Pneumococcal Infections MedDRA version: 21.1 Level: PT Classification code 10069578 Term: Pneumococcal immunisation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Sponsors
Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age and Sex: 1. Male or female toddlers =12 to 56 days before enrollment into the study. 4. Participants whose parent(s)/legal guardian(s) are willing and able to comply with all scheduled visits, investigational plan, and other study procedures. 5. Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study. 6. Expected to be available for the duration of the study and whose parents(s)/legal guardian(s) can be contacted by telephone during study participation. Are the trial subjects under 18? yes Number of subjects for this age range: 360 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Medical Conditions: 1. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 13vPnC, 20vPnC, or any diphtheria toxoid–containing vaccine. 2. Significant neurological disorder or history of seizure (excluding febrile seizure) or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. 3. Major known congenital malformation or serious chronic disorder. 4. History of microbiologically proven invasive disease caused by S pneumoniae. 5. Known or suspected immunodeficiency or other conditions associated with immunosuppression, including, but not limited to, immunoglobulin class/subclass deficiencies, DiGeorge syndrome, generalized malignancy, HIV infection, leukemia, lymphoma, or organ or bone marrow transplant. 6. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 7. Congenital, functional, or surgical asplenia. 8. Other medical condition or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study. Prior/Concomitant Therapy: 9. Previous vaccination with any investigational pneumococcal vaccine, or planned receipt through study participation. 10. Currently receives 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, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. 11. Receipt of blood/plasma products or immunoglobulins (including hepatitis B immunoglobulin) or planned receipt through the last planned blood draw in the study. Prior/Concurrent Clinical Study Experience: 12. 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. An exception to this is an investigational vaccine authorized by the national regulatory agency for use in infants or toddlers to prevent pandemic disease. Participation in purely observational studies is acceptable. Other Exclusions: 13. Children or grandchildren who are direct descendants of investigator site staff members or Pfizer employees who are directly involved in the conduct of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the safety profile of 20vPnC. To describe the immune responses to the additional 7 serotypes after 1 or 2 doses of 20vPnC.;Secondary Objective: To further describe the immune response of 20vPnC after 1 or 2 doses.;Primary end point(s): Primary Safety Endpoints: 1. Prompted local reactions (redness, swelling, and pain at the injection site) 2.Prompted systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability) 3. Adverse events (AEs) 4. Serious Adverse Events (SAEs) Primary Immunogenicity Endpoint: 1. Pneumococcal serotype-specific IgG concentration;Timepoint(s) of evaluation of this end point: Timepoints for Primary Safety Endpoints: In participants receiving at least 1 dose of study intervention with safety follow-up after the assigned vaccination: 1. prompted local reactions within 7 days after the last assigned vaccination in each group 2. prompted systemic events within 7 days after the last assigned vaccination in each group 3. AEs within 1 month after the last assigned vaccination in each group 4. SAEs within 1 month after the last assigned vaccination in each group Timepoint for Primary Immunogenicity Endpoint: In participants complying with the key protocol criteria (evaluable participants) in each group: 1.Percentages of participants with predefined serotype-specific IgG concentrations for the 7 additional serotypes 1 month after the last assigned vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Immunogenicity Endpoints: 1. Pneumococcal serotype-specific IgG concentration 2. Pneumococcal serotype-specific OPA titers;Timepoint(s) of evaluation of this end point: For Pneumococcal serotype-specific IgG concentration Endpoint: - IgG GMCs for the vaccine serotypes 1 month after the last assigned vaccination - Percentages of participants with predefined IgG concentrations for the 13 matched serotypes 1 month after the last assigned vaccination For Pneumococcal serotype-specific OPA titers Endpoint: - OPA GMTs for the vaccine serotypes 1 month after the last vaccination | — |
Countries
Hungary
Contacts
Public ContactClinical Trials.gov Call Centre
Pfizer Inc.
Outcome results
None listed