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RotaTeq- Rotavirus Vaccine, Live, Pentavalent

Phase 3

Vomiting | Monoclonal antibody | Infectious Disease |Merck & Company, Inc.|Last Updated: Apr 13, 2017

Target and mechanism

ModalityMonoclonal antibody

Also known as RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment7,504

FDA Designations

No designations recorded

Clinical trial landscape

RotaTeq- Rotavirus Vaccine, Live, Pentavalent · 1 trial · 3 indications

Phase 3 1
NCT00362648Developing World Study for RotaTeq™ (V260-015)(COMPLETED)Vomiting
COMPLETED7,504 Analytics
PHASE3COMPLETED
Developing World Study for RotaTeq™ (V260-015)(COMPLETED)
Vomiting
NCT003626487,504
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Study Endpoints

Primary Endpoints

Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose
At least 14 days following the third vaccination

Secondary Endpoints

Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
14 days following the 3rd vaccination
Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
14 days following the 3rd vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTALRotaTeq™
2PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
RotaTeq™ - Rotavirus Vaccine, Live, Oral, PentavalentBIOLOGICAL2.0 mL oral dose of RotaTeq™. 14 week treatment period
Comparator: PlaceboBIOLOGICALArm 2: Placebo. 14 week treatment period
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Eligibility Criteria

Age Range4 Weeks to 12 Weeks
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Age 4 weeks through 12 weeks at Dose 1 * Parent able to understand study procedures and give consent Exclusion Criteria: * Clinical evidence of active gastrointestinal disease * Subjects who are currently or expected to participate in other studies of investigational product...

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