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Pneumococcal vaccine Formulation 1

Phase 1

Pneumococcal Infections | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Mar 18, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment294
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01444352Study of an Investigational Pneumococcal Vaccine at Three Dose Levels in Healthy AdultsPHASE1 COMPLETED 100 — — Jun 1, 2010Jan 1, 2011Mar 18, 20151 Switzerland
NCT01444339Study of Two Investigational Pneumococcal Vaccines in Healthy AdultsPHASE1 COMPLETED 131 — — Feb 1, 2010Sep 1, 2010Sep 30, 20111 Switzerland
NCT01444001Study of an Investigational Pneumococcal Vaccine in Healthy Adult VolunteersPHASE1 COMPLETED 63 — — Feb 1, 2007Aug 1, 2007Sep 30, 20111 Switzerland
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Study Endpoints
Primary Endpoints
Number and percentage of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial
Days 0 through 30 post-vaccination

Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.

The occurrence of solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial
Day 0 up to Day 60 post vaccination

Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia

Secondary Endpoints
Immunogenicity of Pneumococcal Vaccine After two Vaccinations
Days 0 and 30 days post-vaccination
Immunogenicity of Investigational Pneumococcal vaccines after 2 vaccinations
Days 0 and 30 post-vaccination
Immunogenicity of pneumococcal vaccine after 2 vaccinations
Day 0 and 30 days post vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Vaccine Formulation 1 (Low dose)EXPERIMENTALParticipants will receive 2 injections of Pneumococcal Vaccine Formulation 1 (Low dose).
Vaccine Formulation 2 (Middle dose)EXPERIMENTALParticipants will receive 2 injections of Pneumococcal Vaccine Formulation 2, (Middle dose).
Vaccine Formulation 3 (High dose)EXPERIMENTALParticipants will receive 2 injections of Pneumococcal Vaccine Formulation 3, (High dose).
Placebo PooledPLACEBO_COMPARATORParticipants who receive 2 injections of tris buffered saline
Pneumococcal Vaccine Formulation 1EXPERIMENTALParticipants will receive an injection of pneumococcal vaccine (Formulation 1, 1 middle dose) on Day 0 and Day 30, respectively.
Pneumococcal Vaccine Formulation 2EXPERIMENTALParticipants will receive an injection of Pneumococcal vaccine (Formulation 2, 2 low doses) on Day 0 and Day 30, respectively.
Pneumococcal Vaccine Formulation 3EXPERIMENTALParticipants will receive an injection of pneumococcal vaccine (Formulation 3, 2 middle doses) on Day 0 and Day 30, respectively.
Pneumococcal Vaccine Formulation 4EXPERIMENTALParticipants will receive an injection of pneumococcal vaccine (Formulation 4, 2 middle doses) on Day 0 and Day 30, respectively.
Pneumococcal Vaccine Formulation 5EXPERIMENTALParticipants will receive an injection of pneumococcal vaccine (Formulation 5, 2 high doses) on Day 0 and Day 30, respectively.
Pooled placebo GroupPLACEBO_COMPARATORParticipants will receive an injection of a placebo on Day 0 and Day 30, respectively.
Pneumococcal Vaccine Dose 1 (Low dose)EXPERIMENTALParticipants will receive 2 injections of Dose 1 investigational Pneumococcal vaccine (Low dose) on Day 0 and Day 30, respectively.
Pneumococcal Vaccine Dose 2 (Middle dose)EXPERIMENTALParticipants will receive 2 injections of the investigational Pneumococcal vaccine (Middle dose) on Day 0 and Day 30, respectively.
Pneumococcal Vaccine Dose 3 (High dose)EXPERIMENTALParticipants will receive 2 injections of the investigational Pneumococcal vaccine (High dose) on Day 0 and Day 30, respectively.
Interventions
NameTypeDescription
Pneumococcal vaccine Formulation 1BIOLOGICAL0.5 mL, Intramuscular (Low dose)
Pneumococcal vaccine Formulation 2BIOLOGICAL0.5 mL, Intramuscular (Middle dose)
Pneumococcal vaccine Formulation 3BIOLOGICAL0.5 mL, Intramuscular (High dose)
PlaceboBIOLOGICAL0.5 mL, Intramuscular
Pneumococcal Vaccine Formulation 4BIOLOGICAL0.5 mL, intramuscular (2 middle doses)
Pneumococcal Vaccine Formulation 5BIOLOGICAL0.5 mL, intramuscular (2 high doses)
Pneumococcal VaccineBIOLOGICAL0.5 mL, intramuscular
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

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-beari...

Countries:Switzerland
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