Study of Two Investigational Pneumococcal Vaccines in Healthy Adults
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01444339 |
Recruitment Status :
Completed
First Posted : September 30, 2011
Last Update Posted : September 30, 2011
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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 |
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 |
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.
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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.
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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.
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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.
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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.
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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.
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Biological: Placebo
0.5 mL, intramuscular
Other Name: Tris buffered saline |
- 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
- 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).

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
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.

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
Switzerland | |
Allschwil, Switzerland |
Study Director: | Medical Director | Sanofi Pasteur Ltd. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Pneumococcal Infections Streptococcus Pneumoniae Infections Pneumococcal Vaccine |
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 |