Pneumococcal Immunization
Conditions
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.
Interventions
BIOLOGICALPneumococcal Conjugate Vaccine
Suspension for Intramuscular injection
BIOLOGICALPrevnar 13®
Suspension for Intramuscular injection
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 49 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serotype-specific opsonophagocytic activity (OPA) titers | 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) |
| Occurrence of unsolicited systemic AEs reported in the 30 minutes after injection | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ≥ 4-fold serotype-specific IgG concentrations increase | Up to 30 days after vaccination | Percentage of participants with ≥ 4-fold serotype-specific IgG concentrations increase from baseline to 1 month post-vaccination for each pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as measured by ECL |
| Serotype-specific OPA titers ratio (post/pre-vaccination) | Up to 30 days after vaccination | GM of serotype-specific OPA titers ratio (post-/pre-vaccination) for each pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as determined by MOPA |
| ≥ 4-fold serotype-specific OPA titers increase | Up to 30 days after vaccination | Percentage of participants with ≥ 4-fold serotype-specific IgG concentrations increase from baseline to post-vaccination for each pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as determined by MOPA |
| Serotype-specific IgG concentrations ratio (post/pre-vaccination) | Up to 30 days after vaccination | GM of serotype-specific IgG concentrations ratio (post-/pre-vaccination) for each pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as measured by ECL assay |
Countries
United States
Outcome results
None listed