Study of an Investigational Pneumococcal Vaccine at Three Dose Levels in Healthy Adults
|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: NCT01444352|
Recruitment Status : Completed
First Posted : September 30, 2011
Last Update Posted : March 18, 2015
This study is designed to evaluate the safety, tolerability, and immunogenicity of an investigational pneumococcal vaccine in healthy adult volunteers.
- To evaluate the safety and tolerability of an investigational pneumococcal vaccine.
- To evaluate the immunogenicity of an investigational Pneumococcal vaccine.
|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: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
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
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: Days 0 through 30 post-vaccination ]Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
- Immunogenicity of Pneumococcal Vaccine After two Vaccinations [ Time Frame: Days 0 and 30 days post-vaccination ]Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01444352
|Study Director:||Medical Director||Sanofi Pasteur Ltd.|