VARIVAX SUMMARY
VARIVAX [Varicella Virus Vaccine Live (Oka/Merck)] is a preparation of the Oka/Merck strain of live, attenuated varicella virus. The virus was initially obtained from a child with natural varicella, then introduced into human embryonic lung cell cultures, adapted to and propagated in embryonic guinea pig cell cultures and finally propagated in human diploid cell cultures (WI-38). Further passage of the virus for varicella vaccine was performed at Merck Research Laboratories (MRL) in human diploid cell cultures (MRC-5) that were free of adventitious agents. This live, attenuated varicella vaccine is a lyophilized preparation containing sucrose, phosphate, glutamate, and processed gelatin as stabilizers.
VARIVAX is indicated for vaccination against varicella in individuals 12 months of age and older.
The duration of protection of VARIVAX is unknown at present and the need for booster doses is not defined. However, a boost in antibody levels has been observed in vaccinees following exposure to natural varicella as well as following a booster dose of VARIVAX administered four to six years postvaccination.
In a highly vaccinated population, immunity for some individuals may wane due to lack of exposure to natural varicella as a result of shifting epidemiology. Post-marketing surveillance studies are ongoing to evaluate the need and timing for booster vaccination.
Vaccination with VARIVAX may not result in protection of all healthy, susceptible children, adolescents, and adults (see CLINICAL PHARMACOLOGY).
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NEWS HIGHLIGHTSMedia Articles Related to Varivax (Varicella Vaccine)
FDA Approves New Drug Treatment For Long-Term Pain Relief After Shingles Attacks
Source: Dermatology News From Medical News Today [2009.11.18]
The Food and Drug Administration (FDA) has approved the approval of Qutenza (capsaicin) 8% patch, a medicated skin patch that relieves the pain of post-herpetic neuralgia (PHN), a serious complication that can occur after a bout with shingles. Shingles is an outbreak of rash or blisters on the skin that is caused by the same virus that causes chickenpox - the varicella-zoster virus.
Published Studies Related to Varivax (Varicella Vaccine)
Safety of a refrigerator-stable varicella vaccine (VARIVAX) in healthy 12- to 15-month-old children: A randomized, double-blind, cross-over study. [2009.07]
The safety of a single injection of the refrigerator-stable formulation of varicella vaccine VARIVAX was assessed in a blind, randomized, cross-over trial... In summary, the refrigerator-stable formulation of VARIVAX had a good safety profile and was well tolerated in healthy children aged 12 to 15 months, consistent with experience with the frozen formulation of VARIVAX.
Safety and immunogenicity of a measles-mumps-rubella-varicella vaccine given as a second dose in children up to six years of age. [2009.05.05]
Two doses of measles-mumps-rubella vaccine (MMR) are widely recommended and consideration is being given to a similar schedule for varicella vaccine. A combined measles-mumps-rubella-varicella vaccine (MMRV) could be considered for this second dose in children previously vaccinated separately with MMR and varicella vaccines...
Immunogenicity and safety of concomitant administration of a measles, mumps and rubella vaccine (M-M-RvaxPro) and a varicella vaccine (VARIVAX) by intramuscular or subcutaneous routes at separate injection sites: a randomised clinical trial. [2009.04.14]
BACKGROUND: When this trial was initiated, the combined measles, mumps and rubella (MMR) vaccine was licensed for subcutaneous administration in all European countries and for intramuscular administration in some countries, whereas varicella vaccine was licensed only for subcutaneous administration. This study evaluated the intramuscular administration of an MMR vaccine (M-M-RvaxPro) and a varicella vaccine (VARIVAX) compared with the subcutaneous route... CONCLUSION: The immunogenicities of M-M-RvaxPro and VARIVAX administered by the intramuscular route were comparable with those following subcutaneous administration, and the tolerability of the two vaccines was comparable regardless of administration route. Integration of both administration routes in the current European indications for the two vaccines will now allow physicians in Europe to choose their preferred administration route in routine clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT00432523.
Immunogenicity and safety of measles-mumps-rubella-varicella (MMRV) vaccine followed by one dose of varicella vaccine in children aged 15 months-2 years or 2-6 years primed with measles-mumps-rubella (MMR) vaccine. [2009.01.14]
In this open, randomized, comparative study (105908/NCT00353288), 458 age-stratified children (15 months-2 years and 2-6 years) previously primed with MMR received one dose of either a combined MMRV vaccine (Priorix-Tetratrade mark, MMRV group) or concomitant MMR and varicella vaccines (Priorixtrade mark and Varilrixtrade mark, MMR+V group), followed 42-56 days later by another dose of varicella vaccine (Varilrixtrade mark) in both groups.
Immunogenicity and safety assessments after one and two doses of a refrigerator-stable tetravalent measles-mumps-rubella-varicella vaccine in healthy children during the second year of life. [2008.08]
BACKGROUND: Measles, mumps, and rubella (MMR) and varicella (V) vaccines are often coadministered at 1 clinic visit. This study (104389/NCT00127023) was undertaken to assess the immunogenicity and safety of a new refrigerator-stable tetravalent MMRV vaccine after 1 dose and after 2 doses administered during the second year of life... CONCLUSIONS: Both after 1 dose and after 2 doses, the MMRV vaccine was at least as immunogenic as concomitant MMR and varicella vaccination suggesting that it could be suitable for use according to current vaccination schedules.
Clinical Trials Related to Varivax (Varicella Vaccine)
Safety,Tolerability and Immunogenicity of Vaccination With Varivax in Healthy Indian Children [Completed]
A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children [Completed]
The purpose of this study is to see if it is safe to give Varivax to HIV-positive children
and whether it protects children from infection. Varivax is a vaccine against varicella
zoster virus (VZV), the virus that causes chickenpox (varicella) and shingles (zoster).
VZV can cause many serious complications in HIV-infected children. Varivax is a VZV vaccine
that has been approved for use in healthy children. More research is needed to find out how
this vaccine will affect HIV-infected children.
A Study of the Safety and Effectiveness of Varivax (the Chicken Pox Vaccine) in Children Who Have Received Kidney Transplants [Completed]
The purpose of this study is to find out whether Varivax is safe for use in children with
kidney transplants and whether it protects children from serious infection. Varivax is a
vaccine against varicella zoster virus (VZV), the virus that causes chicken pox (varicella)
and shingles (zoster).
Healthy children are already receiving Varivax shots to protect them from chicken pox. Few
children with kidney transplants have received Varivax because doctors have been concerned
that Varivax might cause serious reactions in them. On the other hand, VZV infection can be a
life-threatening disease in these children. For this reason, doctors want to learn whether
Varivax might safely prevent VZV infections in children who have had kidney transplants.
The Safety of Oka Varicella in Children Prior to Solid Organ Transplantation [Active, not recruiting]
We hypothesize that children listed to undergo solid organ transplant will experience (at the
very most) a low rate (< 5%) of serious vaccine-related adverse events within 42 days after
immunization with live attenuated Oka/Merck varicella vaccine (VARIVAXâ„¢). We also hypothesize
that the immunogenicity of two doses of VARIVAXâ„¢ in the study population will be similar to
historical data in healthy subjects and that the efficacy of two doses of the vaccine in the
study population will be similar to that of healthy subjects.
Immunogenicity and Safety of Concomitant Administration of MMRâ„¢ rHA and VARIVAX® by Intramuscular Versus Subcutaneous Route [Completed]
Primary objective:
To compare if, when given concomitantly with VARIVAX® by the same route at 12-18 months of
age using separate injection sites, a single dose of M-M-RTMII administered by IM route is as
immunogenic as a single dose of M-M-RTMII administered by SC route in terms of response rates
to measles, mumps and rubella at 42 days following the vaccination.
AND/OR
To compare if, when given concomitantly with M-M-RTMII by the same route at 12-18 months of
age using separate injection sites, a single dose of VARIVAX® administered by IM route is as
immunogenic as a single dose of VARIVAX® administered by SC route in terms of response rate
to varicella at 42 days following the vaccination
Secondary objectives:
- To summarise the antibody titres to measles, mumps, rubella and varicella at 42 days
following the vaccination in children immunised with M-M-R™II and VARIVAX® administered
concomitantly at two separate injection sites by the same route IM or SC,
- To evaluate the safety profiles of M-M-R™II and VARIVAX® administered concomitantly at
two separate injection sites by the same route IM or SC.
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