Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine Candidate in Healthy Adults (19-49 Years)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 175
- Locations
- 2
- Primary Endpoint
- Occurrence of unsolicited systemic AEs reported in the 30 minutes after injection
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 49 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Group 1: Pneumococcal Conjugate Vaccine (PCV) SP0202-I
Participants will receive 1 intramuscular injection of PCV formulation SP0202-I
Intervention: Pneumococcal Conjugate Vaccine (Biological)
Group 2: Pneumococcal Conjugate Vaccine (PCV) SP0202-II
Participants will receive 1 intramuscular injection of PCV formulation SP0202-II
Intervention: Pneumococcal Conjugate Vaccine (Biological)
Group 3: Pneumococcal Conjugate Vaccine (PCV) SP0202-III
Participants will receive 1 intramuscular injection of PCV formulation SP0202-III
Intervention: Pneumococcal Conjugate Vaccine (Biological)
Group 4: Pneumococcal Conjugate Vaccine (PCV) SP0202-IV
Participants will receive 1 intramuscular injection of PCV formulation SP0202-IV
Intervention: Pneumococcal Conjugate Vaccine (Biological)
Group 5: Prevnar 13®
Intervention: Prevnar 13® (Biological)
Outcomes
Primary Outcomes
Occurrence of unsolicited systemic AEs reported in the 30 minutes after injection
Time Frame: Up to 30 minutes post-vaccination
Occurrence of any unsolicited (spontaneously reported) systemic Adverse Events (AEs) reported in the 30 minutes after injection of a SP0202 formulation or Prevnar 13.
Occurrence of solicited injection site and systemic reactions
Time Frame: Up to 7 days post-vaccination
Number of participants reporting solicited injection site reactions (pain, redness, swelling) and solicited systemic reactions (pyrexia, headache, malaise, myalgia, arthralgia, chills)
Occurrence of unsolicited (spontaneously reported) AEs up to 30 days after injection
Time Frame: Up to 30 days after vaccination
Occurrence of unsolicited (spontaneously reported) Adverse Events (AEs) up to 30 days after injection of a SP0202 formulation or Prevnar 13.
Serotype-specific immunoglobulin type G (IgG) concentrations
Time Frame: Up to 30 days after vaccination
Geometric Mean (GM) of serotype-specific IgG concentrations for all pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as measured by electro-chemiluminescence (ECL) assay
Serotype-specific opsonophagocytic activity (OPA) titers
Time Frame: Up to 30 days after vaccination
GM of serotype-specific OPA titers for all pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as determined by multiplex opsonophagocytic assay (MOPA)
Secondary Outcomes
- Serotype-specific IgG concentrations ratio (post/pre-vaccination)(Up to 30 days after vaccination)
- ≥ 4-fold serotype-specific IgG concentrations increase(Up to 30 days after vaccination)
- Serotype-specific OPA titers ratio (post/pre-vaccination)(Up to 30 days after vaccination)
- ≥ 4-fold serotype-specific OPA titers increase(Up to 30 days after vaccination)