Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine Candidate in Healthy Adults (19-49 Years)

Sanofi

Status and phase: Completed; Phase 1

Conditions: Pneumococcal Immunization

Treatments: Biological: Pneumococcal Conjugate Vaccine; Biological: Prevnar 13®

Study type: Interventional

Funder types: Industry

Identifiers

NCT06698198

PSK00007 (Other Identifier)

U1111-1210-0812 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 175 patients

Sex: All

Ages: 19 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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175 participants in 5 patient groups

Group 1: Pneumococcal Conjugate Vaccine (PCV) SP0202-I

Experimental group

Description:

Participants will receive 1 intramuscular injection of PCV formulation SP0202-I

Treatment:

Biological: Pneumococcal Conjugate Vaccine

Group 2: Pneumococcal Conjugate Vaccine (PCV) SP0202-II

Experimental group

Description:

Participants will receive 1 intramuscular injection of PCV formulation SP0202-II

Treatment:

Biological: Pneumococcal Conjugate Vaccine

Group 3: Pneumococcal Conjugate Vaccine (PCV) SP0202-III

Experimental group

Description:

Participants will receive 1 intramuscular injection of PCV formulation SP0202-III

Treatment:

Biological: Pneumococcal Conjugate Vaccine

Group 4: Pneumococcal Conjugate Vaccine (PCV) SP0202-IV

Experimental group

Description:

Participants will receive 1 intramuscular injection of PCV formulation SP0202-IV

Treatment:

Biological: Pneumococcal Conjugate Vaccine

Group 5: Prevnar 13®

Active Comparator group

Treatment:

Biological: Prevnar 13®