Pneumococcal Disease
Conditions
Brief summary
This study evaluated the change in nasopharyngeal carriage (NPC) of Streptococcus pneumoniae (SPn), hypothesizing that it would be reduced post-vaccination with Streptococcus pneumoniae whole cell vaccine with aluminum hydroxide adjuvant (PATH-wSP) and that PATH-wSP would remain safe and well-tolerated over the course of the study.
Detailed description
This study enrolled healthy Kenyan toddlers (12-15 months of age) who participated in the randomized control trial of VAC-010 (NCT02097472), as well as healthy toddlers aged 12 to 15 months who had not participated in the VAC-010 Study. All participants must have received a primary dose of pneumococcal conjugate vaccine (PCV) per local practice prior to enrollment in either VAC-010 or VAC-011. No treatments were administered during this study. The study consisted of the following four groups: Participants who were randomized in study VAC-010 (2:2:1 ratio), defined according to the treatment received in VAC-010: * 1\. PATH-wSP + Booster * 2\. PATH-wSP Only * 3\. Booster Only Participants who did not participate in VAC-010: * 4\. No Intervention Each group consisted of 2 cohorts of participants, Cohort 1 (300 µg PATH-wSP) and Cohort 2 (600 µg PATH-wSP). Enrollment into Cohorts 1 and 2 occurred sequentially; participants in groups 3 and 4 who did not receive PATH-wSP were also enrolled over time and allocated into one of the two cohorts (300 and 600 µg) in order to control for potential seasonal variation in the NPC of S. pneumoniae. Each participant completed a total of 5 scheduled visits. For toddlers enrolled simultaneously in VAC-010, visits corresponded to enrollment (Baseline) and 4, 8, 12, and 24 weeks post final vaccination in VAC-010. For toddlers in the No Intervention group, the first visit corresponded to Baseline and the second to fifth visits corresponded to 12, 16, 20, and 32 weeks later. Nasopharyngeal swabs were taken at each visit following World Health Organization (WHO) guidelines for analysis of nasopharyngeal burden. Treatments received during VAC-010 included: * PATH-wSP: Streptococcus pneumoniae whole cell vaccine with aluminum hydroxide adjuvant * Synflorix™ booster vaccine: pneumococcal polysaccharide conjugate vaccine (adsorbed) * Pentavac booster vaccine: diphtheria, tetanus, pertussis (Whole Cell), hepatitis B (recombinant deoxyribonucleic acid \[rDNA\]) and Haemophilus influenzae type b conjugate vaccine (adsorbed). * Saline control
Interventions
None listed
Sponsors
PATH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Months to 15 Months
Healthy volunteers
Yes
Inclusion criteria
\- For Toddlers Enrolled in VAC-010 (NCT02097472): * Randomization in VAC-010. * Subject's parent must provide voluntary written informed consent for subject to participate in the study, is fully capable of comprehending and complying with study requirements and procedures, able and willing to return for all scheduled follow-up visits, and has expressed availability for the required study period, with access to a consistent means of telephone contact. An illiterate parent will require an impartial witness to be present during consenting process to include discussing the consent form, verbal consent and thumb-printing. * Subject has not completed his or her final vaccination in VAC-010. For Toddlers NOT Enrolled in VAC-010 (PCV-primed-only cohort): * Healthy Kenyan toddlers between 12 to 15 (inclusive) months of age who have completed their primary Expanded Programme on Immunization (EPI) vaccines, with the exception that the birth dose of oral polio vaccine is not required. * Subjects who have not received a PCV booster following primary PCV series. * Subject's parent must provide voluntary written informed consent for subject to participate in the study, is fully capable of comprehending and complying with study requirements and procedures, able and willing to return for all scheduled follow-up visits, and has expressed availability for the required study period, with access to a consistent means of telephone contact. An illiterate parent will require an impartial witness to be present during consenting process to include discussing the consent form, verbal consent and thumb-printing. * Subjects who were not born premature, had a birth weight of \> 2.5 kg, and who have a weight-to-height Z-score of ≥ -2 at the time of enrollment.
Exclusion criteria
\- For Toddlers NOT enrolled in VAC-010 (PCV-primed only): * Use of any investigational or non-registered drug within 90 days prior to screening, or planned during the course of study participation. * Immunosuppression or immunodeficiency (inclusive of human immunodeficiency virus \[HIV\]) by medical history (inclusive of possible HIV through maternal fetal transfer at time of birth or through breast milk). * Chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, or hematological functional abnormality or major congenital defects or illness that requires medical therapy, by medical history or clinical assessment. This includes abnormal vital signs as assessed by toxicity scoring. * Any medical or social condition that in the opinion of the investigator may interfere with the study objectives, pose a risk to the study subject, or prevent the subject from completing the study. * An employee (or first degree relative of employee) of the Sponsor, the Clinical Research Organization (CRO), the investigator or any site personnel. * Disorders that required chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within the 6 months prior to enrollment. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose \>10 mg of prednisone (adult dosage) adjusted for equivalent dosing in toddlers by weight. The use of topical glucocorticoids will be permitted. * Administration of immunoglobulins and/or any blood products within the 6 months preceding enrollment in the study; or anticipation of such administration during the study period. * History of meningitis, seizures or any neurological disorder. * Subject who has evidence of congenital abnormality or developmental delay. * Any evidence of fetal alcohol syndrome or history of alcohol abuse in mother during pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Streptococcus Pneumoniae in Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
| Density of Streptococcus Pneumoniae in the Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events (AE) | 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32. | 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. |
| Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
| Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
| Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
| Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
| Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
| Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
| Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
| Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
| Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
| Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
| Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
| Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | Baseline and Week 32 | 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) |
| Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
| Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
| Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
| Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
| Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Baseline (Week 0), 4 weeks post-vaccination 2 (Week 12), and 6 months post-vaccination 2 (Week 32). | 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) |
| Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
| Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
| Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
| Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
| Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | Week 32 | 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) |
| Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Baseline and Week 32 | 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. |
| Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Week 0, Week 12, Week 16, Week 20, Week 32 | 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 |
| Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline (Week 0) and 6 months post-vaccination 2 (Week 32) | 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. |
Countries
Kenya
Participant flow
Recruitment details
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.
Pre-assignment details
Participants were enrolled sequentially into Cohort 1 (PATH-wSP 300 µg or control) and Cohort 2 (PATH-wSP 600 µg or control).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 49 |
| 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. | 49 |
| 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. | 50 |
| 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. | 50 |
| 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. | 49 |
| 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). | 50 |
| Total | 297 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 | 3 | 3 | 1 | 1 | 0 | 1 |
| Overall Study | Other | 1 | 0 | 2 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Unable to Comply with Protocol | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 1 | 5 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Booster Only (Both Cohorts) | Total | No Intervention | PATH-wSP 300 µg + Booster | PATH-wSP 300 µg Only | PATH-wSP 600 µg + Booster | PATH-wSP 600 µg Only |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 13.1 months STANDARD_DEVIATION 1 | 13.2 months STANDARD_DEVIATION 1.1 | 13.3 months STANDARD_DEVIATION 1.2 | 13.2 months STANDARD_DEVIATION 1.1 | 13.0 months STANDARD_DEVIATION 1.1 | 13.3 months STANDARD_DEVIATION 1.1 | 13.5 months STANDARD_DEVIATION 1.2 |
| Race/Ethnicity, Customized Luhya | 2 Participants | 19 Participants | 1 Participants | 3 Participants | 1 Participants | 7 Participants | 5 Participants |
| Race/Ethnicity, Customized Luo | 46 Participants | 274 Participants | 48 Participants | 45 Participants | 47 Participants | 43 Participants | 45 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 4 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 23 Participants | 157 Participants | 31 Participants | 31 Participants | 25 Participants | 23 Participants | 24 Participants |
| Sex: Female, Male Male | 26 Participants | 140 Participants | 19 Participants | 18 Participants | 24 Participants | 27 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 49 | 0 / 50 | 0 / 50 | 0 / 49 | 0 / 50 |
| other Total, other adverse events | 0 / 49 | 0 / 49 | 1 / 50 | 0 / 50 | 0 / 49 | 0 / 50 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 | 0 / 50 | 3 / 50 | 1 / 49 | 1 / 50 |
Outcome results
Primary
Density of Streptococcus Pneumoniae in the Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: The Nasopharyngeal Carriage (NPC) population with available LytA data at each time point
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae in the Nasopharynx | Visit 3 (Week 16) | 14.7 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae in the Nasopharynx | Visit 4 (Week 20) | 15.1 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae in the Nasopharynx | Visit 5 (Week 32) | 16.8 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae in the Nasopharynx | Visit 2 (Week 12) | 14.0 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae in the Nasopharynx | Visit 1 (Week 0) | 13.5 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae in the Nasopharynx | Visit 2 (Week 12) | 13.0 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae in the Nasopharynx | Visit 3 (Week 16) | 14.5 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae in the Nasopharynx | Visit 4 (Week 20) | 14.0 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae in the Nasopharynx | Visit 1 (Week 0) | 12.5 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae in the Nasopharynx | Visit 5 (Week 32) | 14.9 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae in the Nasopharynx | Visit 3 (Week 16) | 16.8 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae in the Nasopharynx | Visit 1 (Week 0) | 13.9 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae in the Nasopharynx | Visit 2 (Week 12) | 16.4 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae in the Nasopharynx | Visit 4 (Week 20) | 15.5 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae in the Nasopharynx | Visit 5 (Week 32) | 14.9 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae in the Nasopharynx | Visit 4 (Week 20) | 15.1 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae in the Nasopharynx | Visit 1 (Week 0) | 13.8 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae in the Nasopharynx | Visit 3 (Week 16) | 16.5 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae in the Nasopharynx | Visit 2 (Week 12) | 15.9 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae in the Nasopharynx | Visit 5 (Week 32) | 14.8 log LytA copies |
Primary
Prevalence of Streptococcus Pneumoniae in Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae in Nasopharynx | Visit 3 (Week 16) | 85 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae in Nasopharynx | Visit 2 (Week 12) | 77 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae in Nasopharynx | Visit 4 (Week 20) | 85 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae in Nasopharynx | Visit 5 (Week 32) | 81 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae in Nasopharynx | Visit 1 (Week 0) | 76 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae in Nasopharynx | Visit 4 (Week 20) | 43 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae in Nasopharynx | Visit 5 (Week 32) | 43 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae in Nasopharynx | Visit 1 (Week 0) | 43 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae in Nasopharynx | Visit 2 (Week 12) | 44 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae in Nasopharynx | Visit 3 (Week 16) | 43 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae in Nasopharynx | Visit 5 (Week 32) | 71 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae in Nasopharynx | Visit 1 (Week 0) | 86 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae in Nasopharynx | Visit 2 (Week 12) | 80 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae in Nasopharynx | Visit 3 (Week 16) | 81 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae in Nasopharynx | Visit 4 (Week 20) | 81 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae in Nasopharynx | Visit 2 (Week 12) | 47 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae in Nasopharynx | Visit 1 (Week 0) | 46 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae in Nasopharynx | Visit 4 (Week 20) | 44 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae in Nasopharynx | Visit 5 (Week 32) | 43 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae in Nasopharynx | Visit 3 (Week 16) | 45 Participants |
Secondary
Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 5 (Week 32) | 16.3 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 1 (Week 0) | 11.9 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 3 (Week 16) | 9.8 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 4 (Week 20) | 15.1 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 2 (Week 12) | 10.9 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 3 (Week 16) | 13.6 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 1 (Week 0) | 15.0 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 2 (Week 12) | 17.6 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 4 (Week 20) | 12.3 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 2 (Week 12) | 14.4 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 3 (Week 16) | 16.6 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 4 (Week 20) | 15.8 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 1 (Week 0) | 12.9 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 5 (Week 32) | 14.5 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 2 (Week 12) | 18.5 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 4 (Week 20) | 5.4 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 3 (Week 16) | 14.1 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 1 (Week 0) | 14 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 5 (Week 32) | 16.4 log LytA copies |
Secondary
Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 4 (Week 20) | 13.2 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 2 (Week 12) | 10.6 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 5 (Week 32) | 14.5 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 3 (Week 16) | 14.2 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 1 (Week 0) | 12.9 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 3 (Week 16) | 15.6 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 4 (Week 20) | 13.1 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 5 (Week 32) | 14.7 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 2 (Week 12) | 11.6 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 1 (Week 0) | 17.1 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 3 (Week 16) | 17.7 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 1 (Week 0) | 12.2 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 2 (Week 12) | 15.0 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 4 (Week 20) | 13.4 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 5 (Week 32) | 15.8 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 4 (Week 20) | 14.6 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 2 (Week 12) | 12.1 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 1 (Week 0) | 12.3 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 3 (Week 16) | 13.8 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 5 (Week 32) | 16.2 log LytA copies |
Secondary
Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 3 (Week 16) | 14.1 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 1 (Week 0) | 13.7 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 5 (Week 32) | 18.0 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 2 (Week 12) | 14.1 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 4 (Week 20) | 13.7 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 5 (Week 32) | 16.3 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 3 (Week 16) | 12.3 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 4 (Week 20) | 13.1 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 2 (Week 12) | 13.8 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 3 (Week 16) | 15.8 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 5 (Week 32) | 15.2 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 2 (Week 12) | 18.5 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 1 (Week 0) | 16.1 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 4 (Week 20) | 13.7 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 4 (Week 20) | 15.8 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 5 (Week 32) | 12.9 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 1 (Week 0) | 11.0 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 2 (Week 12) | 16.3 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 3 (Week 16) | 18.9 log LytA copies |
Secondary
Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 4 (Week 20) | 13.9 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 2 (Week 12) | 13.0 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 5 (Week 32) | 16.7 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 3 (Week 16) | 13.7 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 1 (Week 0) | 13.2 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 3 (Week 16) | 13.5 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 4 (Week 20) | 17.5 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 5 (Week 32) | 17.3 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 2 (Week 12) | 10.4 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 1 (Week 0) | 10.3 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 3 (Week 16) | 20.0 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 1 (Week 0) | 12.1 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 2 (Week 12) | 15.8 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 4 (Week 20) | 14.9 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 5 (Week 32) | 11.2 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 4 (Week 20) | 17.2 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 2 (Week 12) | 17.9 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 1 (Week 0) | 14.7 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 3 (Week 16) | 17.3 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 5 (Week 32) | 12.8 log LytA copies |
Secondary
Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 4 (Week 20) | 18.1 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 2 (Week 12) | 14.2 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 5 (Week 32) | 17.0 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 3 (Week 16) | 15.1 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 1 (Week 0) | 10.3 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 3 (Week 16) | 10.6 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 4 (Week 20) | 15.3 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 5 (Week 32) | 15.2 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 2 (Week 12) | 12.3 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 1 (Week 0) | 12.9 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 3 (Week 16) | 16.7 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 1 (Week 0) | 12.3 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 2 (Week 12) | 16.9 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 4 (Week 20) | 13.3 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 5 (Week 32) | 12.2 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 4 (Week 20) | 14.9 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 2 (Week 12) | 15.5 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 1 (Week 0) | 11.0 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 3 (Week 16) | 14.6 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 5 (Week 32) | 12.9 log LytA copies |
Secondary
Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 4 (Week 20) | 12.8 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 2 (Week 12) | 13.3 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 1 (Week 0) | 14.6 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 5 (Week 32) | 14.6 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 3 (Week 16) | 14.6 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 5 (Week 32) | 17.7 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 4 (Week 20) | 14.9 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 1 (Week 0) | 12.2 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 2 (Week 12) | 13.7 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 3 (Week 16) | 13.0 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 3 (Week 16) | 16.1 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 1 (Week 0) | 12.7 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 2 (Week 12) | 12.2 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 4 (Week 20) | 16.7 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 5 (Week 32) | 15.3 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 4 (Week 20) | 11.1 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 2 (Week 12) | 18.2 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 1 (Week 0) | 12.9 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 3 (Week 16) | 9.9 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 5 (Week 32) | 14.1 log LytA copies |
Secondary
Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 4 (Week 20) | 8.6 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 2 (Week 12) | 14.3 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 5 (Week 32) | 16.0 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 3 (Week 16) | 13.8 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 1 (Week 0) | 14.1 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 3 (Week 16) | 15.5 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 4 (Week 20) | 16.8 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 5 (Week 32) | 13.4 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 2 (Week 12) | 9.1 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 1 (Week 0) | 11.1 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 3 (Week 16) | 15.3 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 1 (Week 0) | 13.1 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 2 (Week 12) | 14.0 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 4 (Week 20) | 12.8 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 5 (Week 32) | 14.5 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 4 (Week 20) | 11.7 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 2 (Week 12) | 14.3 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 1 (Week 0) | 12.3 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 3 (Week 16) | 19.3 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 5 (Week 32) | 12.2 log LytA copies |
Secondary
Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 3 (Week 16) | 13.9 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 2 (Week 12) | 14.2 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 1 (Week 0) | 12.7 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 5 (Week 32) | 14.6 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 4 (Week 20) | 13.3 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 4 (Week 20) | 14.1 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 1 (Week 0) | 11.1 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 2 (Week 12) | 11.0 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 3 (Week 16) | 12.7 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 5 (Week 32) | 14.2 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 4 (Week 20) | 14.7 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 3 (Week 16) | 15.2 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 5 (Week 32) | 13.6 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 2 (Week 12) | 16.4 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 1 (Week 0) | 9.7 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 2 (Week 12) | 13.3 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 3 (Week 16) | 15.4 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 4 (Week 20) | 17.9 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 5 (Week 32) | 16.6 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 1 (Week 0) | 12.4 log LytA copies |
Secondary
Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 4 (Week 20) | 20.5 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 2 (Week 12) | 15.0 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 5 (Week 32) | 17.2 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 3 (Week 16) | 14.6 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 1 (Week 0) | 14.5 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 3 (Week 16) | 15.0 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 4 (Week 20) | 11.7 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 5 (Week 32) | 14.9 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 2 (Week 12) | 12.6 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 1 (Week 0) | 12.4 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 3 (Week 16) | 14.9 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 1 (Week 0) | 13.4 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 2 (Week 12) | 14.7 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 4 (Week 20) | 16.6 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 5 (Week 32) | 14.5 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 4 (Week 20) | 12.7 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 2 (Week 12) | 15.8 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 1 (Week 0) | 11.6 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 3 (Week 16) | 14.8 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 5 (Week 32) | 12.6 log LytA copies |
Secondary
Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 4 (Week 20) | 12.4 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 2 (Week 12) | 12.1 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 5 (Week 32) | 14.2 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 3 (Week 16) | 11.7 log LytA copies |
| Combined PATH-wSP 300 µg | Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 1 (Week 0) | 11.7 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 3 (Week 16) | 12.1 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 4 (Week 20) | 9.6 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 5 (Week 32) | 11.7 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 2 (Week 12) | 12.2 log LytA copies |
| Combined Control (300 µg) | Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 1 (Week 0) | 9.8 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 3 (Week 16) | 13.7 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 1 (Week 0) | 10.7 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 2 (Week 12) | 13.4 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 4 (Week 20) | 12.1 log LytA copies |
| Combined PATH-wSP 600 µg | Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 5 (Week 32) | 12.1 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 4 (Week 20) | 11.5 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 2 (Week 12) | 12.1 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 1 (Week 0) | 11.7 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 3 (Week 16) | 13.7 log LytA copies |
| Combined Control (600 µg) | Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 5 (Week 32) | 12.2 log LytA copies |
Secondary
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
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)
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiaA: 6 months post-Vaccination | 1014.92 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | BCH0785: 4 weeks post-Vaccination 2 | 555.25 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiaA: 4 weeks post-Vaccination 2 | 930.90 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiuA: 4 weeks post-Vaccination 2 | 938.09 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | StkP: Baseline | 193.50 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | BCH0785: 6 months post-Vaccination 2 | 539.24 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiuA: Baseline | 685.69 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | SPWCA: Baseline | 676.76 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PcpA: 6 months post-Vaccination 2 | 631.99 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PcpA: 4 weeks post-Vaccination 2 | 383.75 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | L460D: Baseline | 261.25 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PcpA: Baseline | 320.15 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | StkP: 6 months post-Vaccination 2 | 304.48 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (MSD): 6 months post-Vaccination 2 | 303.31 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | StkP: 4 weeks post-Vaccination 2 | 334.14 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (MSD): 4 weeks post-Vaccination 2 | 368.08 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PhtD: Baseline | 464.43 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | SPWCA: 6 months post-Vaccination 2 | 849.99 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (MSD): Baseline | 172.25 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | L460D: 6 months post-Vaccination 2 | 499.10 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PhtD: 4 weeks post-Vaccination 2 | 847.28 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | L460D: 4 weeks post-Vaccination 2 | 460.91 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (ELISA): 6 months post-Vaccination 2 | 873.74 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (ELISA): 4 weeks post-Vaccination 2 | 720.33 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PhtD: 6 months post-Vaccination 2 | 1128.66 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | SPWCA: 4 weeks post-Vaccination 2 | 852.45 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (ELISA): Baseline | 397.94 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Pneumolysoid (L460D): 6 months post-Vaccination 2 | 1069.31 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Pneumolysoid (L460D): 4 weeks post-Vaccination 2 | 813.00 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | BCH0785: Baseline | 401.04 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiuA: 6 months post-Vaccination 2 | 1035.89 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Pneumolysoid (L460D): Baseline | 381.12 titer |
| Combined PATH-wSP 300 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiaA: Baseline | 650.37 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | StkP: 6 months post-Vaccination 2 | 331.73 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiaA: 4 weeks post-Vaccination 2 | 851.40 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PhtD: Baseline | 456.19 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PhtD: 6 months post-Vaccination 2 | 1163.21 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | BCH0785: Baseline | 322.75 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | BCH0785: 4 weeks post-Vaccination 2 | 514.90 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | BCH0785: 6 months post-Vaccination 2 | 602.44 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiuA: 4 weeks post-Vaccination 2 | 867.54 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiaA: Baseline | 560.35 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiuA: 6 months post-Vaccination 2 | 1274.26 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiaA: 6 months post-Vaccination | 1055.71 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Pneumolysoid (L460D): Baseline | 330.58 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Pneumolysoid (L460D): 4 weeks post-Vaccination 2 | 786.26 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Pneumolysoid (L460D): 6 months post-Vaccination 2 | 1212.57 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (ELISA): Baseline | 382.99 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (ELISA): 4 weeks post-Vaccination 2 | 571.29 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (ELISA): 6 months post-Vaccination 2 | 824.96 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | L460D: Baseline | 234.51 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | L460D: 4 weeks post-Vaccination 2 | 440.19 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | L460D: 6 months post-Vaccination 2 | 525.38 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (MSD): Baseline | 195.25 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (MSD): 4 weeks post-Vaccination 2 | 357.83 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (MSD): 6 months post-Vaccination 2 | 339.07 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | StkP: 4 weeks post-Vaccination 2 | 240.51 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PhtD: 4 weeks post-Vaccination 2 | 773.24 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiuA: Baseline | 631.45 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PcpA: Baseline | 369.58 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PcpA: 4 weeks post-Vaccination 2 | 358.39 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PcpA: 6 months post-Vaccination 2 | 681.06 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | StkP: Baseline | 142.90 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | SPWCA: Baseline | 665.77 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | SPWCA: 4 weeks post-Vaccination 2 | 782.09 titer |
| Combined Control (300 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | SPWCA: 6 months post-Vaccination 2 | 908.71 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiaA: 6 months post-Vaccination | 732.05 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiuA: 4 weeks post-Vaccination 2 | 925.23 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PcpA: Baseline | 307.97 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | SPWCA: Baseline | 630.23 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | L460D: 6 months post-Vaccination 2 | 508.30 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (ELISA): Baseline | 602.57 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | StkP: 6 months post-Vaccination 2 | 278.27 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PhtD: Baseline | 464.52 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | SPWCA: 6 months post-Vaccination 2 | 828.46 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (MSD): Baseline | 219.55 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiuA: 6 months post-Vaccination 2 | 998.07 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | SPWCA: 4 weeks post-Vaccination 2 | 815.92 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | StkP: 4 weeks post-Vaccination 2 | 253.15 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (MSD): 6 months post-Vaccination 2 | 362.35 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (MSD): 4 weeks post-Vaccination 2 | 349.00 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | BCH0785: 6 months post-Vaccination 2 | 385.46 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiaA: 4 weeks post-Vaccination 2 | 788.37 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (ELISA): 4 weeks post-Vaccination 2 | 870.53 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Pneumolysoid (L460D): Baseline | 785.54 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiaA: Baseline | 604.16 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PcpA: 6 months post-Vaccination 2 | 633.57 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | StkP: Baseline | 163.30 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Pneumolysoid (L460D): 6 months post-Vaccination 2 | 1372.33 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (ELISA): 6 months post-Vaccination 2 | 762.72 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Pneumolysoid (L460D): 4 weeks post-Vaccination 2 | 1600 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiuA: Baseline | 585.28 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | BCH0785: 4 weeks post-Vaccination 2 | 411.22 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | L460D: Baseline | 314.86 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | BCH0785: Baseline | 267.80 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PcpA: 4 weeks post-Vaccination 2 | 387.80 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PhtD: 4 weeks post-Vaccination 2 | 702.42 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PhtD: 6 months post-Vaccination 2 | 926.31 titer |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | L460D: 4 weeks post-Vaccination 2 | 622.67 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | BCH0785: 4 weeks post-Vaccination 2 | 761.38 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PhtD: 6 months post-Vaccination 2 | 1282.89 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PcpA: 6 months post-Vaccination 2 | 779.77 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Pneumolysoid (L460D): 6 months post-Vaccination 2 | 1697.94 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (ELISA): Baseline | 725.31 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (ELISA): 4 weeks post-Vaccination 2 | 1409.82 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PhtD: 4 weeks post-Vaccination 2 | 1174.38 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | StkP: Baseline | 246.51 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (ELISA): 6 months post-Vaccination 2 | 1239.01 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | L460D: Baseline | 346.26 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | SPWCA: 6 months post-Vaccination 2 | 1020.25 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | L460D: 4 weeks post-Vaccination 2 | 917.86 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | L460D: 6 months post-Vaccination 2 | 701.06 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | SPWCA: Baseline | 669.91 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (MSD): Baseline | 231.28 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (MSD): 6 months post-Vaccination 2 | 548.93 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | StkP: 4 weeks post-Vaccination 2 | 444.83 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PhtD: Baseline | 555.72 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | SPWCA: 4 weeks post-Vaccination 2 | 965.60 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | StkP: 6 months post-Vaccination 2 | 470.92 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (MSD): 4 weeks post-Vaccination 2 | 609.24 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PcpA: Baseline | 464.90 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Pneumolysoid (L460D): 4 weeks post-Vaccination 2 | 2330.97 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PcpA: 4 weeks post-Vaccination 2 | 527.74 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiaA: 4 weeks post-Vaccination 2 | 1574.97 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiuA: Baseline | 697.84 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiaA: Baseline | 886.79 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiuA: 4 weeks post-Vaccination 2 | 1164.80 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiuA: 6 months post-Vaccination 2 | 1188.92 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | BCH0785: 6 months post-Vaccination 2 | 726.43 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiaA: 6 months post-Vaccination | 1428.92 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | BCH0785: Baseline | 371.19 titer |
| Combined Control (600 µg) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Pneumolysoid (L460D): Baseline | 832.32 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PcpA: Baseline | 302.03 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | BCH0785: Baseline | 314.85 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | L460D: 4 weeks post-Vaccination 2 | 303.90 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | L460D: Baseline | 241.08 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Pneumolysoid (L460D): 6 months post-Vaccination 2 | 1051.76 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PcpA: 4 weeks post-Vaccination 2 | 351.00 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PcpA: 6 months post-Vaccination 2 | 558.79 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | BCH0785: 6 months post-Vaccination 2 | 460.80 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Pneumolysoid (L460D): Baseline | 497.88 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Pneumolysoid (L460D): 4 weeks post-Vaccination 2 | 545.42 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiuA: Baseline | 608.91 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | StkP: Baseline | 191.77 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (ELISA): 6 months post-Vaccination 2 | 796.22 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | BCH0785: 4 weeks post-Vaccination 2 | 397.66 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (ELISA): 4 weeks post-Vaccination 2 | 514.81 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiuA: 4 weeks post-Vaccination 2 | 743.11 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | SPWCA: Baseline | 660.13 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiaA: 6 months post-Vaccination | 816.56 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | SPWCA: 6 months post-Vaccination 2 | 700.71 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (MSD): 6 months post-Vaccination 2 | 317.09 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiaA: Baseline | 606.15 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | StkP: 4 weeks post-Vaccination 2 | 235.29 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (MSD): 4 weeks post-Vaccination 2 | 213.82 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiuA: 6 months post-Vaccination 2 | 923.97 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (MSD): Baseline | 218.24 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PhtD: 4 weeks post-Vaccination 2 | 575.56 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | L460D: 6 months post-Vaccination 2 | 380.59 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (ELISA): Baseline | 513.79 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | StkP: 6 months post-Vaccination 2 | 305.51 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiaA: 4 weeks post-Vaccination 2 | 805.26 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | SPWCA: 4 weeks post-Vaccination 2 | 762.31 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PhtD: Baseline | 377.18 titer |
| Booster Only (Both Cohorts) | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PhtD: 6 months post-Vaccination 2 | 890.03 titer |
Secondary
Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group
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)
Time frame: Week 32
Population: Immunogenicity population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | 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 |
| Combined PATH-wSP 300 µg | 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 |
| Combined PATH-wSP 300 µg | 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 |
| Combined PATH-wSP 300 µg | 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 |
| Combined PATH-wSP 300 µg | 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 |
| Combined PATH-wSP 300 µg | 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 |
| Combined PATH-wSP 300 µg | 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 |
| Combined PATH-wSP 300 µg | 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 |
| Combined PATH-wSP 300 µg | 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 |
| Combined PATH-wSP 300 µg | 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 |
| Combined PATH-wSP 300 µg | 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 |
| Combined Control (300 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | StkP | 1.09 ratio |
| Combined Control (300 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | PcpA | 1.22 ratio |
| Combined Control (300 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | Pneumolysoid (L460D) | 1.15 ratio |
| Combined Control (300 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | PspA-Fam1 (ELISA) | 1.04 ratio |
| Combined Control (300 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | L460D | 1.38 ratio |
| Combined Control (300 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | PspA-Fam1 (MSD) | 1.07 ratio |
| Combined Control (300 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | PhtD | 1.31 ratio |
| Combined Control (300 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | BCH0785 | 1.31 ratio |
| Combined Control (300 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | SPWCA | 1.30 ratio |
| Combined Control (300 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | PiuA | 1.38 ratio |
| Combined Control (300 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | PiaA | 1.29 ratio |
| Combined PATH-wSP 600 µg | 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 |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | BCH0785 | 0.84 ratio |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | SPWCA | 1.18 ratio |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | Pneumolysoid (L460D) | 1.30 ratio |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | L460D | 1.34 ratio |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | PspA-Fam1 (ELISA) | 0.96 ratio |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | PiaA | 0.90 ratio |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | StkP | 0.91 ratio |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | PiuA | 1.08 ratio |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | PspA-Fam1 (MSD) | 1.14 ratio |
| Combined PATH-wSP 600 µg | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | PhtD | 1.04 ratio |
| Combined Control (600 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | PspA-Fam1 (MSD) | 1.73 ratio |
| Combined Control (600 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | PiuA | 1.29 ratio |
| Combined Control (600 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | PhtD | 1.44 ratio |
| Combined Control (600 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | StkP | 1.54 ratio |
| Combined Control (600 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | BCH0785 | 1.58 ratio |
| Combined Control (600 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | PcpA | 1.40 ratio |
| Combined Control (600 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | PiaA | 1.75 ratio |
| Combined Control (600 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | SPWCA | 1.46 ratio |
| Combined Control (600 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | PspA-Fam1 (ELISA) | 1.56 ratio |
| Combined Control (600 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | L460D | 1.84 ratio |
| Combined Control (600 µg) | Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group | Pneumolysoid (L460D) | 1.61 ratio |
Secondary
Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins
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.
Time frame: Baseline and Week 32
Population: Immunogenicity Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiaA | 1.56 fold-change |
| Combined PATH-wSP 300 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | SPWCA | 1.26 fold-change |
| Combined PATH-wSP 300 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | L460D | 1.91 fold-change |
| Combined PATH-wSP 300 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PhtD | 2.43 fold-change |
| Combined PATH-wSP 300 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PcpA | 1.97 fold-change |
| Combined PATH-wSP 300 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | BCH0785 | 1.34 fold-change |
| Combined PATH-wSP 300 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (ELISA) | 2.20 fold-change |
| Combined PATH-wSP 300 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Pneumolysoid (L460D) | 2.81 fold-change |
| Combined PATH-wSP 300 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiuA | 1.51 fold-change |
| Combined PATH-wSP 300 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (MSD) | 1.76 fold-change |
| Combined PATH-wSP 300 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | StkP | 1.57 fold-change |
| Combined Control (300 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | BCH0785 | 1.87 fold-change |
| Combined Control (300 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Pneumolysoid (L460D) | 3.67 fold-change |
| Combined Control (300 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (ELISA) | 2.15 fold-change |
| Combined Control (300 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PhtD | 2.55 fold-change |
| Combined Control (300 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | StkP | 2.32 fold-change |
| Combined Control (300 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PcpA | 1.84 fold-change |
| Combined Control (300 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | SPWCA | 1.36 fold-change |
| Combined Control (300 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | L460D | 2.24 fold-change |
| Combined Control (300 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiuA | 2.02 fold-change |
| Combined Control (300 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (MSD) | 1.74 fold-change |
| Combined Control (300 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiaA | 1.88 fold-change |
| Combined PATH-wSP 600 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | BCH0785 | 1.44 fold-change |
| Combined PATH-wSP 600 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (MSD) | 1.65 fold-change |
| Combined PATH-wSP 600 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (ELISA) | 1.27 fold-change |
| Combined PATH-wSP 600 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Pneumolysoid (L460D) | 1.75 fold-change |
| Combined PATH-wSP 600 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiuA | 1.71 fold-change |
| Combined PATH-wSP 600 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | L460D | 1.61 fold-change |
| Combined PATH-wSP 600 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PcpA | 2.06 fold-change |
| Combined PATH-wSP 600 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PhtD | 1.99 fold-change |
| Combined PATH-wSP 600 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | StkP | 1.70 fold-change |
| Combined PATH-wSP 600 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiaA | 1.21 fold-change |
| Combined PATH-wSP 600 µg | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | SPWCA | 1.31 fold-change |
| Combined Control (600 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (MSD) | 2.37 fold-change |
| Combined Control (600 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | BCH0785 | 1.96 fold-change |
| Combined Control (600 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | StkP | 1.91 fold-change |
| Combined Control (600 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PcpA | 1.68 fold-change |
| Combined Control (600 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | SPWCA | 1.52 fold-change |
| Combined Control (600 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiuA | 1.70 fold-change |
| Combined Control (600 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiaA | 1.61 fold-change |
| Combined Control (600 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Pneumolysoid (L460D) | 2.04 fold-change |
| Combined Control (600 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (ELISA) | 1.71 fold-change |
| Combined Control (600 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | L460D | 2.02 fold-change |
| Combined Control (600 µg) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PhtD | 2.31 fold-change |
| Booster Only (Both Cohorts) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | L460D | 1.58 fold-change |
| Booster Only (Both Cohorts) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiaA | 1.35 fold-change |
| Booster Only (Both Cohorts) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PiuA | 1.52 fold-change |
| Booster Only (Both Cohorts) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | SPWCA | 1.06 fold-change |
| Booster Only (Both Cohorts) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PcpA | 1.85 fold-change |
| Booster Only (Both Cohorts) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (MSD) | 1.45 fold-change |
| Booster Only (Both Cohorts) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | StkP | 1.59 fold-change |
| Booster Only (Both Cohorts) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | BCH0785 | 1.59 fold-change |
| Booster Only (Both Cohorts) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PspA-Fam1 (ELISA) | 1.55 fold-change |
| Booster Only (Both Cohorts) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | Pneumolysoid (L460D) | 2.11 fold-change |
| Booster Only (Both Cohorts) | Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins | PhtD | 2.36 fold-change |
Secondary
Number of Adverse Events (AE)
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.
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Number of Adverse Events (AE) | Severity: Mild (Grade 1) | 0 adverse events |
| Combined PATH-wSP 300 µg | Number of Adverse Events (AE) | Serious AE: No | 0 adverse events |
| Combined PATH-wSP 300 µg | Number of Adverse Events (AE) | Severity: Severe (Grade 3) | 0 adverse events |
| Combined PATH-wSP 300 µg | Number of Adverse Events (AE) | Related to vaccine: Yes | 0 adverse events |
| Combined PATH-wSP 300 µg | Number of Adverse Events (AE) | Severity: Moderate (Grade 2) | 0 adverse events |
| Combined PATH-wSP 300 µg | Number of Adverse Events (AE) | Related to vaccine: No | 0 adverse events |
| Combined PATH-wSP 300 µg | Number of Adverse Events (AE) | Severity: Potentially Life Threatening (Grade 4) | 0 adverse events |
| Combined PATH-wSP 300 µg | Number of Adverse Events (AE) | Total number of AEs | 0 adverse events |
| Combined PATH-wSP 300 µg | Number of Adverse Events (AE) | Severity: Death (Grade 5) | 0 adverse events |
| Combined PATH-wSP 300 µg | Number of Adverse Events (AE) | Serious AE: Yes | 0 adverse events |
| Combined Control (300 µg) | Number of Adverse Events (AE) | Severity: Severe (Grade 3) | 0 adverse events |
| Combined Control (300 µg) | Number of Adverse Events (AE) | Total number of AEs | 0 adverse events |
| Combined Control (300 µg) | Number of Adverse Events (AE) | Related to vaccine: Yes | 0 adverse events |
| Combined Control (300 µg) | Number of Adverse Events (AE) | Severity: Potentially Life Threatening (Grade 4) | 0 adverse events |
| Combined Control (300 µg) | Number of Adverse Events (AE) | Severity: Mild (Grade 1) | 0 adverse events |
| Combined Control (300 µg) | Number of Adverse Events (AE) | Serious AE: Yes | 0 adverse events |
| Combined Control (300 µg) | Number of Adverse Events (AE) | Severity: Moderate (Grade 2) | 0 adverse events |
| Combined Control (300 µg) | Number of Adverse Events (AE) | Serious AE: No | 0 adverse events |
| Combined Control (300 µg) | Number of Adverse Events (AE) | Severity: Death (Grade 5) | 0 adverse events |
| Combined Control (300 µg) | Number of Adverse Events (AE) | Related to vaccine: No | 0 adverse events |
| Combined PATH-wSP 600 µg | Number of Adverse Events (AE) | Severity: Potentially Life Threatening (Grade 4) | 0 adverse events |
| Combined PATH-wSP 600 µg | Number of Adverse Events (AE) | Severity: Death (Grade 5) | 0 adverse events |
| Combined PATH-wSP 600 µg | Number of Adverse Events (AE) | Serious AE: No | 1 adverse events |
| Combined PATH-wSP 600 µg | Number of Adverse Events (AE) | Related to vaccine: Yes | 0 adverse events |
| Combined PATH-wSP 600 µg | Number of Adverse Events (AE) | Serious AE: Yes | 0 adverse events |
| Combined PATH-wSP 600 µg | Number of Adverse Events (AE) | Severity: Mild (Grade 1) | 1 adverse events |
| Combined PATH-wSP 600 µg | Number of Adverse Events (AE) | Total number of AEs | 1 adverse events |
| Combined PATH-wSP 600 µg | Number of Adverse Events (AE) | Severity: Moderate (Grade 2) | 0 adverse events |
| Combined PATH-wSP 600 µg | Number of Adverse Events (AE) | Severity: Severe (Grade 3) | 0 adverse events |
| Combined PATH-wSP 600 µg | Number of Adverse Events (AE) | Related to vaccine: No | 1 adverse events |
| Combined Control (600 µg) | Number of Adverse Events (AE) | Related to vaccine: No | 4 adverse events |
| Combined Control (600 µg) | Number of Adverse Events (AE) | Severity: Mild (Grade 1) | 0 adverse events |
| Combined Control (600 µg) | Number of Adverse Events (AE) | Serious AE: Yes | 4 adverse events |
| Combined Control (600 µg) | Number of Adverse Events (AE) | Severity: Death (Grade 5) | 0 adverse events |
| Combined Control (600 µg) | Number of Adverse Events (AE) | Severity: Severe (Grade 3) | 4 adverse events |
| Combined Control (600 µg) | Number of Adverse Events (AE) | Related to vaccine: Yes | 0 adverse events |
| Combined Control (600 µg) | Number of Adverse Events (AE) | Severity: Potentially Life Threatening (Grade 4) | 0 adverse events |
| Combined Control (600 µg) | Number of Adverse Events (AE) | Serious AE: No | 0 adverse events |
| Combined Control (600 µg) | Number of Adverse Events (AE) | Severity: Moderate (Grade 2) | 0 adverse events |
| Combined Control (600 µg) | Number of Adverse Events (AE) | Total number of AEs | 4 adverse events |
| Booster Only (Both Cohorts) | Number of Adverse Events (AE) | Related to vaccine: No | 1 adverse events |
| Booster Only (Both Cohorts) | Number of Adverse Events (AE) | Total number of AEs | 1 adverse events |
| Booster Only (Both Cohorts) | Number of Adverse Events (AE) | Serious AE: No | 0 adverse events |
| Booster Only (Both Cohorts) | Number of Adverse Events (AE) | Serious AE: Yes | 1 adverse events |
| Booster Only (Both Cohorts) | Number of Adverse Events (AE) | Severity: Mild (Grade 1) | 0 adverse events |
| Booster Only (Both Cohorts) | Number of Adverse Events (AE) | Severity: Moderate (Grade 2) | 0 adverse events |
| Booster Only (Both Cohorts) | Number of Adverse Events (AE) | Severity: Severe (Grade 3) | 1 adverse events |
| Booster Only (Both Cohorts) | Number of Adverse Events (AE) | Severity: Potentially Life Threatening (Grade 4) | 0 adverse events |
| Booster Only (Both Cohorts) | Number of Adverse Events (AE) | Severity: Death (Grade 5) | 0 adverse events |
| Booster Only (Both Cohorts) | Number of Adverse Events (AE) | Related to vaccine: Yes | 0 adverse events |
| No Intervention | Number of Adverse Events (AE) | Severity: Potentially Life Threatening (Grade 4) | 0 adverse events |
| No Intervention | Number of Adverse Events (AE) | Severity: Severe (Grade 3) | 1 adverse events |
| No Intervention | Number of Adverse Events (AE) | Severity: Moderate (Grade 2) | 0 adverse events |
| No Intervention | Number of Adverse Events (AE) | Related to vaccine: No | 1 adverse events |
| No Intervention | Number of Adverse Events (AE) | Severity: Mild (Grade 1) | 1 adverse events |
| No Intervention | Number of Adverse Events (AE) | Serious AE: Yes | 1 adverse events |
| No Intervention | Number of Adverse Events (AE) | Serious AE: No | 0 adverse events |
| No Intervention | Number of Adverse Events (AE) | Total number of AEs | 1 adverse events |
| No Intervention | Number of Adverse Events (AE) | Related to vaccine: Yes | 0 adverse events |
| No Intervention | Number of Adverse Events (AE) | Severity: Death (Grade 5) | 0 adverse events |
Secondary
Number of Participants With Neutralizing Antibody Response to Pneumolysin
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.
Time frame: Baseline (Week 0) and 6 months post-vaccination 2 (Week 32)
Population: Immunogenicity Population with available neutralizing antibody data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Combined PATH-wSP 300 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:20 titer | 11 Participants |
| Combined PATH-wSP 300 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:320 titer | 2 Participants |
| Combined PATH-wSP 300 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:80 titer | 5 Participants |
| Combined PATH-wSP 300 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:40 titer | 10 Participants |
| Combined PATH-wSP 300 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:20 titer | 10 Participants |
| Combined PATH-wSP 300 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:40 titer | 8 Participants |
| Combined PATH-wSP 300 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:80 titer | 2 Participants |
| Combined PATH-wSP 300 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | <1:20 titer | 12 Participants |
| Combined PATH-wSP 300 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:160 titer | 1 Participants |
| Combined PATH-wSP 300 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:160 titer | 7 Participants |
| Combined PATH-wSP 300 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:320 titer | 2 Participants |
| Combined PATH-wSP 300 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | <1:20 titer | 0 Participants |
| Combined Control (300 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:320 titer | 1 Participants |
| Combined Control (300 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:20 titer | 12 Participants |
| Combined Control (300 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | <1:20 titer | 0 Participants |
| Combined Control (300 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:160 titer | 5 Participants |
| Combined Control (300 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:320 titer | 1 Participants |
| Combined Control (300 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:80 titer | 5 Participants |
| Combined Control (300 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:40 titer | 11 Participants |
| Combined Control (300 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:160 titer | 0 Participants |
| Combined Control (300 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:80 titer | 5 Participants |
| Combined Control (300 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:20 titer | 10 Participants |
| Combined Control (300 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | <1:20 titer | 10 Participants |
| Combined Control (300 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:40 titer | 8 Participants |
| Combined PATH-wSP 600 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:80 titer | 8 Participants |
| Combined PATH-wSP 600 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:40 titer | 9 Participants |
| Combined PATH-wSP 600 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:80 titer | 3 Participants |
| Combined PATH-wSP 600 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | <1:20 titer | 0 Participants |
| Combined PATH-wSP 600 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:160 titer | 2 Participants |
| Combined PATH-wSP 600 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:320 titer | 2 Participants |
| Combined PATH-wSP 600 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:20 titer | 11 Participants |
| Combined PATH-wSP 600 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:160 titer | 4 Participants |
| Combined PATH-wSP 600 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:320 titer | 0 Participants |
| Combined PATH-wSP 600 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:40 titer | 12 Participants |
| Combined PATH-wSP 600 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | <1:20 titer | 12 Participants |
| Combined PATH-wSP 600 µg | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:20 titer | 11 Participants |
| Combined Control (600 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:20 titer | 8 Participants |
| Combined Control (600 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | <1:20 titer | 8 Participants |
| Combined Control (600 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:40 titer | 12 Participants |
| Combined Control (600 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:80 titer | 6 Participants |
| Combined Control (600 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:160 titer | 1 Participants |
| Combined Control (600 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:320 titer | 0 Participants |
| Combined Control (600 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | <1:20 titer | 0 Participants |
| Combined Control (600 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:20 titer | 7 Participants |
| Combined Control (600 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:40 titer | 8 Participants |
| Combined Control (600 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:80 titer | 10 Participants |
| Combined Control (600 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:160 titer | 7 Participants |
| Combined Control (600 µg) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:320 titer | 3 Participants |
| Booster Only (Both Cohorts) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:320 titer | 0 Participants |
| Booster Only (Both Cohorts) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:20 titer | 8 Participants |
| Booster Only (Both Cohorts) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:80 titer | 7 Participants |
| Booster Only (Both Cohorts) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:160 titer | 1 Participants |
| Booster Only (Both Cohorts) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:80 titer | 4 Participants |
| Booster Only (Both Cohorts) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:320 titer | 0 Participants |
| Booster Only (Both Cohorts) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:160 titer | 3 Participants |
| Booster Only (Both Cohorts) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | <1:20 titer | 17 Participants |
| Booster Only (Both Cohorts) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | Baseline | 1:40 titer | 4 Participants |
| Booster Only (Both Cohorts) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:40 titer | 12 Participants |
| Booster Only (Both Cohorts) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | 1:20 titer | 12 Participants |
| Booster Only (Both Cohorts) | Number of Participants With Neutralizing Antibody Response to Pneumolysin | 6 months post-vaccination 2 | <1:20 titer | 0 Participants |
Secondary
Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2
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)
Time frame: Baseline and Week 32
Population: Immunogenicity Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiuA: ≥ 4 Fold-Rise | 9.3 percentage of participants |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiaA: ≥ 4 Fold-Rise | 11.6 percentage of participants |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | SPWCA: ≥ 4 Fold-Rise | 4.7 percentage of participants |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiaA: ≥ 3 Fold-Rise | 23.3 percentage of participants |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiuA: ≥ 2 Fold-Rise | 32.6 percentage of participants |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | L460D: ≥ 2 Fold-Rise | 46.5 percentage of participants |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiaA: ≥ 2 Fold-Rise | 41.9 percentage of participants |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiuA: ≥ 3 Fold-Rise | 20.9 percentage of participants |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | SPWCA: ≥ 3 Fold-Rise | 9.3 percentage of participants |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | Pneumolysoid (L460D): ≥4 Fold-Rise | 44.2 percentage of participants |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | BCH0785: ≥ 2 Fold-Rise | 32.6 percentage of participants |
| Combined PATH-wSP 300 µg | 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 |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | BCH0785: ≥ 3 Fold-Rise | 23.3 percentage of participants |
| Combined PATH-wSP 300 µg | 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 |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | L460D: ≥ 4 Fold-Rise | 14.0 percentage of participants |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | StkP: ≥ 2 Fold-Rise | 32.6 percentage of participants |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PhtD: ≥ 2 Fold-Ris2 | 58.1 percentage of participants |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | L460D: ≥ 3 Fold-Rise | 23.3 percentage of participants |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | StkP: ≥ 3 Fold-Rise | 20.9 percentage of participants |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PhtD: ≥ 4 Fold-Rise | 25.6 percentage of participants |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | StkP: ≥ 4 Fold-Rise | 18.6 percentage of participants |
| Combined PATH-wSP 300 µg | 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 |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PcpA: ≥ 2 Fold-Rise | 46.5 percentage of participants |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | BCH0785: ≥ 4 Fold-Rise | 14.0 percentage of participants |
| Combined PATH-wSP 300 µg | 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 |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PcpA: ≥ 3 Fold-Rise | 30.2 percentage of participants |
| Combined PATH-wSP 300 µg | 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 |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PcpA: ≥ 4 Fold-Rise | 25.6 percentage of participants |
| Combined PATH-wSP 300 µg | 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 |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | Pneumolysoid (L460D): ≥ 3 Fold-Rise | 44.2 percentage of participants |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | SPWCA: ≥ 2 Fold-Rise | 25.6 percentage of participants |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PhtD: ≥ 3 Fold-Rise | 46.5 percentage of participants |
| Combined PATH-wSP 300 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | Pneumolysoid (L460D): ≥ 2 Fold-Rise | 72.1 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | Pneumolysoid (L460D): ≥ 3 Fold-Rise | 57.5 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | SPWCA: ≥ 3 Fold-Rise | 12.5 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PhtD: ≥ 3 Fold-Rise | 40.0 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiaA: ≥ 4 Fold-Rise | 20.0 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | StkP: ≥ 2 Fold-Rise | 52.5 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PcpA: ≥ 2 Fold-Rise | 42.5 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (MSD): ≥ 4 Fold-Rise | 27.5 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiaA: ≥ 3 Fold-Rise | 25.0 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | L460D: ≥ 3 Fold-Rise | 40.0 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | SPWCA: ≥ 2 Fold-Rise | 22.5 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiuA: ≥ 2 Fold-Rise | 52.5 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PcpA: ≥ 4 Fold-Rise | 27.5 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiaA: ≥ 2 Fold-Rise | 40.0 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | StkP: ≥ 3 Fold-Rise | 32.5 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (ELISA): ≥ 2 Fold-Rise | 60.0 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiuA: ≥ 4 Fold-Rise | 22.5 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | L460D: ≥ 2 Fold-Rise | 52.5 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | Pneumolysoid (L460D): ≥4 Fold-Rise | 57.5 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PhtD: ≥ 4 Fold-Rise | 35.0 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PhtD: ≥ 2 Fold-Ris2 | 50.0 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (ELISA): ≥ 4 Fold-Rise | 30.0 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | Pneumolysoid (L460D): ≥ 2 Fold-Rise | 87.5 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | BCH0785: ≥ 2 Fold-Rise | 50.0 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | StkP: ≥ 4 Fold-Rise | 27.5 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (MSD): ≥ 2 Fold-Rise | 37.5 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (MSD): ≥ 3 Fold-Rise | 30.0 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | BCH0785: ≥ 3 Fold-Rise | 27.5 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | SPWCA: ≥ 4 Fold-Rise | 7.5 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PcpA: ≥ 3 Fold-Rise | 35.0 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | L460D: ≥ 4 Fold-Rise | 27.5 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | BCH0785: ≥ 4 Fold-Rise | 15.0 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiuA: ≥ 3 Fold-Rise | 27.5 percentage of participants |
| Combined Control (300 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (ELISA): ≥ 3 Fold-Rise | 42.5 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | StkP: ≥ 3 Fold-Rise | 23.7 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PcpA: ≥ 3 Fold-Rise | 34.2 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiuA: ≥ 3 Fold-Rise | 26.3 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiaA: ≥ 3 Fold-Rise | 7.9 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PhtD: ≥ 3 Fold-Rise | 28.9 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PhtD: ≥ 4 Fold-Rise | 15.8 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | BCH0785: ≥ 2 Fold-Rise | 42.1 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | BCH0785: ≥ 3 Fold-Rise | 18.4 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | BCH0785: ≥ 4 Fold-Rise | 10.5 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | StkP: ≥ 2 Fold-Rise | 42.1 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | StkP: ≥ 4 Fold-Rise | 10.5 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PcpA: ≥ 2 Fold-Rise | 50.0 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PcpA: ≥ 4 Fold-Rise | 26.3 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | SPWCA: ≥ 2 Fold-Rise | 26.3 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | SPWCA: ≥ 3 Fold-Rise | 10.5 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | SPWCA: ≥ 4 Fold-Rise | 0.0 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiuA: ≥ 2 Fold-Rise | 39.5 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiuA: ≥ 4 Fold-Rise | 15.8 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiaA: ≥ 2 Fold-Rise | 26.3 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiaA: ≥ 4 Fold-Rise | 2.6 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | Pneumolysoid (L460D): ≥ 2 Fold-Rise | 60.5 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | Pneumolysoid (L460D): ≥ 3 Fold-Rise | 28.9 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (ELISA): ≥ 2 Fold-Rise | 28.9 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (ELISA): ≥ 4 Fold-Rise | 13.2 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | L460D: ≥ 2 Fold-Rise | 34.2 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | L460D: ≥ 3 Fold-Rise | 15.8 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | L460D: ≥ 4 Fold-Rise | 10.5 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (MSD): ≥ 2 Fold-Rise | 44.7 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | Pneumolysoid (L460D): ≥4 Fold-Rise | 26.3 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (ELISA): ≥ 3 Fold-Rise | 15.8 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (MSD): ≥ 3 Fold-Rise | 31.6 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (MSD): ≥ 4 Fold-Rise | 23.7 percentage of participants |
| Combined PATH-wSP 600 µg | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PhtD: ≥ 2 Fold-Ris2 | 57.9 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (ELISA): ≥ 2 Fold-Rise | 42.9 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | SPWCA: ≥ 2 Fold-Rise | 31.4 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | Pneumolysoid (L460D): ≥ 2 Fold-Rise | 62.9 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PcpA: ≥ 4 Fold-Rise | 22.9 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | Pneumolysoid (L460D): ≥ 3 Fold-Rise | 34.3 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PcpA: ≥ 3 Fold-Rise | 31.4 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiaA: ≥ 2 Fold-Rise | 40.0 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiaA: ≥ 4 Fold-Rise | 17.1 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PcpA: ≥ 2 Fold-Rise | 40.0 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (ELISA): ≥ 3 Fold-Rise | 37.1 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | StkP: ≥ 4 Fold-Rise | 20.0 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PhtD: ≥ 4 Fold-Rise | 17.1 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (ELISA): ≥ 4 Fold-Rise | 22.9 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | StkP: ≥ 3 Fold-Rise | 34.3 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (MSD): ≥ 3 Fold-Rise | 42.9 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | L460D: ≥ 2 Fold-Rise | 48.6 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | StkP: ≥ 2 Fold-Rise | 48.06 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | BCH0785: ≥ 4 Fold-Rise | 25.7 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | L460D: ≥ 4 Fold-Rise | 17.1 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | BCH0785: ≥ 3 Fold-Rise | 28.6 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PhtD: ≥ 2 Fold-Ris2 | 54.3 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (MSD): ≥ 4 Fold-Rise | 31.4 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | Pneumolysoid (L460D): ≥4 Fold-Rise | 34.3 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | BCH0785: ≥ 2 Fold-Rise | 42.9 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PhtD: ≥ 3 Fold-Rise | 40.0 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiuA: ≥ 3 Fold-Rise | 22.9 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | L460D: ≥ 3 Fold-Rise | 31.4 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiuA: ≥ 4 Fold-Rise | 17.1 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiuA: ≥ 2 Fold-Rise | 45.7 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (MSD): ≥ 2 Fold-Rise | 45.7 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | SPWCA: ≥ 4 Fold-Rise | 0.0 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiaA: ≥ 3 Fold-Rise | 20.0 percentage of participants |
| Combined Control (600 µg) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | SPWCA: ≥ 3 Fold-Rise | 2.9 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | L460D: ≥ 3 Fold-Rise | 18.4 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiaA: ≥ 4 Fold-Rise | 10.5 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | SPWCA: ≥ 2 Fold-Rise | 21.1 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | BCH0785: ≥ 4 Fold-Rise | 15.8 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (MSD): ≥ 4 Fold-Rise | 15.8 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | BCH0785: ≥ 3 Fold-Rise | 26.3 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | Pneumolysoid (L460D): ≥ 2 Fold-Rise | 55.3 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PcpA: ≥ 4 Fold-Rise | 31.6 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiuA: ≥ 3 Fold-Rise | 13.2 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PhtD: ≥ 2 Fold-Ris2 | 60.5 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiaA: ≥ 2 Fold-Rise | 36.8 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | Pneumolysoid (L460D): ≥ 3 Fold-Rise | 39.5 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | Pneumolysoid (L460D): ≥4 Fold-Rise | 39.5 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | L460D: ≥ 4 Fold-Rise | 10.5 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PcpA: ≥ 2 Fold-Rise | 39.5 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | SPWCA: ≥ 4 Fold-Rise | 2.6 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | BCH0785: ≥ 2 Fold-Rise | 39.5 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (ELISA): ≥ 2 Fold-Rise | 36.8 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | SPWCA: ≥ 3 Fold-Rise | 2.6 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | StkP: ≥ 4 Fold-Rise | 13.2 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (MSD): ≥ 2 Fold-Rise | 39.5 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (ELISA): ≥ 3 Fold-Rise | 26.3 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PhtD: ≥ 4 Fold-Rise | 28.9 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | StkP: ≥ 3 Fold-Rise | 21.1 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PhtD: ≥ 3 Fold-Rise | 42.1 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiuA: ≥ 4 Fold-Rise | 7.9 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (ELISA): ≥ 4 Fold-Rise | 23.7 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiuA: ≥ 2 Fold-Rise | 34.2 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PspA-Fam1 (MSD): ≥ 3 Fold-Rise | 21.1 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PiaA: ≥ 3 Fold-Rise | 21.1 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | StkP: ≥ 2 Fold-Rise | 36.8 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | L460D: ≥ 2 Fold-Rise | 36.8 percentage of participants |
| Booster Only (Both Cohorts) | Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 | PcpA: ≥ 3 Fold-Rise | 31.6 percentage of participants |
Secondary
Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 4 (Week 20) | 4 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 2 (Week 12) | 7 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 5 (Week 32) | 6 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 3 (Week 16) | 2 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 1 (Week 0) | 6 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 3 (Week 16) | 4 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 4 (Week 20) | 3 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 5 (Week 32) | 0 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 2 (Week 12) | 3 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 1 (Week 0) | 4 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 3 (Week 16) | 7 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 1 (Week 0) | 6 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 2 (Week 12) | 5 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 4 (Week 20) | 5 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 5 (Week 32) | 9 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 4 (Week 20) | 1 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 2 (Week 12) | 1 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 1 (Week 0) | 1 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 3 (Week 16) | 3 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx | Visit 5 (Week 32) | 3 Participants |
Secondary
Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 4 (Week 20) | 6 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 2 (Week 12) | 6 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 5 (Week 32) | 5 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 3 (Week 16) | 4 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 1 (Week 0) | 6 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 3 (Week 16) | 3 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 4 (Week 20) | 5 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 5 (Week 32) | 6 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 2 (Week 12) | 5 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 1 (Week 0) | 2 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 3 (Week 16) | 5 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 1 (Week 0) | 3 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 2 (Week 12) | 5 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 4 (Week 20) | 5 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 5 (Week 32) | 4 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 4 (Week 20) | 1 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 2 (Week 12) | 3 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 1 (Week 0) | 5 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 3 (Week 16) | 1 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx | Visit 5 (Week 32) | 2 Participants |
Secondary
Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 3 (Week 16) | 8 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 1 (Week 0) | 1 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 4 (Week 20) | 7 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 2 (Week 12) | 5 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 5 (Week 32) | 7 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 3 (Week 16) | 1 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 2 (Week 12) | 2 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 4 (Week 20) | 1 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 1 (Week 0) | 0 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 5 (Week 32) | 4 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 5 (Week 32) | 2 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 1 (Week 0) | 2 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 2 (Week 12) | 5 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 3 (Week 16) | 5 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 4 (Week 20) | 6 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 5 (Week 32) | 5 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 4 (Week 20) | 2 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 2 (Week 12) | 4 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 1 (Week 0) | 3 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx | Visit 3 (Week 16) | 1 Participants |
Secondary
Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 4 (Week 20) | 11 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 2 (Week 12) | 16 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 5 (Week 32) | 4 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 3 (Week 16) | 9 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 1 (Week 0) | 10 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 3 (Week 16) | 4 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 4 (Week 20) | 2 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 5 (Week 32) | 1 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 2 (Week 12) | 3 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 1 (Week 0) | 2 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 3 (Week 16) | 5 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 1 (Week 0) | 9 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 2 (Week 12) | 7 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 4 (Week 20) | 9 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 5 (Week 32) | 4 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 4 (Week 20) | 4 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 2 (Week 12) | 5 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 1 (Week 0) | 6 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 3 (Week 16) | 8 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx | Visit 5 (Week 32) | 3 Participants |
Secondary
Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 4 (Week 20) | 2 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 2 (Week 12) | 3 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 5 (Week 32) | 7 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 3 (Week 16) | 1 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 1 (Week 0) | 3 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 3 (Week 16) | 7 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 4 (Week 20) | 6 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 5 (Week 32) | 3 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 2 (Week 12) | 6 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 1 (Week 0) | 4 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 3 (Week 16) | 6 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 1 (Week 0) | 7 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 2 (Week 12) | 9 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 4 (Week 20) | 5 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 5 (Week 32) | 3 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 4 (Week 20) | 6 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 2 (Week 12) | 5 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 1 (Week 0) | 4 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 3 (Week 16) | 3 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx | Visit 5 (Week 32) | 4 Participants |
Secondary
Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 4 (Week 20) | 5 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 2 (Week 12) | 5 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 5 (Week 32) | 4 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 3 (Week 16) | 4 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 1 (Week 0) | 4 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 3 (Week 16) | 5 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 4 (Week 20) | 4 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 5 (Week 32) | 3 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 2 (Week 12) | 5 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 1 (Week 0) | 2 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 3 (Week 16) | 10 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 1 (Week 0) | 6 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 2 (Week 12) | 7 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 4 (Week 20) | 10 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 5 (Week 32) | 8 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 4 (Week 20) | 3 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 2 (Week 12) | 3 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 1 (Week 0) | 5 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 3 (Week 16) | 2 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx | Visit 5 (Week 32) | 2 Participants |
Secondary
Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 4 (Week 20) | 2 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 2 (Week 12) | 8 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 5 (Week 32) | 7 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 3 (Week 16) | 5 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 1 (Week 0) | 8 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 3 (Week 16) | 6 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 4 (Week 20) | 5 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 5 (Week 32) | 3 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 2 (Week 12) | 3 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 1 (Week 0) | 4 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 3 (Week 16) | 8 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 1 (Week 0) | 11 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 2 (Week 12) | 9 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 4 (Week 20) | 6 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 5 (Week 32) | 4 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 4 (Week 20) | 3 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 2 (Week 12) | 4 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 1 (Week 0) | 4 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 3 (Week 16) | 2 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx | Visit 5 (Week 32) | 1 Participants |
Secondary
Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 4 (Week 20) | 6 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 2 (Week 12) | 6 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 5 (Week 32) | 4 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 3 (Week 16) | 9 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 1 (Week 0) | 8 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 3 (Week 16) | 4 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 4 (Week 20) | 5 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 5 (Week 32) | 4 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 2 (Week 12) | 4 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 1 (Week 0) | 4 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 3 (Week 16) | 11 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 1 (Week 0) | 5 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 2 (Week 12) | 7 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 4 (Week 20) | 6 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 5 (Week 32) | 8 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 4 (Week 20) | 4 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 2 (Week 12) | 1 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 1 (Week 0) | 2 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 3 (Week 16) | 2 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx | Visit 5 (Week 32) | 1 Participants |
Secondary
Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 4 (Week 20) | 3 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 1 (Week 0) | 5 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 5 (Week 32) | 4 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 3 (Week 16) | 5 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 2 (Week 12) | 7 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 3 (Week 16) | 6 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 4 (Week 20) | 3 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 5 (Week 32) | 5 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 2 (Week 12) | 4 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 1 (Week 0) | 5 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 1 (Week 0) | 6 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 2 (Week 12) | 6 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 3 (Week 16) | 7 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 4 (Week 20) | 5 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 5 (Week 32) | 5 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 4 (Week 20) | 3 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 2 (Week 12) | 3 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 1 (Week 0) | 2 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 3 (Week 16) | 1 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx | Visit 5 (Week 32) | 2 Participants |
Secondary
Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx
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
Time frame: Week 0, Week 12, Week 16, Week 20, Week 32
Population: Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 4 (Week 20) | 12 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 2 (Week 12) | 17 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 5 (Week 32) | 20 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 3 (Week 16) | 17 Participants |
| Combined PATH-wSP 300 µg | Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 1 (Week 0) | 29 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 3 (Week 16) | 13 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 4 (Week 20) | 15 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 5 (Week 32) | 14 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 2 (Week 12) | 10 Participants |
| Combined Control (300 µg) | Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 1 (Week 0) | 17 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 3 (Week 16) | 23 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 1 (Week 0) | 27 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 2 (Week 12) | 32 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 4 (Week 20) | 26 Participants |
| Combined PATH-wSP 600 µg | Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 5 (Week 32) | 18 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 4 (Week 20) | 8 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 2 (Week 12) | 10 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 1 (Week 0) | 15 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 3 (Week 16) | 10 Participants |
| Combined Control (600 µg) | Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx | Visit 5 (Week 32) | 13 Participants |