Study of Two Investigational Pneumococcal Vaccines in Healthy Adults
NCT ID: NCT01444339
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
131 participants
INTERVENTIONAL
2010-02-28
2010-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Primary Objective:
\- To evaluate the safety and tolerability of two investigational pneumococcal vaccines.
Observational Objective:
\- To evaluate the immunogenicity of the investigational pneumococcal vaccines.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pneumococcal Vaccine Formulation 1
Participants will receive an injection of pneumococcal vaccine (Formulation 1, 1 middle dose) on Day 0 and Day 30, respectively.
Pneumococcal Vaccine Formulation 1
0.5 mL, intramuscular (1 middle dose)
Pneumococcal Vaccine Formulation 2
Participants will receive an injection of Pneumococcal vaccine (Formulation 2, 2 low doses) on Day 0 and Day 30, respectively.
Pneumococcal Vaccine Formulation 2
0.5 mL, intramuscular (2 low doses)
Pneumococcal Vaccine Formulation 3
Participants will receive an injection of pneumococcal vaccine (Formulation 3, 2 middle doses) on Day 0 and Day 30, respectively.
Pneumococcal Vaccine Formulation 3
0.5 mL, intramuscular (2 middle doses)
Pneumococcal Vaccine Formulation 4
Participants will receive an injection of pneumococcal vaccine (Formulation 4, 2 middle doses) on Day 0 and Day 30, respectively.
Pneumococcal Vaccine Formulation 4
0.5 mL, intramuscular (2 middle doses)
Pneumococcal Vaccine Formulation 5
Participants will receive an injection of pneumococcal vaccine (Formulation 5, 2 high doses) on Day 0 and Day 30, respectively.
Pneumococcal Vaccine Formulation 5
0.5 mL, intramuscular (2 high doses)
Pooled placebo Group
Participants will receive an injection of a placebo on Day 0 and Day 30, respectively.
Placebo
0.5 mL, intramuscular
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pneumococcal Vaccine Formulation 1
0.5 mL, intramuscular (1 middle dose)
Pneumococcal Vaccine Formulation 2
0.5 mL, intramuscular (2 low doses)
Pneumococcal Vaccine Formulation 3
0.5 mL, intramuscular (2 middle doses)
Pneumococcal Vaccine Formulation 4
0.5 mL, intramuscular (2 middle doses)
Pneumococcal Vaccine Formulation 5
0.5 mL, intramuscular (2 high doses)
Placebo
0.5 mL, intramuscular
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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.
18 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Ltd.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Allschwil, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bologa M, Kamtchoua T, Hopfer R, Sheng X, Hicks B, Bixler G, Hou V, Pehlic V, Yuan T, Gurunathan S. Safety and immunogenicity of pneumococcal protein vaccine candidates: monovalent choline-binding protein A (PcpA) vaccine and bivalent PcpA-pneumococcal histidine triad protein D vaccine. Vaccine. 2012 Dec 14;30(52):7461-8. doi: 10.1016/j.vaccine.2012.10.076. Epub 2012 Nov 2.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PPR05
Identifier Type: -
Identifier Source: org_study_id