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Canada Communicable Disease Report

 

Canada Communicable Disease Report
Volume 29  ACS-6
1 September 2003

An Advisory Committee Statement (ACS) 
National Advisory Committee on Immunization (NACI)
*

SUPPLEMENTARY STATEMENT ON CONJUGATE MENINGOCOCCAL VACCINES

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Preamble

The National Advisory Committee on Immunization (NACI) provides Health Canada with ongoing and timely medical, scientific, and public health advice relating to immunization. Health Canada acknowledges that the advice and recommendations set out in this statement are based upon the best current available scientific knowledge, and is disseminating this document for information purposes. People administering or using the vaccine should also be aware of the contents of the relevant product monograph(s). Recommendations for use and other information set out here may differ from that set out in the product monograph(s) of the Canadian licensed manufacturer(s) of the vaccine(s). Manufacturer(s) have sought approval of the vaccine(s) and provided evidence as to its safety and efficacy only when it is used in accordance with the product monographs. 

Since the publication on 15 October, 2001, of the National Advisory Committee on Immunization Statement on Recommended Use of Meningococcal Vaccines(1), an additional meningococcal group C conjugate vaccine has been licensed for use in Canada. This update details the recommended use of the two currently licensed conjugate meningococcal group C vaccines (Menjugate®, Merck Frosst, and NeisVac-C®, Baxter International Inc, Shire Biologics). For more detailed information related to the use of meningococcal vaccines and the epidemiology of meningococcal infections in Canada, readers are referred to the original statement(1).

Menjugate® 

Menjugate® is composed of meningococcal group C polysaccharide conjugated to CRM197, a nontoxic mutant diphtheria toxin. The vaccine is supplied as a lyophilized product, which is reconstituted with an adjuvant diluent containing aluminum hydroxide (1 mg/0.5 mL dose) and sodium chloride in sterile water. Each 0.5 mL dose of the reconstituted vaccine contains 10 µg of meningococcal C oligosaccharide conjugated to Corynebacterium diphtheriae CRM197 protein (12.5 µg to 25 µg). Also included in the product are the following compounds: mannitol, sodium phosphate dibasic heptahydrate, and sodium phosphate monobasic monohydrate. The vaccine contains no preservative. The lyophilized product is stable for 24 months when stored between 2° C and 8° C. It should be reconstituted as per the manufacturer's instructions and then used immediately. 

NeisVac-C® 

NeisVac-C® is composed of meningococcal group C polysaccharide conjugated to a detoxified preparation of tetanus toxin and adsorbed onto aluminum hydroxide. It is provided in a single dose of 0.5 mL semi-opaque white to off-white suspension in pre-filled syringes with a rubber cap and a rubber plunger stopper. One dose (0.5 mL) contains 10 µg of Neisseria meningitidis group C polysaccharide, 10-20 µg of tetanus toxoid, 0.5 mg aluminum hydroxide, and 4.1 mg sodium chloride. The vaccine does not contain thimerosal. It is stable for 18 months when stored between 2° C and 8° C. 

Use of Conjugate Meningococcal C Vaccines

These vaccines are effective in reducing the risk of meningococcal group C disease only. They do not provide protection against tetanus or groups A, B, W135, or Y meningococcal disease. 

Either of the two licensed meningococcal C conjugate vaccines (NeisVac-C® and Menjugate®) may be used for the prevention of group C meningococcal disease as described in the statement(1). Recommendations for the use and administration of both vaccines are similar, as follows. 

Menjugate® or NeisVac-C® should be administered as an intramuscular injection, preferably in the anterolateral aspect of the thigh in infants and the deltoid muscle in older children, adolescents, and adults. These vaccines must not be administered subcutaneously or intravenously; they must not be mixed with other vaccines in the same syringe. In both cases, the vaccine may be administered at the same time as tetanus and diphtheria containing vaccines, or measles, mumps and rubella containing vaccines, at a different site, using a different syringe. 

Menjugate® or NeisVac-C® is recommended for routine immunization of infants beginning at 2 months of age. If the vaccine is started at 2 months of age, three doses with at least a 4-week interval between doses should be administered. Infants 4 to 11 months of age who have not previously received the vaccine should be immunized with two doses given at least 4 weeks apart. Children >= 12 months of age, adolescents and adults should receive a single 0.5 mL dose. The need for further booster doses has not yet been established. While there is no published information related to the interchangeability of NeisVac-C® and Menjugate®, the two vaccines have been used safely in this manner without a noticeable decrease in efficacy (Dr. David Salisbury, Principal Medical Officer, Communicable Disease Branch, Department of Health, London, UK: personal communication, 2003). However, when possible, the infant series should be completed with the same vaccine. 

The safety of Menjugate® and NeisVac-C® has not been established during pregnancy. The decision to use the vaccine during pregnancy should weigh the risk of meningococcal group C illness with the theoretical risk of adverse effects to the fetus.

Reference

  1. National Advisory Committee on Immunization. Statement on recommended use of meningococcal vaccines. CCDR 2001;27(ACS-6):2-36.

* Members: Dr. M. Naus (Chairperson), Dr. A. King (Executive Secretary), Dr. I. Bowmer, Dr. G. De Serres, Dr. S. Dobson, Dr. J. Embree, Dr. I. Gemmill, Dr. J. Langley, Dr. A. McGeer, Dr. P. Orr, Dr. B. Tan, A. Zierler.
Liaison Representatives: S. Callery (CHICA), Dr. J. Carsley (CPHA),
Dr. T. Freeman (CFPC), Dr. A. Gruslin (SOGC), A. Honish (CNCI), Dr. B. Larke (CCMOH), Dr. B. Law (ACCA), Dr. V. Lentini (DND), Dr. A. McCarthy (CIDS), Dr. J. Salzman (CATMAT), Dr. L. Samson (CPS), Dr. D. Scheifele (CAIRE), Dr. M. Wharton (CDC).
Ex-Officio Representatives: Dr. A. Klein and Dr. H. Rode (BREC),
Dr. R. Ramsingh (FNIHB), Dr. T. Tam (CIDPC).

This statement was prepared by Drs. J. Embree and M. Naus and approved by NACI.

 

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Last Updated: 2003-09-01 Top