Authors
»
Pfizer Inc., 235 East 42nd Street, New York, NY 10017 -More
Category
»
Primary study
Registry of Trials»EU Clinical Trials Register
Year
»
2019
INTERVENTION: Product Name: 20‐valent Pneumococcal Conjugate Vaccine (20vPnC) Product Code: PF‐06482077 Pharmaceutical Form: Suspension for injection in pre‐filled syringe INN or Proposed INN: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 2.2‐ INN or Proposed INN: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 2.2‐ INN or Proposed INN: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO CRM197 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 2.2‐ INN or Proposed INN: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO CRM197 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 2.2‐ INN or Proposed INN: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A CONJUGATED TO CRM197 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 2.2‐ INN or Proposed INN: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197 Concentration unit: µg microgram CONDITION: Pneumococcal Infections ; MedDRA version: 20.0 Level: PT Classification code 10069578 Term: Pneumococcal immunisation System Organ Class: 10042613 ‐ Surgical and medical procedures Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: ; Main Objective: Primary Safety Objective:; ‐To describe the safety profile of 20vPnC in adults 18 years of age and older.; Primary Immunogenicity Objective Cohort 1 (60 Years of Age and Older):; ‐To demonstrate that the immune responses to the 13 serotypes in 13vPnC (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) induced by 20vPnC in adults 60 years of age and older are noninferior to the immune response induced by 13vPnC.; ‐ To demonstrate that the immune responses to the 7 additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) induced by 20vPnC in adults 60 years of age and older are noninferior to the immune response induced by PPSV23.; ; Primary end point(s): Primary Safety Endpoints (All Cohorts); a. Reported prompted local reactions (redness, swelling, and pain at the injection site) within 10 days after vaccination.; b. Reported prompted systemic events (fever, headache, fatigue, muscle pain, and joint pain) within 7 days after vaccination.; c. Reported adverse events (AEs) within 1 month after vaccination.; d. Reported serious adverse events (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.; Primary Immunogenicity Endpoint – Cohort 1 (60 Years of Age and Older); e. Serotype‐specific opsonophagocytic activity (OPA) titers 1 month after vaccination.; ; Secondary Objective: Cohort 2 (50 Through 59 Years of Age); ‐ To demonstrate that the immune responses to the 20 serotypes in 20vPnC induced in adults 50 through 59 years of age are noninferior to the immune responses induced by 20vPnC in adults 60 through 64 years of age.; Cohort 3 (18 Through 49 Years of Age); ‐ To demonstrate that the immune responses to the 20 serotypes in 20vPnC induced in adults 18 through 49 years of age are noninferior to the immune responses induced by 20vPnC in adults 60 through 64 years of age.; All Cohorts; ‐ To describe the immune responses to 20vPnC in adults 60 years of age and older, 50 through 59 years of age, and 18 through 49 years of age.; ; Timepoint(s) of evaluation of this end point: Primary Safety Endpoints (All Cohorts); a. Within 10 days after vaccination.; b. Within 7 days after vaccination.; c. Within 1 month after vaccination.; d. Within 6 months after vaccination.; Primary Immunogenicity Endpoint – Cohort 1 (60 Years of Age and Older); e. 1 month after vaccination.; SECONDARY OUTCOME: ; Secondary end point(s): Secondary Endpoint – Cohort 2 (50 Through 59 Years of Age); a. Serotype‐specific OPA titers 1 month after vaccination.; Secondary Endpoint – Cohort 3 (18 Through 49 Years of Age); b. Serotype‐specific OPA titers 1 month after vaccination.; Secondary Endpoints – All Cohorts; c. Fold rise in serotype‐specific OPA titers from before to 1 month after vaccination.; d. >/=4‐Fold rise in serotype‐specific OPA titers from before to 1 month after vaccination.; e. Serotype‐specific OPA titers greater than or equal to the lower limit of quantitation (>/= LLOQ) 1 month after vaccination.; ; Timepoint(s) of evaluation of this end point: Secondary Endpoint – Cohort 2 (50 Through 59 Years of Age); a. 1 month after vaccination.; Secondary Endpoint – Cohort 3 (18 Through 49 Years of Age); b. 1 month after vaccination.; Secondary Endpoints – All Cohorts; c. From before to 1 month after vaccination.; d. From before to 1 month after vaccination.; e. 1 month after vaccination.; INCLUSION CRITERIA: 1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study. 2. Willing and able to comply with scheduled visits, treatment plan, and other study procedures. 3. Expected to be available for the duration of the study and can be contacted by telephone during study participation. 4. Cohort 1: Male or female adults 60 years of age and older. Cohort 2: Male or female adults 50 through 59 years of age. Cohort 3: Male or female adults 18 through 49 years of age. 5. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for w
Epistemonikos ID: c2c3ed008b522d1fcacc33cfc09c8436e4b6d275
First added on: Jul 27, 2021