0
We're unable to sign you in at this time. Please try again in a few minutes.
Retry
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
Retry
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
From the Centers for Disease Control and Prevention |

Licensure of a Meningococcal Conjugate Vaccine for Children Aged 2 Through 10 Years and Updated Booster Dose Guidance for Adolescents and Other Persons at Increased Risk for Meningococcal Disease—Advisory Committee on Immunization Practices (ACIP), 2011 FREE

JAMA. 2012;307(1):27-28. doi:.
Text Size: A A A
Published online

MMWR. 2011;60:1018-1019

2 tables omitted

In January 2011, the Food and Drug Administration lowered the approval age range for use of MenACWY-CRM (Menveo, Novartis Vaccines and Diagnostics), a quadrivalent meningococcal conjugate vaccine, to include persons aged 2 through 55 years. One other quadrivalent meningococcal conjugate vaccine, MenACWY-D (Menactra, Sanofi Pasteur), is licensed in the United States for prevention of meningococcal disease caused by serogroups A, C, Y, and W-135 among persons aged 2 through 55 years; MenACWY-D also is licensed as a 2-dose series for children aged 9 through 23 months.1,2 The Advisory Committee on Immunization Practices (ACIP) recommends that persons aged 2 through 55 years at increased risk for meningococcal disease and all adolescents aged 11 through 18 years be immunized with meningococcal conjugate vaccine. ACIP further recommended, in January 2011, that all adolescents receive a booster dose of quadrivalent meningococcal conjugate vaccine at age 16 years.3 This report summarizes data supporting the extended age indication for MenACWY-CRM and the interchangeability of the two licensed meningococcal conjugate vaccines.

SAFETY AND IMMUNOGENICITY IN CHILDREN AGED 2 THROUGH 10 YEARS

The safety and immunogenicity of MenACWY-CRM in children aged 2 through 10 years was evaluated in a multicenter, randomized controlled trial.1 A human complement serum bactericidal assay (hSBA) was used to measure antibody responses. Following a single MenACWY-CRM dose, seroresponses to group C, Y, and W-135 in children aged 2 through 5 years and 6 through 10 years were noninferior to responses after a single MenACWY-D dose. Seroresponse was defined as the proportion of subjects with a postvaccination hSBA titer ≥8 if the prevaccination (baseline) titer was <4, or at least a fourfold higher hSBA titer than baseline if the prevaccination titer was ≥4. Overall, the percentage of MenACWY-CRM and MenACWY-D participants aged 2 through 10 years with hSBA titers ≥8 was, respectively, 75% and 80% for serogroup A, 72% and 68% for serogroup C, 90% and 79% for serogroup W-135, and 77% and 60% for serogroup Y.4 Injection-site reactions within 7 days after vaccination included pain, erythema, and induration, and were common, with pain being most common. The most common systemic adverse effects were headache and irritability. Rates of adverse effects were similar to those seen after vaccination with MenACWY-D. Serious adverse events were reported in <1% of MenACWY-CRM recipients, and none were attributed to the vaccine.

USE OF MENINGOCOCCAL CONJUGATE VACCINE IN CHILDREN AGED 2 THROUGH 10 YEARS

ACIP recommends vaccination with meningococcal conjugate vaccine for children aged 2 through 10 years at increased risk for meningococcal disease.3 A 2-dose primary series is recommended for children with terminal complement deficiencies (e.g., C5–C9, properidin, factor H, or factor D deficiencies) or anatomic or functional asplenia.5,6 A single primary dose is recommended for children with increased risk for disease because they are travelers to or residents of countries in which meningococcal disease is hyperendemic or epidemic (e.g., the meningitis belt of sub-Saharan Africa).3 Either meningococcal conjugate vaccine can be used in children aged 2 through 10 years and both are preferred over quadrivalent meningococcal polysaccharide vaccine. This recommendation supersedes the previous recommendation that children aged 2 through 10 years should receive only MenACWY-D when meningococcal vaccination is indicated.2 Children aged 2 through 10 years with no increased risk for meningococcal disease are not recommended to receive any meningococcal vaccine.6

INTERCHANGEABILITY OF MENACWY-CRM AND MENACWY-D

In January 2011, ACIP recommended a single booster dose of meningococcal conjugate vaccine for adolescents who received a previous dose before age 16 years.3 For persons aged 2 through 55 years at increased risk for meningococcal disease (i.e., persons with asplenia or terminal complement deficiencies, or laboratory workers who work with Neisseria meningitidis), a booster dose is recommended if they remain at increased risk.3,7

In a postlicensure study, persistence of hSBA antibodies and the safety and immunogenicity of MenACWY-CRM vaccination were evaluated in persons 3 years after they had received a single dose of MenACWY-CRM or MenACWY-D (Novartis, unpublished data, 2011). The percentage of participants with hSBA titers ≥8 36 months after a single dose of MenACWY-CRM or MenACWY-D at ages 11 through 18 years was similar for all serogroups. After revaccination with MenACWY-CRM, ≥99% of persons previously immunized with MenACWY-CRM or MenACWY-D had hSBA titers ≥8. Injection-site reactions reported within 7 days after revaccination among those who had received MenACWY-CRM followed by MenACWY-CRM or MenACWY-D followed by MenACWY-CRM included pain (45% versus 48%), erythema (7% versus 9%), and induration (11% versus 5%). Systemic adverse events reported by the same groups were headache (24% versus 27%), malaise (5% versus 10%), nausea (8% versus 10%), and fever (2% versus none). The solicited adverse event rates reported after revaccination were similar to the rates reported after primary immunization. At this time, no data exist on the use of MenACWY-D following primary vaccination with MenACWY-CRM. Health-care providers should use every opportunity to provide the booster dose when indicated, regardless of the vaccine brand used for the previous dose or doses.

REFERENCES

Food and Drug Administration.  Product approval information: package insert. Menveo (Meningococcal [Groups A, C, Y, W-135] oligosaccharide diphtheria CRM197 conjugate vaccine). Rockville, MD: US Department of Health and Human Services, Food and Drug Administration; 2011. Available at http://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm201349.pdf. Accessed August 3, 2011
Centers for Disease Control and Prevention (CDC).  Licensure of a meningococcal conjugate vaccine (Menveo) and guidance for use - Advisory Committee on Immunization Practices (ACIP), 2010.  MMWR. 2010;59(9):273
PubMed
Centers for Disease Control and Prevention (CDC).  Updated recommendations for use of meningococcal conjugate vaccines —Advisory Committee on Immunization Practices (ACIP), 2010.  MMWR. 2011;60(3):72-76
PubMed
Halperin SA, Gupta A, Jeanfreau R,  et al.  Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age.  Vaccine. 2010;28(50):7865-7872
PubMed   |  Link to Article
CDC.  Prevention and control of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP).  MMWR. 2005;54(RR-7):
Advisory Committee on Immunization Practices (ACIP) Centers for Disease Control and Prevention (CDC).  Report from the Advisory Committee on Immunization Practices (ACIP): decision not to recommend routine vaccination of all children aged 2-10 years with quadrivalent meningococcal conjugate vaccine (MCV4).  MMWR. 2008;57(17):462-465
PubMed
Centers for Disease Control and Prevention (CDC).  Updated recommendation from the Advisory Committee on Immunization Practices (ACIP) for revaccination of persons at prolonged increased risk for meningococcal disease.  MMWR. 2009;58(37):1042-1043
PubMed

Figures

Tables

References

Food and Drug Administration.  Product approval information: package insert. Menveo (Meningococcal [Groups A, C, Y, W-135] oligosaccharide diphtheria CRM197 conjugate vaccine). Rockville, MD: US Department of Health and Human Services, Food and Drug Administration; 2011. Available at http://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm201349.pdf. Accessed August 3, 2011
Centers for Disease Control and Prevention (CDC).  Licensure of a meningococcal conjugate vaccine (Menveo) and guidance for use - Advisory Committee on Immunization Practices (ACIP), 2010.  MMWR. 2010;59(9):273
PubMed
Centers for Disease Control and Prevention (CDC).  Updated recommendations for use of meningococcal conjugate vaccines —Advisory Committee on Immunization Practices (ACIP), 2010.  MMWR. 2011;60(3):72-76
PubMed
Halperin SA, Gupta A, Jeanfreau R,  et al.  Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age.  Vaccine. 2010;28(50):7865-7872
PubMed   |  Link to Article
CDC.  Prevention and control of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP).  MMWR. 2005;54(RR-7):
Advisory Committee on Immunization Practices (ACIP) Centers for Disease Control and Prevention (CDC).  Report from the Advisory Committee on Immunization Practices (ACIP): decision not to recommend routine vaccination of all children aged 2-10 years with quadrivalent meningococcal conjugate vaccine (MCV4).  MMWR. 2008;57(17):462-465
PubMed
Centers for Disease Control and Prevention (CDC).  Updated recommendation from the Advisory Committee on Immunization Practices (ACIP) for revaccination of persons at prolonged increased risk for meningococcal disease.  MMWR. 2009;58(37):1042-1043
PubMed

Letters

CME
Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.

Multimedia

Some tools below are only available to our subscribers or users with an online account.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Articles Related By Topic
Related Collections
PubMed Articles