Study of an Investigational Pneumococcal Vaccine at Three Dose Levels in Healthy Adults
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|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).
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): NCT01444352
|Study Director:||Medical Director||Sanofi Pasteur Ltd.|