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

NCT04583618 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: PSK00009U1111-1238-9824
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 17

Brief 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

Conditions

Pneumococcal Immunization

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (5)

SP0202-IIb

EXPERIMENTAL

One dose at Day 1

Biological: Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb

SP0202-VI

EXPERIMENTAL

One dose at Day 1

Biological: Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI

SP0202-VII

EXPERIMENTAL

One dose at Day 1

Biological: Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VII

Prevnar 13

ACTIVE COMPARATOR

One dose at Day 1

Biological: Pneumococcal 13 - valent conjugate vaccine-Prevnar 13

Pneumovax 23

ACTIVE COMPARATOR

One dose at Day 1

Biological: Pneumococcal Vaccine Polyvalent-Pneumovax 23

Interventions

Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb BIOLOGICAL

Pharmaceutical form:Suspension for injection Route of administration: intramuscular

SP0202-IIb

Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI BIOLOGICAL

Pharmaceutical form:Suspension for injection Route of administration: intramuscular

SP0202-VI

Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VII BIOLOGICAL

Pharmaceutical form:Suspension for injection Route of administration: intramuscular

SP0202-VII

Pneumococcal 13 - valent conjugate vaccine-Prevnar 13 BIOLOGICAL

Pharmaceutical form:Suspension for injection Route of administration: intramuscular

Prevnar 13

Pneumococcal Vaccine Polyvalent-Pneumovax 23 BIOLOGICAL

Pharmaceutical form:Solution for injection Route of administration: intramuscular

Pneumovax 23

Eligibility Criteria

• Age: 50 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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 \[COVID-19\]).

Sponsors & Collaborators

• Sanofi: lead

Study Sites (17)

Emmaus Research Center, Inc Site Number : 8400014

Anaheim, California, 92804, United States

Location

Peninsula Research Associates Site Number : 8400012

Rolling Hills Estates, California, 90274, United States

Location

Paradigm Clinical Research Center Wheat Ridge Site Number : 8400002

Wheat Ridge, Colorado, 80033, United States

Location

Jacksonville Center for Clinical Research Site Number : 8400016

Jacksonville, Florida, 32216, United States

Location

Suncoast Research Associates, LLC Site Number : 8400017

Miami, Florida, 33173, United States

Location

Advanced Clinical Research - Magic View Site Number : 8400003

Meridian, Idaho, 83642, United States

Location

Velocity Clinical Research Valparaiso Site Number : 8400001

Valparaiso, Indiana, 46383, United States

Location

Velocity Clinical Research Site Number : 8400005

Metairie, Louisiana, 70006, United States

Location

Be Well Clinical Studies Site Number : 8400018

Lincoln, Nebraska, 68516, United States

Location

WR-CRCN, LLC Site Number : 8400013

Las Vegas, Nevada, 89106, United States

Location

Biotrial Inc Site Number : 8400006

Newark, New Jersey, 07103, United States

Location

Plains Clinical Research Center, LLC Site Number : 8400011

Fargo, North Dakota, 58104, United States

Location

Aventiv Research Columbus Site Number : 8400007

Columbus, Ohio, 43213, United States

Location

Velocity Clinical Research, Medford Site Number : 8400010

Medford, Oregon, 97504, United States

Location

Preferred Primary Care Physicians Site Number : 8400009

Pittsburgh, Pennsylvania, 15236, United States

Location

Coastal Carolina Research Center - N Charleston Site Number : 8400004

North Charleston, South Carolina, 29405, United States

Location

JBR Clinical Research Site Number : 8400008

Salt Lake City, Utah, 84107, United States

Location

Related Links

• PSK00009 Plain Language Results Summary

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi Pasteur

Contact-US@sanofi.com

800-633-1610 ext: 6#

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 12, 2020
• Study Start: October 8, 2020
• Primary Completion: August 9, 2021
• Study Completion: January 20, 2022
• Last Updated: September 8, 2025
• Results First Posted: August 27, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (17)