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Trial record 1 of 1 for:    PPR05
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Study of Two Investigational Pneumococcal Vaccines in Healthy Adults

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ClinicalTrials.gov Identifier: NCT01444339
Recruitment Status : Completed
First Posted : September 30, 2011
Last Update Posted : September 30, 2011
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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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 the safety and tolerability of two investigational pneumococcal vaccines.

Observational Objective:

- To evaluate the immunogenicity of the investigational pneumococcal vaccines.


Condition or disease Intervention/treatment Phase
Pneumococcal Infections Streptococcus Pneumoniae Infections Pneumococcal Pneumonia Biological: Pneumococcal Vaccine Formulation 1 Biological: Pneumococcal Vaccine Formulation 2 Biological: Pneumococcal Vaccine Formulation 3 Biological: Pneumococcal Vaccine Formulation 4 Biological: Pneumococcal Vaccine Formulation 5 Biological: Placebo Phase 1

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 30 days apart of same investigational pneumococcal vaccine at same or increased dose level. All participants will be monitored for safety for 30 days after each vaccination.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : February 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pneumococcal Vaccine Formulation 1
Participants will receive an injection of pneumococcal vaccine (Formulation 1, 1 middle dose) on Day 0 and Day 30, respectively.
 Biological: Pneumococcal Vaccine Formulation 1
0.5 mL, intramuscular (1 middle dose)
Experimental: Pneumococcal Vaccine Formulation 2
Participants will receive an injection of Pneumococcal vaccine (Formulation 2, 2 low doses) on Day 0 and Day 30, respectively.
 Biological: Pneumococcal Vaccine Formulation 2
0.5 mL, intramuscular (2 low doses)
Experimental: Pneumococcal Vaccine Formulation 3
Participants will receive an injection of pneumococcal vaccine (Formulation 3, 2 middle doses) on Day 0 and Day 30, respectively.
 Biological: Pneumococcal Vaccine Formulation 3
0.5 mL, intramuscular (2 middle doses)
Experimental: Pneumococcal Vaccine Formulation 4
Participants will receive an injection of pneumococcal vaccine (Formulation 4, 2 middle doses) on Day 0 and Day 30, respectively.
 Biological: Pneumococcal Vaccine Formulation 4
0.5 mL, intramuscular (2 middle doses)
Experimental: Pneumococcal Vaccine Formulation 5
Participants will receive an injection of pneumococcal vaccine (Formulation 5, 2 high doses) on Day 0 and Day 30, respectively.
 Biological: Pneumococcal Vaccine Formulation 5
0.5 mL, intramuscular (2 high doses)
Placebo Comparator: Pooled placebo Group
Participants will receive an injection of a placebo on Day 0 and Day 30, respectively.
 Biological: Placebo
0.5 mL, intramuscular
Other Name: Tris buffered saline


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: 30 days post-vaccination ]
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia


Secondary Outcome Measures :
  1. Immunogenicity of Investigational Pneumococcal vaccines after 2 vaccinations [ Time Frame: Days 0 and 30 post-vaccination ]
    Evaluation of immune responses to antigen component of the investigational vaccine by enzyme linked immunosorbent assay (ELISA).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01444339


Locations
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Switzerland
Allschwil, Switzerland
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Medical Director Sanofi Pasteur Ltd.
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01444339    
Other Study ID Numbers: PPR05
First Posted: September 30, 2011    Key Record Dates
Last Update Posted: September 30, 2011
Last Verified: September 2011
Keywords provided by Sanofi:
Pneumococcal Infections
Streptococcus Pneumoniae Infections
Pneumococcal Vaccine
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Pneumonia
Pneumonia, Pneumococcal
Pneumococcal Infections
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
 Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Pneumonia, Bacterial
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs