Phase 3
N=764
A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older
Pneumococcal Vaccines · Pneumococcal Conjugate Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT01646398 ↗Enrolled (actual)
764
Serious AEs
0.1%
Results posted
Sep 2013
Primary outcome: Primary: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination — 103; 78; 44; 61 titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13-valent pneumococcal conjugate vaccine (Biological); 23-valent pneumococcal polysaccharide vaccine (Biological)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination |
103; 78; 44; 61; 1016; 392 | — |
| PRIMARY Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination |
74.0; 47.2 | — |
| SECONDARY Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination |
103; 78; 44; 61; 1016; 392 | — |
Summary
The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of 23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older.
Eligibility Criteria
Inclusion Criteria
- Healthy Japanese male and female adults aged 65 years old and older at time of enrollment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of the study vaccine, are eligible.
- Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study or for at least 28 days after the last dose of the study vaccine whichever is longer.
Exclusion Criteria
- History of severe adverse reaction including hypersensitivity such as anaphylaxis associated with a vaccine or vaccine component.
- Previous vaccination with any licensed or experimental pneumococcal vaccine.
- Documented Streptococcus pneumoniae infection within the past 5 years.
- Residence in a nursing home, long-term care facility, or other institution or requirement of semiskilled nursing care.
Data sourced from ClinicalTrials.gov (NCT01646398). 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.