Pneumonia and ear infections caused by S pneumoniae. MedDRA version: 14.1 Level: LLT Classification code 10042194 Term: Streptococcus pneumoniae meningitis System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 10042195 Term: Streptococcus pneumoniae pneumonia System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 10042197 Term: Streptococcus pneumoniae septicaemia System Organ Clas
Conditions
Sponsors
Pfizer Inc, 235 East 42nd Street, New York, NY 10017
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Evidence of a personally signed and dated informed consent document indicating that the subject’s parent/legal guardian has been informed of all pertinent aspects of the study. 2. Aged 2 months (=56 to =98 days) at time of enrollment (day of birth is considered to be day 1 in this study). 3. Available for entire study period and whose parent/legal guardian can be reached by telephone. 4. Healthy infant as determined by medical history, physical examination, and judgment of the investigator. 5. Parent/legal guardian is able to complete all relevant study procedures during study participation. Are the trial subjects under 18? yes Number of subjects for this age range: 908 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: Subjects presenting with any of the following will not be included in the study: 1. Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib conjugate vaccines. 2. A previous anaphylactic reaction to any vaccine or vaccine-related component. 3. Allergy or contraindication to paracetamol or ibuprofen administration including known renal disease or anomaly that may increase the risk associated with administration of ibuprofen (including clinically significant vesiculoureteral reflux, anatomic abnormality, etc). 4. Chronic use of any medications with known drug interactions with paracetamol or ibuprofen. 5. Contraindication to vaccination with pneumococcal conjugate, diphtheria, tetanus, pertussis, polio, Hib, or HBV vaccines. 6. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 7. Known or suspected immune deficiency or suppression. 8. History of culture-proven invasive disease caused by S pneumoniae. 9. Major known congenital malformation or serious chronic disorder. 10. 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. 11. Receipt of blood products or gamma-globulin within 12 weeks before the first dose of 13vPnC until the blood draw approximately 1 month after the last dose of 13vPnC. 12. Other severe 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 subject inappropriate for entry into this study. 13. Receipt of any investigational drugs or medical devices within 28 days before the first dose of 13vPnC until the blood draw approximately 1 month after the last dose of 13vPnC. 14. Subject is a direct descendent (child or grandchild) of any study personnel or Pfizer employee.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the impact of prophylactic paracetamol or ibuprofen administration on the immunogenicity of 13vPnC as measured by serotype-specific IgG geometric mean concentrations (GMCs) after completion of the infant series.;Secondary Objective: ? To assess the impact of prophylactic paracetamol or ibuprofen administration on the immunogenicity of 13vPnC as measured by serotype-specific IgG geometric mean concentrations (GMCs) after the toddler dose. ? To assess the impact of prophylactic paracetamol or ibuprofen administration on the immunogenicity of 13vPnC as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) in a subset of subjects after completion of the infant series. ? To assess the impact of prophylactic paracetamol or ibuprofen administration on the immunogenicity of Infanrix hexa as measured by geometric mean antibody concentrations/titers (GMCs/GMTs) to INFANRIX hexa antigens after completion of the infant series and after the toddler dose.;Primary end point(s): The serotype specific IgG geometric mean concentrations (GMCs) for each of the pneumococcal serotypes measured 1 month after the infant series.;Timepoint(s) of evaluation of this end point: Visit 4 and Visit 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The proportion of subjects achieving a serotype specific IgG antibody concentration =0.35 µg/mL for each of the pneumococcal serotypes measured 1 month after the infant series.;Timepoint(s) of evaluation of this end point: Visit 4 and Visit 6 | — |
Countries
Poland
Contacts
Public ContactClinical Trials.gov Call Centre
Pfizer Inc
Outcome results
None listed