ProQuad

/ MSD

Individuals 12 months of age to 12 years of age
Individuals from 12 months of age should receive two doses or a single dose followed by a second dose of a monovalent varicella vaccine to ensure optimal protection against varicella. At least one month must elapse between the first and second dose of any live viral attenuated vaccine. It is preferred that the second dose be administered within three months following the first dose.
Individuals between 9 and 12 months of age
Immunogenicity and safety data show administered to individuals between 9 and 12 months of age, under special circumstances (e.g., in accordance with official recommendations or when early protection is considered necessary). In such cases, individuals should receive a second dose, given a minimum of 3 months apart, to ensure optimal protection against measles and varicella.

Simultaneous vaccination against measles, mumps, rubella, and varicella in individuals from 12 months of age to 12 years of age. Administered to individuals from 9 months of age under special circumstances: outbreak situations, or travel to a region with high prevalence of measles.

* Hypersensitivity to any varicella vaccine or measles, mumps, or rubella vaccine or to any of the excipients.
* Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic system.
* Current immunosuppressive therapy (including high doses of corticosteroids). It is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids (e.g. for asthma prophylaxis or replacement therapy).
* Severe humoral or cellular (primary or acquired) immunodeficiency, e.g., severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage in children below 12 months: CD4+ <25%, children between 12-35 months: CD4+ <20%; children between 36-59 months: CD4+ <15%.
* In severely immunocompromised individuals inadvertently vaccinated with measles-containing vaccine, measles inclusion body encephalitis, pneumonitis, and fatal outcome as a direct consequence of disseminated measles vaccine virus infection have been reported.
* Family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated.
* Active untreated tuberculosis. Children under treatment for tuberculosis have not experienced exacerbation of the disease when immunised with live measles virus vaccine. No studies have been reported to date on the effect of measles virus vaccines on children with untreated tuberculosis.
* Vaccination should be postponed during any illness with fever >38.5°C.
* Pregnancy. Furthermore, pregnancy should be avoided for 1 month following vaccination.

Traceability
Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
Live measles vaccine and live mumps vaccine are produced in chick embryo cell culture. Persons with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g. hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion may be at an enhanced risk of immediate-type hypersensitivity reactions. The potential risk-to-benefit ratio should be carefully evaluated before considering vaccination in such cases.
Due caution should be employed in the administration of this medical product to persons with individual or family history of convulsions, or a history of cerebral injury. The physician should be alert to the temperature elevation that may occur following vaccination.
Individuals less than 12 months of age who are vaccinated with a measles-containing vaccine during measles outbreaks or for other reasons may fail to respond to the vaccine due to the presence of circulating antibodies of maternal origin and/or immaturity of the immune system.
Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination as Reye syndrome has been reported following the use of salicylates during wild-type varicella infection.
Vaccination may not result in protection in all vaccine recipients.
Transmission
Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7 to 28 days after vaccination. There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals. Consequently, transmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk; however, transmission of the rubella vaccine virus to infants via breast milk has been documented without any evidence of clinical disease. There are no reports of transmission of the more attenuated Enders’ Edmonston strain of measles virus or the Jeryl Lynn strain of mumps virus from vaccine recipients to susceptible contacts.
Post-marketing experience suggests that transmission of varicella vaccine virus (Oka/Merck strain) resulting in varicella infection including disseminated disease may rarely occur between vaccine recipients (who develop or do not develop a varicella-like rash) and contacts susceptible to varicella including healthy as well as high-risk individuals.
High-risk individuals susceptible to varicella include:
• immunocompromised individuals
• pregnant women without documented positive history of varicella (chickenpox) or laboratory evidence of prior infection
• newborn infants of mothers without documented positive history of varicella or laboratory evidence of prior infection.
Vaccine recipients should attempt to avoid, whenever possible, close association with high-risk individuals susceptible to varicella for up to 6 weeks following vaccination. In circumstances where contact with high-risk individuals susceptible to varicella is unavoidable, the potential risk of transmission of the varicella vaccine virus should be weighed against the risk of acquiring and transmitting wild-type varicella virus.
Thrombocytopenia
This vaccine should be given subcutaneously to individuals with thrombocytopenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals.
individuals who experienced thrombocytopenia following the first dose of a live measles, mumps, and rubella vaccine may develop thrombocytopenia with repeat doses. Serologic status may be evaluated to determine whether or not additional doses of vaccine are needed. The risk-to-benefit ratio should be carefully evaluated before considering vaccination in such cases.
Febrile seizures
In the 5- to 12-day timeframe after the administration of the first dose of quadrivalent measles, mumps, rubella and varicella vaccines in children, an increased risk of febrile seizure was observed compared to concomitant administration of measles, mumps, rubella and varicella vaccines.
Other
Vaccination may be considered in patients with selected immune deficiencies where the benefits outweigh the risks (asymptomatic HIV patients, IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease, and complement deficiency diseases).
Immunocompromised patients who have no contraindication for this vaccination may not respond as well as immunocompetent patients; therefore, some of these patients may acquire measles, mumps, rubella, or varicella in case of contact, despite appropriate vaccine administration. These patients should be monitored carefully for signs of measles, parotitis, rubella, and varicella.
Post-exposure prophylaxis
No clinical data are available for administered after exposure to measles, mumps, rubella, or varicella. However, post-exposure prophylaxis for varicella and measles has been demonstrated with Varicella Vaccine live (Oka/Merck) and the measles-containing vaccines manufactured by Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA (herein after MSD), respectively.
Encephalitis
Encephalitis has been reported during post-marketing use of live attenuated measles, mumps, rubella and varicella vaccines. In a few cases, fatal outcomes have been observed, especially in patients who were immunocompromised. Vaccinees/parents should be instructed to seek prompt medical attention if they/their child experience, after vaccination, symptoms suggestive of encephalitis such as loss or reduced levels of consciousness, convulsions or ataxia accompanied by fever and headache.
See prescribing information for full details

Very common: Fever, Erythema or Pain/Tenderness/Soreness at
the injection site.
Common: Irritability, Diarrhoea, Vomiting, Measles-like rash, Rash, Varicella-like rash, Ecchymosis or Swelling at the injection site, Injection site rash.

* At least 1 month should elapse between receipt of a live virus vaccine and this medical product.
* Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with this medical product.
* Do not give immunoglobulin (IG) or Varicella-Zoster Immune Globulin (VZIG) concomitantly
* Administration of immune globulins concomitantly with this medical product may interfere with the expected immune response. Vaccination should be deferred for at least 3 months following blood or plasma transfusions, or administration of immune globulins (IG). However, the appropriate suggested interval between transfusion or IG administration and vaccination will vary with the type of transfusion or indication for, and dose of, IG (e.g. 5 months for VZIG).
* Administration of varicella zoster virus antibody-containing blood products, including VZIG or other immune globulin preparations, within 1 month following a dose of this medical product may reduce the immune response to the vaccine and hence reduce its protective efficacy. Therefore, administration of any of these products should be avoided within 1 month after a dose of this medical product unless considered to be essential.
Concomitant use with other vaccines:
Clinical studies have demonstrated that this medical product can be given simultaneously (but at separate injection sites) with Prevenar and/or hepatitis A vaccine, or with monovalent or combination vaccines comprised of diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, or hepatitis B antigen. In these clinical studies, it was demonstrated that the immune responses were unaffected. The safety profiles of the administered vaccines were comparable.
There are insufficient data to support the use of this medical product with any other vaccines.
See prescribing information for full details

Pregnancy: Pregnant women should not be vaccinated. In a review of more than 3,500 susceptible women who were unknowingly in early stages of pregnancy
when vaccinated with a rubella-containing vaccine, no cases of congenital rubella syndrome were reported.
Post-marketing surveillance has identified congenital rubella syndrome associated with a rubella vaccine strain following inadvertent vaccination of a pregnant woman with a measles, mumps, and rubella vaccine.
Foetal damage has not been documented when measles, mumps or varicella vaccines have been given to pregnant women.
Pregnancy should be avoided for 1 month following vaccination. Women who intend to become pregnant should be advised to delay.
Lactation: Studies have shown that breast-feeding postpartum women vaccinated with live attenuated rubella vaccine may secrete the virus in breast milk and transmit it to breast-fed infants. In the infants with serological evidence of rubella infection, none had symptomatic disease. There is no evidence that varicella vaccine virus is excreted in breast milk. It is not known whether measles or mumps vaccine virus
is secreted in human milk. Therefore, caution should be exercised when considering whether to administer to a breast-feeding woman.

Administration of a higher than recommended dose was reported rarely and the adverse reaction profile was comparable to that observed with the recommended dose.