Clinical trial NCT00562354: Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults Aged >= 50 Years
Official title: A Phase 3, Open-Label Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a 13vPnC When Administered to Healthy Japanese Adults Aged >= 65 Years and 50 to 64 Years in Japan Who Have Not Received a Previous Dose of 23-Valent Pneumococcal Polysaccharide Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: Vaccines, Pneumococcal Conjugate Vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-11-22
Enrollment: 271
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Primary outcomes:
measure: Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population
timeFrame: 1 month after vaccination
measure: 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
timeFrame: 1 month after vaccination
measure: Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population
timeFrame: Prevaccination (Day 1), 1 month after vaccination
measure: 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
timeFrame: Prevaccination (Day 1), 1 month after vaccination
Secondary outcomes:
measure: Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group
timeFrame: 1 month after vaccination
measure: Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population
timeFrame: 1 month after vaccination
measure: 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
timeFrame: 1 month after vaccination
measure: 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
timeFrame: 1 month after vaccination
measure: Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population
timeFrame: 1 month after vaccination
measure: 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
timeFrame: 1 month after vaccination
measure: 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
timeFrame: 1 month after vaccination
measure: Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population
timeFrame: 1 month after vaccination
measure: 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
timeFrame: 1 month after vaccination
measure: 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
timeFrame: 1 month after vaccination
measure: Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population
timeFrame: 1 month after vaccination
measure: 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
timeFrame: 1 month after vaccination
measure: Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group
timeFrame: 1 month after vaccination
measure: Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population
timeFrame: 1 month after vaccination
measure: 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
timeFrame: 1 month after vaccination
measure: Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population
timeFrame: Day 1 through 14
measure: Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
timeFrame: Day 1 through 14
measure: Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population
timeFrame: Day 1 through 14
measure: Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
timeFrame: Day 1 through 14
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Sumida-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Shiramoto M, Irie S, Juergens C, Yamaji M, Tamai S, Aizawa M, Belanger T, Gruber WC, Scott DA, Schmoele-Thoma B. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine when administered to healthy Japanese adults aged >/=50 years. An open-label trial. Hum Vaccin Immunother. 2014;10(7):1850-8. doi: 10.4161/hv.28633.