Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1238-9824 | Registry Identifier | ICTRP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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Primary Objectives:
The duration of each participant's participation was approximately 6 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP0202-IIb | Experimental | One dose at Day 1 |
|
| SP0202-VI | Experimental | One dose at Day 1 |
|
| SP0202-VII | Experimental | One dose at Day 1 |
|
| Prevnar 13 | Active Comparator | One dose at Day 1 |
|
| Pneumovax 23 | Active Comparator | One dose at Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb | Biological | Pharmaceutical form:Suspension for injection Route of administration: intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Titers were expressed in terms of 1/dilution. | Post-vaccination at Day 31 |
| Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Ratio was calculated as post-vaccination titer at Day 31 to pre-vaccination titer at Day 1. | Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31 |
| Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | The GMCs for serotype specific pneumococcal IgG antibodies were measured using ECL, a multiplexed serological assay which allowed for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens. | Post-vaccination at Day 31 |
| Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | The GMCs for serotype specific pneumococcal IgG antibodies were measured using ECL, a multiplexed serological assay which allowed for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens. Ratio was calculated as post-vaccination titer at Day 31 to pre-vaccination titer at Day 1. | Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31 |
| Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) |
Not provided
Not provided
Inclusion criteria :
- Aged 50 to 84 years on the day of inclusion .
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emmaus Research Center, Inc Site Number : 8400014 | Anaheim | California | 92804 | United States | ||
| Peninsula Research Associates Site Number : 8400012 |
Not provided
| Label | URL |
|---|---|
| PSK00009 Plain Language Results Summary | View source |
Not provided
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Not provided
Not provided
Not provided
Not provided
A total of 750 participants were enrolled in this study.
This study was conducted at 17 investigational sites in United States between 08 Oct 2020 to 20 Jan 2022.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: SP0202-IIb | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single intramuscular (IM) injection of SP0202-IIb formulation at Day 1. |
| FG001 | Group 2: SP0202-VI |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2020 | Jul 31, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI | Biological | Pharmaceutical form:Suspension for injection Route of administration: intramuscular |
|
| Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VII | Biological | Pharmaceutical form:Suspension for injection Route of administration: intramuscular |
|
| Pneumococcal 13 - valent conjugate vaccine-Prevnar 13 | Biological | Pharmaceutical form:Suspension for injection Route of administration: intramuscular |
|
| Pneumococcal Vaccine Polyvalent-Pneumovax 23 | Biological | Pharmaceutical form:Solution for injection Route of administration: intramuscular |
|
An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions.
| Within 30 minutes post-vaccination |
| Number of Participants With Solicited Injection Site Reactions | A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. An injection site reaction was an AR at and around the injection site. Solicited injection site reactions included injection site pain, injection site erythema and injection site swelling. | Up to 7 Days post-vaccination (Day 8) |
| Number of Participants With Solicited Systemic Reactions | A solicited reaction was an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia and shivering. | Up to 7 Days post-vaccination (Day 8) |
| Number of Participants With Unsolicited AEs | An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination. | Within 30 days post-vaccination |
| Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor could be appropriate. AESI included analyphylaxis. | From the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days |
| Rolling Hills Estates |
| California |
| 90274 |
| United States |
| Paradigm Clinical Research Center Wheat Ridge Site Number : 8400002 | Wheat Ridge | Colorado | 80033 | United States |
| Jacksonville Center for Clinical Research Site Number : 8400016 | Jacksonville | Florida | 32216 | United States |
| Suncoast Research Associates, LLC Site Number : 8400017 | Miami | Florida | 33173 | United States |
| Advanced Clinical Research - Magic View Site Number : 8400003 | Meridian | Idaho | 83642 | United States |
| Velocity Clinical Research Valparaiso Site Number : 8400001 | Valparaiso | Indiana | 46383 | United States |
| Velocity Clinical Research Site Number : 8400005 | Metairie | Louisiana | 70006 | United States |
| Be Well Clinical Studies Site Number : 8400018 | Lincoln | Nebraska | 68516 | United States |
| WR-CRCN, LLC Site Number : 8400013 | Las Vegas | Nevada | 89106 | United States |
| Biotrial Inc Site Number : 8400006 | Newark | New Jersey | 07103 | United States |
| Plains Clinical Research Center, LLC Site Number : 8400011 | Fargo | North Dakota | 58104 | United States |
| Aventiv Research Columbus Site Number : 8400007 | Columbus | Ohio | 43213 | United States |
| Velocity Clinical Research, Medford Site Number : 8400010 | Medford | Oregon | 97504 | United States |
| Preferred Primary Care Physicians Site Number : 8400009 | Pittsburgh | Pennsylvania | 15236 | United States |
| Coastal Carolina Research Center - N Charleston Site Number : 8400004 | North Charleston | South Carolina | 29405 | United States |
| JBR Clinical Research Site Number : 8400008 | Salt Lake City | Utah | 84107 | United States |
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.
| FG002 | Group 3: SP0202-VII | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1. |
| FG003 | Group 4: Prevnar 13 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1. |
| FG004 | Group 5: Pneumovax 23 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1. |
| Safety Analysis Set (SafAS) Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Randomized population included all participants with data in the case report form (CRF).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: SP0202-IIb | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1. |
| BG001 | Group 2: SP0202-VI | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1. |
| BG002 | Group 3: SP0202-VII | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1. |
| BG003 | Group 4: Prevnar 13 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1. |
| BG004 | Group 5: Pneumovax 23 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Titers were expressed in terms of 1/dilution. | PPAS was subset of the FAS. FAS included subset of randomized participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least one serotype). Only participants with data collected for each specified category are reported. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Post-vaccination at Day 31 |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Ratio was calculated as post-vaccination titer at Day 31 to pre-vaccination titer at Day 1. | PPAS was subset of the FAS. FAS included subset of randomized participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least one serotype). Only participants with data collected for each specified category are reported. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31 |
| ||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | The GMCs for serotype specific pneumococcal IgG antibodies were measured using ECL, a multiplexed serological assay which allowed for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens. | PPAS was subset of the FAS. FAS included subset of randomized participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least one serotype). Only participants with data collected for each specified category are reported. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | Post-vaccination at Day 31 |
| ||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | The GMCs for serotype specific pneumococcal IgG antibodies were measured using ECL, a multiplexed serological assay which allowed for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens. Ratio was calculated as post-vaccination titer at Day 31 to pre-vaccination titer at Day 1. | PPAS was subset of the FAS. FAS included subset of randomized participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least one serotype). Only participants with data collected for each specified category are reported. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31 |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions. | Safety analysis set (SafAS) included participants who had received the study vaccine. All participants had their safety analyzed according to the vaccine they actually received. | Posted | Count of Participants | Participants | Within 30 minutes post-vaccination |
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Solicited Injection Site Reactions | A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. An injection site reaction was an AR at and around the injection site. Solicited injection site reactions included injection site pain, injection site erythema and injection site swelling. | SafAS included participants who had received the study vaccine. All participants had their safety analyzed according to the vaccine they actually received. Only those participants with data collected for each category at each specified timepoint are reported. | Posted | Count of Participants | Participants | Up to 7 Days post-vaccination (Day 8) |
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Solicited Systemic Reactions | A solicited reaction was an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia and shivering. | SafAS included participants who had received the study vaccine. All participants had their safety analyzed according to the vaccine they actually received. Only those participants with data collected for each category at each specified timepoint are reported. | Posted | Count of Participants | Participants | Up to 7 Days post-vaccination (Day 8) |
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Unsolicited AEs | An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination. | SafAS included participants who had received the study vaccine. All participants had their safety analyzed according to the vaccine they actually received. | Posted | Count of Participants | Participants | Within 30 days post-vaccination |
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor could be appropriate. AESI included analyphylaxis. | SafAS included participants who had received the study vaccine. All participants had their safety analyzed according to the vaccine they actually received. | Posted | Count of Participants | Participants | From the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days |
|
AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: SP0202-IIb | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1. | 0 | 151 | 3 | 151 | 113 | 151 |
| EG001 | Group 2: SP0202-VI | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1. | 1 | 151 | 7 | 151 | 122 | 151 |
| EG002 | Group 3: SP0202-VII | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1. | 1 | 148 | 3 | 148 | 112 | 148 |
| EG003 | Group 4: Prevnar 13 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1. | 0 | 149 | 2 | 149 | 102 | 149 |
| EG004 | Group 5: Pneumovax 23 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1. | 0 | 150 | 2 | 150 | 93 | 150 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDra 24.1 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDra 24.1 | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDra 24.1 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDra 24.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDra 24.1 | Systematic Assessment |
| |
| Covid-19 Pneumonia | Infections and infestations | MedDra 24.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDra 24.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDra 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 24.1 | Systematic Assessment |
| |
| Pneumonia Aspiration | Infections and infestations | MedDra 24.1 | Systematic Assessment |
| |
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDra 24.1 | Systematic Assessment |
| |
| Oropharyngeal Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Plasma Cell Myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Systematic Assessment |
| |
| Cerebral Haemorrhage | Nervous system disorders | MedDra 24.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDra 24.1 | Systematic Assessment |
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| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDra 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | MedDra 24.1 | Systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDra 24.1 | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDra 24.1 | Systematic Assessment |
| |
| Injection Site Swelling | General disorders | MedDra 24.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDra 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 24.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDra 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 24.1 | Systematic Assessment |
|
The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi Pasteur | 800-633-1610 ext: 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 28, 2021 | Jul 31, 2024 | SAP_001.pdf |
| Male |
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| Black or African American |
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| Native Hawaiian or other Pacific Islander |
|
| White |
|
| Asian |
|
| Multiple |
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| Not reported |
|
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| Serotype 3 |
|
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| Serotype 4 |
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| Serotype 5 |
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| Serotype 6A |
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| Serotype 6B |
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| Serotype 7F |
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| Serotype 9V |
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| Serotype 14 |
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| Serotype 18C |
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| Serotype 19A |
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| Serotype 19F |
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| Serotype 23F |
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| Serotype 8 |
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| Serotype 9N |
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| Serotype 10A |
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| Serotype 11A |
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| Serotype 12F |
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| Serotype 15B |
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| Serotype 22F |
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| Serotype 33F |
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Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1. |
| OG003 | Group 4: Prevnar 13 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1. |
| OG004 | Group 5: Pneumovax 23 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1. |
|
|
| OG003 | Group 4: Prevnar 13 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1. |
| OG004 | Group 5: Pneumovax 23 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1. |
|
|
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1. |
| OG003 | Group 4: Prevnar 13 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1. |
| OG004 | Group 5: Pneumovax 23 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1. |
|
|
| OG003 | Group 4: Prevnar 13 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1. |
| OG004 | Group 5: Pneumovax 23 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1. |
|
|
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.
| OG003 | Group 4: Prevnar 13 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1. |
| OG004 | Group 5: Pneumovax 23 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1. |
|
|
| OG003 | Group 4: Prevnar 13 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1. |
| OG004 | Group 5: Pneumovax 23 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1. |
|
|
| Group 4: Prevnar 13 |
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1. |
| OG004 | Group 5: Pneumovax 23 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1. |
|
|
| OG002 |
| Group 3: SP0202-VII |
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1. |
| OG003 | Group 4: Prevnar 13 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1. |
| OG004 | Group 5: Pneumovax 23 | Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1. |
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