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Blood Sampling

Phase 3

Infections, Meningococcal | Unknown | Other |Pfizer, Inc.|Last Updated: Jun 17, 2019

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_CONTROLLED
Total Trials1
Total Enrollment184
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01900899Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy ChildrenPHASE3 COMPLETED 184 — — Jul 1, 2013Nov 1, 2017Jun 17, 201910 Finland
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Study Endpoints
Primary Endpoints
Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination
24 months after booster Vaccination

Serogroups included MenA, MenC, MenW-135 and MenY.

Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination
36 months after booster Vaccination

Serogroups included MenA, MenC, MenW-135 and MenY.

Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination
48 months after booster Vaccination

Serogroups included MenA, MenC, MenW-135 and MenY.

Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination
60 months after booster Vaccination

Serogroups included MenA, MenC, MenW-135 and MenY.

Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination
72 months after booster Vaccination

Serogroups included MenA, MenC, MenW-135 and MenY.

Secondary Endpoints
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
24, 36, 48, 60 and 72 months after booster Vaccination
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
24, 36, 48, 60 and 72 months after booster Vaccination
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs)
Baseline up to the Month 72 after booster vaccination (up to 6 years)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
ACWY-TT groupEXPERIMENTALSubjects primed and boosted with the MenACWY-TT vaccine.
MenCCRM groupACTIVE_COMPARATORSubjects primed and boosted with the Meningitec vaccine.
Interventions
NameTypeDescription
Blood SamplingPROCEDUREAt 2, 3, 4, 5, 6 years after booster vaccination.
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Eligibility Criteria
SexALL
Healthy VolunteersYes
Study Sites10

Inclusion Criteria: All subjects must satisfy ALL the following criteria at study entry: * Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female who has received pri...

Countries:Finland
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