Study of Two Investigational Pneumococcal Vaccines in Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01444339
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 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 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: Pneumococcal Vaccine Formulation 4
Biological: Pneumococcal Vaccine Formulation 5
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: 30 days 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 Investigational Pneumococcal vaccines after 2 vaccinations [ Time Frame: Days 0 and 30 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: 131
Study Start Date: February 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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:

  • 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
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: NCT01444339

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: NCT01444339     History of Changes
Other Study ID Numbers: PPR05
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 Vaccine

Additional relevant MeSH terms:
Communicable Diseases
Infection
Pneumococcal Infections
Pneumonia
Pneumonia, Pneumococcal
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 22, 2014