Pneumococcal ImmunizationPhase 2NCT04583618

Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years.

A Phase 2 study testing Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb, Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI and Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VII in people with Pneumococcal Immunization, run by Sanofi at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Primary Objectives: Assessed the immune response of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23 30 days after the administration of the single dose vaccination Assessed the safety profile of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23 Read more about this study

Who is it for?: Ages 50 to 84 yearsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Immunization
What is being tested?: Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb, Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI and Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VII
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 750 participants
Where: 17 sitesUnited States
Study dates: 8 Oct 2020to 20 Jan 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 84 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Aged 50 to 84 years on the day of inclusion .

Who cannot join

Participant was pregnant, or lactating, or of childbearing potential and was not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, the female must have been post-menopausal for at least 1 year, or surgically sterile.
Participation at the time of the study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device or medical procedure.
Received any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit, except for influenza vaccination, which may be received at least 2 weeks before study vaccine. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
Previous vaccination against S. pneumoniae with either a pneumococcal conjugated vaccine (PCV) or a pneumococcal polysaccharide vaccine (PPSV).
Received immune globulins, blood or blood-derived products in the past 3 months.
Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).

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History of S. pneumoniae infection or disease, confirmed either serologically, or microbiologically.
History of Guillain-Barré syndrome occurring within 6 weeks after a prior dose of a TTxd-containing vaccine.
Experienced an Arthus-type hypersensitivity reaction following a prior dose of a TTxd-containing vaccine < 10 years ago.
Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances .
Verbal report of thrombocytopenia contraindicating IM vaccination in the Investigator's opinion.
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination in the Investigator's opinion.
At risk of invasive pneumococcal disease (eg, participants with functional or anatomic asplenia, participants with severe asthma, participants travelling to countries with high endemicity).
Current alcohol abuse or drug addiction.
Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
Any condition that in the opinion of the Investigator could interfere with the evaluation of the vaccine (eg, under investigation or monitoring for possible coronavirus disease 2019 [COVID-19]).
Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4 F). A prospective participant should not be included in the study until the condition has resolved or until 3 days after the febrile event has subsided.
Received oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Emmaus Research Center, Inc Site Number : 8400014
Anaheim, California, 92804
Aventiv Research Columbus Site Number : 8400007
Columbus, Ohio, 43213
Plains Clinical Research Center, LLC Site Number : 8400011
Fargo, North Dakota, 58104
Jacksonville Center for Clinical Research Site Number : 8400016
Jacksonville, Florida, 32216
WR-CRCN, LLC Site Number : 8400013
Las Vegas, Nevada, 89106
Be Well Clinical Studies Site Number : 8400018
Lincoln, Nebraska, 68516
Velocity Clinical Research, Medford Site Number : 8400010
Medford, Oregon, 97504
Advanced Clinical Research - Magic View Site Number : 8400003
Meridian, Idaho, 83642
Velocity Clinical Research Site Number : 8400005
Metairie, Louisiana, 70006
Suncoast Research Associates, LLC Site Number : 8400017
Miami, Florida, 33173
Biotrial Inc Site Number : 8400006
Newark, New Jersey, 07103
Coastal Carolina Research Center - N Charleston Site Number : 8400004
North Charleston, South Carolina, 29405
Preferred Primary Care Physicians Site Number : 8400009
Pittsburgh, Pennsylvania, 15236
Peninsula Research Associates Site Number : 8400012
Rolling Hills Estates, California, 90274
JBR Clinical Research Site Number : 8400008
Salt Lake City, Utah, 84107
Velocity Clinical Research Valparaiso Site Number : 8400001
Valparaiso, Indiana, 46383
Paradigm Clinical Research Center Wheat Ridge Site Number : 8400002
Wheat Ridge, Colorado, 80033

Other trials in United States

About this study

Official title: Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine in Healthy Adults Aged 50 to 84 Years

Primary Objectives:

Assessed the immune response of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23 30 days after the administration of the single dose vaccination
Assessed the safety profile of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23

Read the detailed description

The duration of each participant's participation was approximately 6 months.

Conditions: Pneumococcal Immunization
Being tested: Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb, Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI, Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VII, Pneumococcal 13 - valent conjugate vaccine-Prevnar 13, Pneumococcal Vaccine Polyvalent-Pneumovax 23

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIbBiological
Pharmaceutical form:Suspension for injection Route of administration: intramuscular
Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VIBiological
Pharmaceutical form:Suspension for injection Route of administration: intramuscular
Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VIIBiological
Pharmaceutical form:Suspension for injection Route of administration: intramuscular
Pneumococcal 13 - valent conjugate vaccine-Prevnar 13Biological
Pharmaceutical form:Suspension for injection Route of administration: intramuscular
Pneumococcal Vaccine Polyvalent-Pneumovax 23Biological
Pharmaceutical form:Solution for injection Route of administration: intramuscular

Study groups in NCT04583618
Study group	Role	What they receive
SP0202-IIb	Experimental	One dose at Day 1 Receives: Biological: Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb
SP0202-VI	Experimental	One dose at Day 1 Receives: Biological: Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI
SP0202-VII	Experimental	One dose at Day 1 Receives: Biological: Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VII
Prevnar 13	Active comparator	One dose at Day 1 Receives: Biological: Pneumococcal 13 - valent conjugate vaccine-Prevnar 13
Pneumovax 23	Active comparator	One dose at Day 1 Receives: Biological: Pneumococcal Vaccine Polyvalent-Pneumovax 23

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 202020 Jan 2022

First posted12 Oct 2020
Study start8 Oct 2020
Primary completion9 Aug 2021
Study completion20 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pneumococcal ImmunizationStudies of the same condition, open and under way.
More trials run by SanofiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 750 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04583618
Sponsor's protocol ID: PSK00009
Other IDs: U1111-1238-9824
Status last verified: Sep 2025
First submitted: 5 Oct 2020
Last updated: 8 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents
Pneumococcal Disease
Enrolling by invitation
Randomized Controlled Trial Of Text Messages To Increase Pneumococcal Vaccination In Adults In Chile.
Pneumococcal Infections, Immunization Programs
Not yet recruitingPhase 4
Preoperative Pneumococcal and Influenza Vaccination to Prevent Postoperative Pulmonary Infection in Patients Undergoing Lung Resection for Pulmonary Nodules or Lung Cancer
Pneumococcal Polysaccharide Vaccine, Influenza Vaccines

All Pneumococcal Immunization trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine in Healthy Adults Aged 50 to 84 Years
ClinicalTrials.gov ID: NCT04583618
Acronym / sponsor ID: PSK00009
Conditions: Pneumococcal Immunization
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 750 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: 8 Oct 2020 (actual)
Primary completion: 9 Aug 2021 (actual)
Study completion: 20 Jan 2022 (actual)
First posted: 12 Oct 2020 (actual)
Results: Posted 27 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary Objectives:

Assessed the immune response of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23 30 days after the administration of the single dose vaccination
Assessed the safety profile of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23

Detailed description

The duration of each participant's participation was approximately 6 months.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
SP0202-IIb	Experimental	Biological: Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIbOne dose at Day 1
SP0202-VI	Experimental	Biological: Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VIOne dose at Day 1
SP0202-VII	Experimental	Biological: Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VIIOne dose at Day 1
Prevnar 13	Active comparator	Biological: Pneumococcal 13 - valent conjugate vaccine-Prevnar 13One dose at Day 1
Pneumovax 23	Active comparator	Biological: Pneumococcal Vaccine Polyvalent-Pneumovax 23One dose at Day 1

Who may qualify

Ages: 50 to 84 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Aged 50 to 84 years on the day of inclusion .

Key exclusion criteria (20 listed)

Participant was pregnant, or lactating, or of childbearing potential and was not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, the female must have been post-menopausal for at least 1 year, or surgically sterile.
Participation at the time of the study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device or medical procedure.
Received any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit, except for influenza vaccination, which may be received at least 2 weeks before study vaccine. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
Previous vaccination against S. pneumoniae with either a pneumococcal conjugated vaccine (PCV) or a pneumococcal polysaccharide vaccine (PPSV).
Received immune globulins, blood or blood-derived products in the past 3 months.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIbPharmaceutical form:Suspension for injection Route of administration: intramuscular	Biological	SP0202-IIb
Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VIPharmaceutical form:Suspension for injection Route of administration: intramuscular	Biological	SP0202-VI
Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VIIPharmaceutical form:Suspension for injection Route of administration: intramuscular	Biological	SP0202-VII
Pneumococcal 13 - valent conjugate vaccine-Prevnar 13Pharmaceutical form:Suspension for injection Route of administration: intramuscular	Biological	Prevnar 13
Pneumococcal Vaccine Polyvalent-Pneumovax 23Pharmaceutical form:Solution for injection Route of administration: intramuscular	Biological	Pneumovax 23

Primary outcome

Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Time frame: Post-vaccination at Day 31
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.
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Time frame: Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31
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.
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Time frame: Post-vaccination at Day 31
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.
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Time frame: Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31
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.
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
Time frame: Within 30 minutes post-vaccination
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.
Number of Participants With Solicited Injection Site Reactions
Time frame: Up to 7 Days post-vaccination (Day 8)
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.
Number of Participants With Solicited Systemic Reactions
Time frame: Up to 7 Days post-vaccination (Day 8)
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.
Number of Participants With Unsolicited AEs
Time frame: Within 30 days post-vaccination
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.
Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)
Time frame: From the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days
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.

Results and safety

Results posted to the registry on 27 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: SP0202-IIb	151	148
Group 2: SP0202-VI	151	148
Group 3: SP0202-VII	149	141
Group 4: Prevnar 13	149	147
Group 5: Pneumovax 23	150	148

Primary outcome: Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA

Time frame: Post-vaccination at Day 31. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Group 1: SP0202-IIb n = 135	Group 2: SP0202-VI n = 143	Group 3: SP0202-VII n = 134	Group 4: Prevnar 13 n = 139	Group 5: Pneumovax 23 n = 136
Serotype 1	128 (92.5 to 177)	127 (90.3 to 178)	158 (113 to 220)	254 (183 to 353)	289 (213 to 392)
Serotype 3	136 (109 to 170)	217 (176 to 269)	263 (214 to 323)	157 (126 to 196)	177 (142 to 221)
Serotype 4	1494 (1175 to 1900)	1306 (1029 to 1658)	2134 (1675 to 2719)	2941 (2360 to 3664)	1873 (1415 to 2480)
Serotype 5	241 (166 to 349)	230 (160 to 330)	201 (143 to 281)	536 (378 to 760)	377 (272 to 523)
Serotype 6A	2931 (2143 to 4010)	3074 (2389 to 3957)	2672 (1923 to 3714)	3350 (2418 to 4641)	443 (288 to 681)
Serotype 6B	3699 (2857 to 4788)	3582 (2763 to 4645)	3479 (2595 to 4664)	5122 (3916 to 6699)	2153 (1561 to 2969)
Serotype 7F	3487 (2811 to 4326)	2841 (2262 to 3568)	2403 (1878 to 3074)	4253 (3309 to 5466)	2250 (1721 to 2943)
Serotype 9V	826 (607 to 1123)	828 (614 to 1117)	986 (700 to 1388)	1641 (1274 to 2114)	1159 (863 to 1556)

Population analysed: 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.

Primary outcome: Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA

Time frame: Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31. Geometric mean (95% Confidence Interval). Unit: Ratio

Measure	Group 1: SP0202-IIb n = 135	Group 2: SP0202-VI n = 143	Group 3: SP0202-VII n = 134	Group 4: Prevnar 13 n = 138	Group 5: Pneumovax 23 n = 136
Serotype 1	8.40 (6.28 to 11.2)	10.5 (7.95 to 14.0)	9.79 (7.15 to 13.4)	21.3 (15.6 to 29.0)	19.1 (14.4 to 25.3)
Serotype 3	7.06 (5.55 to 8.99)	12.9 (10.1 to 16.4)	13.7 (10.7 to 17.4)	8.52 (6.71 to 10.8)	9.52 (7.56 to 12.0)
Serotype 4	20.7 (14.7 to 29.3)	28.8 (20.6 to 40.3)	33.0 (22.2 to 49.2)	58.9 (41.2 to 84.1)	25.7 (18.2 to 36.4)
Serotype 5	15.2 (11.0 to 21.0)	19.5 (14.3 to 26.7)	12.2 (9.10 to 16.4)	37.4 (26.9 to 52.1)	24.2 (18.2 to 32.2)
Serotype 6A	60.8 (42.8 to 86.5)	69.4 (48.3 to 99.8)	59.2 (40.9 to 85.8)	79.1 (54.4 to 115)	9.18 (6.34 to 13.3)
Serotype 6B	29.1 (20.6 to 41.2)	25.7 (18.1 to 36.6)	29.2 (19.5 to 43.6)	49.3 (34.8 to 69.7)	16.6 (11.5 to 23.8)
Serotype 7F	50.8 (32.8 to 78.9)	49.0 (32.5 to 73.7)	24.0 (14.9 to 38.7)	79.1 (51.6 to 121)	31.0 (21.0 to 45.8)
Serotype 9V	9.50 (7.01 to 12.9)	9.90 (7.20 to 13.6)	12.7 (8.90 to 18.0)	17.2 (12.2 to 24.1)	10.6 (7.78 to 14.4)

Primary outcome: Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL

Time frame: Post-vaccination at Day 31. Geometric mean (95% Confidence Interval). Unit: mcg/mL

Measure	Group 1: SP0202-IIb n = 137	Group 2: SP0202-VI n = 144	Group 3: SP0202-VII n = 134	Group 4: Prevnar 13 n = 139	Group 5: Pneumovax 23 n = 141
Serotype 1	2.98 (2.29 to 3.88)	3.28 (2.59 to 4.17)	4.17 (3.29 to 5.28)	5.93 (4.49 to 7.85)	7.43 (5.75 to 9.60)
Serotype 3	0.746 (0.616 to 0.903)	0.977 (0.818 to 1.17)	1.22 (1.01 to 1.49)	0.899 (0.738 to 1.10)	0.858 (0.717 to 1.03)
Serotype 4	1.97 (1.60 to 2.43)	1.63 (1.32 to 2.00)	2.27 (1.81 to 2.84)	3.28 (2.61 to 4.12)	1.72 (1.38 to 2.13)
Serotype 5	2.35 (1.78 to 3.10)	2.16 (1.62 to 2.87)	2.16 (1.68 to 2.78)	4.34 (3.20 to 5.90)	3.98 (3.09 to 5.12)
Serotype 6A	6.04 (4.45 to 8.22)	5.00 (3.83 to 6.54)	4.83 (3.57 to 6.54)	7.89 (5.90 to 10.5)	1.53 (1.16 to 2.02)
Serotype 6B	5.73 (4.17 to 7.89)	3.62 (2.66 to 4.93)	4.37 (3.22 to 5.95)	6.45 (4.92 to 8.45)	2.47 (1.86 to 3.28)
Serotype 7F	6.56 (5.23 to 8.22)	5.56 (4.58 to 6.75)	5.35 (4.30 to 6.65)	10.1 (8.01 to 12.6)	4.23 (3.34 to 5.35)
Serotype 9V	2.91 (2.29 to 3.72)	3.17 (2.52 to 4.00)	4.31 (3.43 to 5.41)	5.30 (4.20 to 6.68)	3.48 (2.75 to 4.41)

Primary outcome: Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL

Time frame: Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31. Geometric mean (95% Confidence Interval). Unit: Ratio

Measure	Group 1: SP0202-IIb n = 137	Group 2: SP0202-VI n = 144	Group 3: SP0202-VII n = 134	Group 4: Prevnar 13 n = 139	Group 5: Pneumovax 23 n = 141
Serotype 1	5.39 (4.33 to 6.70)	6.47 (5.27 to 7.95)	6.41 (5.11 to 8.03)	11.6 (9.21 to 14.6)	11.5 (9.09 to 14.5)
Serotype 3	2.99 (2.49 to 3.61)	4.02 (3.40 to 4.76)	4.93 (4.07 to 5.97)	3.86 (3.21 to 4.65)	3.52 (3.01 to 4.12)
Serotype 4	6.52 (5.32 to 7.98)	5.91 (4.93 to 7.07)	7.33 (5.90 to 9.10)	10.8 (8.71 to 13.3)	5.47 (4.57 to 6.55)
Serotype 5	5.43 (4.32 to 6.82)	5.81 (4.67 to 7.22)	4.60 (3.75 to 5.66)	10.6 (8.15 to 13.7)	8.93 (7.15 to 11.1)
Serotype 6A	13.8 (10.5 to 18.2)	12.2 (9.79 to 15.3)	12.6 (9.76 to 16.4)	19.3 (14.9 to 24.9)	3.30 (2.75 to 3.96)
Serotype 6B	12.2 (9.31 to 16.0)	9.63 (7.59 to 12.2)	10.7 (8.10 to 14.0)	16.2 (12.8 to 20.5)	5.51 (4.51 to 6.74)
Serotype 7F	10.6 (8.37 to 13.4)	9.67 (7.86 to 11.9)	7.93 (6.30 to 9.99)	16.3 (12.8 to 20.7)	6.80 (5.67 to 8.16)
Serotype 9V	5.65 (4.59 to 6.95)	6.29 (5.09 to 7.76)	7.87 (6.28 to 9.86)	9.12 (7.53 to 11.0)	6.30 (5.17 to 7.68)

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: SP0202-IIb	3 of 151 (2%)	113 of 151 (74.8%)	0 of 151
Group 2: SP0202-VI	7 of 151 (4.6%)	122 of 151 (80.8%)	1 of 151
Group 3: SP0202-VII	3 of 148 (2%)	112 of 148 (75.7%)	1 of 148
Group 4: Prevnar 13	2 of 149 (1.3%)	102 of 149 (68.5%)	0 of 149
Group 5: Pneumovax 23	2 of 150 (1.3%)	93 of 150 (62%)	0 of 150

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
PSK00009 Plain Language Results SummaryLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Sciences & Operations study director

Sanofi

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA (time frame: Post-vaccination at Day 31). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04583618.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.