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
RotarixSuspension1000000 ccid50OralGlaxosmithkline Inc2008-12-16Not applicableCanada
RotarixKit1000000 [CCID_50]/1mLGlaxoSmithKline Biologicals SA2008-08-012009-11-24Us
RotarixKit1000000 [CCID_50]/1mLGlaxoSmithKline Biologicals SA2011-01-13Not applicableUs
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 (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 (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 (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 (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
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]. 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].

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.
2-MethoxyethanolThe risk or severity of infection can be increased when Rotavirus Vaccine is combined with 2-Methoxyethanol.
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.
9-(N-methyl-L-isoleucine)-cyclosporin AThe risk or severity of infection can be increased when Rotavirus Vaccine is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.
AbataceptThe therapeutic efficacy of Rotavirus Vaccine can be decreased when used in combination with Abatacept.
AbataceptThe risk or severity of infection can be increased when Rotavirus Vaccine is combined with Abatacept.
AbetimusThe therapeutic efficacy of Rotavirus Vaccine can be decreased when used in combination with Abetimus.
AbetimusThe risk or severity of infection can be increased when Rotavirus Vaccine is combined with Abetimus.
Acetyl sulfisoxazoleThe therapeutic efficacy of Rotavirus Vaccine can be decreased when used in combination with Acetyl sulfisoxazole.
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
1CompletedPreventionInfections, Rotavirus1
1CompletedPreventionInfections, Rotavirus / Rotavirus Gastroenteritis2
1CompletedPreventionRotavirus Gastroenteritis1
1RecruitingPreventionHealthy Volunteers1
1TerminatedPreventionRotavirus1
1, 2Active Not RecruitingPreventionRotavirus Gastroenteritis1
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, Rotavirus1
2CompletedPreventionInfections, Rotavirus / Rotavirus Gastroenteritis2
2CompletedPreventionMeningitis / Meningococcal Infections1
2CompletedPreventionRotavirus Gastroenteritis / Viral Hepatitis B1
2CompletedTreatmentHuman Immunodeficiency Virus (HIV) Infections / Infections, Rotavirus1
2WithdrawnPreventionInfections, Rotavirus1
2, 3CompletedPreventionDiarrhea / Fevers / Irritability / Nausea / Vomited1
2, 3Not Yet RecruitingPreventionDiarrhea / Diarrhea Rotavirus1
3Active Not RecruitingPreventionInfections, Rotavirus1
3Active Not RecruitingPreventionRotavirus Vaccines1
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
3CompletedPreventionFevers / Infections, Rotavirus1
3CompletedPreventionGastroenteritis / Rotavirus1
3CompletedPreventionHaemophilus Influenzae Type B1
3CompletedPreventionHaemophilus Influenzae Type B / Neisseria Meningitidis1
3CompletedPreventionHealthy Volunteers / Infants / Viral Hepatitis B1
3CompletedPreventionInfections, Rotavirus3
3CompletedPreventionInfections, Rotavirus / Meningococcal Meningitis1
3CompletedPreventionInfections, Rotavirus / Pneumococcal Diseases / Streptococcus Pneumoniae Vaccines1
3CompletedPreventionInfections, Rotavirus / Rotavirus Gastroenteritis3
3CompletedPreventionInfections, Rotavirus / Rotavirus Vaccines3
3CompletedPreventionPneumococcal Diseases / Streptococcal Infections1
3CompletedPreventionRotavirus Diarrhea / Tropical Enteropathy / Vaccine Virus Shedding1
3CompletedPreventionRotavirus Gastroenteritis1
3CompletedPreventionRotavirus Vaccines1
3CompletedPreventionStreptococcal Infections2
3Enrolling by InvitationPreventionInfections, Rotavirus1
3Not Yet RecruitingPreventionInfections, Pneumococcal1
3RecruitingPreventionHealthy Volunteers (Meningococcal Infection)1
3RecruitingPreventionMeningococcal Infections1
4Active Not RecruitingOtherInfections, Rotavirus / Intussusception1
4Active Not RecruitingPreventionDiarrhea / Gastroenteritis1
4CompletedPreventionInfections, Rotavirus1
4CompletedPreventionInfections, Rotavirus / Rotavirus Gastroenteritis1
4CompletedPreventionIntestinal Failure / Rotavirus Vaccines1
4CompletedPreventionMeasles Antibody Seroconversion / Rotavirus GMT / Rotavirus IgA Seropositivity / Rubella Antibody Seroconversion1
4CompletedPreventionRotavirus Disease1
4CompletedPreventionRotavirus Gastroenteritis4
4CompletedPreventionRotavirus Vaccines1
4Not Yet RecruitingPreventionDiarrhea / Rotavirus1
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 October 23, 2018 21:48