Clinical trial NCT06698198: Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine Candidate in Healthy Adults (19-49 Years)
Official title: Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine Candidate in Healthy Adults (19-49 Years)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pneumococcal Immunization
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-11-20
Enrollment: 175
Sex: ALL
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of unsolicited systemic AEs reported in the 30 minutes after injection
timeFrame: Up to 30 minutes post-vaccination
measure: Occurrence of solicited injection site and systemic reactions
timeFrame: Up to 7 days post-vaccination
measure: Occurrence of unsolicited (spontaneously reported) AEs up to 30 days after injection
timeFrame: Up to 30 days after vaccination
measure: Serotype-specific immunoglobulin type G (IgG) concentrations
timeFrame: Up to 30 days after vaccination
measure: Serotype-specific opsonophagocytic activity (OPA) titers
timeFrame: Up to 30 days after vaccination
Secondary outcomes:
measure: Serotype-specific IgG concentrations ratio (post/pre-vaccination)
timeFrame: Up to 30 days after vaccination
measure: ≥ 4-fold serotype-specific IgG concentrations increase
timeFrame: Up to 30 days after vaccination
measure: Serotype-specific OPA titers ratio (post/pre-vaccination)
timeFrame: Up to 30 days after vaccination
measure: ≥ 4-fold serotype-specific OPA titers increase
timeFrame: Up to 30 days after vaccination
Other outcomes:
Locations:
city: Metairie
country: United States
facility: Investigational Site Number: 0002
state: Louisiana
city: Newark
country: United States
facility: Investigational Site Number: 0001
state: New Jersey
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: