Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine Candidate in Healthy Adults (19-49 Years)
NCT ID: NCT06698198
Last Updated: 2024-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
175 participants
INTERVENTIONAL
2018-12-03
2019-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Group 1: Pneumococcal Conjugate Vaccine (PCV) SP0202-I
Participants will receive 1 intramuscular injection of PCV formulation SP0202-I
Pneumococcal Conjugate Vaccine
Suspension for Intramuscular injection
Group 2: Pneumococcal Conjugate Vaccine (PCV) SP0202-II
Participants will receive 1 intramuscular injection of PCV formulation SP0202-II
Pneumococcal Conjugate Vaccine
Suspension for Intramuscular injection
Group 3: Pneumococcal Conjugate Vaccine (PCV) SP0202-III
Participants will receive 1 intramuscular injection of PCV formulation SP0202-III
Pneumococcal Conjugate Vaccine
Suspension for Intramuscular injection
Group 4: Pneumococcal Conjugate Vaccine (PCV) SP0202-IV
Participants will receive 1 intramuscular injection of PCV formulation SP0202-IV
Pneumococcal Conjugate Vaccine
Suspension for Intramuscular injection
Group 5: Prevnar 13®
Prevnar 13®
Suspension for Intramuscular injection
Interventions
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Pneumococcal Conjugate Vaccine
Suspension for Intramuscular injection
Prevnar 13®
Suspension for Intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* Informed Consent Form (ICF) has been signed and dated
* Able to attend all scheduled visits and to comply with all trial procedures
* Body mass index within the range of 18.5 and 29.9 kg/m2
Exclusion Criteria
* Participation at the time of 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 in the 4 weeks following trial injection, except for influenza vaccination, which may be received at least 2 weeks before SP0202 or Prevnar 13 injection.
* Previous vaccination against S. pneumoniae with either a pneumococcal conjugate vaccine (PCV) or a Pneumococcal polysaccharide vaccines (PPSV).
* Receipt of immune globulins, blood or blood-derived products in the past 3 months.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
19 Years
49 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number: 0002
Metairie, Louisiana, United States
Investigational Site Number: 0001
Newark, New Jersey, United States
Countries
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Other Identifiers
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PSK00007
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1210-0812
Identifier Type: REGISTRY
Identifier Source: secondary_id
PSK00007
Identifier Type: -
Identifier Source: org_study_id
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