Study of an Investigational Pneumococcal Vaccine in Healthy Adult Volunteers
1 other identifier
interventional
63
1 country
1
Brief Summary
This study was designed to evaluate the safety, tolerability, and immunogenicity of three doses of an investigational pneumococcal vaccine in healthy adult volunteers. Primary Objective:
- To evaluate the safety and tolerability of an investigational Pneumococcal vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2007
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 28, 2011
CompletedFirst Posted
Study publicly available on registry
September 30, 2011
CompletedSeptember 30, 2011
September 1, 2011
6 months
September 28, 2011
September 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The occurrence of solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia
Day 0 up to Day 60 post vaccination
Secondary Outcomes (1)
Immunogenicity of pneumococcal vaccine after 2 vaccinations
Day 0 and 30 days post vaccination
Study Arms (3)
Pneumococcal Vaccine Dose 1 (Low dose)
EXPERIMENTALParticipants will receive 2 injections of Dose 1 investigational Pneumococcal vaccine (Low dose) on Day 0 and Day 30, respectively.
Pneumococcal Vaccine Dose 2 (Middle dose)
EXPERIMENTALParticipants will receive 2 injections of the investigational Pneumococcal vaccine (Middle dose) on Day 0 and Day 30, respectively.
Pneumococcal Vaccine Dose 3 (High dose)
EXPERIMENTALParticipants will receive 2 injections of the investigational Pneumococcal vaccine (High dose) on Day 0 and Day 30, respectively.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system) that could interfere with trial conduct or and/or raise a safety concern
- 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
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Unknown Facility
Allschwil, Switzerland
Related Publications (1)
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.
PMID: 23131206DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2011
First Posted
September 30, 2011
Study Start
February 1, 2007
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
September 30, 2011
Record last verified: 2011-09