II. Indications

  1. Primary Series in the first year of life in the United States

III. Pharmacokinetics

  1. Oral Tetravalent live virus Vaccine

IV. Preparations

  1. Rotarix (RV1)
    1. Monovalent two dose series
  2. RotaTeq (RV5)
    1. Pentavalent three dose series

V. Dosing

  1. Schedule (4 week minimum interval between doses)
    1. Dose 1: Age 2 months
      1. First dose must be between ages 6-15 weeks - previously 12 weeks
      2. Avoid starting series after 15 weeks of age
    2. Dose 2: Age 4 months
    3. Dose 3: Age 6 months
      1. Third dose must be given by 8 months of age
      2. Third dose is required if RotaTeq was used for any dose, or unknown
      3. Third dose is not needed if Rotarix (RV1) was given for first two doses
  2. Dose
    1. Give full vial for each dose (no need to repeat if infant spits up part of dose)

VI. Contraindications

  1. Immunocompromised infants
  2. Severe concurrent illness including Gastroenteritis
  3. History of Intussusception
  4. Allergy to Vaccine components

VII. Adverse Effects

  1. Fever after first dose within 3 days
  2. Adverse effects increase after age 12 months
  3. Possible association with Kawasaki's Disease
    1. Geier (2008) Med Sci Monit 14(3):PH9-16 [PubMed]
  4. Increased Incidence of Intussusception
    1. Most significant with RotaShield Vaccine (Removed from the U.S. market)
    2. Rotarix and RotaTeq are safer
      1. Intussusception risk is now minimal (0.79 in 100,000 cases)
    3. Intussusception typically occurs days 3 to 6 after first Rotavirus Vaccine dose
      1. Haber (2013) Pediatrics 131(6): 1042-9 [PubMed]
    4. References
      1. Dennehy (2001) Infect Dis Clin North Am 15(1):189-207 [PubMed]
      2. Geier (2008) Med Sci Monit 14(3):PH9-16 [PubMed]
      3. Nakagomi (2001) N Engl J Med 344(24):1866 [PubMed]
      4. Zanardi (2001) Pediatrics 107(6):E97 [PubMed]

VIII. Efficacy

  1. Prevents 50-70% of all Rotavirus cases
  2. Prevents 70-90% of severe Rotavirus cases
  3. Seropositive response: 92%
  4. For every 4 million children immunized against Rotavirus
    1. Physician visits decrease by 255,000
    2. Emergency Department visits decrease by 137,000
    3. Hospitalizations decreased by 44,000
    4. Deaths decrease by 13
    5. Cortese (2009) MMWR Recomm Rep 58(RR-2):1-25 [PubMed]

IX. Resources

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Related Studies

Ontology: Rotavirus Vaccines (C0597418)

Definition (NCI) A viral vaccine that prevents against rotavirus infection, the leading cause of severe acute gastroenteritis.
Definition (MSH) Vaccines or candidate vaccines used to prevent infection with ROTAVIRUS.
Definition (CSP) vaccines or candidate vaccines used to prevent infection with rotavirus.
Concepts Pharmacologic Substance (T121) , Immunologic Factor (T129) , Amino Acid, Peptide, or Protein (T116)
MSH D022243
SnomedCT 116077000, 398866008
French Vaccins contre les rotavirus, Vaccins antirotavirus, Vaccins anti-rotavirus
Swedish Rotavirusvacciner
English rotavirus vaccine, Rotavirus Vaccines [Chemical/Ingredient], Rotavirus Vaccines, Vaccines, Rotavirus, Rotavirus Vaccine, Rotavirus Vaccine, Live, Oral, Rotavirus vaccine (product), Rotavirus vaccine (substance), Rotavirus vaccine
Czech rotaviry - vakcíny
Finnish Rotavirusrokotteet
Russian ROTAVIRUSNYE VAKTSINY, VAKTSINY ROTAVIRUSNYE, ВАКЦИНЫ РОТАВИРУСНЫЕ, РОТАВИРУСНЫЕ ВАКЦИНЫ
Japanese ロタウイルスワクチン, ワクチン-Rotavirus, ワクチン-ロタウイルス
Italian Vaccini contro le infezioni da Rotavirus
Polish Szczepionki przeciw zakażeniu rotawirusem, Szczepionki przeciw rotawirusom
Spanish vacuna contra Rotavirus (sustancia), vacuna contra Rotavirus, vacuna contra rotavirus (producto), vacuna contra rotavirus (sustancia), vacuna contra rotavirus, Vacunas contra Rotavirus
German Rotavirusvakzine
Portuguese Vacinas contra Rotavirus

Ontology: RotaShield (C0723145)

Concepts Pharmacologic Substance (T121) , Immunologic Factor (T129)
English RotaShield, rotashield