Status:
COMPLETED
Study of Two Investigational Pneumococcal Vaccines in Healthy Adults
Lead Sponsor:
Sanofi
Conditions:
Pneumococcal Infections
Streptococcus Pneumoniae Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This study is designed to evaluate the safety, tolerability, and immunogenicity of two investigational pneumococcal vaccines at three dose levels in healthy adults. Primary Objective: \- To evaluate...
Detailed Description
An initial cohort of 6 participants will receive a single dose of one of two investigational pneumococcal vaccines. After safety evaluation of that cohort, additional cohorts will receive 2 injections...
Eligibility Criteria
Inclusion
- Aged 18 to 50 years on the day of inclusion
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and comply with all trial procedures
- Subject is healthy, as determined by medical history and physical examination
- For a woman of child-bearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to first vaccination until 4 weeks after the last vaccination.
Exclusion
- Known pregnancy or positive serum/urine pregnancy test
- Currently breastfeeding a child
- Chronic illness, that in the opinion of the investigator, is at a stage that could interfere with trial conduct or completion
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Known systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine(s) or to a vaccine containing any of the same substances
- Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
- Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
- Planned receipt of any vaccine in the 4 weeks following the trial vaccination
- Known seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
- Laboratory confirmed / self-reported thrombocytopenia contraindicating intramuscular vaccination
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Identified as a study site employee who is involved in the protocol and may have direct access to trial-related data
- Previous vaccination against pneumococcal disease (in the previous 5 years)
- History of pneumococcal infection (confirmed either clinically, serologically, or microbiologically) within 5 years
- At high risk for pneumococcal infection during the trial
- Living in a household with children \< 5 years of age.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT01444339
Start Date
February 1 2010
End Date
September 1 2010
Last Update
September 30 2011
Active Locations (1)
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1
Allschwil, Switzerland