Components of

Rotavirus Vaccines

Components Page
Excipients Table
Allergens Table
       
Name RotaTeq Rotarix
Manufacturer Merck Sharp & Dohme Corp GlaxoSmithKline Biologicals
Viability Live Live
Indicated Ages 6-32 weeks 6-24 weeks
Dose 2 mL 1 mL
Schedule 3 doses: 6-12 weeks, then at 4-10 week intervals (before 32 weeks of age) 2 doses: 6 weeks of age, then after at least 4 weeks (before 24 weeks of age)
Route Oral Oral
Appearance Pale yellow clear liquid that may have a pink tint White, turbid suspension
Concentration Rotavirus Reassortants:
• G1, ≥2.2 x 106 infectious units
• G2, ≥2.8 x 106 infectious units
• G3, ≥2.2 x 106 infectious units
• G4, ≥2.0 x 106 infectious units
• P1A, ≥2.3 x 106 infectious units
• Rotavirus type G1P, 106.0 median Cell Culture Infective Dose
Preservative None None
Adjuvant None None
Excipients Unspecified amounts:
• Sucrose
• Sodium citrate
• Sodium phosphate monobasic monohydrate
• Sodium hydroxide,
• Polysorbate 80
• Cell culture media
• Fetal bovine serum, trace amounts
• PCV 1&2
Unspecified amounts:
• Amino Acids
• Calcium carbonate
• Calcium chloride
• Concentrated Vitamin solution
• Dextran
• D-glucose
• Dulbecco's Modified Eagle Medium (DMEM)
• Ferric nitrate
• L-cystine
• L-glutamine
• L-tyrosine
• Magnesium Sulfate
• PCV-1
• Phenol red
• Sodium chloride
• Sodium phosphate
• Sodium pyruvate
• Solidum hydrogenocarbonate
• Sorbitol
• Sucrose
• Xanthan
Allergens • Fetal Bovine Serum, trace amounts • The tip caps of the prefilled diluent contain natural rubber latex
Media • Buffered stabilizer solution • Dulbecco’s Modified Eagle Medium (DMEM)
Packaging • 10-pack of single-dose tubes
• 25-pack of single dose tubes
10-packs of single-dose vials with oral applicator diluents
Storage 2-8°C (36-46°F)
Do not freeze
2-8°C (35-46°F)
Do not freeze
PI date March 2018 April 2016
    table last updated 4/25/18