Pneumococcal Infections
Conditions
Interventions
Trade Name: Prevenar 13/Prevnar 13
Product Name: 13-valent pneumococcal conjugate vaccine
Pharmaceutical Form: Injection
Product Name: Haemophilius influenza Type b Vaccine
Pharmaceutical Form: Sol
Sponsors
Pfizer, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Evidence of a personally signed and dated ICD indicating that the parent(s)/legal guardian has been informed of all pertinent aspects of the study. -Aged 6 weeks (42 days) to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Participation in other studies involving investigational drug(s)/vaccine(s) since birth (Cohort 1 only) or in the 6 months prior to study entry (Cohorts 2, 3, and 4) and/or during study participation. -Other acute or chronic medical or psychiatric condition, including recent 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. -Vaccination with licensed or investigational pneumococcal vaccine. -Previous vaccination with licensed or investigational Hib vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the immune responses to the 13 pneumococcal serotypes induced by 13vPnC in infants and children 7 months to <6 years of age (Cohorts 2, 3, and 4) compared to immune responses in infants 6 weeks to 2 months of age (Cohort 1). To evaluate the safety profile of 13vPnC in infants and children 7 months to <6 years of age (Cohorts 2, 3, and 4) as measured by the incidence rates of local reactions, systemic events (including the use of antipyretic medication, and adverse events (AEs);Secondary Objective: To describe the functional antibody responses as measured by opsonophagocytic activity (OPA) to the 13 pneumococcal serotypes induced by 13vPnC in infants and children 7 months to <6 years of age (Cohorts 2, 3, and 4) compared to responses in infants 6 weeks to 2 months of age (Cohort 1). ? To describe the immune responses to 13vPnC compared to Hib vaccinated controls in Cohorts 2, 3, and 4. To describe the circulating antibody levels to the 13 pneumococcal serotypes from before vaccination through 5 years of age (4 years after the last study vaccination) in Cohort 1 ? To evaluate the safety profile of 13vPnC as measured by the incidence rates of adverse events (AEs) in Cohort 1. ;Primary end point(s): Serotype-specific IgG geometric mean concentrations(GMCs) for each of the pneumococcal serotypes compared to IgG GMCs 1 month after the last dose of 13vPnC in cohorts 2, 3 and 4 and 1 month after the infant series in cohort 1 Number of local reactions and systemic events in Cohorts 2, 3 and 4 7 days after each vaccination Number of Adverse Events (AE) from the signing of the informed consent document (ICD) to 1 month after the last vaccination (13vPnC or Hib) in Cohort 2, 3 and 4 1 month after the last vaccination (13vPnC or Hib) in Cohort 2, 3 and 4 Number of newly diagnosed chronic medical conditions in Cohort 2, 3 and 4 1 month after the last study vaccination to 6 months afte | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1 month after the last dose of 13vPnC in cohorts 2,3, 4 and 1 month after infant series in cohort 1 1 month after the last vaccination in Cohort 2, 3, 4, whichever comes last, up to 9 months Before vaccination through 5 years of age Up to 1 month after vaccination 3 in Cohort 1 1 month after vaccination 3 to vaccination 4 in Cohort 1 Vaccination 4 to 1 month after vaccination 4 in Cohort 1 1 month after vaccination 4 to 6 months after vaccination 4 in Cohort 1 Up to 6 months after vaccination 4 in Cohort 1 ;Secondary end point(s): Opsonophagocytic activity (OPA) to the vaccine specific serotypes compared to vaccine specific responses OPA 1 month after the last dose of 13vPnC in cohorts 2,3, 4 and 1 month after infant series in cohort 1 Serotype specific IgG GMC and OPA GMTs for each of the pneumococcal serotypes compared to IgG and OPA 1 month after the last vaccination in Cohort 2, 3, 4, whichever comes last, up to 9 months Serotype specific IgG GMC for each of the pneumococcal serotypes Before vaccination through 5 years of age Number of AEs from the signing of the informed consent document (ICD) to 1 month after vaccination 3 in Cohort 1 Up to 1 month after vaccination 3 in Cohort 1 Number of newly diagnosed chronic medical conditions from 1 month after vaccination 3 to vaccination 4 in Cohort 1 1 month after vaccination 3 to vaccination 4 in Cohort 1 Number of AEs from vaccination 4 to 1 month after vaccination 4 in Cohort 1 Vaccination 4 to 1 month after vaccination 4 in Cohort 1 Number of newly diagnosed chronic medical conditions from 1 month after vaccination 4 to 6 months after vaccination 4 in Cohort 1 1 month after vaccination 4 to 6 months after vaccination 4 in Cohort 1 Number of serious adverse events (SAEs) from the signing of the informed consent document (ICD) to 6 months after vaccination 4 in Cohort 1 Up to 6 months after vaccination 4 in Cohort 1 | — |
Countries
China
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer Inc
Outcome results
None listed