Vaccine Information: RotaTeq (Page 4 of 4)

14.3 Multiple Rotavirus Seasons

The efficacy of RotaTeq through a second rotavirus season was evaluated in a single study (Study 006). Efficacy against any grade of severity of rotavirus gastroenteritis caused by rotavirus types G1, G2, G3, and G4 through the two rotavirus seasons after vaccination was 71.3% (95% CI: 64.7, 76.9). The efficacy of RotaTeq in preventing cases occurring only during the second rotavirus season postvaccination was 62.6% (95% CI: 44.3, 75.4). The efficacy of RotaTeq beyond the second season postvaccination was not evaluated.

14.4 Rotavirus Gastroenteritis Regardless of Type

The rotavirus types identified in the efficacy subset of Study 006 and Study 007 were G1P1A[8]; G2P1[4]; G3P1A[8]; G4P1A[8]; and G9P1A[8].

In Study 006, the efficacy of RotaTeq against any grade of severity of naturally occurring rotavirus gastroenteritis regardless of type was 71.8% (95% CI: 64.5, 77.8) and efficacy against severe rotavirus disease was 98.0% (95% CI: 88.3, 99.9). The ITT efficacy starting at dose 1 was 50.9% (95% CI: 41.6, 58.9) for any grade of severity of rotavirus disease and was 96.4% (95% CI: 86.3, 99.6) for severe rotavirus disease.

In Study 007, the primary efficacy of RotaTeq against any grade of severity of rotavirus gastroenteritis regardless of type was 72.7% (95% CI: 51.9, 85.4) and efficacy against severe rotavirus disease was 100% (95% CI: 12.7, 100). The ITT efficacy starting at dose 1 was 48.0% (95% CI: 21.6, 66.1) for any grade of severity of rotavirus disease and was 100% (95% CI: 30.4, 100.0) for severe rotavirus disease.

14.5 Rotavirus Gastroenteritis by Type

The efficacy against any grade of severity of rotavirus gastroenteritis by type was evaluated in Study 006 and Study 029. The efficacy cohort analysis from Study 006 is shown in Table 11.

Table 11: Type-specific efficacy of RotaTeq against any grade of severity of rotavirus gastroenteritis among infants in Study 006 efficacy cohort through the first rotavirus season postvaccination (Per Protocol)
*
Includes rotavirus antigen-positive samples in which the specific type could not be identified by PCR
Type identified by PCR Number of cases % Efficacy(95% Confidence Interval)
RotaTeq(N=2,834) Placebo(N=2,839)
G1P1A[8] 72 286 74.9 (67.3, 80.9)
G2P1[4] 6 17 63.4 (2.6, 88.2)
G3P1A[8] 1 6 NS
G4P1A[8] 3 6 NS
G9P1A[8] 1 3 NS
Unidentified * 11 15 NS
N=number vaccinatedNS=not significant

Additional analyses were conducted to evaluate efficacy in the prevention of rotavirus gastroenteritis due to G9P1A[8].

  • In Study 029 (a Phase 3 randomized, blinded, placebo-controlled study conducted in Japan), efficacy on the pre-specified primary endpoint (rotavirus gastroenteritis caused by G1, G2, G3, G4, and G-serotypes associated with serotype P1A[8] (e.g., G9)) was 74.5% (95% CI: 39.9, 90.6). G9P1A[8]-associated gastroenteritis was observed in 0/356 and 5/354 subjects in the RotaTeq and placebo groups, respectively (100% (95% CI: -9.0, 100)).
  • In a post hoc analysis of health care utilization data from 68,038 infants (RotaTeq 34,035 and placebo 34,003) in Study 006, using a case definition that included culture confirmation, hospitalization and emergency departments visits for rotavirus gastroenteritis, cases due to G9P1A[8] were reduced (RotaTeq 0 cases: placebo 14 cases) by 100% (95% CI: 69.6, 100.0).

14.6 Immunogenicity

A relationship between antibody responses to RotaTeq and protection against rotavirus gastroenteritis has not been established. In phase 3 studies, 92.9% to 100% of 439 recipients of RotaTeq achieved a 3-fold or more rise in serum anti-rotavirus IgA after a three-dose regimen when compared to 12.3%-20.0% of 397 placebo recipients.

15 REFERENCES

  1. Murphy TV, Gargiullo PM, Massoudi MS et al. Intussusception among infants given an oral rotavirus vaccine. N Engl J Med 2001;344:564-572.
  2. Yih WK, Lieu TA, Kulldorff M, et al. Intussusception risk after rotavirus vaccination in US infants. Mini-Sentinel. www.mini-sentinel.org.
  3. Tate JE, Simonsen L, Viboud C, et al. Trends in intussusception hospitalizations among US infants, 1993-2004: implications for monitoring the safety of the new rotavirus vaccination program. Pediatrics 2008;121(5):e1125-e1132.
  4. Centers for Disease Control and Prevention. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR-2):1-35.
  5. Parashar UD et al. Global illness and deaths caused by rotavirus disease in children. Emerg Infect Dis 2003;9(5):565-572.
  6. Parashar UD, Holman RC, Clarke MJ, Bresee JS, Glass RI. Hospitalizations associated with rotavirus diarrhea in the United States, 1993 through 1995: surveillance based on the new ICD-9-CM rotavirus-specific diagnostic code. J Infect Dis 1998;177:13-7.

16 HOW SUPPLIED/STORAGE AND HANDLING

RotaTeq, 2 mL, a solution for oral use, is a pale yellow clear liquid that may have a pink tint. It is supplied as follows:

NDC 0006-4047-41 package of 10 individually pouched single-dose tubes.

NDC 0006-4047-20 package of 25 individually pouched single-dose tubes.

The plastic dosing tube and cap do not contain latex.

16.1 Storage and Handling

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.

RotaTeq should be discarded in approved biological waste containers according to local regulations.

The product must be used before the expiration date.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Parents or guardians should be given a copy of the required vaccine information and be given the “Patient Information” appended to this insert. Parents and/or guardians should be encouraged to read the patient information that describes the benefits and risks associated with the vaccine and ask any questions they may have during the visit [see Warnings and Precautions (5) and Patient Information].

Manuf. and Dist. by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

Copyright © 2006-2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

uspi-v260-os-2008r024


Patient Information
RotaTeq® (pronounced “RŌ-tuh-tek”)
rotavirus vaccine, live, oral, pentavalent

Read this information carefully before your child receives each dose of RotaTeq® in case any information about the vaccine changes. Your child will need 3 doses of the vaccine over the course of a few months. This leaflet is a summary of certain information about RotaTeq and does not take the place of talking with your child’s doctor, who can give you more complete information written for health care professionals.

What is RotaTeq?

RotaTeq is an oral vaccine used to help prevent rotavirus infection in children. Rotavirus infection can cause fever, vomiting, and diarrhea that can be severe and can lead to loss of body fluids (dehydration), hospitalization and even death in some children. RotaTeq may not fully protect all children that get the vaccine, and if your child already has the virus it will not help them.

Who should not receive RotaTeq?

Your child should not get RotaTeq if:

  • He or she had an allergic reaction after getting a dose of this vaccine.
  • He or she is allergic to any of the ingredients of the vaccine. A list of ingredients can be found at the end of this leaflet.
  • He or she has Severe Combined Immunodeficiency Disease (SCID).
  • He or she has ever had intussusception, a form of blockage of the intestines.

What should I tell the doctor before my child gets RotaTeq?

Tell your doctor if your child:

  • Has illness with fever. A mild fever or cold by itself is not reason to delay taking the vaccine.
  • Has diarrhea or has been vomiting.
  • Has not been gaining weight or is not growing as expected.
  • Has a blood disorder.
  • Has any type of cancer.
  • Has a weak immune system because of a disease (this includes HIV/AIDS).
  • Gets treatment or takes medicines that may weaken the immune system (such as high doses of steroids) or has received a blood transfusion or blood products within the past 42 days.
  • Was born with gastrointestinal problems, or has had a blockage or abdominal surgery.
  • Has regular close contact with a member of family or household who has a weak immune system such as someone with cancer or someone taking medicines that weaken their immune system.

What are the possible side effects of RotaTeq?

The most common side effects reported after taking RotaTeq were diarrhea, vomiting, fever, runny nose and sore throat, wheezing or coughing, and ear infection.

Call your child’s doctor or go to the emergency department right away if your child has any of the following problems after getting RotaTeq, even if it has been several weeks since the last dose because these may be signs of a serious problem called intussusception:

  • bad vomiting
  • bad diarrhea
  • severe stomach pain
  • blood in the stool.

Intussusception happens when a part of the intestine gets blocked or twisted.

Since FDA approval, reports of infants with intussusception following RotaTeq have been received by the Vaccine Adverse Event Reporting System (VAERS). Intussusception occurred days and sometimes weeks after vaccination. Some infants needed hospitalization, surgery on their intestines, or a special enema to treat this problem. Death due to intussusception has occurred.

A study conducted after approval of RotaTeq showed an increased risk of intussusception in the 21 days after the first dose of RotaTeq, but especially in the first 7 days.

Other reported side effects include:

  • allergic reactions, which may be severe and may include face and mouth swelling, difficulty breathing, wheezing, hives, and/or skin rash; and
  • Kawasaki disease (a serious condition that can affect the heart; symptoms may include fever, rash, red eyes, red mouth, swollen glands, swollen hands and feet and, if not treated, death can occur).

Call your doctor right away if your child has any side effects that concern you or seem to get worse.

These are NOT all the possible side effects of RotaTeq. You can ask your doctor for a more complete list.

You, as a parent or guardian, may also report any adverse reactions to your child’s doctor or directly to VAERS. The VAERS toll-free number is 1-800-822-7967 or report online to www.vaers.hhs.gov.

Events that have been identified or reported as side effects following RotaTeq can happen when no vaccine has been given.

What other important information should I know?

Since FDA approval, the spread of vaccine virus to non-vaccinated contacts has been reported. Tell your doctor if you have someone in your household who has a weak immune system, cancer or is taking medications that can weaken the immune system so that your doctor can provide further advice. Hand washing is recommended after diaper changes to help prevent the spread of vaccine virus.

Can RotaTeq be given with other vaccines?

Your child may get RotaTeq at the same time as other childhood vaccines.

How is RotaTeq given?

The vaccine is given by mouth. Your child will receive 3 doses of the vaccine. The first dose is given when your child is 6 to 12 weeks of age, the second dose is given 4 to 10 weeks later and the third dose is given 4 to 10 weeks after the second dose. The last (third) dose should be given to your child by 32 weeks of age.

Your doctor will gently squeeze the vaccine into your child’s mouth (see Figure 1). Your infant may spit out some or all of it. If this happens, the dose does not need to be given again during that visit.

Image of Figure

Figure 1

What do I do if my child misses a dose of RotaTeq?

All 3 doses of the vaccine should be given to your child by 32 weeks of age. Your doctor will tell you when your child should come for the follow-up doses. It is important to keep those appointments. If you forget or are not able to go back at the planned time, ask your doctor for advice.

What else should I know about RotaTeq?

This leaflet gives a summary of certain information about the vaccine. If you have any questions or concerns about RotaTeq, talk to your doctor.

What are the ingredients in RotaTeq?

5 live rotavirus strains (G1, G2, G3, G4, and P1).

Sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80 and also fetal bovine serum.

Manuf. and Dist. by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Copyright © 2008-2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

Revised: 08/2020

usppi-v260-os-2008r020


PRINCIPAL DISPLAY PANEL — Carton 10 Single-Dose 2 mL Tubes

Manuf. and Dist. by:
Merck Sharp & Dohme Corp., a sub. of
MERCK & CO., INC.
Whitehouse Station, NJ 08889, USA

NDC 0006-4047-41
10 Single-Dose
2 mL Tubes

Rotavirus Vaccine, Live,
Oral, Pentavalent
RotaTeq®

FOR ORAL USE ONLY. NOT FOR INJECTION.
Administer orally without mixing with any
other vaccines or solutions.

Each 2 mL oral dose contains 5 rotavirus reassortants that have been propagated
in Vero cells. The minimum dose levels (infectious units, IU) are as follows:G1 (2.2 x 106) IU; G2 (2.8 x 106) IU; G3 (2.2 x 106) IU; G4 (2.0 x 106) IU and P1 (2.3 x 106) IU.

RotaTeq contains no preservatives.

Rx only

PRINCIPAL DISPLAY PANEL -- Carton 10 Single-Dose 2 mL Tubes
(click image for full-size original)
ROTATEQ rotavirus vaccine, live, oral, pentavalent solution
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4047
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN (HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN) HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN 2200000 [iU] in 2 mL
HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN (HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN) HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN 2800000 [iU] in 2 mL
HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN (HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN) HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN 2200000 [iU] in 2 mL
HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN (HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN) HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN 2000000 [iU] in 2 mL
HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN (HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN) HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN 2300000 [iU] in 2 mL
Inactive Ingredients
Ingredient Name Strength
ALBUMIN BOVINE
POLYSORBATE 80
SODIUM HYDROXIDE
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SUCROSE
SODIUM CITRATE, UNSPECIFIED FORM
Product Characteristics
Color YELLOW, PINK (pale yellow clear, may have a pink tint) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-4047-41 10 POUCH25 POUCH in 1 CARTON contains a POUCH (0006-4047-02)
1 NDC:0006-4047-20 10 POUCH25 POUCH in 1 CARTON contains a POUCH (0006-4047-02)
1 NDC:0006-4047-02 1 TUBE in 1 POUCH This package is contained within the CARTON (0006-4047-41) and contains a TUBE (0006-4047-01)
1 NDC:0006-4047-01 2 mL in 1 TUBE This package is contained within a POUCH (0006-4047-02) and a CARTON (0006-4047-41) and a CARTON (0006-4047-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125122 02/03/2006
Labeler — Merck Sharp & Dohme Corp. (001317601)

Revised: 08/2020 Merck Sharp & Dohme Corp.

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