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

  • End date
    Jan 19, 2022
  • participants needed
  • sponsor
Updated on 19 July 2021


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.

Condition Pneumoccocal Immunisation
Treatment Pneumococcal Vaccine Polyvalent, Pneumococcal Conjugate Vaccine - formulation 1, Pneumococcal Conjugate Vaccine - formulation 2, Pneumococcal Conjugate Vaccine - formulation 3, Pneumococcal 13 - valent conjugate vaccine
Clinical Study IdentifierNCT04583618
Last Modified on19 July 2021


Yes No Not Sure

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-Barr 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
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