Study of Two Investigational Pneumococcal Vaccines in Healthy Adults
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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 |
- 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
- 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 |
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
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:
|
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 May 19, 2013