Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults Aged >= 50 Years
NCT00562354
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Adult Trials: 18+ Years
- 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.
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults Aged >= 50 Years | |||
| Official Title ICMJE | 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 | |||
| 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention | |||
| Condition ICMJE | Healthy | |||
| Intervention ICMJE | Biological: 13vPnC
13vPnC for both stratum | |||
| Study Arms ICMJE |
| |||
| Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 271 | |||
| Original Estimated Enrollment ICMJE | 270 | |||
| Actual Study Completion Date ICMJE | December 2007 | |||
| Actual Primary Completion Date | December 2007 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 50 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Japan | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00562354 | |||
| Other Study ID Numbers ICMJE | 6115A1-3004 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | October 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||