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## Complete Summary

#### GUIDELINE TITLE

Prevention and control of meningococcal disease: recommendations for use
of meningococcal vaccines in pediatric patients.

#### BIBLIOGRAPHIC SOURCE(S)

American Academy of Pediatrics Committee on Infectious Diseases.
Prevention and control of meningococcal disease: recommendations for use
of meningococcal vaccines in pediatric patients. Pediatrics 2005
Aug;116(2):496-505.
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15995007)

#### GUIDELINE STATUS

This is the current release of the guideline.

American Academy of Pediatrics (AAP) Policies are reviewed every 3 years
by the authoring body, at which time a recommendation is made that the
policy be retired, revised, or reaffirmed without change. Until the
Board of Directors approves a revision or reaffirmation, or retires a
statement, the current policy remains in effect.

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse**: This guideline
references a drug(s) for which important revised regulatory and/or
warning information has been released.

-   [October 23, 2006 update, Menactra (Meningococcal Conjugate
    Vaccine)](http://www.fda.gov/medwatch/safety/2006/safety06.htm#Menactra):
    Updated alert to consumers and health care providers regarding
    reports of Guillain Barre Syndrome (GBS) following administration of
    Meningococcal Conjugate Vaccine A, C, Y, and W135.

-   [October 3, 2005, Menactra (Meningococcal Conjugate
    Vaccine)](http://www.fda.gov/medwatch/safety/2005/safety05.htm#Menactra):
    The U.S. Food and Drug Administration (FDA) and the Centers for
    Disease Control and Prevention (CDC) notified consumers and health
    care providers of five reports of Guillain Barre Syndrome following
    administration of Meningococcal Conjugate Vaccine A, C, Y, and W135
    (trade name Menactra).

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 CONTRAINDICATIONS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Meningococcal disease

#### GUIDELINE CATEGORY

Prevention

#### CLINICAL SPECIALTY

Family Practice\
Internal Medicine\
Obstetrics and Gynecology\
Pediatrics\
Preventive Medicine

#### INTENDED USERS

Advanced Practice Nurses\
Allied Health Personnel\
Health Plans\
Hospitals\
Managed Care Organizations\
Nurses\
Physician Assistants\
Physicians

#### GUIDELINE OBJECTIVE(S)

To provide the rationale for use of meningococcal conjugate vaccine
(MCV4) in adolescents and to update recommendations for use of the
meningococcal polysaccharide vaccine (MPSV4) in pediatric patients

#### TARGET POPULATION

-   Pediatric patients aged 11 years and older

-   Children 2 to 10 years of age at increased risk of meningococcal
    disease

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  Annual visits to a health care professional

2.  Immunization with:

    -   Tetravalent meningococcal (A,C,Y,W-135) polysaccharide vaccine
        (MPSV4 \[Menomune-A/C/Y/W-135\])

    -   Tetravalent meningococcal (A,C,Y,W-135) conjugate vaccine (MCV4
        \[Menactra\])

3.  Reimmunization of individuals previously vaccinated

#### MAJOR OUTCOMES CONSIDERED

-   Rate of meningococcal disease among vaccinated populations

-   Occurrence of outbreaks of meningococcal disease

-   Immunogenicity and clinical efficacy of meningococcal vaccines

-   Duration of protection after meningococcal vaccination

-   Adverse reactions following immunization

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Searches of Electronic Databases\
Searches of Unpublished Data

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Not stated

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**Rating System of Quality of Scientific Evidence**

**I**. Evidence obtained from at least 1 properly designed, randomized,
controlled trial

**II-1**. Evidence obtained from well-designed, controlled trials
without randomization

**II-2**. Evidence obtained from well-designed cohort or case-control
analytic studies, preferentially from more than 1 center or group

**II-3**. Evidence obtained from multiple time series with or without
intervention or dramatic results in uncontrolled experiments (such as
the results of the introduction of penicillin treatment in the 1940s)

**III**. Opinions of respected authorities, based on clinical
experience, descriptive studies, or reports of expert committees

#### METHODS USED TO ANALYZE THE EVIDENCE

Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

Not stated

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

*Cost of Meningococcal Vaccines*

Whether universal immunization of adolescents with tetravalent A, C, Y,
W-135 meningococcal vaccine would result in a net cost or a net savings
to society is dependent on invasive meningococcal disease (IMD)
incidence, which varies by year, the rates of death or permanent
sequelae, and the cost of immunization. A recent study from the U.S.
Centers for Disease Control and Prevention (CDC) suggests that universal
immunization of adolescents would be cost-effective. However, variations
in the epidemiology of and outcomes from IMD by region make it
impossible to generate a precise estimate of cost-benefit. If, as
expected, universal adolescent immunization with meningococcal conjugate
vaccine (MCV4) becomes a reality in the next few years, more precise
estimates should become available.

The total cost of immunizing a single adolescent with MCV4 includes
direct and indirect costs. The direct costs include supplies (e.g.,
vaccine \[MCV4 = \$82.00 and meningococcal polysaccharide vaccine
(MPSV4) = \$86.10 per dose\], syringe with needle), personnel, and
administrative expenses. Public and private insurers should be
responsible for payment of costs for MCV4. MCV4 is included in the
Vaccines for Children program. For private insurers, avoiding financial
responsibility by transferring this to intermediate risk-bearing
entities (e.g., independent practice associations or other physician
groups), individual physicians, or college health services will result
in adolescents not being immunized in a timely fashion. Physicians incur
significant administrative expenses ensuring that adolescents are
immunized with recommended vaccines in a timely fashion, including
explaining risk and benefits of immunization to adolescents and parents;
ordering, purchasing, storing, and administering the vaccine; recording
immunizations in records; and other activities. Physicians should
receive reimbursement for expenses associated with each vaccine
administration.

#### METHOD OF GUIDELINE VALIDATION

Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Not stated

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

The evidence grades **(I-III)** are defined at the end of the \"Major
Recommendations\" field.

1.  Two cohorts of adolescents should be immunized routinely with
    meningococcal conjugate vaccine (MCV4): 1) young adolescents at the
    11- to 12-year visit; and 2) adolescents at high school entry or 15
    years of age, whichever comes first **(both evidence grade I)**.
    Within 3 years, the goal will be routine immunization of all
    adolescents with MCV4 beginning at 11 years of age.

2.  Adolescents should visit a health care professional at 11 to 12
    years of age, when immunization status and other preventive services
    can be addressed. Subsequent annual visits throughout adolescence
    also are recommended for all adolescents.

3.  Entering college students who plan to live in dormitories should be
    immunized with MCV4 routinely **(evidence grade II-2)**.

4.  People at increased risk of meningococcal disease should be
    immunized with MCV4 if they are at least 11 years of age. These
    persons include:

    -   Adolescents who have a terminal complement deficiency or
        adolescents who have anatomic or functional asplenia **(evidence
        grade II-3)**

    -   Adolescents who travel to or reside in countries where
        *Neisseria meningitidis* is hyperendemic or epidemic (U.S.
        Centers for Disease Control and Prevention \[CDC\] Travelers\'
        Health Hotline 877/FYI-TRIP or online at
        [www.cdc.gov/travel/](http://www.cdc.gov/travel/)) **(evidence
        grade II-3)**

5.  Because people with human immunodeficiency virus (HIV) infection are
    likely to be at higher risk of meningococcal disease, although not
    to the extent that they are at risk of invasive *Streptococcus
    pneumoniae* infection, they may elect to be immunized with MCV4 if
    they are at least 11 years of age.

6.  Children 2 to 10 years of age at increased risk of meningococcal
    disease (see recommendations 3 and 4) should be immunized with
    meningococcal polysaccharide vaccine (MPSV4), because MCV4 is not
    yet licensed for use in these children.

7.  People who wish to decrease their risk of meningococcal disease may
    elect to receive MCV4 if they are 11 years or older.

8.  For control of meningococcal outbreaks caused by vaccine-preventable
    serogroups (A, C, Y, or W-135), MPSV4 or MCV4 should be used for
    people 11 years or older **(evidence grade II-2)**. MCV4 is
    preferred, but MPSV4 is acceptable. For children 2 to 10 years of
    age, MPSV4 should be used.

9.  Immunization with MCV4 may be indicated for adolescents previously
    immunized with MPSV4. These people should be considered for
    reimmunization 3 to 5 years after receiving MPSV4 if they remain at
    increased risk of meningococcal disease.

10. Public and private insurers should be responsible for payment of
    costs of MCV4, its administration to adolescents for whom MCV4 is
    recommended, and administrative costs involved in providing vaccines
    to high-risk people.

**Evidence Grading**

**I**. Evidence obtained from at least 1 properly designed, randomized,
controlled trial

**II-1**. Evidence obtained from well-designed, controlled trials
without randomization

**II-2**. Evidence obtained from well-designed cohort or case-control
analytic studies, preferentially from more than 1 center or group

**II-3**. Evidence obtained from multiple time series with or without
intervention or dramatic results in uncontrolled experiments (such as
the results of the introduction of penicillin treatment in the 1940s)

**III**. Opinions of respected authorities, based on clinical
experience, descriptive studies, or reports of expert committees

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting the recommendations is provided for
selected recommendations (see \"Major Recommendations\").

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Prevention of meningococcal disease and its sequelae

#### POTENTIAL HARMS

**Adverse Reactions Following Immunization**

-   Among adolescents 11 to 18 years of age, safety of administering
    tetravalent meningococcal conjugate vaccine (MCV4) and tetravalent
    meningococcal polysaccharide vaccine (MPSV4) was assessed in 2
    randomized controlled trials. The percentage of subjects reporting
    systemic adverse events was similar in both groups (see Table 4 in
    the original guideline document). Approximately half of the
    adolescents experienced at least one systemic adverse reaction, but
    less than 5% experienced at least one severe systemic reaction.
    Fever was reported by 3.4 to 5.1% of adolescents who received MCV4
    and by 2.5 to 3.0% of adolescents who received MPSV4, a difference
    that was not significant.

-   Local adverse reactions were more common among adolescents who
    received MCV4 than among adolescents who received MPSV4 (Table 5 of
    the original guideline document). Of adolescents who received MCV4,
    13.1 to 16.9% reported pain that limited movement in the arm of
    injection, compared with 2.6 to 3.9% of adolescents who received
    MPSV4. These differences in frequency of local reactions could be
    attributable in part to different methods of administering the 2
    vaccines (MCV4 is administered intramuscularly; MPSV4 is
    administered subcutaneously). The frequency of local adverse
    reactions reported after MCV4 administration was similar to that
    reported after tetanus and diphtheria (Td) administration, which,
    like MCV4, is given intramuscularly.

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

Immunization with meningococcal conjugate vaccine (MCV4) is
contraindicated among people known to have hypersensitivity to any
component of the vaccine, including diphtheria toxoid, and to dry,
natural rubber latex, which is used in the vial stopper.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Staying Healthy

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

American Academy of Pediatrics Committee on Infectious Diseases.
Prevention and control of meningococcal disease: recommendations for use
of meningococcal vaccines in pediatric patients. Pediatrics 2005
Aug;116(2):496-505.
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15995007)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2005 May 25

#### GUIDELINE DEVELOPER(S)

American Academy of Pediatrics - Medical Specialty Society

#### SOURCE(S) OF FUNDING

American Academy of Pediatrics

#### GUIDELINE COMMITTEE

Committee on Infectious Diseases

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Committee on Infectious Diseases, 2003-2004*: Margaret B. Rennels, MD,
*Chairperson*; H. Cody Meissner, MD, *Vice Chairperson*; \*Carol J.
Baker, MD; Robert S. Baltimore, MD; Joseph A. Bocchini, Jr, MD; Penelope
H. Dennehy, MD; Robert W. Frenck, Jr, MD; Caroline B. Hall, MD; Sarah S.
Long, MD; Julia A. McMillan, MD; Keith R. Powell, MD; Lorry G. Rubin,
MD; Thomas N. Saari, MD

*Liaisons*: Richard D. Clover, MD, American Academy of Family
Physicians; Steven Cochi, MD, Centers for Disease Control and
Prevention; Joanne Embree, MD, Canadian Paediatric Society; Marc
Fischer, MD, Centers for Disease Control and Prevention; Bruce Gellin,
MD, MPH, National Vaccine Program Office; Mamodikoe Makhene, MD,
National Institutes of Health; Douglas Pratt, MD, Food and Drug
Administration; Jeffrey R. Starke, MD, American Thoracic Society

*Ex Officio*: Larry K. Pickering, Red Book Editor

*Staff*: Alison Siwek, MPH

\*Lead author

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

American Academy of Pediatrics (AAP) Policies are reviewed every 3 years
by the authoring body, at which time a recommendation is made that the
policy be retired, revised, or reaffirmed without change. Until the
Board of Directors approves a revision or reaffirmation, or retires a
statement, the current policy remains in effect.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[American Academy of Pediatrics (AAP) Policy Web
site](http://aappolicy.aappublications.org/cgi/content/full/pediatrics;116/2/496).

Print copies: Available from American Academy of Pediatrics, 141
Northwest Point Blvd., P.O. Box 927, Elk Grove Village, IL 60009-0927.

#### AVAILABILITY OF COMPANION DOCUMENTS

None available

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on July 25, 2005. The information
was verified by the guideline developer on August 23, 2005. This summary
was updated by ECRI on October 5, 2005 following the U.S. Food and Drug
Administration (FDA) advisory on Menactra (Meningococcal Conjugate
Vaccine A, C, Y, and W135). This summary was updated by ECRI on October
25, 2006 following the updated FDA advisory on Menactra (Meningococcal
Conjugate Vaccine).

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions. Please contact the
Permissions Editor, American Academy of Pediatrics (AAP), 141 Northwest
Point Blvd, Elk Grove Village, IL 60007.

### DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008