Rotavirus Vaccine

Identification

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Name
Rotavirus Vaccine
Accession Number
DB10276  (DB10303, DB10304, DB10305, DB10306, DB10307)
Type
Biotech
Groups
Approved
Biologic Classification
Vaccines
Other vaccines
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.

Synonyms
  • Rota virus, live attenuated
  • Rotavirus vaccine, live, oral
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
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
RotarixSuspension1000000 ccid50OralGlaxosmithkline Inc2008-12-16Not applicableCanada
RotarixKit1000000 [CCID_50]/1mLGlaxoSmithKline Biologicals SA2011-01-13Not applicableUs
RotarixKit1000000 [CCID_50]/1mLGlaxoSmithKline Biologicals SA2008-08-012009-11-24Us
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 End
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 Limited2006-02-03Not applicableUs
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
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 Limited2006-02-03Not applicableUs
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
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 Limited2006-02-03Not applicableUs
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
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 Limited2006-02-03Not applicableUs
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
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 Limited2006-02-03Not applicableUs
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
Categories
UNII
Not Available
CAS number
Not Available

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
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.

Additional Data Available
Adverse Effects

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Additional Data Available
Contraindications

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

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Additional Data Available
Blackbox Warnings

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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
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
DrugInteraction
2-MethoxyethanolThe therapeutic efficacy of Rotavirus Vaccine can be decreased when used in combination with 2-Methoxyethanol.
25-desacetylrifapentineThe therapeutic efficacy of Rotavirus Vaccine can be decreased when used in combination with 25-desacetylrifapentine.
6-Deoxyerythronolide BThe therapeutic efficacy of Rotavirus Vaccine can be decreased when used in combination with 6-Deoxyerythronolide B.
9-(N-methyl-L-isoleucine)-cyclosporin AThe therapeutic efficacy of Rotavirus Vaccine can be decreased when used in combination with 9-(N-methyl-L-isoleucine)-cyclosporin A.
AbataceptThe therapeutic efficacy of Rotavirus Vaccine can be decreased when used in combination with Abatacept.
AbetimusThe therapeutic efficacy of Rotavirus Vaccine can be decreased when used in combination with Abetimus.
Acetyl sulfisoxazoleThe therapeutic efficacy of Rotavirus Vaccine can be decreased when used in combination with Acetyl sulfisoxazole.
ActeosideThe therapeutic efficacy of Rotavirus Vaccine can be decreased when used in combination with Acteoside.
AdalimumabThe therapeutic efficacy of Rotavirus Vaccine can be decreased when used in combination with Adalimumab.
AfelimomabThe therapeutic efficacy of Rotavirus Vaccine can be decreased when used in combination with Afelimomab.
Additional Data Available
  • Extended Description
    Extended Description

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  • Severity
    Severity

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  • Evidence Level
    Evidence Level

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  • Action
    Action

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Food Interactions
Not Available

References

General References
  1. Rotateq FDA Label [Link]
  2. CDC: About Rotavirus [Link]
External Links
PubChem Substance
347910468
ATC Codes
J07BH01 — Rota virus, live attenuated
AHFS Codes
  • 80:12.00 — Vaccines
FDA label
Download (227 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1Active Not RecruitingPreventionHealthy Volunteers1
1CompletedPreventionInfections, Rotavirus1
1CompletedPreventionInfections, Rotavirus / Rotavirus Gastroenteritis2
1CompletedPreventionRotavirus Gastroenteritis1
1TerminatedPreventionRotavirus1
1, 2Active Not RecruitingPreventionRotavirus Gastroenteritis1
2Active Not RecruitingPreventionInfectious Diseases1
2CompletedNot AvailableFevers / Irritability / Nausea / Severe or persistent diarrhea / Vomited1
2CompletedPreventionAcellular Pertussis / Diphtheria / Haemophilus Influenzae Type B / Neisseria Meningitidis / Poliomyelitis / Tetanus / Viral Hepatitis B1
2CompletedPreventionInfections, Rotavirus1
2CompletedPreventionInfections, Rotavirus / Rotavirus Gastroenteritis2
2CompletedPreventionMeningitis / Meningococcal Infections1
2CompletedPreventionRotavirus Gastroenteritis / Viral Hepatitis B1
2CompletedTreatmentHuman Immunodeficiency Virus (HIV) Infections / Infections, Rotavirus1
2WithdrawnPreventionInfections, Rotavirus1
2, 3CompletedPreventionFevers / Irritability / Nausea / Severe or persistent diarrhea / Vomited1
2, 3RecruitingPreventionDiarrhea Rotavirus / Severe or persistent diarrhea1
3Active Not RecruitingPreventionSevere Rotavirus Gastroenteritis1
3CompletedPreventionAcellular Pertussis / Diphtheria / Haemophilus Influenzae Type B / Haemophilus Influenzae Type b Diseases / Pertussis / Poliomyelitis / Tetanus1
3CompletedPreventionAcellular Pertussis / Diphtheria / Haemophilus Influenzae Type B / Poliomyelitis / Tetanus / Viral Hepatitis B1
3CompletedPreventionBacterial Infections / Neisseria Meningitidis / Virus Diseases2
3CompletedPreventionBacterial Infections / Virus Diseases4
3CompletedPreventionFevers / Infections, Rotavirus1
3CompletedPreventionFevers / Severe or persistent diarrhea / Vomiting1
3CompletedPreventionGastroenteritis / Rotavirus1
3CompletedPreventionHaemophilus Influenzae Type B1
3CompletedPreventionHaemophilus Influenzae Type B / Neisseria Meningitidis1
3CompletedPreventionHealthy Volunteers / Infants / Viral Hepatitis B1
3CompletedPreventionInfections, Rotavirus4
3CompletedPreventionInfections, Rotavirus / Meningococcal Meningitis1
3CompletedPreventionInfections, Rotavirus / Pneumococcal Diseases / Streptococcus Pneumoniae Vaccines1
3CompletedPreventionInfections, Rotavirus / Rotavirus Gastroenteritis3
3CompletedPreventionInfections, Rotavirus / Rotavirus Vaccines3
3CompletedPreventionInfections, Rotavirus / Rotavirus / Rotavirus Vaccines1
3CompletedPreventionPneumococcal Diseases / Streptococcal Infections1
3CompletedPreventionRotavirus Diarrhea / Tropical Enteropathy / Vaccine Virus Shedding1
3CompletedPreventionRotavirus Gastroenteritis1
3CompletedPreventionRotavirus Vaccines1
3CompletedPreventionStreptococcal Infections2
3Enrolling by InvitationPreventionInfections, Rotavirus1
3Not Yet RecruitingPreventionRotavirus Infection of Children1
3RecruitingPreventionHealthy Volunteers (Meningococcal Infection)1
3RecruitingPreventionInfections, Pneumococcal1
3RecruitingPreventionInfections, Pneumococcal / Vaccines, Pneumococcal1
3RecruitingPreventionMeningococcal Infections1
4Active Not RecruitingOtherInfections, Rotavirus / Intussusception1
4Active Not RecruitingPreventionGastroenteritis / Severe or persistent diarrhea1
4CompletedBasic ScienceImmunity to Oral Polio Vaccine / Immunity to Oral Rotavirus Vaccine / Shedding of Oral Rotavirus Vaccine1
4CompletedPreventionInfections, Rotavirus1
4CompletedPreventionInfections, Rotavirus / Rotavirus Gastroenteritis1
4CompletedPreventionIntestinal Failure / Rotavirus Vaccines1
4CompletedPreventionMeasles Antibody Seroconversion / Rotavirus Geometric Mean Titer (GMT) / Rotavirus GMT / Rotavirus IgA Seropositivity / Rotavirus Immunoglobulin A (IgA) Seropositivity / Rubella Antibody Seroconversion1
4CompletedPreventionRotavirus Disease1
4CompletedPreventionRotavirus Gastroenteritis4
4CompletedPreventionRotavirus Vaccines1
4CompletedTreatmentDiarrhea Rotavirus1
4RecruitingPreventionRotavirus / Severe or persistent diarrhea1
4RecruitingPreventionViral Gastroenteritis Due to Rotavirus1
4Unknown StatusPreventionRotavirus1
4Unknown StatusTreatmentPoliomyelitis1
Not AvailableCompletedNot AvailableInfections, Rotavirus3
Not AvailableCompletedNot AvailableInfections, Rotavirus / Prophylaxis Against Gastroenteritis Caused by Rotavirus1
Not AvailableCompletedNot AvailableInfections, Rotavirus / Rotavirus Gastroenteritis / Rotavirus Vaccines1
Not AvailableTerminatedNot AvailablePediatric Gastroenteritis1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
Kit1000000 [CCID_50]/1mL
SuspensionOral1000000 ccid50
SolutionOral
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Taxonomy

Classification
Not classified

Drug created on November 30, 2015 14:23 / Updated on July 16, 2019 06:23