infections caused by the pneumococ bacteria Pneumococcal Infections
Conditions
Interventions
6. STUDY INTERVENTION
Study intervention is defined as any investigational intervention(s), marketed
product(s), placebo, or medical device(s) intended to be administered to a
study participant acco
Sponsors
Pfizer
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: Section 5.1 in protocol 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). 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. 5. Participants whose parent(s)/legal guardian(s) is capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion criteria
Exclusion criteria: Section 5.2 in protocol 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 pneumonia 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. 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 (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Objective: - To describe the safety profile of 20vPnC Primary Concomitant Immunogenicity Objective - To demonstrate that the immune responses induced by concomitant vaccine antigens given with 20vPnC are noninferior to immune responses induced by concomitant vaccine antigens given with 13vPnC at 1 month after Dose 3 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 -To demonstrate that the serotype- specific IgG GMCs for the 7 additional serotypes in the 20vPnC group are noninferior to the lowest IgG GMCs among the 13 serotypes in the 13vPnC group at 1 month after Dose 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 - | — |
Countries
Netherlands
Outcome results
None listed