Trial record 10 of 20 for:    "Pneumonia, Pneumococcal"

Study of an Investigational Pneumococcal Vaccine at Three Dose Levels in Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01444352
First received: September 28, 2011
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

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.

Condition Intervention Phase
Pneumococcal Infections
Streptococcus Pneumoniae Infections
Pneumococcal Pneumonia
Biological: Pneumococcal vaccine Formulation 1
Biological: Pneumococcal vaccine Formulation 2
Biological: Pneumococcal vaccine Formulation 3
Biological: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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: Days 0 through 30 post-vaccination ] [ Designated as safety issue: No ]
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.


Secondary Outcome Measures:
  • Immunogenicity of Pneumococcal Vaccine After two Vaccinations [ Time Frame: Days 0 and 30 days post-vaccination ] [ Designated as safety issue: No ]
    Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA).


Enrollment: 100
Study Start Date: June 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine Formulation 1 (Low dose)
Participants will receive 2 injections of Pneumococcal Vaccine Formulation 1 (Low dose).
Biological: Pneumococcal vaccine Formulation 1
0.5 mL, Intramuscular (Low dose)
Experimental: Vaccine Formulation 2 (Middle dose)
Participants will receive 2 injections of Pneumococcal Vaccine Formulation 2, (Middle dose).
Biological: Pneumococcal vaccine Formulation 2
0.5 mL, Intramuscular (Middle dose)
Experimental: Vaccine Formulation 3 (High dose)
Participants will receive 2 injections of Pneumococcal Vaccine Formulation 3, (High dose).
Biological: Pneumococcal vaccine Formulation 3
0.5 mL, Intramuscular (High dose)
Placebo Comparator: Placebo Pooled
Participants who receive 2 injections of tris buffered saline
Biological: Placebo
0.5 mL, Intramuscular
Other Name: Tris Buffered Saline

Detailed Description:

An initial cohort of 10 participants will receive a single dose of investigational pneumococcal vaccine. After safety assessment of this cohort during a 24-hour in-unit observation period, additional cohorts will receive two injections of the study vaccine 30 days apart, at three dose levels, in ascending doses by cohort, pending safety review at each dose level. All participants will be monitored for safety for 30 days after each vaccination.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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:

  • 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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444352

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

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01444352     History of Changes
Other Study ID Numbers: PPR06
Study First Received: September 28, 2011
Last Updated: September 29, 2011
Health Authority: Switzerland: Federal Office of Public Health

Keywords provided by Sanofi:
Pneumococcal infections
Streptococcus pneumoniae Infections
Pneumococcal Vaccines

Additional relevant MeSH terms:
Pneumonia, Pneumococcal
Communicable Diseases
Infection
Pneumococcal Infections
Pneumonia
Bacterial Infections
Gram-Positive Bacterial Infections
Lung Diseases
Pneumonia, Bacterial
Respiratory Tract Diseases
Respiratory Tract Infections
Streptococcal Infections

ClinicalTrials.gov processed this record on October 23, 2014