In clinical trials,^4,5,9-15 VARIVAX was administered to 11,102 healthy children, adolescents, and adults. VARIVAX was generally well tolerated.

In a double-blind, placebo-controlled study among 914 healthy children and adolescents who were serologically confirmed to be susceptible to varicella, the only adverse reactions that occurred at a significantly (p<0.05) greater rate in vaccine recipients than in placebo recipients were pain and redness at the injection site.⁴

In clinical trials involving healthy children monitored for up to 42 days after a single dose of VARIVAX, the frequency of fever, injection-site complaints, or rashes were reported as follows:

In addition, the most frequently (³1%) reported adverse experiences, without regard to causality, are listed in decreasing order of frequency: upper respiratory illness, cough, irritability/nervousness, fatigue, disturbed sleep, diarrhea, loss of appetite, vomiting, otitis, diaper rash/contact rash, headache, teething, malaise, abdominal pain, other rash, nausea, eye complaints, chills, lymphadenopathy, myalgia, lower respiratory illness, allergic reactions (including allergic rash, hives), stiff neck, heat rash/prickly heat, arthralgia, eczema/dry skin/dermatitis, constipation, itching.

Pneumonitis has been reported rarely (<1%) in children vaccinated with VARIVAX; a causal relationship has not been established.

Febrile seizures have occurred rarely (<0.1%) in children vaccinated with VARIVAX; a causal relationship has not been established.

In clinical trials involving healthy adolescents and adults, the majority of whom received two doses of VARIVAX and were monitored for up to 42 days after any dose, the frequency of fever, injection-site complaints, or rashes were reported as follows:

In addition, the most frequently (³1%) reported adverse experiences, without regard to causality, are listed in decreasing order of frequency: upper respiratory illness, headache, fatigue, cough, myalgia, disturbed sleep, nausea, malaise, diarrhea, stiff neck, irritability/nervousness, lymphadenopathy, chills, eye complaints, abdominal pain, loss of appetite, arthralgia, otitis, itching, vomiting, other rashes, constipation, lower respiratory illness, allergic reactions (including allergic rash, hives), contact rash, cold/canker sore. As with any vaccine, there is the possibility that broad use of the vaccine could reveal adverse reactions not observed in clinical trials.

The following additional adverse reactions have been reported since the vaccine has been marketed:

Anaphylaxis in individuals with or without an allergic history.

Thrombocytopenia.

Encephalitis; cerebrovascular accident; transverse myelitis; Guillain-Barré syndrome; Bell's palsy; ataxia; non-febrile seizures; dizziness; paresthesia.

Pharyngitis; Pneumonia/Pneumonitis.

Stevens-Johnson syndrome; erythema multiforme; Henoch-Schönlein purpura; secondary bacterial infections of skin and soft tissue, including impetigo and cellulitis; herpes zoster.

See PRECAUTIONS, General, regarding the administration of immune globulins, salicylates, and transfusions.

Drug Interactions, Use with Other Vaccines

Results from clinical studies indicate that VARIVAX can be administered concomitantly with M-M-R II, COMVAX, or TETRAMUNE (see CLINICAL PHARMACOLOGY, Studies with Other Vaccines).

Limited data from an experimental product containing varicella vaccine suggest that VARIVAX can be administered concomitantly with DTaP and PedvaxHIB using separate sites and syringes (see CLINICAL PHARMACOLOGY, Studies with Other Vaccines).⁵ However, there are no data relating to simultaneous administration of VARIVAX with DTP or OPV.

4. Weibel, R.E.; et al.: Live Attenuated Varicella Virus Vaccine, N Engl J Med. 310(22): 1409-1415, 1984.

5. Unpublished data; files of Merck Research Laboratories. 9. Arbeter, A.M.; et al.: Varicella Vaccine Trials in Healthy Children, A Summary of Comparative and Follow-up Studies, AJDC 138: 434-438, 1984.

10. Weibel, R.E.; et al.: Live Oka/Merck Varicella Vaccine in Healthy Children, JAMA 254(17): 2435-2439, 1985.

11. 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).

12. Johnson, C.E.; et al.: Live Attenuated Vaccine in Healthy 12 to 24 month old Children, Pediatrics 81: 512-518, 1988.

13. Gershon, A.A.; et al.: Immunization of Healthy Adults with Live Attenuated Varicella Vaccine, J Infect Dis, 158(1): 132-137, 1988.

14. Gershon, A.A.; et al.: Live Attenuated Varicella Vaccine: Protection in Healthy Adults Compared with Leukemic Children, J Infect Dis, 161: 661-666, 1990.

15. 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.

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