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 infants born at >36 weeks of gestation and 2 months of age (=42 to =112 days) at the time of consent (the day of birth is considered day of life 1). Type of Participant and Disease Characteristics: 2. Participants whose parent(s)/legal guardian(s) are willing and able to comply with all scheduled visits, treatment plan, and other study procedures. 3. Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study. 4. Expected to be available for the duration of the study and whose parents(s)/legal guardian can be contacted by telephone during study participation. Informed Consent: 5. Participants whose parent(s)/legal guardian(s) is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol. Are the trial subjects under 18? yes Number of subjects for this age range: 1200 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 investigational product or any diphtheria toxoid–containing vaccine. 2. Significant neurological disorder or history of seizure including febrile seizure or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma, such as Erb’s palsy and/or hypotonic-hyporesponsive episodes. 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, human immunodeficiency virus (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 acute or chronic medical or psychiatric condition 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 participant inappropriate for entry into this study. Prior/Concomitant Therapy: 9. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation. 10. Prior receipt of diphtheria, tetanus, pertussis, poliomyelitis, and/or Hib vaccine. 11. 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 investigational product administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin, eyes, or ears) corticosteroids are permitted. 12. Receipt of blood/plasma products or immunoglobulins (including hepatitis B immunoglobulin) since birth or planned receipt through the last planned blood draw in the study (Visit 5, 13-month visit). Prior/Concurrent Clinical Study Experience: 13. 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 or intrauterine exposure to investigational vaccines. Participation in purely observational studies is acceptable. Diagnostic Assessments: Not applicable. Other Exclusions: 14. 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: Primary Safety Objective To describe the safety profile of 20vPnC Primary Pneumococcal Immunogenicity Objectives To demonstrate that the percentages of participants with predefined serotype-specific IgG concentrations for the 13 serotypes in the 20vPnC group are noninferior to the percentages of the corresponding serotypes in the 13vPnC group at 1 month after Dose 3 To demonstrate that the percentages of participants with predefined serotype-specific IgG concentrations for the 7 additional serotypes in the 20vPnC group are noninferior to the lowest percentage among the 13 serotypes in the 13vPnC group at 1 month after Dose 3 To demonstrate that the serotype-specific IgG GMCs for the 13 serotypes in the 20vPnC group are noninferior to the GMCs for the corresponding serotypes in the 13vPnC group at 1 month after Dose 3 Please refer to the protocol for a full list of primary objectives. ;Secondary Objective: Secondary Pneumococcal Immunogenicity Objective To further describe the immune responses induced by 20vPnC Secondary Concomitant Immunogenicity Objective To further describe the immune responses induced by specific concomitant vaccine antigens given with 20vPnC or 13vPnC;Primary end point(s): Primary Safety Endpoints a. Prompted local reactions (redness, swelling, and pain at the injection site) b. Prompted systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability) c. Adverse events (AEs) d. Serious adverse events (SAEs) e. Newly diagnosed chronic medical conditions (NDCMCs) Primary Pneumococcal Immunogenicity Endpoints f. Pneumococcal serotype-specific IgG concentrations Primary Concomitant Immunogenicity Endpoints g. Antibody levels to diphtheria toxoid, tetanus toxoid, and pertussis antigens (PT, FHA, PRN) h. Antibody levels to HBsAg i. Antibody levels to poliovirus strains (types 1, 2, and 3) j. Antibody levels to Hib k. Antibody levels to measles, mumps, rubella, and varicella virus;Timepoint(s) of evaluat | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: a. before Dose 3 (Visit 4) and 1 month after Dose 3 b. 1 month after Dose 2 and before Dose 3 (Visit 4) to 1 month after Dose 3 c. 1 month after Dose 2 d. 1 month after Dose 2 e. 1 month after Dose 2;Secondary end point(s): Secondary Pneumococcal Immunogenicity Endpoints a. Pneumococcal serotype specific opsonophagocytic activity (OPA) titers b. Pneumococcal serotype specific IgG concentrations Secondary Concomitant Immunogenicity Endpoints c. Antibody levels to diphtheria toxoid, tetanus toxoid, and pertussis antigens (PT, FHA, PRN) d. Antibody levels to poliovirus strains (types 1, 2, and 3) e. Antibody levels to Hib | — |
Countries
Australia, Belgium, Czechia, Czech Republic, Denmark, Estonia, Finland, Italy, Netherlands, Norway, Poland, Romania, Slovakia, Sweden
Contacts
Public ContactClinical Trials.gov Call Centre
Pfizer Inc.
Outcome results
None listed