Study of an Investigational Pneumococcal Vaccine in Healthy Adult Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01444001
First received: September 28, 2011
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

This study was designed to evaluate the safety, tolerability, and immunogenicity of three doses of an investigational pneumococcal vaccine in healthy adult volunteers.

Primary Objective:

  • To evaluate the safety and tolerability of an investigational Pneumococcal vaccine.

Condition Intervention Phase
Pneumococcal Infections
Pneumococcal Pneumonia
Biological: Pneumococcal Vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The occurrence of solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial [ Time Frame: Day 0 up to Day 60 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 2 vaccinations [ Time Frame: Day 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: 63
Study Start Date: February 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pneumococcal Vaccine Dose 1 (Low dose)
Participants will receive 2 injections of Dose 1 investigational Pneumococcal vaccine (Low dose) on Day 0 and Day 30, respectively.
Biological: Pneumococcal Vaccine
0.5 mL, intramuscular
Experimental: Pneumococcal Vaccine Dose 2 (Middle dose)
Participants will receive 2 injections of the investigational Pneumococcal vaccine (Middle dose) on Day 0 and Day 30, respectively.
Biological: Pneumococcal Vaccine
0.5 mL, intramuscular
Experimental: Pneumococcal Vaccine Dose 3 (High dose)
Participants will receive 2 injections of the investigational Pneumococcal vaccine (High dose) on Day 0 and Day 30, respectively.
Biological: Pneumococcal Vaccine
0.5 mL, intramuscular

Detailed Description:

Each volunteer participant will receive two injections with one of three vaccine doses, administered on Day 0 and Day 30, in a dose-ascending manner, pending safety review at each dose level. All participants will be monitored for safety for 30 days after each injection.

  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
  • Healthy, as determined by medical history and clinical examination
  • Informed consent obtained
  • Able to attend all scheduled visits and to comply with all trial procedures
  • For a woman, inability to bear a child or negative urine pregnancy test at each vaccination visit
  • For a woman of child-bearing potential: use of two medically acceptable, effective methods of contraception (oral contraceptive, intrauterine device, diaphragm, spermicide, or condom) or abstinence throughout the study participation starting at least 30 days prior to the first vaccination up to at least 30 days after the last vaccination.

Exclusion Criteria:

  • Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system) that could interfere with trial conduct or and/or raise a safety concern
  • For a woman, breast-feeding
  • Participation in another clinical trial in the 30 days preceding the first trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
  • Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
  • Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures
  • Blood or blood-derived products received in the past 3 months
  • Any vaccination in the 30 days preceding the first trial vaccination
  • Vaccination planned in the 30 days following any trial vaccination
  • Known Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C seropositivity
  • Known thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
  • Febrile illness (≥ 38.0°C [or 100.4°F]) within 72 hours of inclusion/vaccination
  • Previous vaccination in the preceding 5 years against pneumococcal disease with another vaccine
  • History of pneumococcal infection (confirmed either clinically, serologically, or microbiologically) within 5 years
  • Subject at high risk of pneumococcal infection during the trial
  • Subjects living in a household with children < 5 years of age
  • Antibiotic usage or upper or lower respiratory tract infection within one week before any blood draw for immunogenicity (Visits 1, 3, and 5).
  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: NCT01444001

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: NCT01444001     History of Changes
Other Study ID Numbers: PPR01
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
Pneumococcal Vaccines
pneumococcal protein

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

ClinicalTrials.gov processed this record on August 01, 2014