Study of an Investigational Pneumococcal Vaccine in Healthy Adult Volunteers
NCT ID: NCT01444001
Last Updated: 2011-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
63 participants
INTERVENTIONAL
2007-02-28
2007-08-31
Brief Summary
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Primary Objective:
* To evaluate the safety and tolerability of an investigational Pneumococcal vaccine.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Pneumococcal Vaccine Dose 1 (Low dose)
Participants will receive 2 injections of Dose 1 investigational Pneumococcal vaccine (Low dose) on Day 0 and Day 30, respectively.
Pneumococcal Vaccine
0.5 mL, intramuscular
Pneumococcal Vaccine Dose 2 (Middle dose)
Participants will receive 2 injections of the investigational Pneumococcal vaccine (Middle dose) on Day 0 and Day 30, respectively.
Pneumococcal Vaccine
0.5 mL, intramuscular
Pneumococcal Vaccine Dose 3 (High dose)
Participants will receive 2 injections of the investigational Pneumococcal vaccine (High dose) on Day 0 and Day 30, respectively.
Pneumococcal Vaccine
0.5 mL, intramuscular
Interventions
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Pneumococcal Vaccine
0.5 mL, intramuscular
Pneumococcal Vaccine
0.5 mL, intramuscular
Pneumococcal Vaccine
0.5 mL, intramuscular
Eligibility Criteria
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Inclusion Criteria
* Healthy, as determined by medical history and clinical examination
* Informed consent obtained
* Able to attend all scheduled visits and to comply with all trial procedures
* For a woman, inability to bear a child or negative urine pregnancy test at each vaccination visit
* For a woman of child-bearing potential: use of two medically acceptable, effective methods of contraception (oral contraceptive, intrauterine device, diaphragm, spermicide, or condom) or abstinence throughout the study participation starting at least 30 days prior to the first vaccination up to at least 30 days after the last vaccination.
Exclusion Criteria
* For a woman, breast-feeding
* Participation in another clinical trial in the 30 days preceding the first trial vaccination
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
* Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
* Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures
* Blood or blood-derived products received in the past 3 months
* Any vaccination in the 30 days preceding the first trial vaccination
* Vaccination planned in the 30 days following any trial vaccination
* Known Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C seropositivity
* Known thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination
* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
* Febrile illness (≥ 38.0°C \[or 100.4°F\]) within 72 hours of inclusion/vaccination
* Previous vaccination in the preceding 5 years against pneumococcal disease with another vaccine
* History of pneumococcal infection (confirmed either clinically, serologically, or microbiologically) within 5 years
* Subject at high risk of pneumococcal infection during the trial
* Subjects living in a household with children \< 5 years of age
* Antibiotic usage or upper or lower respiratory tract infection within one week before any blood draw for immunogenicity (Visits 1, 3, and 5).
18 Years
50 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Ltd.
Locations
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Allschwil, , Switzerland
Countries
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References
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Seiberling M, Bologa M, Brookes R, Ochs M, Go K, Neveu D, Kamtchoua T, Lashley P, Yuan T, Gurunathan S. Safety and immunogenicity of a pneumococcal histidine triad protein D vaccine candidate in adults. Vaccine. 2012 Dec 14;30(52):7455-60. doi: 10.1016/j.vaccine.2012.10.080. Epub 2012 Nov 3.
Related Links
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Related Info
Other Identifiers
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PPR01
Identifier Type: -
Identifier Source: org_study_id