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Immunisation - Rotavirus

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Rotarix® (RV1) Oral Vaccine Information

  • GlaxoSmithKline NZ Limited (GSK) 
  • Rotarix is a liquid suspension of live attenuated RIX4414 strain of human rotavirus of the G1P[8] type for the use in the prevention of gastroenteritis3 

Indications

  • Protection against rotavirus infection. Rotavirus is likely to affect all children by the age of five years. Dehydration from rotavirus gastro-enteritis can lead to hospitalisation, which is most common in children under two years of age3

Contraindications

  • Known history of allergy to Rotarix® or any of its constituents 
  • Infants with severe combined immune-deficiency syndrome (SCID). 
  • Infants who have suffered from intussusception. 
  • Rotavirus vaccines should not be given to infants with uncorrected congenital malformation of the GI tract 
  • Use with caution in patients with a history of gastroenteritis or necrotising enterocolitis 
  • Babies on steroids when vaccinations due - discuss with consultant. 

Supplied As

  • Clear, colourless liquid, free of particles, for ORAL administration only. 
  • Supplied in a syringe type applicator with a plunger stopper 

Dosage

  • Vaccination course consists of 2 doses (1.5mls per dose) at 6 weeks and 3 months 
  • For catch-up schedules, the 1st dose should be given before age 15 weeks (latest is 14 weeks and 6 days), and the 2nd dose should be given before age 25 weeks (latest is 24 weeks and 6 days). 
  • If the oral volume (1.5mls) can be tolerated, Rotarix® vaccine should be given at the same time as other scheduled six week and three month immunisations.

Administration

See full administration instructions below

  • There should be a minimum of 4 weeks between doses. 
  • OralRotarix® vaccine must be administered ORALLY without mixing with any other oral vaccine or solution.Rotarix® must not be given via a nasogastric tube as this will reduce the efficacy. 
  • If a dose is regurgitated or vomited do not repeat the dose.4,5 

Compatibity

  • Rotarix® may be given at the same time as other routine childhood vaccinations, Prevenar 13®, Infanrix-hexa® 
  • Rotarix® may also be given at the same time as other live attenuated vaccines e.g. BCG 
  • No need to withhold Rotarix® after receiving blood products as is required for other parenteral live attenuated vaccines 

Precautions

  • Ensure use of universal precautions when handling infants who have recently received rotavirus vaccination to avoid any risk of contamination or faecal-oral spread. 
  • Immunosuppressed infants including those on immunosuppressive therapy (other than SCID, where it is contraindicated). Infants born to mothers on immunosuppressive therapies (eg, DMARDs) (see section 17.6.2 of NZ immunization handbook). 
  • Shedding of the virus in stools occurs after vaccination and lasts 10 days on average with peak around the 7th day. All soiled nappies should be placed immediately in the main rubbish bin. 

Storage

Rotarix® should be protected from light and stored in the vaccine fridge at 2-8°C. Do not freeze

Adverse Reactions

  • Fever
  • Diarrhoea 
  • Vomiting 
  • Intussusception 
  • Anaphylaxis 
  • Urticarial 
  • Angioedema

Rotarix® is generally well tolerated.

Oral administration in NICU

The Rotavirus Vaccine (Rotarix®) is part of the Immunisation schedule. For the vaccine to be effective the first dose must be given before 14 weeks of age and the second dose course completed by 24 weeks of age. There will be some infants in NICU who will need to have their first dose before or at discharge. RotaTeq® is a live ORAL vaccine.

Rotarix® vaccine comes in a syringe-type applicator with a plunger stopper.

Babies who can tolerate the oral volume (1.5mls) should receive the first dose of vaccine at the same time as the 6 week immunisations (or soon after). The second dose should not be given before 4 weeks after the first dose.

The vaccine is to be administered ORALLY without mixing with any other vaccines or solutions.

Rotarix® vaccine may be administered via a nasogastric tube provided that the infant does not have an uncorrected gastrointestinal malformation that predisposes to intussusception1

The vaccine is ready to use (no reconstitution or dilution is required).

The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed, discard the vaccine.

Rotarix® oral vaccine can be administered by any member of the nursing staff on the drug register as long as the following criteria are met:

Prior to giving

  • The vaccine must be charted by the medical practitioner/NS-ANP
  • Consent must be obtained from a parent (contraindications include - moderate/ severe gastroenteritis; history of allergic reaction to previous dose; history of uncorrected congenital malformation of GI tract; severe combined immune-deficiency syndrome)
  • Any baby who has had any gut pathology/surgery should be discussed with the consultant before the vaccine is prescribed
  • Caution with parents or family members with immune deficiencies (due to shedding)

Administration

  • The vaccine is kept in the vaccine fridge in the medication room
  • Check the fridge temperature (4-8c)
  • Gloves must be worn to administer the vaccine
  • Sit the baby up in feeding position to administer
  • Vaccine should be administered ORALLY
  • Rotarix® vaccine can be given via the nasogastric tube to any infant who cannot tolerate the volume orally1.
  • Remove the protective cap from the oral applicator
  • Administer, orally, into the child's mouth towards the cheek. Give the entire content of the oral applicator
  • Allow the baby to swallow the vaccine
  • If the baby spits the vaccine out - do not repeat
  • To administer via an nasogastric tube: check that NG tube is correctly positioned, attach 5 ml syringe to NG tube, dispense vaccine into syringe and gently plunge, follow with 1ml of sterile water to clear NG tube.
  • Following administration, the baby must be observed for at least 20minutes
  • Following administration, nurse using standard precautions due to shedding of the vaccine virus in the stools. Excretion of the vaccine in stools last for 10 days on average with peak excretion around the 7th day.
  • Ensure all disposable nappies are put directly into rubbish bags not into rubbish bags on bedside trollies.

Documentation

  • NIR3 form to be filled out. Place the copy of the completed form in the immunisation folder
  • Post the top (white) copy of the NIR3 form to NIR (envelopes and address stickers are in the immunisation folder)
  • Complete the Immunisation page of the Well Child Book
  • Document in the baby's clinical notes including the vaccine number and expiry date
  • Document on the baby's observation chart
  • Document in the Data Base - under immunisations in the comments box
  • Note on the Baby's Care Map under Immunisations
  • Notify the Clinical Charge Nurse

Comments

  • For the first two years of life, in countries with low mortality rates both Rotarix® and Rotateq® vaccines prevented over 80% of cases of severe rotavirus diarrhoea (Immunisation Handbook 2017 pg 460) 
  • It is expected the vaccination will give protection against rotavirus for 3 years following the last dose.4,5 
  • Infants who have already had rotavirus should still receive Rotarix® vaccination.4,5
  • The reason for the recommended dosing schedule is because this is the patient group that the vaccine has been tested in.3,4,5 
  • Each 1.5ml vaccine dose contains not less than 106 CCID50 (cell culture infectious dose 50%) of the RIX strain of human virus. The vaccine also contains sucrose, di-sodium adipate, Dulbecco"s Modified Eagle Medium

References

  1. www.immune.org.nz/sites/default/files/resources/Written%20Resources/AdministrationRVQA20170807V01Final.pdfwww.nzfc.org.nz
  2. www.nzfc.org.nz 
  3. http://www.medsafe.govt.nz/profs/datasheet/r/Rotarixliquidvac.pdf 
  4. www.immune.org.nz Rotavirus and Rotarix® vaccine; Factsheet for vaccinators and health professionals 
  5. http://www.health.govt.nz/publication/immunisation-handbook-2017

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Document Control

  • Date last published: 28 February 2018
  • Document type: Clinical Guideline
  • Services responsible: Neonatology
  • Owner: Newborn Services Clinical Practice Committee
  • Editor: Sarah Bellhouse
  • Review frequency: 2 years