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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
175
Suspension for Intramuscular injection
Suspension for Intramuscular injection
Investigational Site Number: 0002
Metairie, Louisiana, United States
Investigational Site Number: 0001
Newark, New Jersey, United States
Occurrence of unsolicited systemic AEs reported in the 30 minutes after injection
Occurrence of any unsolicited (spontaneously reported) systemic Adverse Events (AEs) reported in the 30 minutes after injection of a SP0202 formulation or Prevnar 13.
Time frame: Up to 30 minutes post-vaccination
Occurrence of solicited injection site and systemic reactions
Number of participants reporting solicited injection site reactions (pain, redness, swelling) and solicited systemic reactions (pyrexia, headache, malaise, myalgia, arthralgia, chills)
Time frame: Up to 7 days post-vaccination
Occurrence of unsolicited (spontaneously reported) AEs up to 30 days after injection
Occurrence of unsolicited (spontaneously reported) Adverse Events (AEs) up to 30 days after injection of a SP0202 formulation or Prevnar 13.
Time frame: Up to 30 days after vaccination
Serotype-specific immunoglobulin type G (IgG) concentrations
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
Time frame: Up to 30 days after vaccination
Serotype-specific opsonophagocytic activity (OPA) titers
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)
Time frame: Up to 30 days after vaccination
Serotype-specific IgG concentrations ratio (post/pre-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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 30 days after vaccination
≥ 4-fold serotype-specific IgG concentrations increase
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
Time frame: Up to 30 days after vaccination
Serotype-specific OPA titers ratio (post/pre-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
Time frame: Up to 30 days after vaccination
≥ 4-fold serotype-specific OPA titers increase
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
Time frame: Up to 30 days after vaccination