Institute for Vaccine Safety - Rotavirus Vaccine Components

Components of
Rotavirus Vaccine

Excipients Table
Allergens Table
Components Table

Indication	Prevention of Rotavirus Gastroenteritis
Proprietary Name	RotaTeq	Rotarix
Manufacturer	Merck	GlaxoSmith Kline
Viability	Live	Live
Microorganism	Four reassortant rotaviruses express one of the outer capsid proteins (G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein (P7) from the bovine rotavirus parent strain The fifth reassortant virus expresses the attachment protein, P1A (genotype P[8]), from the human rotavirus parent strain and the outer capsid protein G6 from the bovine rotavirus parent strain	Derived from the human 89-12 strain which belongs to G1P[8] type. The rotavirus strain is propagated on Vero cells. After reconstitution, the final formulation (1 mL) contains at least 10^{6.0 median Cell Culture Infective Dose (CCID_{50) of live, attenuated rotavirus.}}
Dose	2 mL	1 mL
Recommended Age	6-32 months	6-24 weeks
Route	Oral	Oral
Dose form	Liquid	Liquid
Appearance	Pale yellow clear liquid that may have a pink tint	White and turbid
Concentration	2.0 - 2.8 x 10⁶ infectious units of each reassortant	≥ 10^{6 median Cell Culture Infective Dose (CCID_{50) of live, attenuated rotavirus}}
Preservatives	None	None
Adjuvant	None	None
Excipients	Fetal bovine serum (trace) Polysorbate 80 Sodium citrate Sodium phosphate monobasic monohydrate Sodium hydroxide Sucrose	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 Phenol red Sodium chloride Sodium phosphate Sodium pyruvate Solidum hydrogenocarbonate Sorbitol Sucrose Xanthan
Allergens	Fetal bovine serum (trace)	Latex, contained in the oral applicator
Media	Cell culture	Dulbecco’s Modified Eagle Medium (DMEM)
Packaging	1 individually pouched single-dose tube 10-pack of individually pouched single-dose tubes	ROTARIX is available as a vial of lyophilized vaccine, a prefilled oral applicator of liquid diluent (1 mL) with a plunger stopper, and a transfer adapter for reconstitution. Supplied as: NDC 58160-805-11 (package of 10)
Routine Storage	Store and transport refrigerated at 2-8°C (36-46°F). RotaTeq should be administered as soon as possible after being removed from refrigeration. For information regarding stability under conditions other than those recommended, call 1-800-MERCK-90. Protect from light	May be stored refrigerated at 2° to 8°C (36° to 46°F) or at room temperature up to 25°C (77°F), after reconstitution. Discard the reconstituted vaccine if not used within 24 hours in biological waste container. Do not freeze. Discard if the vaccine has been frozen.
*updated November 2008*

This page was last updated on November 07, 2012