Phase 3
N=271
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults Aged >= 50 Years
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00562354 ↗Enrolled (actual)
271
Serious AEs
0.7%
Results posted
Nov 2011
Primary outcome: Primary: Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population — 124; 62; 1333; 215 titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13vPnC (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population |
124; 62; 1333; 215; 2256; 2861 | — |
| PRIMARY Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years |
93; 162; 53; 73; 1209; 1464 | — |
| PRIMARY Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population |
23.3; 11.5; 79.6; 42.4; 48.8; 16.6 | — |
| PRIMARY Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years |
18.7; 28.8; 9.8; 13.6; 50.7; 123.3 | — |
| SECONDARY Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group |
93; 164; 54; 73; 1331; 1786 | — |
| SECONDARY Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population |
91.6; 89.8; 95.2; 88.6; 98.5; 98.5 | — |
| SECONDARY Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years |
89.1; 94.0; 87.9; 91.8; 93.5; 96.9 | — |
| SECONDARY Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group |
89.1; 94.0; 87.9; 91.8; 93.5; 96.9 | — |
| SECONDARY Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population |
89.7; 84.4; 84.9; 87.1; 84.5; 68.4 | — |
| SECONDARY Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years |
86.0; 93.2; 81.7; 87.1; 79.2; 90.4 | — |
| SECONDARY Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group |
86.0; 93.2; 81.7; 87.1; 79.2; 90.4 | — |
| SECONDARY Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population |
88.9; 76.0; 74.6; 85.1; 75.4; 57.0 | — |
| SECONDARY Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years |
86.0; 91.7; 73.3; 78.8; 65.3; 83.7 | — |
| SECONDARY Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group |
86.0; 91.7; 73.3; 78.8; 65.3; 83.7 | — |
| SECONDARY Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population |
6.05; 1.53; 4.57; 8.34; 7.93; 8.31 | — |
| SECONDARY Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years |
4.65; 7.95; 1.38; 1.69; 3.63; 5.78 | — |
| SECONDARY Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group |
4.65; 7.69; 1.35; 1.69; 3.53; 5.35 | — |
| SECONDARY Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population |
11.38; 2.89; 15.89; 4.15; 4.23; 4.32 | — |
| SECONDARY Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years |
8.86; 14.77; 2.40; 3.47; 11.33; 22.44 | — |
| SECONDARY Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population |
14.4; 8.7; 9.3; 0.5; 11.5; 7.2 | — |
| SECONDARY Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years |
7.1; 20.9; 7.1; 10.0; 1.0; 16.7 | — |
| SECONDARY Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population |
3.4; 2.9; 0.5; 31.2; 19.9; 12.7 | — |
| SECONDARY Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years |
3.1; 3.7; 2.0; 3.7; 1.0; 0.0 | — |
Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate (13vPnC) vaccine in healthy Japanese adults aged >= 50 years.
Eligibility Criteria
Inclusion Criteria
- Japanese descent male and female adults who do not have the potential to bear children >= 50 years of age.
- Determined to be eligible for the study based on medical history, physical examination, and clinical judgment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of study vaccine, are eligible.
- Sexually active men must agree and commit to use a medically accepted form of contraception during the study and for at least 3 months after vaccination.
Exclusion Criteria
- History of severe adverse reaction associated with a vaccine.
- Receipt of any vaccine within 30 days before study vaccination, except influenza vaccine.
- Documented S pneumoniae infection within the past 5 years before study vaccination.
Data sourced from ClinicalTrials.gov (NCT00562354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.