Rotavirus vaccine

Identification

Name
Rotavirus vaccine
Accession Number
DB10276
Description

Rotavirus commonly infects children and infants causing severe diarrhea and vomiting leading to potentially fatal dehydration.2 Two rotavirus vaccines are available for the prevention of rotavirus gastroenteritis, Rotateq and Rotarix. Rotateq is a live vaccine consisting of 5 reassorted human-bovine viral strains.1 Rotarix is a live attenuated vaccine containing the 89-12 human strain.Label Rotavirus vaccines are 90% effective in protecting against severe rotavirus infection.2

Type
Biotech
Groups
Approved
Biologic Classification
Vaccines
Other vaccines
Synonyms
  • Rota virus, live attenuated
  • Rotavirus vaccine, live, oral

Pharmacology

Indication

Rotarix is indicated for prevention of rotavirus gastroenteritis caused by G1, G3, G4, and G9 types in infants aged 6-24 weeks Label.

Rotateq is indicated for the prevention of rotavirus gastroenteritis caused by G1, G2, G3, G4, and G9 types in infants aged 6-32 weeks 1.

Associated Conditions
Contraindications & Blackbox Warnings
Learn about our commercial Contraindications & Blackbox Warnings data.
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Pharmacodynamics

Rotarix and Rotateq contain live attenuated and live virus respectively. The virus replicates in the intesine and interacts with the patient's immune system to produce immunity Label,1. Seroconversion has been defined as the appearance of anti-rotavirus IgA antibodies at concentrations greater than 20 U/mL post-vaccination in the serum of infants previously negative for rotavirus Label.

Mechanism of action

The exact mechanism specific to the rotavirus vaccines' interaction with the immune system is uncharacterized Label,1.

Absorption
Not Available
Volume of distribution
Not Available
Protein binding
Not Available
Metabolism
Not Available
Route of elimination
Not Available
Half-life

The median duration of viral shedding was observed to be 10 days Label.

Clearance
Not Available
Adverse Effects
Learn about our commercial Adverse Effects data.
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Toxicity

Rotavirus vaccine may produce severe diarrhea and vomiting as a result of rotavirus infection Label. Post marketing reports suggest an increased risk of intussusception with rotavirus vaccine but this is unsupported by clinical data.

Affected organisms
Not Available
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
AbataceptThe therapeutic efficacy of Rotavirus vaccine can be decreased when used in combination with Abatacept.
AdalimumabThe therapeutic efficacy of Rotavirus vaccine can be decreased when used in combination with Adalimumab.
AldesleukinThe therapeutic efficacy of Rotavirus vaccine can be decreased when used in combination with Aldesleukin.
AlefaceptThe therapeutic efficacy of Rotavirus vaccine can be decreased when used in combination with Alefacept.
AlemtuzumabThe therapeutic efficacy of Rotavirus vaccine can be decreased when used in combination with Alemtuzumab.
AltretamineThe therapeutic efficacy of Rotavirus vaccine can be decreased when used in combination with Altretamine.
AmsacrineThe therapeutic efficacy of Rotavirus vaccine can be decreased when used in combination with Amsacrine.
AnakinraThe therapeutic efficacy of Rotavirus vaccine can be decreased when used in combination with Anakinra.
Antilymphocyte immunoglobulin (horse)The therapeutic efficacy of Rotavirus vaccine can be decreased when used in combination with Antilymphocyte immunoglobulin (horse).
Antithymocyte immunoglobulin (rabbit)The therapeutic efficacy of Rotavirus vaccine can be decreased when used in combination with Antithymocyte immunoglobulin (rabbit).
Additional Data Available
  • Extended Description
    Extended Description

    Extended description of the mechanism of action and particular properties of each drug interaction.

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  • Severity
    Severity

    A severity rating for each drug interaction, from minor to major.

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  • Evidence Level
    Evidence Level

    A rating for the strength of the evidence supporting each drug interaction.

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  • Action
    Action

    An effect category for each drug interaction. Know how this interaction affects the subject drug.

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Food Interactions
Not Available

Products

Product Ingredients
IngredientUNIICASInChI Key
Human Rotavirus A type G1P(8) strain RIX4414 live antigenKZ3L01D2PCNot AvailableNot applicable
Human Rotavirus A type G1P7(5) strain WI79 live antigen3L3RG28B7QNot AvailableNot applicable
Human Rotavirus A type G2P7(5) strain SC2 live antigenJU499IS53HNot AvailableNot applicable
Human Rotavirus A type G3P7(5) strain WI78 live antigenZ65J02I7CWNot AvailableNot applicable
Human Rotavirus A type G4P7(5) strain BRB live antigen6334XMP4KCNot AvailableNot applicable
Human Rotavirus A type G6P1A(8) strain WI79 live antigenL1977Q86S5Not AvailableNot applicable
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
Rotarix1000000 [CCID_50]/1mLOralGlaxoSmithKline Biologicals SA2011-01-13Not applicableUS flag
RotarixKit1000000 [CCID_50]/1mLOralGlaxoSmithKline Biologicals SA2008-08-012009-11-24US flag
RotarixSuspension1000000 CCID50/1.5mLOralGlaxosmithkline Inc2008-12-16Not applicableCanada flag
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
RotaTeqHuman Rotavirus A type G1P7(5) strain WI79 live antigen (2200000 [iU]/2mL) + Human Rotavirus A type G2P7(5) strain SC2 live antigen (2800000 [iU]/2mL) + Human Rotavirus A type G3P7(5) strain WI78 live antigen (2200000 [iU]/2mL) + Human Rotavirus A type G4P7(5) strain BRB live antigen (2000000 [iU]/2mL) + Human Rotavirus A type G6P1A(8) strain WI79 live antigen (2300000 [iU]/2mL)SolutionOralMerck Sharp & Dohme Corp.2006-02-03Not applicableUS flag
RotaTeqHuman Rotavirus A type G1P7(5) strain WI79 live antigen (2210000 unit) + Human Rotavirus A type G2P7(5) strain SC2 live antigen (2840000 unit) + Human Rotavirus A type G3P7(5) strain WI78 live antigen (2220000 unit) + Human Rotavirus A type G4P7(5) strain BRB live antigen (2040000 unit) + Human Rotavirus A type G6P1A(8) strain WI79 live antigen (2290000 unit)SolutionOralMerck Ltd.2006-10-16Not applicableCanada flag
RotaTeqHuman Rotavirus A type G1P7(5) strain WI79 live antigen (2200000 [iU]/2mL) + Human Rotavirus A type G2P7(5) strain SC2 live antigen (2800000 [iU]/2mL) + Human Rotavirus A type G3P7(5) strain WI78 live antigen (2200000 [iU]/2mL) + Human Rotavirus A type G4P7(5) strain BRB live antigen (2000000 [iU]/2mL) + Human Rotavirus A type G6P1A(8) strain WI79 live antigen (2300000 [iU]/2mL)SolutionOralMerck Sharp & Dohme Corp.2006-02-03Not applicableUS flag
RotaTeqHuman Rotavirus A type G1P7(5) strain WI79 live antigen (2210000 unit) + Human Rotavirus A type G2P7(5) strain SC2 live antigen (2840000 unit) + Human Rotavirus A type G3P7(5) strain WI78 live antigen (2220000 unit) + Human Rotavirus A type G4P7(5) strain BRB live antigen (2040000 unit) + Human Rotavirus A type G6P1A(8) strain WI79 live antigen (2290000 unit)SolutionOralMerck Ltd.2006-10-16Not applicableCanada flag
RotaTeqHuman Rotavirus A type G1P7(5) strain WI79 live antigen (2200000 [iU]/2mL) + Human Rotavirus A type G2P7(5) strain SC2 live antigen (2800000 [iU]/2mL) + Human Rotavirus A type G3P7(5) strain WI78 live antigen (2200000 [iU]/2mL) + Human Rotavirus A type G4P7(5) strain BRB live antigen (2000000 [iU]/2mL) + Human Rotavirus A type G6P1A(8) strain WI79 live antigen (2300000 [iU]/2mL)SolutionOralMerck Sharp & Dohme Corp.2006-02-03Not applicableUS flag
RotaTeqHuman Rotavirus A type G1P7(5) strain WI79 live antigen (2210000 unit) + Human Rotavirus A type G2P7(5) strain SC2 live antigen (2840000 unit) + Human Rotavirus A type G3P7(5) strain WI78 live antigen (2220000 unit) + Human Rotavirus A type G4P7(5) strain BRB live antigen (2040000 unit) + Human Rotavirus A type G6P1A(8) strain WI79 live antigen (2290000 unit)SolutionOralMerck Ltd.2006-10-16Not applicableCanada flag
RotaTeqHuman Rotavirus A type G1P7(5) strain WI79 live antigen (2200000 [iU]/2mL) + Human Rotavirus A type G2P7(5) strain SC2 live antigen (2800000 [iU]/2mL) + Human Rotavirus A type G3P7(5) strain WI78 live antigen (2200000 [iU]/2mL) + Human Rotavirus A type G4P7(5) strain BRB live antigen (2000000 [iU]/2mL) + Human Rotavirus A type G6P1A(8) strain WI79 live antigen (2300000 [iU]/2mL)SolutionOralMerck Sharp & Dohme Corp.2006-02-03Not applicableUS flag
RotaTeqHuman Rotavirus A type G1P7(5) strain WI79 live antigen (2210000 unit) + Human Rotavirus A type G2P7(5) strain SC2 live antigen (2840000 unit) + Human Rotavirus A type G3P7(5) strain WI78 live antigen (2220000 unit) + Human Rotavirus A type G4P7(5) strain BRB live antigen (2040000 unit) + Human Rotavirus A type G6P1A(8) strain WI79 live antigen (2290000 unit)SolutionOralMerck Ltd.2006-10-16Not applicableCanada flag
RotaTeqHuman Rotavirus A type G1P7(5) strain WI79 live antigen (2200000 [iU]/2mL) + Human Rotavirus A type G2P7(5) strain SC2 live antigen (2800000 [iU]/2mL) + Human Rotavirus A type G3P7(5) strain WI78 live antigen (2200000 [iU]/2mL) + Human Rotavirus A type G4P7(5) strain BRB live antigen (2000000 [iU]/2mL) + Human Rotavirus A type G6P1A(8) strain WI79 live antigen (2300000 [iU]/2mL)SolutionOralMerck Sharp & Dohme Corp.2006-02-03Not applicableUS flag
RotaTeqHuman Rotavirus A type G1P7(5) strain WI79 live antigen (2210000 unit) + Human Rotavirus A type G2P7(5) strain SC2 live antigen (2840000 unit) + Human Rotavirus A type G3P7(5) strain WI78 live antigen (2220000 unit) + Human Rotavirus A type G4P7(5) strain BRB live antigen (2040000 unit) + Human Rotavirus A type G6P1A(8) strain WI79 live antigen (2290000 unit)SolutionOralMerck Ltd.2006-10-16Not applicableCanada flag

Categories

ATC Codes
J07BH01 — Rota virus, live attenuated
Drug Categories
Classification
Not classified

Chemical Identifiers

UNII
Not Available
CAS number
Not Available

References

General References
  1. Rotateq FDA Label [Link]
  2. CDC: About Rotavirus [Link]
PubChem Substance
347910468
Wikipedia
Rotavirus_vaccine
AHFS Codes
  • 80:12.00 — Vaccines
FDA label
Download (227 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedBasic ScienceImmunity to Oral Polio Vaccine / Immunity to Oral Rotavirus Vaccine / Shedding of Oral Rotavirus Vaccine1
4CompletedOtherInfections, Rotavirus / Intussusception1
4CompletedPreventionBCG Infection / Immune Response / Reaction - Vaccine1
4CompletedPreventionDiarrhea / Gastroenteritis1
4CompletedPreventionInfections, Rotavirus2
4CompletedPreventionInfections, Rotavirus / Rotavirus Vaccines1
4CompletedPreventionInfections, Rotavirus / Vaccine Response Impaired / Vaccine Virus Shedding1
4CompletedPreventionIntestinal Failure / Rotavirus Vaccines1
4CompletedPreventionMeasles Antibody Seroconversion / Rotavirus Geometric Mean Titer (GMT) / Rotavirus Immunoglobulin A (IgA) Seropositivity / Rubella Antibody Seroconversion1
4CompletedPreventionPoliomyelitis1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
KitOral1000000 [CCID_50]/1mL
SuspensionOral1000000 CCID50/1.5ml
SuspensionOral1000000 [CCID_50]/1mL
SuspensionOral1 ml
SolutionOral
SolutionOral2200000 [iU]/2mL
SolutionOral2 ml
SuspensionOral2.2 mcg
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Drug created on November 30, 2015 14:23 / Updated on October 26, 2020 22:41

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