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

Phase 2

Completed

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

• Registration Number: NCT04583618
• Lead Sponsor: Sanofi

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-05
• Study Start: 2020-10-08
• Study First Posted: 2020-10-12
• Primary Completion: 2021-08-09
• Study Completion: 2022-01-20
• Disposition First Submitted: 2022-08-01
• Disposition First Submitted QC: 2022-08-01
• Disposition First Posted: 2022-08-04
• Status Verified: 2024-07
• Results First Submitted: 2024-07-31
• Results First Submitted QC: 2024-07-31
• Last Update Submitted: 2024-07-31
• Results First Posted: 2024-08-27
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pneumovax 23	Pneumococcal Vaccine Polyvalent-Pneumovax 23	One dose at Day 1
SP0202-IIb	Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb	One dose at Day 1
SP0202-VII	Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VII	One dose at Day 1
SP0202-VI	Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI	One dose at Day 1
Prevnar 13	Pneumococcal 13 - valent conjugate vaccine-Prevnar 13	One dose at Day 1

Primary Outcome Measures

Name	Time	Method
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)	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 Unsolicited AEs	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 Solicited Systemic Reactions	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.
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL	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.
Number of Participants With Solicited Injection Site Reactions	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.
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA	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	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 Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL	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 Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)	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.

Trial Locations

Locations (17)

Coastal Carolina Research Center - N Charleston Site Number : 8400004; 🇺🇸 North Charleston, South Carolina, United States

Velocity Clinical Research, Medford Site Number : 8400010; 🇺🇸 Medford, Oregon, United States

Preferred Primary Care Physicians Site Number : 8400009; 🇺🇸 Pittsburgh, Pennsylvania, United States

Suncoast Research Associates, LLC Site Number : 8400017; 🇺🇸 Miami, Florida, United States

WR-CRCN, LLC Site Number : 8400013; 🇺🇸 Las Vegas, Nevada, United States

JBR Clinical Research Site Number : 8400008; 🇺🇸 Salt Lake City, Utah, United States

Advanced Clinical Research - Magic View Site Number : 8400003; 🇺🇸 Meridian, Idaho, United States

Emmaus Research Center, Inc Site Number : 8400014; 🇺🇸 Anaheim, California, United States

Peninsula Research Associates Site Number : 8400012; 🇺🇸 Rolling Hills Estates, California, United States

Paradigm Clinical Research Center Wheat Ridge Site Number : 8400002; 🇺🇸 Wheat Ridge, Colorado, United States

Jacksonville Center for Clinical Research Site Number : 8400016; 🇺🇸 Jacksonville, Florida, United States

Velocity Clinical Research Valparaiso Site Number : 8400001; 🇺🇸 Valparaiso, Indiana, United States

Be Well Clinical Studies Site Number : 8400018; 🇺🇸 Lincoln, Nebraska, United States

Aventiv Research Columbus Site Number : 8400007; 🇺🇸 Columbus, Ohio, United States

Biotrial Inc Site Number : 8400006; 🇺🇸 Newark, New Jersey, United States

Velocity Clinical Research Site Number : 8400005; 🇺🇸 Metairie, Louisiana, United States

Plains Clinical Research Center, LLC Site Number : 8400011; 🇺🇸 Fargo, North Dakota, United States