Clinical trial NCT04583618: Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years.
Official title: Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine in Healthy Adults Aged 50 to 84 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumococcal Immunization
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2020-10-12
Enrollment: 750
Sex: ALL
Minimum age (years): 50
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
timeFrame: Post-vaccination at Day 31
measure: Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
timeFrame: Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31
measure: Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
timeFrame: Post-vaccination at Day 31
measure: Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
timeFrame: Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31
measure: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
timeFrame: Within 30 minutes post-vaccination
measure: Number of Participants With Solicited Injection Site Reactions
timeFrame: Up to 7 Days post-vaccination (Day 8)
measure: Number of Participants With Solicited Systemic Reactions
timeFrame: Up to 7 Days post-vaccination (Day 8)
measure: Number of Participants With Unsolicited AEs
timeFrame: Within 30 days post-vaccination
measure: Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)
timeFrame: From the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Emmaus Research Center, Inc Site Number : 8400014
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates Site Number : 8400012
state: California
city: Wheat Ridge
country: United States
facility: Paradigm Clinical Research Center Wheat Ridge Site Number : 8400002
state: Colorado
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research Site Number : 8400016
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates, LLC Site Number : 8400017
state: Florida
city: Meridian
country: United States
facility: Advanced Clinical Research - Magic View Site Number : 8400003
state: Idaho
city: Valparaiso
country: United States
facility: Velocity Clinical Research Valparaiso Site Number : 8400001
state: Indiana
city: Metairie
country: United States
facility: Velocity Clinical Research Site Number : 8400005
state: Louisiana
city: Lincoln
country: United States
facility: Be Well Clinical Studies Site Number : 8400018
state: Nebraska
city: Las Vegas
country: United States
facility: WR-CRCN, LLC Site Number : 8400013
state: Nevada
city: Newark
country: United States
facility: Biotrial Inc Site Number : 8400006
state: New Jersey
city: Fargo
country: United States
facility: Plains Clinical Research Center, LLC Site Number : 8400011
state: North Dakota
city: Columbus
country: United States
facility: Aventiv Research Columbus Site Number : 8400007
state: Ohio
city: Medford
country: United States
facility: Velocity Clinical Research, Medford Site Number : 8400010
state: Oregon
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians Site Number : 8400009
state: Pennsylvania
city: North Charleston
country: United States
facility: Coastal Carolina Research Center - N Charleston Site Number : 8400004
state: South Carolina
city: Salt Lake City
country: United States
facility: JBR Clinical Research Site Number : 8400008
state: Utah
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: