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(Rotavirus Vaccine, Live, Pentavalent) Oral Solution


RotaTeq is a live, oral pentavalent vaccine that contains 5 live reassortant rotaviruses. The rotavirus parent strains of the reassortants were isolated from human and bovine hosts. 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 (serotype P7) from the bovine rotavirus parent strain. The fifth reassortant virus expresses the attachment protein, P1A (genotype P[8]), herein referred to as serotype P1A[8], from the human rotavirus parent strain and the outer capsid protein of serotype G6 from the bovine rotavirus parent strain (see Table 7).

Table 7

Name of Reassortant Human Rotavirus Parent Strains and Outer Surface Protein Compositions Bovine Rotavirus Parent Strain and Outer Surface Protein Composition Reassortant Outer Surface Protein Composition (Human Rotavirus Component in Bold) Minimum Dose Levels (106 infectious units)
G1 WI79 - G1P1A[8] WC3 - G6, P7[5] G1 P7[5] 2.2
G2 SC2 - G2P2[6] G2P7[5] 2.8
G3 WI78 - G3P1A[8] G3P7[5] 2.2
G4 BrB - G4P2[6] G4P7[5] 2.0
P1A[8] WI79 - G1P1A[8] G6P1A[8] 2.3

The reassortants are propagated in Vero cells using standard cell culture techniques in the absence of antifungal agents.

The reassortants are suspended in a buffered stabilizer solution. Each vaccine dose contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. RotaTeq contains no preservatives.

In the manufacturing process for RotaTeq, a porcine-derived material is used. DNA from porcine circoviruses (PCV) 1 and 2 has been detected in RotaTeq. PCV-1 and PCV-2 are not known to cause disease in humans.

RotaTeq is a pale yellow clear liquid that may have a pink tint.

The plastic dosing tube and cap do not contain latex.

What are the possible side effects of rotavirus oral vaccine (Rotarix, RotaTeq)?

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous dose caused any side effects. Becoming infected with rotavirus is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of the...

Read All Potential Side Effects and See Pictures of RotaTeq »

What are the precautions when taking rotavirus vaccine, live, oral, pentavalent (RotaTeq)?

Before your child takes this vaccine, tell the health care professional if your child is allergic to it; or if he/she has any other allergies. This product may contain inactive ingredients (such as latex found in the packaging of some products), which can cause allergic reactions or other problems. Talk to your health care professional for more details.

Before using this vaccine, tell your health care professional your child's medical history, especially of: current fever/illness, current vomiting/diarrhea, stomach/intestinal problems (such as blockage, intussusception), not gaining weight/growing as expected, blood cancer (such as leukemia, lymphoma), blood disorders (such as hemophilia), immune system problems (such as HIV/AIDS, SCID).

Family or household members with...

Read All Potential Precautions of RotaTeq »

Last reviewed on RxList: 2/8/2017
This monograph has been modified to include the generic and brand name in many instances.

RotaTeq - User Reviews

RotaTeq User Reviews

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