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Pneumococcal 13-valent conjugate vaccine

Phase 3

Neisseria Meningitidis | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: May 21, 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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment956
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01218451NeisVac-C Single Prime Study in InfantsPHASE3 COMPLETED 956 — — Sep 1, 2010Jun 1, 2012May 21, 201524 Poland, Spain
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Study Endpoints
Primary Endpoints
Number of subjects with seroprotective antibody titers (rSBA titers >= 8) 1 month after completion of the primary vaccination in single-dose groups compared to the two-dose group
1 month
Number of subjects with seroprotective antibody titers (rSBA titers >= 8) prior to the administration of the booster dose
6 to 9 months (from 4-6 months of age until 12-13 months of age)
Number of subjects with seroprotective antibody titers (rSBA titers >= 128) 1 month after the administration of the booster dose
1 month after booster dose (administered between 12-13 months of age)
Secondary Endpoints
Antibody titers (rSBA) titers one month after completion of the primary vaccination
1 month after primary vaccination
Antibody titers (rSBA titers) prior to the administration of the booster dose
Prior to booster dose
Antibody titers (rSBA titers)one month after the administration of the booster dose
1 month after administration of booster dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTALSingle dose of NeisVac-C vaccine at 4 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age
Group 2EXPERIMENTALSingle dose of NeisVac-C vaccine at 6 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age
Group 3ACTIVE_COMPARATORTwo doses of NeisVac-C vaccine at 2 and 4 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age
Interventions
NameTypeDescription
Meningococcal group C polysaccharide conjugate vaccineBIOLOGICAL0.5 mL dose, subcutaneous administration in right anterolateral thigh
Pneumococcal 13-valent conjugate vaccineBIOLOGICAL0.5 mL dose, subcutaneous administration in right anterolateral thigh
Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccineBIOLOGICAL0.5 mL dose, subcutaneous administration in right anterolateral thigh
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Eligibility Criteria
Age Range8 Weeks — 11 Weeks
SexALL
Healthy VolunteersYes
Study Sites24

Inclusion Criteria: * Subject is an infant aged 8 to 11 weeks at the time of first vaccination * Subject is clinically healthy as determined by the investigator's clinical judgment through collection of medical history and physical examination * Subject was born at full term of pregnancy (\>= 37 we...

Countries:PolandSpain
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