Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.
NCT02124161
ABOUT THIS STUDY
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1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.
2. Male or female adults 50 years of age or older.
3. Documented vaccination with 1 or more prior doses of 23vPS, the last given at least 1 year prior to study enrollment.
4. Negative urine pregnancy test for all female subjects who are of child bearing potential.
1. Previous vaccination with Prevnar®, Prevnar 13®, or any other investigational
pneumococcal conjugate vaccine.
2. History of severe adverse reactions associated with any vaccine or vaccine-related
component.
3. Allergic to egg proteins (egg or egg products) and chicken proteins.
4. History of Guillain-Barré syndrome.
5. Vaccination with any influenza vaccine within 6 months (182 days) before
investigational product administration.
6. Documented S pneumoniae infection within the past 5 years before investigational
product administration.
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Descriptive Information | ||||
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Brief Title ICMJE | Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults. | |||
Official Title ICMJE | A Phase 4, Randomized, Double-blind Trial To Evaluate The Immunogenicity And Safety Of A 13-valent Pneumococcal Conjugate Vaccine When Administered Concomitantly With Seasonal Inactivated Influenza Vaccine In Adults 50 Years And Older Who Received 1 Or More Doses Of 23-valent Pneumococcal Polysaccharide Vaccine Prior To Study Enrollment. | |||
Brief Summary | The purpose of this study is to evaluate the immunogenicity and safety of 13-valent pneumococcal polysaccharide vaccine when given concomitantly with seasonal inactivated influenza vaccine to adults 50 years and older who have previously received 23-valent pneumococcal polysaccharide vaccine. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Basic Science | |||
Condition ICMJE | PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* 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 | 882 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | May 2015 | |||
Actual Primary Completion Date | May 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02124161 | |||
Other Study ID Numbers ICMJE | B1851138 | |||
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 | April 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |