Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine Candidate in Healthy Adults (19-49 Years)
Completed · Phase 1
Conditions studied: Pneumococcal Immunization
In brief
This was a Phase I, randomized, active-controlled, observer-blinded, multi-center study to assess the safety and the immunogenicity of 4 Pneumococcal Conjugate Vaccines (PCV) candidates in parallel with Prevnar 13, in Healthy Adults (19-49 years) in the United States.
Key facts
- Study ID
- NCT06698198
- Run by
- Sanofi Pasteur, a Sanofi Company
- People needed
- 175
- Starts
- 2018-12-03
- Expected to finish
- 2019-09-30
- Last updated by the study team
- 2024-11-20
Who can join
Age: 19 and older, up to 49. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Men or women aged 19 to 49 years on the day of inclusion ("19 to 49 years" means from the day of the 19th birthday to the day before the 50th birthday)
- 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
You may not qualify if…
- Subject 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 vaccine injection until at least 4 weeks after injection. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile.
- 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.
Where it is running
- Investigational Site Number: 0002 — Metairie, Louisiana, United States
- Investigational Site Number: 0001 — Newark, New Jersey, United States
Full record on ClinicalTrials.gov
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