Pneumococcal Infections MedDRA version: 20.0 Level: PT Classification code 10069578 Term: Pneumococcal immunisation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
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 POLYSACC
Sponsors
Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Eligibility
Sex/Gender
All
Inclusion criteria
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. Male or female adults >/=65 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 worsening disease within 12 weeks before receipt of investigational product. 6. Female subject of nonchildbearing potential; male subject not able to father children; male subject who is able to father children and willing to use a highly effective method of contraception as outlined in this protocol until at least 28 days after the last dose of investigational product. Note: Female subjects of nonchildbearing potential must meet the criteria described in the Woman of Childbearing Potential (WOCBP) 7. Male or female adults who meet 1 of the following: a. Vaccination with PPSV23 >/=1 year and /=6 months prior to vaccination in the study, and no prior PPSV23 vaccination (Cohort B). c. Vaccination with 13vPnC followed by PPSV23 (PPSV23 vaccination >/=1 year prior to vaccination in the study) (Cohort C). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 875
Exclusion criteria
Exclusion criteria: 1. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study. 2. Participation in other studies involving investigational drug(s), investigational vaccines, or investigational devices within 28 days prior to study entry and/or during study participation. Participation in purely observational studies is acceptable. 3. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 20vPnC, 13vPnC, or any other diphtheria toxoid?containing vaccine, or PPSV23. 4. Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator?s opinion, excludes the subject from participating in the study. 5. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 6. History of microbiologically proven invasive disease caused by S pneumoniae. 7. Subjects who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, or planned receipt through the last blood draw. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, subjects should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before investigational product administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. 8. Subjects with known or suspected immunodeficiency or other conditions associated with immunosuppression, including, but not limited to, immunoglobulin class/subclass deficiencies, generalized malignancy, human immunodeficiency virus (HIV) infection, leukemia, lymphoma, or organ or bone marrow transplant. 9. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 10. Receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration, or planned receipt through study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Safety Objective: -To describe the safety profile of 20vPnC. Primary Immunogenicity Objective: -To describe the immune responses to 20vPnC in adults previously vaccinated with PPSV23, previously vaccinated with 13vPnC, or previously vaccinated with both 13vPnC and PPSV23.;Secondary Objective: -To further describe the immune responses to 20vPnC in adults previously vaccinated with PPSV23, previously vaccinated with 13vPnC, or previously vaccinated with both 13vPnC and PPSV23.;Primary end point(s): Primary Safety Endpoints: 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: e. Pneumococcal serotype-specific OPA titers 1 month after vaccination.;Timepoint(s) of evaluation of this end point: Primary Safety Endpoints: 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: e. 1 month after vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a. Fold rise in serotype-specific OPA titers from before to 1 month after vaccination. b. >/=4-Fold rise in serotype-specific OPA titers from before to 1 month after vaccination. c. 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: a. From before to 1 month after vaccination. b. From before to 1 month after vaccination. c. 1 month after vaccination. | — |
Countries
Sweden, United States
Contacts
Public ContactClinical Trials.gov Call Centre
Pfizer Inc.
Outcome results
None listed