Rotavirus vaccine

Identification

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
RotarixSuspensionOralGlaxosmithkline Inc2008-12-16Not applicableCanada
Rotarix1000000 [CCID_50]/1mLOralGlaxoSmithKline Biologicals SA2011-01-13Not applicableUs
RotarixKit1000000 [CCID_50]/1mLOralGlaxoSmithKline 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 (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 (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 (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 (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 (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 Corp.2006-02-03Not applicableUs
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
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
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
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
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

Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.

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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

Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.

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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
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
2-MethoxyethanolThe therapeutic efficacy of Rotavirus vaccine can be decreased when used in combination with 2-Methoxyethanol.
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.
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.
AldesleukinThe therapeutic efficacy of Rotavirus vaccine can be decreased when used in combination with Aldesleukin.
AldosteroneThe therapeutic efficacy of Rotavirus vaccine can be decreased when used in combination with Aldosterone.
AlefaceptThe therapeutic efficacy of Rotavirus vaccine can be decreased when used in combination with Alefacept.
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

References

General References
  1. Rotateq FDA Label [Link]
  2. CDC: About Rotavirus [Link]
External Links
PubChem Substance
347910468
Wikipedia
Rotavirus_vaccine
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 / Rotavirus1
1CompletedPreventionInfections, Rotavirus / Rotavirus Gastroenteritis3
1CompletedPreventionRotavirus Gastroenteritis2
1CompletedPreventionShort bowel condition / Short Bowel Syndrome (SBS)1
1TerminatedPreventionRotavirus1
1, 2Active Not RecruitingPreventionRotavirus Gastroenteritis1
1, 2CompletedPreventionHealthy Volunteers1
1, 2Unknown StatusPreventionDiarrhea1
1, 2Unknown StatusPreventionRotavirus Gastroenteritis1
1, 2WithdrawnPreventionInfections, Rotavirus1
2Active Not RecruitingPreventionInfectious Diseases1
2CompletedNot AvailableDiarrhea / Fevers / Irritability / Nausea / Vomited1
2CompletedPreventionAcellular Pertussis / Diphtheria / Haemophilus Influenzae Type B / Neisseria Meningitidis / Poliomyelitis / Tetanus / Viral Hepatitis B1
2CompletedPreventionInfections, Rotavirus2
2CompletedPreventionInfections, Rotavirus / Rotavirus Gastroenteritis2
2CompletedPreventionInfections, Rotavirus / Rotavirus Gastroenteritis / Rotavirus Vaccines1
2CompletedPreventionMeningitis / Meningococcal Infections1
2CompletedPreventionRotavirus Gastroenteritis / Viral Hepatitis B1
2CompletedTreatmentHuman Immunodeficiency Virus (HIV) Infections / Infections, Rotavirus1
2Not Yet RecruitingTreatmentRotavirus Vaccines1
2RecruitingPreventionDiphtheria Immunisation / Haemophilus Influenzae Type b Immunisation / Hepatitis B Immunisation / Measles Immunisation / Mumps Immunisation / Pertussis Immunisation / Pneumococcal Immunisation / Polio Immunisation / Rubella Immunisation / Tetanus Immunisation / Varicella Immunisation1
2WithdrawnPreventionInfections, Rotavirus1
2, 3CompletedPreventionDiarrhea / Diarrhea Rotavirus1
2, 3CompletedPreventionDiarrhea / Fevers / Irritability / Nausea / Vomited1
2, 3CompletedTreatmentRotavirus Gastroenteritis1
3Active Not RecruitingPreventionInfections, Pneumococcal2
3Active Not RecruitingPreventionInfections, Pneumococcal / Vaccines, Pneumococcal1
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
3CompletedPreventionDiarrhea / Fevers / Vomiting1
3CompletedPreventionDiphtheria / Haemophilus Influenzae Type B / Poliomyelitis / Tetanus / Viral Hepatitis B / Whooping Cough1
3CompletedPreventionFevers / Infections, Rotavirus1
3CompletedPreventionGastroenteritis / Infections, Rotavirus2
3CompletedPreventionGastroenteritis / Rotavirus2
3CompletedPreventionHaemophilus Influenzae Type B1
3CompletedPreventionHaemophilus Influenzae Type B / Neisseria Meningitidis1
3CompletedPreventionHealthy Volunteers / Infants / Viral Hepatitis B1
3CompletedPreventionInfections, Rotavirus5
3CompletedPreventionInfections, Rotavirus / Meningococcal Meningitis1
3CompletedPreventionInfections, Rotavirus / Pneumococcal Diseases / Streptococcus Pneumoniae Vaccines1
3CompletedPreventionInfections, Rotavirus / Rotavirus Gastroenteritis6
3CompletedPreventionInfections, Rotavirus / Rotavirus Vaccines4
3CompletedPreventionInfections, Rotavirus / Rotavirus / Rotavirus Vaccines1
3CompletedPreventionMalaria Vaccines / Plasmodium Infections1
3CompletedPreventionMeningococcal Meningitis1
3CompletedPreventionPneumococcal Diseases / Streptococcal Infections / Streptococcus Pneumoniae Vaccines1
3CompletedPreventionRotavirus1
3CompletedPreventionRotavirus Diarrhea / Tropical Enteropathy / Vaccine Virus Shedding1
3CompletedPreventionRotavirus Gastroenteritis5
3CompletedPreventionRotavirus Vaccines1
3CompletedPreventionStreptococcal Infections2
3CompletedTreatmentGastroenteritis / Infections, Rotavirus1
3CompletedTreatmentHealthy Infants / Mothers1
3CompletedTreatmentRotavirus Disease1
3Enrolling by InvitationPreventionInfections, Rotavirus1
3Not Yet RecruitingPreventionDiphtheria Immunisation / Haemophilus Influenzae Type b Immunisation / Hepatitis B Immunisation / Pertussis Immunisation / Pneumococcal Immunisation / Polio Immunisation / Rotavirus Immunisation / Tetanus Immunisation1
3RecruitingPreventionHealthy Volunteers (Meningococcal Infection)3
3RecruitingPreventionMeningococcal Infections2
3SuspendedPreventionRotavirus Infection of Children1
3Unknown StatusPreventionViral Gastroenteritis Due to Rotavirus1
3WithdrawnPreventionDiphtheria / Pertussis / Rotavirus Gastroenteritis / Tetanus1
4Active Not RecruitingOtherInfections, Rotavirus / Intussusception1
4Active Not RecruitingPreventionDiarrhea / Gastroenteritis1
4CompletedBasic ScienceImmunity to Oral Polio Vaccine / Immunity to Oral Rotavirus Vaccine / Shedding of Oral Rotavirus Vaccine1
4CompletedPreventionBCG Infection / Immune Response / Reaction - Vaccine1
4CompletedPreventionInfections, Rotavirus1
4CompletedPreventionInfections, Rotavirus / Rotavirus Gastroenteritis1
4CompletedPreventionInfections, Rotavirus / Rotavirus Gastroenteritis / Rotavirus Vaccines1
4CompletedPreventionInfections, Rotavirus / Vaccine Response Impaired / Vaccine Virus Shedding1
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
4CompletedPreventionPoliomyelitis1
4CompletedPreventionRotavirus Disease1
4CompletedPreventionRotavirus Gastroenteritis4
4CompletedPreventionRotavirus / Rotavirus Vaccines1
4CompletedTreatmentDiarrhea Rotavirus1
4RecruitingPreventionDiarrhea / Rotavirus1
4RecruitingPreventionViral Gastroenteritis Due to Rotavirus1
4Unknown StatusPreventionRotavirus1
4Unknown StatusTreatmentPoliomyelitis1
Not AvailableCompletedNot AvailableInfections, Rotavirus4
Not AvailableCompletedNot AvailableInfections, Rotavirus / Prophylaxis Against Gastroenteritis Caused by Rotavirus1
Not AvailableCompletedNot AvailableInfections, Rotavirus / Rotavirus Gastroenteritis / Rotavirus Vaccines1
Not AvailableCompletedPreventionDiarrhoeal Disease / Gaining an Improved Understanding of the Reduced Performance of Live Attenuated Oral Rotavirus Vaccines in LMIC Infants1
Not AvailableCompletedPreventionInfections, Rotavirus / Intestinal Bacteria Flora Disturbance / Reaction - Vaccine Nos / Streptococcal Pneumonia / Tetanus1
Not AvailableTerminatedNot AvailablePediatric Gastroenteritis1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
KitOral1000000 [CCID_50]/1mL
SuspensionOral
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 03, 2020 22:12

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