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Rotavirus Vaccine, Live, , Pentavalent

Phase 3

Gastroenteritis | Monoclonal antibody | Other |Merck & Company, Inc.|Last Updated: Apr 13, 2017

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
UNCONTROLLED
Total Trials1
Total Enrollment110
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00496054Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021)PHASE3 COMPLETED 110 — — May 1, 2008Oct 1, 2008Apr 13, 2017 - —
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Study Endpoints
Primary Endpoints
The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA
Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA)
Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)
Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)
Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)
Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)
Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA)
Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA
Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1
Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2
Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3
Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4
Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1
Baseline and Approximately 6 Months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
RotaTeq™ Vaccine (V260)EXPERIMENTALEvaluation of Safety, Tolerability and Immunogenicity of Vaccination with RotaTeq™ in Healthy Infants in India.
Interventions
NameTypeDescription
Rotavirus Vaccine, Live, Oral, PentavalentBIOLOGICALPentavalent vaccine 9G1, G2, G3, G4 \& P1) given 3 times. Dose 1 will be administered at study entry; Dose 2 will be administered 4 to 10 weeks (28 to 70 days) after Dose 1; and Dose 3 will be administered 4 to 10 weeks (28 to 70 days) after Dose 2.
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Eligibility Criteria
Age Range6 Weeks — 12 Weeks
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Age 6 weeks through exactly 12 weeks * Healthy infants Exclusion Criteria: * Clinical evidence of active gastrointestinal illness * Fever, with a rectal temperature of greater than and equal to thirty eight degree celsius at the time of immunization * History of congenital a...

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