61
|
1.09 ratio
Interval 0.72 to 1.65
|
0.91 ratio
Interval 0.56 to 1.48
|
1.54 ratio
Interval 0.96 to 2.46
|
—
|
—
|
|
Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group
PcpA
|
1.13 ratio
Interval 0.57 to 2.23
|
1.22 ratio
Interval 0.66 to 2.24
|
1.13 ratio
Interval 0.58 to 2.22
|
1.40 ratio
Interval 0.72 to 2.71
|
—
|
—
|
|
Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group
SPWCA
|
1.21 ratio
Interval 0.97 to 1.51
|
1.30 ratio
Interval 1.06 to 1.59
|
1.18 ratio
Interval 0.96 to 1.46
|
1.46 ratio
Interval 1.18 to 1.79
|
—
|
—
|
|
Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group
PiuA
|
1.12 ratio
Interval 0.75 to 1.68
|
1.38 ratio
Interval 0.92 to 2.07
|
1.08 ratio
Interval 0.73 to 1.6
|
1.29 ratio
Interval 0.85 to 1.94
|
—
|
—
|
|
Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group
PiaA
|
1.24 ratio
Interval 0.84 to 1.83
|
1.29 ratio
Interval 0.85 to 1.96
|
0.90 ratio
Interval 0.6 to 1.34
|
1.75 ratio
Interval 1.19 to 2.57
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 32Population: Immunogenicity Population
Immunogenicity was evaluated based on the following assays: 1. IgG response to pneumolysoid \[L460D\] and pneumococcal surface protein A family 1 \[PspA-Fam1\] was measured by enzyme-linked immunosorbent assay (ELISA). 2. IgG response to the following pneumococcal proteins was measured using the Meso Scale Discovery (MSD) platform: * L460D * PspA-Fam1 * Pneumococcal histidine triad D (PhtD) * Boston Children's Hospital protein 785 (BCH0785) * Serine threonine kinase protein (StkP) * Pneumococcal choline-binding protein A (PcpA) * Streptococcus pneumonia whole cell antigen (SPWCA) * Pneumococcal iron uptake protein A (PiuA) * Pneumococcal iron acquisition protein A (PiaA) The fold-change was calculated as the 6-month post-vaccination (Week 32) IgG response divided by the Baseline IgG response.
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=43 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=40 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=38 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=35 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
n=38 Participants
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
Pneumolysoid (L460D)
|
2.81 fold-change
Interval 2.09 to 3.76
|
3.67 fold-change
Interval 2.88 to 4.67
|
1.75 fold-change
Interval 1.36 to 2.24
|
2.04 fold-change
Interval 1.54 to 2.69
|
2.11 fold-change
Interval 1.47 to 3.03
|
—
|
|
Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PspA-Fam1 (ELISA)
|
2.20 fold-change
Interval 1.64 to 2.94
|
2.15 fold-change
Interval 1.5 to 3.1
|
1.27 fold-change
Interval 0.89 to 1.81
|
1.71 fold-change
Interval 1.2 to 2.43
|
1.55 fold-change
Interval 1.15 to 2.08
|
—
|
|
Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
L460D
|
1.91 fold-change
Interval 1.51 to 2.42
|
2.24 fold-change
Interval 1.81 to 2.78
|
1.61 fold-change
Interval 1.27 to 2.04
|
2.02 fold-change
Interval 1.64 to 2.5
|
1.58 fold-change
Interval 1.25 to 1.99
|
—
|
|
Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PspA-Fam1 (MSD)
|
1.76 fold-change
Interval 1.25 to 2.49
|
1.74 fold-change
Interval 1.13 to 2.66
|
1.65 fold-change
Interval 1.17 to 2.32
|
2.37 fold-change
Interval 1.64 to 3.44
|
1.45 fold-change
Interval 1.05 to 2.02
|
—
|
|
Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PhtD
|
2.43 fold-change
Interval 1.87 to 3.16
|
2.55 fold-change
Interval 1.96 to 3.31
|
1.99 fold-change
Interval 1.48 to 2.68
|
2.31 fold-change
Interval 1.81 to 2.95
|
2.36 fold-change
Interval 1.77 to 3.15
|
—
|
|
Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
BCH0785
|
1.34 fold-change
Interval 1.04 to 1.73
|
1.87 fold-change
Interval 1.48 to 2.36
|
1.44 fold-change
Interval 1.1 to 1.88
|
1.96 fold-change
Interval 1.49 to 2.46
|
1.59 fold-change
Interval 1.28 to 1.98
|
—
|
|
Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
StkP
|
1.57 fold-change
Interval 1.17 to 2.11
|
2.32 fold-change
Interval 1.8 to 2.99
|
1.70 fold-change
Interval 1.32 to 2.19
|
1.91 fold-change
Interval 1.48 to 2.46
|
1.59 fold-change
Interval 1.28 to 1.98
|
—
|
|
Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PcpA
|
1.97 fold-change
Interval 1.44 to 2.71
|
1.84 fold-change
Interval 1.16 to 2.94
|
2.06 fold-change
Interval 1.36 to 3.12
|
1.68 fold-change
Interval 1.19 to 2.36
|
1.85 fold-change
Interval 1.19 to 2.88
|
—
|
|
Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
SPWCA
|
1.26 fold-change
Interval 1.04 to 1.52
|
1.36 fold-change
Interval 1.17 to 1.59
|
1.31 fold-change
Interval 1.11 to 1.56
|
1.52 fold-change
Interval 1.35 to 1.72
|
1.06 fold-change
Interval 0.88 to 1.28
|
—
|
|
Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PiuA
|
1.51 fold-change
Interval 1.22 to 1.88
|
2.02 fold-change
Interval 1.62 to 2.51
|
1.71 fold-change
Interval 1.32 to 2.2
|
1.70 fold-change
Interval 1.38 to 2.1
|
1.52 fold-change
Interval 1.24 to 1.85
|
—
|
|
Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
PiaA
|
1.56 fold-change
Interval 1.18 to 2.07
|
1.88 fold-change
Interval 1.39 to 2.56
|
1.21 fold-change
Interval 0.99 to 1.49
|
1.61 fold-change
Interval 1.23 to 2.12
|
1.35 fold-change
Interval 1.03 to 1.76
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 32Population: Immunogenicity Population
The percentage of participants with a seroresponse, defined as a ≥ 2, ≥ 3, and ≥ 4 fold-rise above Baseline in IgG antibody levels against Pneumococcal proteins. Fold-rise was calculated as the 6-month post-vaccination (Week 32) IgG response divided by the Baseline IgG level. Immunogenicity was evaluated based on the following assays: 1. IgG response to pneumolysoid \[L460D\] and pneumococcal surface protein A family 1 \[PspA-Fam1\] was measured by enzyme-linked immunosorbent assay (ELISA). 2. IgG response to the following pneumococcal proteins was measured using the Meso Scale Discovery (MSD) platform: * L460D * PspA-Fam1 * Pneumococcal histidine triad D (PhtD) * Boston Children's Hospital protein 785 (BCH0785) * Serine threonine kinase protein (StkP) * Pneumococcal choline-binding protein A (PcpA) * Streptococcus pneumonia whole cell antigen (SPWCA) * Pneumococcal iron uptake protein A (PiuA) * Pneumococcal iron acquisition protein A (PiaA)
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=43 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=40 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=38 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=35 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
n=38 Participants
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
Pneumolysoid (L460D): ≥ 2 Fold-Rise
|
72.1 percentage of participants
Interval 58.74 to 83.04
|
87.5 percentage of participants
Interval 75.5 to 94.94
|
60.5 percentage of participants
Interval 45.9 to 73.86
|
62.9 percentage of participants
Interval 47.56 to 76.44
|
55.3 percentage of participants
Interval 40.75 to 69.13
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
Pneumolysoid (L460D): ≥ 3 Fold-Rise
|
44.2 percentage of participants
Interval 31.2 to 57.8
|
57.5 percentage of participants
Interval 43.31 to 70.82
|
28.9 percentage of participants
Interval 17.16 to 43.33
|
34.3 percentage of participants
Interval 21.12 to 49.55
|
39.5 percentage of participants
Interval 26.14 to 54.1
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
Pneumolysoid (L460D): ≥4 Fold-Rise
|
44.2 percentage of participants
Interval 31.2 to 57.8
|
57.5 percentage of participants
Interval 43.31 to 70.82
|
26.3 percentage of participants
Interval 15.03 to 40.54
|
34.3 percentage of participants
Interval 21.12 to 49.55
|
39.5 percentage of participants
Interval 26.14 to 54.1
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
PspA-Fam1 (ELISA): ≥ 2 Fold-Rise
|
41.9 percentage of participants
Interval 29.08 to 55.52
|
60.0 percentage of participants
Interval 45.78 to 73.06
|
28.9 percentage of participants
Interval 17.16 to 43.33
|
42.9 percentage of participants
Interval 28.58 to 58.08
|
36.8 percentage of participants
Interval 23.83 to 51.47
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
PspA-Fam1 (ELISA): ≥ 3 Fold-Rise
|
32.6 percentage of participants
Interval 20.88 to 46.13
|
42.5 percentage of participants
Interval 29.18 to 56.69
|
15.8 percentage of participants
Interval 7.11 to 28.8
|
37.1 percentage of participants
Interval 23.56 to 52.44
|
26.3 percentage of participants
Interval 15.03 to 40.54
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
PspA-Fam1 (ELISA): ≥ 4 Fold-Rise
|
25.6 percentage of participants
Interval 15.06 to 38.77
|
30.0 percentage of participants
Interval 18.31 to 44.03
|
13.2 percentage of participants
Interval 5.33 to 25.7
|
22.9 percentage of participants
Interval 11.91 to 37.48
|
23.7 percentage of participants
Interval 12.95 to 37.69
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
L460D: ≥ 2 Fold-Rise
|
46.5 percentage of participants
Interval 33.35 to 60.05
|
52.5 percentage of participants
Interval 38.48 to 66.23
|
34.2 percentage of participants
Interval 21.56 to 48.8
|
48.6 percentage of participants
Interval 33.79 to 63.54
|
36.8 percentage of participants
Interval 23.83 to 51.47
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
L460D: ≥ 3 Fold-Rise
|
23.3 percentage of participants
Interval 13.2 to 36.25
|
40.0 percentage of participants
Interval 26.94 to 54.22
|
15.8 percentage of participants
Interval 7.11 to 28.8
|
31.4 percentage of participants
Interval 18.73 to 46.61
|
18.4 percentage of participants
Interval 8.98 to 31.83
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
L460D: ≥ 4 Fold-Rise
|
14.0 percentage of participants
Interval 6.26 to 25.69
|
27.5 percentage of participants
Interval 16.25 to 41.39
|
10.5 percentage of participants
Interval 3.68 to 22.49
|
17.1 percentage of participants
Interval 7.74 to 31.06
|
10.5 percentage of participants
Interval 3.68 to 22.49
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
PspA-Fam1 (MSD): ≥ 2 Fold-Rise
|
32.6 percentage of participants
Interval 20.88 to 46.13
|
37.5 percentage of participants
Interval 24.73 to 51.72
|
44.7 percentage of participants
Interval 30.87 to 59.25
|
45.7 percentage of participants
Interval 31.17 to 60.83
|
39.5 percentage of participants
Interval 26.14 to 54.1
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
PspA-Fam1 (MSD): ≥ 3 Fold-Rise
|
25.6 percentage of participants
Interval 15.06 to 38.77
|
30.0 percentage of participants
Interval 18.31 to 44.03
|
31.6 percentage of participants
Interval 19.34 to 46.09
|
42.9 percentage of participants
Interval 28.58 to 58.08
|
21.1 percentage of participants
Interval 10.93 to 34.79
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
PspA-Fam1 (MSD): ≥ 4 Fold-Rise
|
20.9 percentage of participants
Interval 11.38 to 33.68
|
27.5 percentage of participants
Interval 16.25 to 41.39
|
23.7 percentage of participants
Interval 12.95 to 37.69
|
31.4 percentage of participants
Interval 18.73 to 46.61
|
15.8 percentage of participants
Interval 7.11 to 28.8
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
PhtD: ≥ 2 Fold-Ris2
|
58.1 percentage of participants
Interval 44.48 to 70.92
|
50.0 percentage of participants
Interval 36.11 to 63.89
|
57.9 percentage of participants
Interval 43.31 to 71.52
|
54.3 percentage of participants
Interval 39.17 to 68.83
|
60.5 percentage of participants
Interval 45.9 to 73.86
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
PhtD: ≥ 3 Fold-Rise
|
46.5 percentage of participants
Interval 33.35 to 60.05
|
40.0 percentage of participants
Interval 26.94 to 54.22
|
28.9 percentage of participants
Interval 17.16 to 43.33
|
40.0 percentage of participants
Interval 26.05 to 55.28
|
42.1 percentage of participants
Interval 28.48 to 56.69
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
PhtD: ≥ 4 Fold-Rise
|
25.6 percentage of participants
Interval 15.06 to 37.77
|
35.0 percentage of participants
Interval 22.55 to 49.49
|
15.8 percentage of participants
Interval 7.11 to 28.8
|
17.1 percentage of participants
Interval 7.74 to 31.06
|
28.9 percentage of participants
Interval 17.16 to 43.33
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
BCH0785: ≥ 2 Fold-Rise
|
32.6 percentage of participants
Interval 20.88 to 46.13
|
50.0 percentage of participants
Interval 36.11 to 63.89
|
42.1 percentage of participants
Interval 28.48 to 56.69
|
42.9 percentage of participants
Interval 28.58 to 58.08
|
39.5 percentage of participants
Interval 26.14 to 54.1
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
BCH0785: ≥ 3 Fold-Rise
|
23.3 percentage of participants
Interval 13.2 to 36.25
|
27.5 percentage of participants
Interval 16.25 to 41.39
|
18.4 percentage of participants
Interval 8.98 to 31.83
|
28.6 percentage of participants
Interval 16.4 to 43.63
|
26.3 percentage of participants
Interval 15.03 to 40.54
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
StkP: ≥ 2 Fold-Rise
|
32.6 percentage of participants
Interval 20.88 to 46.13
|
52.5 percentage of participants
Interval 38.48 to 66.23
|
42.1 percentage of participants
Interval 28.48 to 56.69
|
48.06 percentage of participants
Interval 33.79 to 63.54
|
36.8 percentage of participants
Interval 23.83 to 51.47
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
StkP: ≥ 4 Fold-Rise
|
18.6 percentage of participants
Interval 9.61 to 31.07
|
27.5 percentage of participants
Interval 16.25 to 41.39
|
10.5 percentage of participants
Interval 3.68 to 22.49
|
20.0 percentage of participants
Interval 9.78 to 34.3
|
13.2 percentage of participants
Interval 5.33 to 25.7
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
PcpA: ≥ 3 Fold-Rise
|
30.2 percentage of participants
Interval 18.9 to 43.71
|
35.0 percentage of participants
Interval 22.55 to 49.19
|
34.2 percentage of participants
Interval 21.56 to 48.8
|
31.4 percentage of participants
Interval 18.73 to 46.61
|
31.6 percentage of participants
Interval 19.34 to 46.09
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
PcpA: ≥ 4 Fold-Rise
|
25.6 percentage of participants
Interval 15.06 to 38.77
|
27.5 percentage of participants
Interval 16.25 to 41.39
|
26.3 percentage of participants
Interval 15.03 to 40.54
|
22.9 percentage of participants
Interval 11.91 to 37.48
|
31.6 percentage of participants
Interval 19.34 to 46.09
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
SPWCA: ≥ 2 Fold-Rise
|
25.6 percentage of participants
Interval 15.06 to 38.77
|
22.5 percentage of participants
Interval 12.27 to 35.98
|
26.3 percentage of participants
Interval 15.03 to 40.54
|
31.4 percentage of participants
Interval 18.73 to 46.61
|
21.1 percentage of participants
Interval 10.93 to 34.79
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
SPWCA: ≥ 3 Fold-Rise
|
9.3 percentage of participants
Interval 3.24 to 20.04
|
12.5 percentage of participants
Interval 5.06 to 24.5
|
10.5 percentage of participants
Interval 3.68 to 22.49
|
2.9 percentage of participants
Interval 0.15 to 12.85
|
2.6 percentage of participants
Interval 0.13 to 11.89
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
SPWCA: ≥ 4 Fold-Rise
|
4.7 percentage of participants
Interval 0.83 to 13.93
|
7.5 percentage of participants
Interval 2.08 to 18.26
|
0.0 percentage of participants
Interval 0.0 to 7.58
|
0.0 percentage of participants
Interval 0.0 to 8.2
|
2.6 percentage of participants
Interval 0.13 to 11.89
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
PiuA: ≥ 2 Fold-Rise
|
32.6 percentage of participants
Interval 20.88 to 46.13
|
52.5 percentage of participants
Interval 38.48 to 66.23
|
39.5 percentage of participants
Interval 26.14 to 54.1
|
45.7 percentage of participants
Interval 31.17 to 60.83
|
34.2 percentage of participants
Interval 21.56 to 48.8
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
PiaA: ≥ 2 Fold-Rise
|
41.9 percentage of participants
Interval 29.08 to 55.52
|
40.0 percentage of participants
Interval 26.94 to 54.22
|
26.3 percentage of participants
Interval 15.03 to 40.54
|
40.0 percentage of participants
Interval 26.05 to 55.28
|
36.8 percentage of participants
Interval 23.83 to 51.47
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
PiaA: ≥ 3 Fold-Rise
|
23.3 percentage of participants
Interval 13.2 to 36.25
|
25.0 percentage of participants
Interval 14.24 to 38.71
|
7.9 percentage of participants
Interval 2.19 to 19.16
|
20.0 percentage of participants
Interval 9.78 to 34.3
|
21.1 percentage of participants
Interval 10.93 to 34.79
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
PiaA: ≥ 4 Fold-Rise
|
11.6 percentage of participants
Interval 4.7 to 22.91
|
20.0 percentage of participants
Interval 10.36 to 33.2
|
2.6 percentage of participants
Interval 0.13 to 11.89
|
17.1 percentage of participants
Interval 7.74 to 31.06
|
10.5 percentage of participants
Interval 3.68 to 22.49
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
BCH0785: ≥ 4 Fold-Rise
|
14.0 percentage of participants
Interval 6.26 to 25.69
|
15.0 percentage of participants
Interval 6.74 to 27.47
|
10.5 percentage of participants
Interval 3.68 to 22.49
|
25.7 percentage of participants
Interval 14.12 to 40.58
|
15.8 percentage of participants
Interval 7.11 to 28.8
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
StkP: ≥ 3 Fold-Rise
|
20.9 percentage of participants
Interval 11.38 to 33.68
|
32.5 percentage of participants
Interval 20.41 to 46.63
|
23.7 percentage of participants
Interval 12.95 to 37.69
|
34.3 percentage of participants
Interval 21.12 to 49.55
|
21.1 percentage of participants
Interval 10.93 to 34.79
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
PcpA: ≥ 2 Fold-Rise
|
46.5 percentage of participants
Interval 33.35 to 60.05
|
42.5 percentage of participants
Interval 29.18 to 56.69
|
50.0 percentage of participants
Interval 35.74 to 64.26
|
40.0 percentage of participants
Interval 26.05 to 55.28
|
39.5 percentage of participants
Interval 26.14 to 54.1
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
PiuA: ≥ 3 Fold-Rise
|
20.9 percentage of participants
Interval 11.38 to 33.68
|
27.5 percentage of participants
Interval 16.25 to 41.39
|
26.3 percentage of participants
Interval 15.03 to 40.54
|
22.9 percentage of participants
Interval 11.91 to 37.48
|
13.2 percentage of participants
Interval 5.33 to 25.7
|
—
|
|
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
PiuA: ≥ 4 Fold-Rise
|
9.3 percentage of participants
Interval 3.24 to 20.04
|
22.5 percentage of participants
Interval 12.27 to 35.98
|
15.8 percentage of participants
Interval 7.11 to 28.8
|
17.1 percentage of participants
Interval 7.74 to 31.06
|
7.9 percentage of participants
Interval 2.19 to 19.16
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and 6 months post-vaccination 2 (Week 32)Population: Immunogenicity Population with available neutralizing antibody data.
Neutralizing antibody responses to pneumolysin were assessed at Baseline and 6 months post vaccination 2 using an in vitro toxin neutralization assay that measures the ability of antibodies to neutralize wild-type pneumolysin-induced lysis of rabbit red blood cells. Each sample was categorized as negative (\< 1/20 dilution) or positive (with titer between 1/20 and 1/320 dilution). Responses at higher dilutions indicate higher levels of neutralizing antibodies to pneumolysin.
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=35 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=34 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=37 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=35 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
n=34 Participants
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Neutralizing Antibody Response to Pneumolysin
Baseline · 1:80 titer
|
2 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
—
|
|
Number of Participants With Neutralizing Antibody Response to Pneumolysin
6 months post-vaccination 2 · <1:20 titer
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Neutralizing Antibody Response to Pneumolysin
6 months post-vaccination 2 · 1:320 titer
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
—
|
|
Number of Participants With Neutralizing Antibody Response to Pneumolysin
Baseline · <1:20 titer
|
12 Participants
|
10 Participants
|
12 Participants
|
8 Participants
|
17 Participants
|
—
|
|
Number of Participants With Neutralizing Antibody Response to Pneumolysin
Baseline · 1:20 titer
|
10 Participants
|
10 Participants
|
11 Participants
|
8 Participants
|
8 Participants
|
—
|
|
Number of Participants With Neutralizing Antibody Response to Pneumolysin
Baseline · 1:40 titer
|
8 Participants
|
8 Participants
|
9 Participants
|
12 Participants
|
4 Participants
|
—
|
|
Number of Participants With Neutralizing Antibody Response to Pneumolysin
Baseline · 1:160 titer
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Neutralizing Antibody Response to Pneumolysin
Baseline · 1:320 titer
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Neutralizing Antibody Response to Pneumolysin
6 months post-vaccination 2 · 1:20 titer
|
11 Participants
|
12 Participants
|
11 Participants
|
7 Participants
|
12 Participants
|
—
|
|
Number of Participants With Neutralizing Antibody Response to Pneumolysin
6 months post-vaccination 2 · 1:40 titer
|
10 Participants
|
11 Participants
|
12 Participants
|
8 Participants
|
12 Participants
|
—
|
|
Number of Participants With Neutralizing Antibody Response to Pneumolysin
6 months post-vaccination 2 · 1:80 titer
|
5 Participants
|
5 Participants
|
8 Participants
|
10 Participants
|
7 Participants
|
—
|
|
Number of Participants With Neutralizing Antibody Response to Pneumolysin
6 months post-vaccination 2 · 1:160 titer
|
7 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.Population: All enrolled participants
An AE was defined as any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or psychological/physiologic observations occurring in a person in a clinical study. The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=49 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=49 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=50 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=50 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
n=49 Participants
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
n=50 Participants
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Number of Adverse Events (AE)
Total number of AEs
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
4 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Adverse Events (AE)
Serious AE: Yes
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
4 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Adverse Events (AE)
Severity: Mild (Grade 1)
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
|
Number of Adverse Events (AE)
Severity: Moderate (Grade 2)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events (AE)
Severity: Severe (Grade 3)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
4 adverse events
|
1 adverse events
|
1 adverse events
|
|
Number of Adverse Events (AE)
Severity: Potentially Life Threatening (Grade 4)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events (AE)
Severity: Death (Grade 5)
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events (AE)
Related to vaccine: Yes
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events (AE)
Serious AE: No
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events (AE)
Related to vaccine: No
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
4 adverse events
|
1 adverse events
|
1 adverse events
|
SECONDARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point
Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 11A/D/E \[11A\] is reported. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=81 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=43 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=83 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=50 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx
Visit 3 (Week 16)
|
2 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx
Visit 4 (Week 20)
|
4 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx
Visit 1 (Week 0)
|
6 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx
Visit 2 (Week 12)
|
7 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx
Visit 5 (Week 32)
|
6 Participants
|
0 Participants
|
9 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point
Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 13 is reported. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=83 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=43 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=85 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=50 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx
Visit 1 (Week 0)
|
6 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx
Visit 2 (Week 12)
|
6 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx
Visit 4 (Week 20)
|
6 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx
Visit 3 (Week 16)
|
4 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx
Visit 5 (Week 32)
|
5 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point
Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 15A is reported. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=83 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=43 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=85 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=50 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx
Visit 1 (Week 0)
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx
Visit 5 (Week 32)
|
7 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx
Visit 4 (Week 20)
|
7 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx
Visit 2 (Week 12)
|
5 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx
Visit 3 (Week 16)
|
8 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point
Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 15B/C \[15B\] is reported. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=83 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=43 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=85 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=50 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx
Visit 2 (Week 12)
|
16 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx
Visit 3 (Week 16)
|
9 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx
Visit 4 (Week 20)
|
11 Participants
|
2 Participants
|
9 Participants
|
4 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx
Visit 1 (Week 0)
|
10 Participants
|
2 Participants
|
9 Participants
|
6 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx
Visit 5 (Week 32)
|
4 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point
Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 19A is reported. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=83 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=43 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=85 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=50 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx
Visit 1 (Week 0)
|
3 Participants
|
4 Participants
|
7 Participants
|
4 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx
Visit 2 (Week 12)
|
3 Participants
|
6 Participants
|
9 Participants
|
5 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx
Visit 3 (Week 16)
|
1 Participants
|
7 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx
Visit 4 (Week 20)
|
2 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx
Visit 5 (Week 32)
|
7 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point
Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 19F is reported. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=83 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=43 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=85 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=50 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx
Visit 2 (Week 12)
|
5 Participants
|
5 Participants
|
7 Participants
|
3 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx
Visit 1 (Week 0)
|
4 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx
Visit 3 (Week 16)
|
4 Participants
|
5 Participants
|
10 Participants
|
2 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx
Visit 4 (Week 20)
|
5 Participants
|
4 Participants
|
10 Participants
|
3 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx
Visit 5 (Week 32)
|
4 Participants
|
3 Participants
|
8 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point
Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 3 is reported. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=83 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=43 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=85 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=50 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx
Visit 1 (Week 0)
|
8 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx
Visit 2 (Week 12)
|
6 Participants
|
4 Participants
|
7 Participants
|
1 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx
Visit 3 (Week 16)
|
9 Participants
|
4 Participants
|
11 Participants
|
2 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx
Visit 4 (Week 20)
|
6 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx
Visit 5 (Week 32)
|
4 Participants
|
4 Participants
|
8 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point
Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 35B is reported. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=83 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=43 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=85 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=50 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx
Visit 1 (Week 0)
|
8 Participants
|
4 Participants
|
11 Participants
|
4 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx
Visit 2 (Week 12)
|
8 Participants
|
3 Participants
|
9 Participants
|
4 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx
Visit 3 (Week 16)
|
5 Participants
|
6 Participants
|
8 Participants
|
2 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx
Visit 4 (Week 20)
|
2 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx
Visit 5 (Week 32)
|
7 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point
Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 6A/B \[6A\] is reported. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=83 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=43 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=85 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=50 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx
Visit 1 (Week 0)
|
5 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx
Visit 2 (Week 12)
|
7 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx
Visit 3 (Week 16)
|
5 Participants
|
6 Participants
|
7 Participants
|
1 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx
Visit 4 (Week 20)
|
3 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx
Visit 5 (Week 32)
|
4 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point
Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype NT4b is reported. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=83 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=43 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=85 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=50 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx
Visit 1 (Week 0)
|
29 Participants
|
17 Participants
|
27 Participants
|
15 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx
Visit 2 (Week 12)
|
17 Participants
|
10 Participants
|
32 Participants
|
10 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx
Visit 3 (Week 16)
|
17 Participants
|
13 Participants
|
23 Participants
|
10 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx
Visit 4 (Week 20)
|
12 Participants
|
15 Participants
|
26 Participants
|
8 Participants
|
—
|
—
|
|
Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx
Visit 5 (Week 32)
|
20 Participants
|
14 Participants
|
18 Participants
|
13 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.
The density of Streptococcus pneumoniae serotype 11A/D/E \[11A\] in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=7 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=4 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=9 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=3 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx
Visit 1 (Week 0)
|
11.9 log LytA copies
Interval 10.2 to 13.6
|
15.0 log LytA copies
Interval 9.8 to 16.7
|
12.9 log LytA copies
Interval 3.2 to 16.7
|
14 log LytA copies
Interval 14.0 to 14.0
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx
Visit 2 (Week 12)
|
10.9 log LytA copies
Interval 7.1 to 15.3
|
17.6 log LytA copies
Interval 11.9 to 19.7
|
14.4 log LytA copies
Interval 12.3 to 15.7
|
18.5 log LytA copies
Interval 18.5 to 18.5
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx
Visit 3 (Week 16)
|
9.8 log LytA copies
Interval 9.4 to 10.3
|
13.6 log LytA copies
Interval 11.5 to 14.9
|
16.6 log LytA copies
Interval 14.7 to 21.3
|
14.1 log LytA copies
Interval 9.0 to 16.9
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx
Visit 4 (Week 20)
|
15.1 log LytA copies
Interval 13.9 to 22.3
|
12.3 log LytA copies
Interval 10.5 to 13.4
|
15.8 log LytA copies
Interval 13.3 to 20.3
|
5.4 log LytA copies
Interval 5.4 to 5.4
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx
Visit 5 (Week 32)
|
16.3 log LytA copies
Interval 16.1 to 19.9
|
—
|
14.5 log LytA copies
Interval 11.1 to 17.3
|
16.4 log LytA copies
Interval 14.5 to 17.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.
The density of Streptococcus pneumoniae serotype 13 in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=6 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=6 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=5 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=5 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx
Visit 1 (Week 0)
|
12.9 log LytA copies
Interval 9.8 to 15.0
|
17.1 log LytA copies
Interval 7.0 to 17.1
|
12.2 log LytA copies
Interval 9.8 to 13.8
|
12.3 log LytA copies
Interval 10.0 to 18.6
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx
Visit 2 (Week 12)
|
10.6 log LytA copies
Interval 5.1 to 16.1
|
11.6 log LytA copies
Interval 5.7 to 14.3
|
15.0 log LytA copies
Interval 3.0 to 17.3
|
12.1 log LytA copies
Interval 10.3 to 15.8
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx
Visit 3 (Week 16)
|
14.2 log LytA copies
Interval 10.7 to 17.7
|
15.6 log LytA copies
Interval 12.9 to 19.3
|
17.7 log LytA copies
Interval 14.0 to 20.3
|
13.8 log LytA copies
Interval 13.8 to 13.8
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx
Visit 4 (Week 20)
|
13.2 log LytA copies
Interval 10.7 to 16.7
|
13.1 log LytA copies
Interval 11.6 to 14.0
|
13.4 log LytA copies
Interval 11.6 to 18.7
|
14.6 log LytA copies
Interval 14.6 to 14.6
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx
Visit 5 (Week 32)
|
14.5 log LytA copies
Interval 11.4 to 19.0
|
14.7 log LytA copies
Interval 10.2 to 15.1
|
15.8 log LytA copies
Interval 10.0 to 22.3
|
16.2 log LytA copies
Interval 13.8 to 18.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.
The density of Streptococcus pneumoniae serotype 15A in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=8 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=4 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=6 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=5 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx
Visit 1 (Week 0)
|
13.7 log LytA copies
Interval 13.7 to 13.7
|
—
|
16.1 log LytA copies
Interval 15.1 to 17.2
|
11.0 log LytA copies
Interval 9.8 to 13.4
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx
Visit 2 (Week 12)
|
14.1 log LytA copies
Interval 11.3 to 16.0
|
13.8 log LytA copies
Interval 11.2 to 16.3
|
18.5 log LytA copies
Interval 15.6 to 18.7
|
16.3 log LytA copies
Interval 11.7 to 19.2
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx
Visit 3 (Week 16)
|
14.1 log LytA copies
Interval 12.4 to 17.2
|
12.3 log LytA copies
Interval 12.3 to 12.3
|
15.8 log LytA copies
Interval 13.2 to 16.8
|
18.9 log LytA copies
Interval 18.9 to 18.9
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx
Visit 4 (Week 20)
|
13.7 log LytA copies
Interval 11.2 to 16.8
|
13.1 log LytA copies
Interval 13.1 to 13.1
|
13.7 log LytA copies
Interval 11.8 to 16.2
|
15.8 log LytA copies
Interval 13.8 to 17.9
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx
Visit 5 (Week 32)
|
18.0 log LytA copies
Interval 14.5 to 19.2
|
16.3 log LytA copies
Interval 14.2 to 21.3
|
15.2 log LytA copies
Interval 14.8 to 15.6
|
12.9 log LytA copies
Interval 9.2 to 19.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.
The density of Streptococcus pneumoniae serotype 15B/C \[15B\] in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=16 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=4 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=9 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=8 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx
Visit 1 (Week 0)
|
13.2 log LytA copies
Interval 11.5 to 14.6
|
10.3 log LytA copies
Interval 8.7 to 11.9
|
12.1 log LytA copies
Interval 9.8 to 15.6
|
14.7 log LytA copies
Interval 10.9 to 16.5
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx
Visit 2 (Week 12)
|
13.0 log LytA copies
Interval 10.9 to 15.0
|
10.4 log LytA copies
Interval 8.3 to 15.8
|
15.8 log LytA copies
Interval 14.7 to 17.2
|
17.9 log LytA copies
Interval 16.3 to 19.3
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx
Visit 3 (Week 16)
|
13.7 log LytA copies
Interval 11.4 to 15.7
|
13.5 log LytA copies
Interval 12.9 to 16.4
|
20.0 log LytA copies
Interval 16.5 to 20.9
|
17.3 log LytA copies
Interval 14.4 to 18.9
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx
Visit 4 (Week 20)
|
13.9 log LytA copies
Interval 11.7 to 16.4
|
17.5 log LytA copies
Interval 14.9 to 20.2
|
14.9 log LytA copies
Interval 11.1 to 17.2
|
17.2 log LytA copies
Interval 12.3 to 19.2
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx
Visit 5 (Week 32)
|
16.7 log LytA copies
Interval 14.8 to 20.2
|
17.3 log LytA copies
Interval 17.3 to 17.3
|
11.2 log LytA copies
Interval 3.7 to 15.7
|
12.8 log LytA copies
Interval 10.6 to 13.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.
The density of Streptococcus pneumoniae serotype 19A in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=7 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=7 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=9 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=6 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx
Visit 1 (Week 0)
|
10.3 log LytA copies
Interval 6.4 to 15.7
|
12.9 log LytA copies
Interval 8.7 to 15.2
|
12.3 log LytA copies
Interval 11.4 to 14.6
|
11.0 log LytA copies
Interval 7.4 to 15.3
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx
Visit 2 (Week 12)
|
14.2 log LytA copies
Interval 5.2 to 15.3
|
12.3 log LytA copies
Interval 9.9 to 13.5
|
16.9 log LytA copies
Interval 11.3 to 18.6
|
15.5 log LytA copies
Interval 11.4 to 19.6
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx
Visit 3 (Week 16)
|
15.1 log LytA copies
Interval 15.1 to 15.1
|
10.6 log LytA copies
Interval 7.0 to 16.0
|
16.7 log LytA copies
Interval 13.2 to 17.7
|
14.6 log LytA copies
Interval 13.6 to 14.9
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx
Visit 4 (Week 20)
|
18.1 log LytA copies
Interval 16.0 to 20.2
|
15.3 log LytA copies
Interval 8.7 to 18.2
|
13.3 log LytA copies
Interval 12.0 to 17.0
|
14.9 log LytA copies
Interval 7.8 to 19.5
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx
Visit 5 (Week 32)
|
17.0 log LytA copies
Interval 13.7 to 19.2
|
15.2 log LytA copies
Interval 13.0 to 22.4
|
12.2 log LytA copies
Interval 5.4 to 16.8
|
12.9 log LytA copies
Interval 5.8 to 20.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.
The density of Streptococcus pneumoniae serotype 19F in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=5 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=5 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=10 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=5 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx
Visit 1 (Week 0)
|
14.6 log LytA copies
Interval 13.4 to 16.4
|
12.2 log LytA copies
Interval 10.6 to 13.8
|
12.7 log LytA copies
Interval 11.1 to 16.2
|
12.9 log LytA copies
Interval 12.3 to 20.0
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx
Visit 2 (Week 12)
|
13.3 log LytA copies
Interval 12.1 to 17.8
|
13.7 log LytA copies
Interval 13.0 to 15.3
|
12.2 log LytA copies
Interval 11.6 to 17.5
|
18.2 log LytA copies
Interval 10.1 to 19.7
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx
Visit 3 (Week 16)
|
14.6 log LytA copies
Interval 10.2 to 17.7
|
13.0 log LytA copies
Interval 11.8 to 17.9
|
16.1 log LytA copies
Interval 14.4 to 17.4
|
9.9 log LytA copies
Interval 5.8 to 13.9
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx
Visit 4 (Week 20)
|
12.8 log LytA copies
Interval 5.4 to 15.4
|
14.9 log LytA copies
Interval 11.5 to 19.7
|
16.7 log LytA copies
Interval 13.9 to 17.9
|
11.1 log LytA copies
Interval 10.1 to 12.6
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx
Visit 5 (Week 32)
|
14.6 log LytA copies
Interval 10.6 to 17.8
|
17.7 log LytA copies
Interval 7.7 to 17.9
|
15.3 log LytA copies
Interval 13.7 to 17.1
|
14.1 log LytA copies
Interval 13.3 to 14.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.
The density of Streptococcus pneumoniae serotype 3 in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=9 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=5 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=11 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=4 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx
Visit 1 (Week 0)
|
12.7 log LytA copies
Interval 10.7 to 14.2
|
11.1 log LytA copies
Interval 3.7 to 14.7
|
9.7 log LytA copies
Interval 8.3 to 15.6
|
12.4 log LytA copies
Interval 7.7 to 15.0
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx
Visit 2 (Week 12)
|
14.2 log LytA copies
Interval 10.9 to 18.6
|
11.0 log LytA copies
Interval 8.4 to 14.3
|
16.4 log LytA copies
Interval 13.5 to 17.9
|
13.3 log LytA copies
Interval 13.3 to 13.3
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx
Visit 3 (Week 16)
|
13.9 log LytA copies
Interval 11.2 to 15.7
|
12.7 log LytA copies
Interval 11.3 to 15.9
|
15.2 log LytA copies
Interval 14.1 to 16.7
|
15.4 log LytA copies
Interval 14.8 to 16.1
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx
Visit 4 (Week 20)
|
13.3 log LytA copies
Interval 10.9 to 17.5
|
14.1 log LytA copies
Interval 11.8 to 15.5
|
14.7 log LytA copies
Interval 13.6 to 19.4
|
17.9 log LytA copies
Interval 12.5 to 20.6
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx
Visit 5 (Week 32)
|
14.6 log LytA copies
Interval 12.0 to 19.7
|
14.2 log LytA copies
Interval 11.4 to 17.0
|
13.6 log LytA copies
Interval 11.0 to 17.4
|
16.6 log LytA copies
Interval 16.6 to 16.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.
The density of Streptococcus pneumoniae serotype 35B in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=8 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=6 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=11 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=4 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx
Visit 1 (Week 0)
|
14.1 log LytA copies
Interval 11.1 to 16.0
|
11.1 log LytA copies
Interval 8.5 to 13.0
|
13.1 log LytA copies
Interval 10.8 to 14.7
|
12.3 log LytA copies
Interval 11.2 to 13.4
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx
Visit 2 (Week 12)
|
14.3 log LytA copies
Interval 9.0 to 15.1
|
9.1 log LytA copies
Interval 8.4 to 17.8
|
14.0 log LytA copies
Interval 9.7 to 17.2
|
14.3 log LytA copies
Interval 11.7 to 16.0
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx
Visit 3 (Week 16)
|
13.8 log LytA copies
Interval 8.3 to 15.5
|
15.5 log LytA copies
Interval 13.1 to 18.4
|
15.3 log LytA copies
Interval 12.1 to 19.3
|
19.3 log LytA copies
Interval 17.9 to 20.8
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx
Visit 4 (Week 20)
|
8.6 log LytA copies
Interval 2.0 to 15.3
|
16.8 log LytA copies
Interval 12.4 to 18.5
|
12.8 log LytA copies
Interval 11.4 to 15.4
|
11.7 log LytA copies
Interval 1.5 to 16.1
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx
Visit 5 (Week 32)
|
16.0 log LytA copies
Interval 10.2 to 18.0
|
13.4 log LytA copies
Interval 12.8 to 18.4
|
14.5 log LytA copies
Interval 11.3 to 16.4
|
12.2 log LytA copies
Interval 12.2 to 12.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.
The density of Streptococcus pneumoniae serotype 6A/B \[6A\] in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=7 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=6 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=7 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=3 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx
Visit 1 (Week 0)
|
14.5 log LytA copies
Interval 7.1 to 17.6
|
12.4 log LytA copies
Interval 9.0 to 14.5
|
13.4 log LytA copies
Interval 11.4 to 14.3
|
11.6 log LytA copies
Interval 10.1 to 13.2
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx
Visit 2 (Week 12)
|
15.0 log LytA copies
Interval 13.2 to 18.9
|
12.6 log LytA copies
Interval 8.1 to 14.6
|
14.7 log LytA copies
Interval 9.6 to 17.2
|
15.8 log LytA copies
Interval 1.5 to 16.7
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx
Visit 3 (Week 16)
|
14.6 log LytA copies
Interval 11.9 to 17.5
|
15.0 log LytA copies
Interval 10.6 to 18.0
|
14.9 log LytA copies
Interval 12.3 to 19.5
|
14.8 log LytA copies
Interval 14.8 to 14.8
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx
Visit 4 (Week 20)
|
20.5 log LytA copies
Interval 16.9 to 21.5
|
11.7 log LytA copies
Interval 3.1 to 12.6
|
16.6 log LytA copies
Interval 9.3 to 17.9
|
12.7 log LytA copies
Interval 12.2 to 18.7
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx
Visit 5 (Week 32)
|
17.2 log LytA copies
Interval 14.7 to 17.3
|
14.9 log LytA copies
Interval 11.4 to 19.1
|
14.5 log LytA copies
Interval 8.3 to 16.4
|
12.6 log LytA copies
Interval 11.3 to 14.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 12, Week 16, Week 20, Week 32Population: NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.
The density of Streptococcus pneumoniae serotype NT4b in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2
Outcome measures
| Measure |
Combined PATH-wSP 300 µg
n=29 Participants
All participants who received PATH-wSP 300 µg, including participants in the PATH-wSP 300 µg + Booster and participants in the PATH-wSP 300 µg Only treatment groups.
|
Combined Control (300 µg)
n=17 Participants
Participants enrolled during Cohort 1 who received booster-only or no intervention.
|
Combined PATH-wSP 600 µg
n=32 Participants
All participants who received PATH-wSP 600 µg, including participants in the PATH-wSP 600 µg + Booster and participants in the PATH-wSP 600 µg Only treatment groups.
|
Combined Control (600 µg)
n=15 Participants
All participants enrolled during Cohort 2 who received booster-only or no intervention.
|
Booster Only (Both Cohorts)
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx
Visit 1 (Week 0)
|
11.7 log LytA copies
Interval 8.5 to 13.7
|
9.8 log LytA copies
Interval 8.2 to 12.5
|
10.7 log LytA copies
Interval 9.9 to 13.1
|
11.7 log LytA copies
Interval 9.4 to 13.1
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx
Visit 2 (Week 12)
|
12.1 log LytA copies
Interval 9.1 to 14.8
|
12.2 log LytA copies
Interval 9.8 to 12.9
|
13.4 log LytA copies
Interval 12.4 to 14.9
|
12.1 log LytA copies
Interval 7.7 to 15.0
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx
Visit 3 (Week 16)
|
11.7 log LytA copies
Interval 9.8 to 13.7
|
12.1 log LytA copies
Interval 9.7 to 14.5
|
13.7 log LytA copies
Interval 11.2 to 14.5
|
13.7 log LytA copies
Interval 11.1 to 15.9
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx
Visit 4 (Week 20)
|
12.4 log LytA copies
Interval 10.0 to 14.3
|
9.6 log LytA copies
Interval 8.5 to 12.0
|
12.1 log LytA copies
Interval 10.1 to 13.6
|
11.5 log LytA copies
Interval 9.7 to 13.1
|
—
|
—
|
|
Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx
Visit 5 (Week 32)
|
14.2 log LytA copies
Interval 12.9 to 16.6
|
11.7 log LytA copies
Interval 9.8 to 13.2
|
12.1 log LytA copies
Interval 9.1 to 13.3
|
12.2 log LytA copies
Interval 10.5 to 13.0
|
—
|
—
|
Adverse Events
PATH-wSP 300 µg + Booster
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PATH-wSP 300 µg Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PATH-wSP 600 µg + Booster
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PATH-wSP 600 µg Only
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Booster Only (Both Cohorts)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
No Intervention
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PATH-wSP 300 µg + Booster
n=49 participants at risk
Toddlers who enrolled in Cohort 1 of Study VAC-010 and received 300 µg PATH-wSP plus the two booster vaccines (Synflorix and Pentavac) followed by a 2nd injection of 300 µg PATH-wSP 8 weeks later.
|
PATH-wSP 300 µg Only
n=49 participants at risk
Toddlers who enrolled in Cohort 1 of Study VAC-010 and received 300 µg PATH-wSP and 2 saline injections followed by a 2nd injection of 300 µg PATH-wSP 8 weeks later.
|
PATH-wSP 600 µg + Booster
n=50 participants at risk
Toddlers who enrolled in Cohort 2 of Study VAC-010 and received 600 µg PATH-wSP plus the two booster vaccines (Synflorix and Pentavac) followed by a 2nd injection of 600 µg PATH-wSP 8 weeks later.
|
PATH-wSP 600 µg Only
n=50 participants at risk
Toddlers who enrolled in Cohort 2 of Study VAC-010 and received 600 µg PATH-wSP and 2 saline injections followed by a 2nd injection of 600 µg PATH-wSP 8 weeks later.
|
Booster Only (Both Cohorts)
n=49 participants at risk
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
n=50 participants at risk
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Cerebral malaria
|
0.00%
0/49 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
0.00%
0/49 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
0.00%
0/50 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
2.0%
1/50 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
0.00%
0/49 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
0.00%
0/50 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/49 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
0.00%
0/49 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
0.00%
0/50 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
2.0%
1/50 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
0.00%
0/49 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
0.00%
0/50 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/49 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
0.00%
0/49 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
0.00%
0/50 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
2.0%
1/50 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
0.00%
0/49 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
0.00%
0/50 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
|
Infections and infestations
Malaria
|
0.00%
0/49 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
0.00%
0/49 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
0.00%
0/50 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
2.0%
1/50 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
2.0%
1/49 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
2.0%
1/50 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
Other adverse events
| Measure |
PATH-wSP 300 µg + Booster
n=49 participants at risk
Toddlers who enrolled in Cohort 1 of Study VAC-010 and received 300 µg PATH-wSP plus the two booster vaccines (Synflorix and Pentavac) followed by a 2nd injection of 300 µg PATH-wSP 8 weeks later.
|
PATH-wSP 300 µg Only
n=49 participants at risk
Toddlers who enrolled in Cohort 1 of Study VAC-010 and received 300 µg PATH-wSP and 2 saline injections followed by a 2nd injection of 300 µg PATH-wSP 8 weeks later.
|
PATH-wSP 600 µg + Booster
n=50 participants at risk
Toddlers who enrolled in Cohort 2 of Study VAC-010 and received 600 µg PATH-wSP plus the two booster vaccines (Synflorix and Pentavac) followed by a 2nd injection of 600 µg PATH-wSP 8 weeks later.
|
PATH-wSP 600 µg Only
n=50 participants at risk
Toddlers who enrolled in Cohort 2 of Study VAC-010 and received 600 µg PATH-wSP and 2 saline injections followed by a 2nd injection of 600 µg PATH-wSP 8 weeks later.
|
Booster Only (Both Cohorts)
n=49 participants at risk
Toddlers who enrolled in Cohort 1 or Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.
|
No Intervention
n=50 participants at risk
Toddlers who enrolled during Cohort 1 or Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/49 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
0.00%
0/49 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
2.0%
1/50 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
0.00%
0/50 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
0.00%
0/49 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
0.00%
0/50 • 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.
The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place