Study of an Investigational Pneumococcal Vaccine at Three Dose Levels in Healthy Adults
1 other identifier
interventional
100
1 country
1
Brief Summary
This study is designed to evaluate the safety, tolerability, and immunogenicity of an investigational pneumococcal vaccine in healthy adult volunteers. Primary Objective:
- To evaluate the safety and tolerability of an investigational pneumococcal vaccine. Observational Objective:
- To evaluate the immunogenicity 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 Jun 2010
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
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 28, 2011
CompletedFirst Posted
Study publicly available on registry
September 30, 2011
CompletedMarch 18, 2015
March 1, 2015
7 months
September 28, 2011
March 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number and percentage of participants reporting 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.
Days 0 through 30 post-vaccination
Secondary Outcomes (1)
Immunogenicity of Pneumococcal Vaccine After two Vaccinations
Days 0 and 30 days post-vaccination
Study Arms (4)
Vaccine Formulation 1 (Low dose)
EXPERIMENTALParticipants will receive 2 injections of Pneumococcal Vaccine Formulation 1 (Low dose).
Vaccine Formulation 2 (Middle dose)
EXPERIMENTALParticipants will receive 2 injections of Pneumococcal Vaccine Formulation 2, (Middle dose).
Vaccine Formulation 3 (High dose)
EXPERIMENTALParticipants will receive 2 injections of Pneumococcal Vaccine Formulation 3, (High dose).
Placebo Pooled
PLACEBO COMPARATORParticipants who receive 2 injections of tris buffered saline
Interventions
0.5 mL, Intramuscular (Low dose)
0.5 mL, Intramuscular (Middle dose)
0.5 mL, Intramuscular (High dose)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- History of anaphylactic reaction or asthma
- Unknown 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, 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 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, except for pandemic influenza vaccination which may be received at least two weeks before the study vaccines
- Planned receipt of any vaccine in the 4 weeks following the trial vaccination, except for pandemic influenza vaccination in the event of a local or national immunization program
- Known seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
- Laboratory confirmed/self-reported thrombocytopenia contraindicating intramuscular (IM) vaccination
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Allschwil, Switzerland
Related Publications (1)
Kamtchoua T, Bologa M, Hopfer R, Neveu D, Hu B, Sheng X, Corde N, Pouzet C, Zimmermann G, Gurunathan S. Safety and immunogenicity of the pneumococcal pneumolysin derivative PlyD1 in a single-antigen protein vaccine candidate in adults. Vaccine. 2013 Jan 2;31(2):327-33. doi: 10.1016/j.vaccine.2012.11.005. Epub 2012 Nov 12.
PMID: 23153437DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- 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
June 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
March 18, 2015
Record last verified: 2015-03