Rotavirus vaccine

Identification

Brand Names
Rotarix, Rotateq
Generic Name
Rotavirus vaccine
DrugBank Accession Number
DB10276
Background

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
Attenuated
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.

Pharmacology
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Associated Conditions
Contraindications & Blackbox Warnings
Contraindications
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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
Adverseeffects
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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.

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).
Interactions
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Food Interactions
Not Available

Products

Products2
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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
RotarixSuspension1000000 CCID50/mlOralGlaxo Smith Kline Biologicals S.A.2021-02-11Not applicableEU flag
RotarixKit1000000 [CCID_50]/1mLOralGlaxoSmithKline Biologicals SA2011-01-13Not applicableUS flag
RotarixSuspension1000000 CCID50/mlOralGlaxo Smith Kline Biologicals S.A.2021-02-11Not applicableEU flag
RotarixSuspension1000000 CCID50/mlOralGlaxo Smith Kline Biologicals S.A.2021-02-11Not applicableEU flag
RotarixSuspension1000000 CCID50/1.5mLOralGlaxosmithkline Inc2008-12-16Not applicableCanada flag
RotarixSuspension1000000 CCID50/mlOralGlaxo Smith Kline Biologicals S.A.2021-02-11Not applicableEU flag
RotarixSuspension1000000 CCID50/mlOralGlaxo Smith Kline Biologicals S.A.2021-02-11Not applicableEU flag
RotarixSuspension1000000 CCID50/mlOralGlaxo Smith Kline Biologicals S.A.2021-02-11Not applicableEU flag
RotarixKit1000000 [CCID_50]/1mLOralGlaxoSmithKline Biologicals SA2008-08-012009-11-24US flag
RotarixSuspension1000000 CCID50/mlOralGlaxo Smith Kline Biologicals S.A.2021-02-11Not applicableEU flag
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
RotateqHuman Rotavirus A type G1P7(5) strain WI79 live antigen (2200000 IU) + Human Rotavirus A type G2P7(5) strain SC2 live antigen (2800000 IU) + Human Rotavirus A type G3P7(5) strain WI78 live antigen (2200000 IU) + Human Rotavirus A type G4P7(5) strain BRB live antigen (2000000 IU) + Human Rotavirus A type G6P1A(8) strain WI79 live antigen (2300000 IU)SolutionOralMsd Vaccins2021-02-10Not applicableEU 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 (2200000 IU) + Human Rotavirus A type G2P7(5) strain SC2 live antigen (2800000 IU) + Human Rotavirus A type G3P7(5) strain WI78 live antigen (2200000 IU) + Human Rotavirus A type G4P7(5) strain BRB live antigen (2000000 IU) + Human Rotavirus A type G6P1A(8) strain WI79 live antigen (2300000 IU)SolutionOralMsd Vaccins2021-02-10Not applicableEU flag
RotaTeqHuman Rotavirus A type G1P7(5) strain WI79 live antigen (2210000 unit / dose) + Human Rotavirus A type G2P7(5) strain SC2 live antigen (2840000 unit / dose) + Human Rotavirus A type G3P7(5) strain WI78 live antigen (2220000 unit / dose) + Human Rotavirus A type G4P7(5) strain BRB live antigen (2040000 unit / dose) + Human Rotavirus A type G6P1A(8) strain WI79 live antigen (2290000 unit / dose)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 / dose) + Human Rotavirus A type G2P7(5) strain SC2 live antigen (2840000 unit / dose) + Human Rotavirus A type G3P7(5) strain WI78 live antigen (2220000 unit / dose) + Human Rotavirus A type G4P7(5) strain BRB live antigen (2040000 unit / dose) + Human Rotavirus A type G6P1A(8) strain WI79 live antigen (2290000 unit / dose)SolutionOralMSD PHARMA (SINGAPORE) PTE. LTD.2007-06-22Not applicable
RotateqHuman Rotavirus A type G1P7(5) strain WI79 live antigen (2200000 IU) + Human Rotavirus A type G2P7(5) strain SC2 live antigen (2800000 IU) + Human Rotavirus A type G3P7(5) strain WI78 live antigen (2200000 IU) + Human Rotavirus A type G4P7(5) strain BRB live antigen (2000000 IU) + Human Rotavirus A type G6P1A(8) strain WI79 live antigen (2300000 IU)SolutionOralMsd Vaccins2021-02-10Not applicableEU 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 / dose) + Human Rotavirus A type G2P7(5) strain SC2 live antigen (2840000 unit / dose) + Human Rotavirus A type G3P7(5) strain WI78 live antigen (2220000 unit / dose) + Human Rotavirus A type G4P7(5) strain BRB live antigen (2040000 unit / dose) + Human Rotavirus A type G6P1A(8) strain WI79 live antigen (2290000 unit / dose)SolutionOralMSD PHARMA (SINGAPORE) PTE. LTD.2007-06-22Not applicable
RotateqHuman Rotavirus A type G1P7(5) strain WI79 live antigen (2200000 IU) + Human Rotavirus A type G2P7(5) strain SC2 live antigen (2800000 IU) + Human Rotavirus A type G3P7(5) strain WI78 live antigen (2200000 IU) + Human Rotavirus A type G4P7(5) strain BRB live antigen (2000000 IU) + Human Rotavirus A type G6P1A(8) strain WI79 live antigen (2300000 IU)SolutionOralMsd Vaccins2021-02-10Not applicableEU flag

Categories

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

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
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 / Intussusception (IS)1
4CompletedPreventionBCG Infection / Immune Responses / Vaccine Reaction1
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
Powder, for suspensionOral1000000 CCID50/ml
SuspensionOral1000000 [CCID_50]/1mL
SuspensionOral1000000 CCID50/ml
SuspensionOral1000000 CCID50/1.5ml
SuspensionOral
SolutionOral
SolutionOral2210000 unit / dose
SolutionOral
SuspensionOral
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Drug created on November 30, 2015 21:23 / Updated on October 24, 2021 16:00