Neonatal Drug Therapy Manual

Rotavirus Live Oral Vaccine

Disclaimer: Official controlled document is the CHEO and Ottawa Hospital online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
RotaTeq (Rot-5), RotaRix (Rot-1)
Original Date: 
September 2019
Revised Date: 
August 2022

Routine childhood immunization

  • Oral , gently squeeze dose from ready-to-use dosing tube into infant's mouth toward the inner cheek until dosing tube is empty
  • Do not mix or dilute vaccine with any other solution
  • May be administered before or after food, milk or breast milk
  • Given the very small volume of fluid in the rotavirus vaccine, infants should preferably be given the vaccine orally. If oral administration is not possible, the vaccine may be administered via feeding tube. Ensure appropriate tube placement and flush the tube pre and post administration of vaccine. Consideration should be given as to why the infant has a feeding tube, as this vaccine is contraindicated if the infant has an uncorrected gastrointestinal malformation that predisposes to intussusception.
  • Can be administered via gastrostomy tube.  There should be no problem flushing the tube after vaccine has been given.

  • Discard empty tube and cap in biological waste.

    ** If for any reason an incomplete dose is given (e.g., infant spits or regurgitates the vaccine), do not administer a replacement dose.  The infant can continue to receive any remaining doses of the series at the designed time interval.



RotaTeq (Rot-5, live, oral, pentavalent, attenuated, human rotavirus vaccine)

  • 2 mL per dose for 3 doses
  • The first dose should be given when at least 34 weeks corrected gestational age or at 2 months of age (whichever is latest) followed by two subsequent doses at 4 to 10 weeks intervals (Generally at 2, 4 and 6 months of age)
  • The final dose should be administered before 32 weeks of age


Rotarix (Rot-1, live, oral, monovalent, attenuated, human rotavirus vaccine)

  • 1.5 mL per dose for 2 doses
  • The first dose should be given when at least 34 weeks corrected gestational age or at 2 months of age (whichever is latest) followed by one subsequent doses at 4 to 10 weeks intervals (Generally at 2 and 4 months of age)
  • The final dose should be administered by 24 weeks of age. 


  • The series should not be started in infants > 15 weeks of age beyond which the risk of intussusception tends to increase
  • The rotavirus vaccine should be completed with the same vaccine product.  However, if the product used for the first dose is not available or unknown, the vaccine series should be completed with the available product.  If any dose in the series was RotaTeq or is unknown, a total of three doses of vaccine should be administered.

Side Effects: 
  • Fever, diarrhea, vomiting and irritability were reported within the first week after doses 1,2 and 3 in approximately 2 - 5 % of immunized infants
Parameters to Monitor: 
  • Systemic: fever, irritability
  • Other routine infant vaccines such as Dtap HIB (Pediacel/Pentacel), Hepatitis B, and Pneumococcal (Prevnar) may be given concurrently with rotavirus vaccine
  • Routine precautions are recommended following vaccine administration which includes the use of gloves when it is anticipated that hands will come into contact with tissue, blood or body fluids (such as when changing diapers).
  • No extra precautions are required for pregnant nurses other than listed above.



  • Known or suspected severe combined immunodeficiency (SCID) or other significant immunocompromising condition
  • In utero exposure to anti-tumor necrosis factor (anti-TNF) agents / Monoclonal Antibody (for example Adalimumab, Infliximab) 
  • History of intussusception or greater susceptibility to intussusception
  • Known or suspected NEC
  • Patient receiving steroids at a dose greater than physiological maintenance
  • Patient is NPO
  • Moderate-to-severe illness

-Lexi-Comp Online database (accessed aug 2022)
-Rotarix® and Rotateq® monographs, (accessed online Aug 2022)
- Esposito, S, Pugni L, Mosca F, Principi N.  Rotarix and RotaTeq administration to preterm infants in the neonatal intensive care unit: Review of available evidence.  Vaccine 36 (2018) 5430-5434
- Hiramatsu H, Suzuki R, Nagatani A, Boda H, Miyata M, Hattori F et al.  Rotavirus Vaccination Can Be Performated Without Viral Dissemination in the Neonatal Intensive Care Unit.  J Infect Dis 2018; 217: 589-96
- Hofstetter AM, Lacombe K, Klein EJ, Jones C, Strelitz B, Jacobson E et al. Risk of Rotavirus Nosocomial Spread After Inpatient Pentavalent Rotavirus Vaccination
- Smith CK, McNeal MM, Meyer NR, Haase S, Dekker CL.  Rotavirus shedding in premature infants following first immunization.  Vaccine (2011) 8141-8146
- Le Saux N. CPS Infectious Diseases and Immunization Committee.  Recommendations for the use of rotavirus vaccines in infants.  Jun 30 2017
- Álvarez Aldeán J, et al. Recommendations for vaccination against ROTAvirus in PREMature newborns (ROTAPREM)]. An Pediatr (Engl Ed). 2019 Sep;91(3):205.e1-205.

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