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

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

Study Overview

• Status: Completed
• Conditions: Pneumococcal Immunization
• Intervention / Treatment: Biological: Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb; Biological: Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI; Biological: Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VII; Biological: Pneumococcal 13 - valent conjugate vaccine-Prevnar 13; Biological: Pneumococcal Vaccine Polyvalent-Pneumovax 23

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 750
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria :

- Aged 50 to 84 years on the day of inclusion .

Exclusion criteria:

• 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).
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SP0202-IIb; One dose at Day 1	Biological: Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb; Pharmaceutical form:Suspension for injection Route of administration: intramuscular
Experimental: SP0202-VI; One dose at Day 1	Biological: Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI; Pharmaceutical form:Suspension for injection Route of administration: intramuscular
Experimental: SP0202-VII; One dose at Day 1	Biological: Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VII; Pharmaceutical form:Suspension for injection Route of administration: intramuscular
Active Comparator: Prevnar 13; One dose at Day 1	Biological: Pneumococcal 13 - valent conjugate vaccine-Prevnar 13; Pharmaceutical form:Suspension for injection Route of administration: intramuscular
Active Comparator: Pneumovax 23; One dose at Day 1	Biological: Pneumococcal Vaccine Polyvalent-Pneumovax 23; Pharmaceutical form:Solution for injection Route of administration: intramuscular

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

Helpful Links

• PSK00009 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2020
• Primary Completion (Actual): August 9, 2021
• Study Completion (Actual): January 20, 2022

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (Actual): October 12, 2020

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: PSK00009; U1111-1238-9824 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No