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

 -  To assess the immune response of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23
 30 days after the administration of the single dose vaccination

 -  To assess the safety profile of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23
The duration of each participant's participation will be approximately 6 months.
Inclusion criteria :

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

 -  Able to attend all scheduled visits and to comply with all trial procedures.

 Exclusion criteria:

 -  Participant is pregnant, or lactating, or of childbearing potential and 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, a female must be 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.

 -  Receipt of 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).

 -  Receipt of 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.

 -  Receipt of 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 is not intended to contain all considerations relevant to a patient's
 potential participation in a clinical trial.