13-valent Pneumococcal Conjugate Vaccine Study in Adults => 50 Years of Age in Mexico
NCT01432262
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Adult Trials: 18+ Years
- Male or female older than 50 years of age
- Eligibility must be determined by medical history, physical exam and clinical judgment
- Able to complete an electronic diary
- Available for duration of study
- Negative pregnancy test for subjects in group 2 age 50 to 64 years
- Practice abstinence or use reliable birth control if age is 50 to 64 years
- History of allergic reaction to any vaccine
- Previous vaccination with licensed or experimental pneumococcal vaccine
- S. pneumonia infection within past 5 years before investigational product
administration
- Known or suspected immunodeficiency or received treatment including cytotoxic agents
or systemic corticosteroids, serious chronic disorder such as malignancy cancer
- Receipt of plasma products or immunoglobulins within 60 days
- Bleeding conditions or diathesis
- Receipt of investigational product within 28 days before study entry
- Other severe acute or chronic medical or psychiatric condition
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | 13-valent Pneumococcal Conjugate Vaccine Study in Adults => 50 Years of Age in Mexico | |||
| Official Title ICMJE | A Phase 3, Open Label, Single Arm, Multicenter, Trial to Assess The Safety, Tolerability And Immunogenicity Of 13-Valent Pneumococcal Conjugate Vaccine In Healthy Adults Aged => 50 Years of Age Who Are Naive To 23-Valent Pneumococcal Polysaccharide Vaccine in Mexico. | |||
| Brief Summary | The purpose of this study will be to assess the safety, tolerability, and immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) when given to healthy adults older than 50 years of age who haven't received 23-valent pneumococcal polysaccharide vaccine in Mexico. | |||
| 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 | Pneumococcal Infections | |||
| Intervention ICMJE | Biological: vaccine-13vPnC
Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1) Other Name: 13-valent pneumococcal conjugate vaccine | |||
| Study Arms ICMJE |
| |||
| Publications * | Tinoco JC, Juergens C, Ruiz Palacios GM, Vazquez-Narvaez J, Enkerlin-Pauwells HL, Sundaraiyer V, Pathirana S, Kalinina E, Gruber WC, Scott DA, Schmoele-Thoma B. Open-label trial of immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults ? 50 years of age in Mexico. Clin Vaccine Immunol. 2015 Feb;22(2):185-92. doi: 10.1128/CVI.00711-14. Epub 2014 Dec 10. | |||
* 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 | 324 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | December 2011 | |||
| Actual Primary Completion Date | December 2011 (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 | Mexico | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01432262 | |||
| Other Study ID Numbers ICMJE | B1851048 6115A1-3020 | |||
| 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 | January 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||