Vaccine Information: VARIVAX (Page 4 of 5)

14.3 Persistence of Immune Response

One-Dose Regimen in Children

In clinical studies involving healthy children who received 1 dose of vaccine, detectable VZV antibodies were present in 99.0% (3886/3926) at 1 year, 99.3% (1555/1566) at 2 years, 98.6% (1106/1122) at 3 years, 99.4% (1168/1175) at 4 years, 99.2% (737/743) at 5 years, 100% (142/142) at 6 years, 97.4% (38/39) at 7 years, 100% (34/34) at 8 years, and 100% (16/16) at 10 years postvaccination.

Two-Dose Regimen in Children

In recipients of 1 dose of VARIVAX over 9 years of follow-up, the geometric mean titers (GMTs) and the percent of subjects with VZV antibody titers ≥5 gpELISA units/mL generally increased. The GMTs and percent of subjects with VZV antibody titers ≥5 gpELISA units/mL in the 2-dose recipients were higher than those in the 1-dose recipients for the first year of follow-up and generally comparable thereafter. The cumulative rate of VZV antibody persistence with both regimens remained very high at year 9 (99.0% for the 1-dose group and 98.8% for the 2-dose group).

Two-Dose Regimen in Adolescents and Adults

In clinical studies involving healthy adolescents and adults who received 2 doses of vaccine, detectable VZV antibodies were present in 97.9% (568/580) at 1 year, 97.1% (34/35) at 2 years, 100% (144/144) at 3 years, 97.0% (98/101) at 4 years, 97.4% (76/78) at 5 years, and 100% (34/34) at 6 years postvaccination.

A boost in antibody levels has been observed in vaccinees following exposure to wild-type varicella, which could account for the apparent long-term persistence of antibody levels in these studies.

14.4 Studies with Other Vaccines

Concomitant Administration with M-M-R II

In combined clinical studies involving 1080 children 12 to 36 months of age, 653 received VARIVAX and M-M-R II concomitantly at separate injection sites and 427 received the vaccines six weeks apart. Seroconversion rates and antibody levels to measles, mumps, rubella, and varicella were comparable between the two groups at approximately six weeks postvaccination.

Concomitant Administration with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) and Oral Poliovirus Vaccine (OPV)

In a clinical study involving 318 children 12 months to 42 months of age, 160 received an investigational varicella-containing vaccine (a formulation combining measles, mumps, rubella, and varicella in one syringe) concomitantly with booster doses of DTaP and OPV (no longer licensed in the United States). The comparator group of 144 children received M-M-R II concomitantly with booster doses of DTaP and OPV followed by VARIVAX six weeks later. At six weeks postvaccination, seroconversion rates for measles, mumps, rubella, and VZV and the percentage of vaccinees whose titers were boosted for diphtheria, tetanus, pertussis, and polio were comparable between the two groups. Anti-VZV levels were decreased when the investigational vaccine containing varicella was administered concomitantly with DTaP {17}. No clinically significant differences were noted in adverse reactions between the two groups.

Concomitant Administration with PedvaxHIB®

In a clinical study involving 307 children 12 to 18 months of age, 150 received an investigational varicella-containing vaccine (a formulation combining measles, mumps, rubella, and varicella in one syringe) concomitantly with a booster dose of PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)], while 130 received M-M-R II concomitantly with a booster dose of PedvaxHIB followed by VARIVAX 6 weeks later. At six weeks postvaccination, seroconversion rates for measles, mumps, rubella, and VZV, and GMTs for PedvaxHIB were comparable between the two groups. Anti-VZV levels were decreased when the investigational vaccine containing varicella was administered concomitantly with PedvaxHIB {18}. No clinically significant differences in adverse reactions were seen between the two groups.

Concomitant Administration with M-M-R II and COMVAX

In a clinical study involving 822 children 12 to 15 months of age, 410 received COMVAX [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine] (no longer licensed in the US), M-M-R II, and VARIVAX concomitantly at separate injection sites, and 412 received COMVAX followed by M-M-R II and VARIVAX given concomitantly at separate injection sites, 6 weeks later. At 6 weeks postvaccination, the immune responses for the subjects who received the concomitant doses of COMVAX, M-M-R II, and VARIVAX were similar to those of the subjects who received COMVAX followed 6 weeks later by M-M-R II and VARIVAX with respect to all antigens administered. There were no clinically important differences in reaction rates when the three vaccines were administered concomitantly versus six weeks apart.

15 REFERENCES

  1. Weibel, R.E.; et al.: Live Attenuated Varicella Virus Vaccine. Efficacy Trial in Healthy Children. N Engl J Med. 310(22): 1409-1415, 1984.
  2. Arbeter, A.M.; et al.: Varicella Vaccine Trials in Healthy Children. A Summary of Comparative and Follow-up Studies. Am J Dis Child. 138: 434-438, 1984.
  3. Weibel, R.E.; et al.: Live Oka/Merck Varicella Vaccine in Healthy Children. Further Clinical and Laboratory Assessment. JAMA. 254(17): 2435-2439, 1985.
  4. Chartrand, D.M.; et al.: New Varicella Vaccine Production Lots in Healthy Children and Adolescents. Abstracts of the 1988 Inter-Science Conference Antimicrobial Agents and Chemotherapy: 237(Abstract #731).
  5. Johnson, C.E.; et al.: Live Attenuated Varicella Vaccine in Healthy 12- to 24-Month-Old Children. Pediatrics. 81(4): 512-518, 1988.
  6. Gershon, A.A.; et al.: Immunization of Healthy Adults with Live Attenuated Varicella Vaccine. J Infect Dis. 158(1): 132-137, 1988.
  7. Gershon, A.A.; et al.: Live Attenuated Varicella Vaccine: Protection in Healthy Adults Compared with Leukemic Children. J Infect Dis. 161: 661-666, 1990.
  8. White, C.J.; et al.: Varicella Vaccine (VARIVAX) in Healthy Children and Adolescents: Results From Clinical Trials, 1987 to 1989. Pediatrics. 87(5): 604-610, 1991.
  9. Peter, G.; et al (eds): Report of the Committee on Infectious Diseases, Twenty-fourth Edition, American Academy of Pediatrics, 344-357, 1997.
  10. Galea, S.; et al.: The Safety Profile of Varicella Vaccine: A 10-Year Review. J Infect Dis. 197(S2): 165-169, 2008.
  11. Hammerschlag, M.R.; et al.: Herpes Zoster in an Adult Recipient of Live Attenuated Varicella Vaccine. J Infect Dis. 160(3): 535-537, 1989.
  12. Guess, H.A.; et al.: Population-Based Studies of Varicella Complications. Pediatrics. 78(suppl): 723-727, 1986.
  13. Kuter, B.J.; et al.: Ten Year Follow-up of Healthy Children who Received One or Two Injections of Varicella Vaccine. Pediatr Infect Dis J. 23: 132-37, 2004.
  14. Kuter, B.J.; et al.: Oka/Merck Varicella Vaccine in Healthy Children: Final Report of a 2-Year Efficacy Study and 7-Year Follow-up Studies. Vaccine. 9: 643-647, 1991.
  15. Bernstein, H.H.; et al.: Clinical Survey of Natural Varicella Compared with Breakthrough Varicella After Immunization with Live Attenuated Oka/Merck Varicella Vaccine. Pediatrics. 92(6): 833-837, 1993.
  16. Wharton, M.: The Epidemiology of Varicella-zoster Virus Infections. Infect Dis Clin North Am. 10(3):571-581, 1996.
  17. White, C.J. et al.: Measles, Mumps, Rubella, and Varicella Combination Vaccine: Safety and Immunogenicity Alone and in Combination with Other Vaccines Given to Children. Clin Infect Dis. 24(5): 925-931, 1997.
  18. Reuman, P.D.; et al.: Safety and Immunogenicity of Concurrent Administration of Measles-Mumps-Rubella-Varicella Vaccine and PedvaxHIB® Vaccines in Healthy Children Twelve to Eighteen Months Old. Pediatr Infect Dis J. 16(7): 662-667, 1997.

16 HOW SUPPLIED/STORAGE AND HANDLING

No. 4827/4309 —VARIVAX is supplied as follows:

(1) a box of 10 single-dose vials of lyophilized vaccine (package A), NDC 0006-4827-00
(2) a box of 10 vials of diluent (package B).

Storage

Vaccine Vial

During shipment, maintain the vaccine at a temperature between –58°F and +5°F (–50°C and –15°C). Use of dry ice may subject VARIVAX to temperatures colder than –58°F (–50°C).

Before reconstitution, store the lyophilized vaccine in a freezer at a temperature between –58°F and +5°F (–50°C and –15°C). Any freezer (e.g. , chest, frost-free) that reliably maintains an average temperature between –58°F and +5°F (–50°C and –15°C) and has a separate sealed freezer door is acceptable for storing VARIVAX. Routine defrost cycling of a frost-free freezer is acceptable.

VARIVAX may be stored at refrigerator temperature (36°F to 46°F, 2°C to 8°C) for up to 72 continuous hours prior to reconstitution. Vaccine stored at 2°C to 8°C which is not used within 72 hours of removal from +5°F (–15°C) storage should be discarded.

Before reconstitution, protect from light.

DISCARD IF RECONSTITUTED VACCINE IS NOT USED WITHIN 30 MINUTES.

Diluent Vial

The vial of diluent should be stored separately at room temperature (68°F to 77°F, 20°C to 25°C), or in the refrigerator.

For information regarding the product or questions regarding storage conditions, call 1-800-9-VARIVAX (1-800-982-7482).

17 PATIENT COUNSELING INFORMATION

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

Discuss the following with the patient:

  • Question the patient, parent, or guardian about reactions to previous vaccines.
  • Provide a copy of the patient information (PPI) located at the end of this insert and discuss any questions or concerns.
  • Inform patient, parent, or guardian that vaccination with VARIVAX may not result in protection of all healthy, susceptible children, adolescents, and adults.
  • Inform female patients to avoid pregnancy for three months following vaccination.
  • Inform patient, parent, or guardian of the benefits and risks of VARIVAX.
  • Instruct patient, parent, or guardian to report any adverse reactions or any symptoms of concern to their healthcare professional.

The U.S. Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine. For information or a copy of the vaccine reporting form, call the VAERS toll-free number at 1-800-822-7967, or report online at www.vaers.hhs.gov.

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 © 1995-2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

uspi-v210-i-fro-2009r718

Patient Information
VARIVAX® (pronounced “VAR ih vax”)
Varicella Virus Vaccine Live

This is a summary of information about VARIVAX®. You should read it before you or your child get the vaccine. If you have any questions about the vaccine after reading this leaflet, you should ask your healthcare professional. This is a summary only. It does not take the place of talking about VARIVAX with your doctor, nurse, or other healthcare professional. Only your healthcare professional can decide if VARIVAX is right for you or your child.

What is VARIVAX and how does it work?

VARIVAX is also known as Varicella Virus Vaccine Live. It is a live virus vaccine that is given as a shot. It is meant to help prevent chickenpox. Chickenpox is sometimes called varicella (pronounced VAR ih sell a).

VARIVAX contains a weakened form of chickenpox virus.

VARIVAX works by helping the immune system protect you or your child from getting chickenpox.

VARIVAX may not protect everyone who gets it.

VARIVAX does not treat chickenpox once you or your child have it.

What do I need to know about chickenpox?

Chickenpox is an illness that occurs most often in children who are 5 to 9 years old. It can be passed to others. The illness can include headache, fever, and general discomfort. Then an itchy rash occurs, which can turn into blisters. The most common complication is that the blisters can get infected. Less common but very serious complications can occur. These include pneumonia, inflammation of the brain, Reye syndrome (which affects the liver and the brain), and death. Severe disease and serious complications are more likely to occur in adolescents and adults.

Who should not get VARIVAX?

Do not get VARIVAX if you or your child:

  • are allergic to any of its ingredients. (This includes gelatin or neomycin. See the ingredient list at the end of this leaflet.)
  • have a weakened immune system (which includes taking high doses of steroids by mouth or in a shot).
  • have a fever.
  • have active tuberculosis that is not treated.
  • are pregnant or plan to get pregnant within the next three months.

What should I tell my healthcare professional before getting VARIVAX?

Tell your healthcare professional if you or your child:

  • have or have had any medical problems.
  • have received blood or plasma transfusions or human serum globulin.
  • take any medicines. (This includes non-prescription medicines and dietary supplements.)
  • have any allergies. (This includes allergies to neomycin or gelatin.)
  • had an allergic reaction to any other vaccine.

How is VARIVAX given?

VARIVAX is given as a shot to people who are 12 months old or older. If your child is 12 months to 12 years old and your doctor gives a second dose, the second dose must be given at least 3 months after the first shot.

A second dose should be given to those who first get the vaccine when they are 13 years old or older. This second dose should be given 4 to 8 weeks after the first dose.

Your doctor or healthcare professional will use the official recommendations to decide the number of shots needed and when to get them.

If a dose is missed, your healthcare professional will let you know when you should have it.

What should you or your child avoid when getting VARIVAX?

Do not take aspirin or aspirin-containing products for 6 weeks after getting VARIVAX.

In rare circumstances, it is possible to catch chickenpox, including severe chickenpox, from a person who has been vaccinated with VARIVAX. This may occur in persons who have not previously been vaccinated or had chickenpox, as well as persons who fall into one of the following categories:

  • people who have a weakened immune system.
  • pregnant women who have never had chickenpox.
  • newborn babies whose mothers have never had chickenpox.
  • newborn babies born at less than 28 weeks of pregnancy.

Whenever possible, individuals who have been vaccinated with VARIVAX should attempt to avoid close contact for up to six weeks following the vaccination, with anyone who falls into one of the categories above. Tell your doctor or healthcare professional if you or your child expect to have close contact with someone who falls into one of these groups.

What are the possible side effects of VARIVAX?

The most common side effects reported after taking VARIVAX are:

  • Fever
  • Pain, swelling, itching, or redness at the site of the shot
  • Chickenpox-like rash on the body or at the site of the shot
  • Irritability

Other less common side effects have also been reported.

  • Tingling of the skin
  • Shingles (herpes zoster)

Tell your healthcare professional if you have any of the following problems within a short time after getting VARIVAX because they may be signs of an allergic reaction:

  • Shortness of breath or wheezing
  • Rash or hives

Other side effects have been reported. Some of them were serious. These include bruising more easily than normal; red or purple, flat, pinhead spots under the skin; severe paleness; difficulty walking; severe skin disorders; skin infection; and chickenpox. Rarely, swelling of the brain (encephalitis), stroke, inflammation of the coverings of the brain and spinal cord (meningitis), inflammation of the lungs (known as pneumonia or pneumonitis), and seizures with or without a fever have been reported. It is not known if these rare side effects are related to the vaccine.

Your doctor has a more complete list of side effects for VARIVAX.

Tell your doctor or healthcare professional if you or your child have any new or unusual symptoms after getting VARIVAX.

Report the following to your doctor or your child’s doctor:

  • any adverse reactions following vaccination
  • exposure to VARIVAX during pregnancy
  • exposure to VARIVAX during the 3 months before getting pregnant.

You may also report these events to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231, or directly to the Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to www.vaers.hhs.gov.

What are the ingredients of VARIVAX?

Active Ingredient: a weakened form of chickenpox virus.

Inactive Ingredients: sucrose, hydrolyzed gelatin, sodium chloride, monosodium L-glutamate, sodium phosphate dibasic, potassium phosphate monobasic, potassium chloride, residual components of MRC-5 cells including DNA and protein, sodium phosphate monobasic, EDTA, neomycin, fetal bovine serum.

What else should I know about VARIVAX?

This leaflet summarizes important information about VARIVAX.

If you would like more information, talk to your healthcare professional, visit the web site at www.merckvaccines.com, or call 1-800-Merck-90.

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 © 1995-2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

usppi-v210-i-fro-2009r711

PRINCIPAL DISPLAY PANEL — 1 Single Dose 0.5 mL Vial Carton

NDC 0006-4826-00

1 Single-dose 0.5-mL Vial

VARICELLA VIRUS VACCINE
LIVE
VARIVAX®

STORE FROZEN

Oka/Merck Strain. Human cell
tissue culture origin containing
trace quantities of neomycin.Contains no preservatives.

Rx only

A

PRINCIPAL DISPLAY PANEL -- 1 Single Dose 0.5 mL Vial Carton
(click image for full-size original)

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