Menomune (Meningococcal Polysaccharide Vaccine) - Summary

MENOMUNE SUMMARY

Menomune^® -A/C/Y/W-135, Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined, for subcutaneous use, is a freeze-dried preparation of the group-specific polysaccharide antigens from Neisseria meningitidis, Group A, Group C, Group Y and Group W-135. N meningitidis are cultivated with Mueller Hinton agar¹ and Watson Scherp² media. The purified polysaccharide is extracted from the Neisseria meningitidis cells and separated from the media by procedures which include centrifugation, detergent precipitation, alcohol precipitation, solvent or organic extraction and diafiltration. No preservative is added during manufacture.

Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined, is indicated for active immunization against invasive meningococcal disease caused by these serogroups.⁵

Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined may be used to prevent and control outbreaks of serogroup C meningococcal disease.⁵

For evaluation and management of suspected outbreaks, it is recommended that the health-care workers consult the MMWR for guidance.⁵

Routine vaccination is recommended for the following high-risk groups:⁵

1. Deficiencies in late Complement components (C3, C5-C9).
2. Functional or actual asplenia.
3. Persons with laboratory or industrial exposure to N meningitidis aerosols.
4. Travelers to, and residents of, hyperendemic areas such as sub-Saharan Africa. For information concerning geographic areas for which vaccination is recommended, contact CDC at 404-332-4559.

The American College Health Association (ACHA) also recommends that college students consider vaccination to reduce the risk for potentially fatal meningococcal disease.¹⁹

Vaccinations also should be considered for household or institutional contacts of persons with meningococcal disease and for medical and laboratory personnel at risk of exposure to meningococcal disease.

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NEWS HIGHLIGHTS

Published Studies Related to Menomune (Meningococcal Polysaccharide Vaccine)

Antibody persistence in UK pre-school children following primary series with an acellular pertussis-containing pentavalent vaccine given concomitantly with meningococcal group C conjugate vaccine, and response to a booster dose of an acellular pertussis-containing quadrivalent vaccine. [2009.08.13]
This open-label, randomised, controlled study examined antibody persistence following infant vaccination at 2, 3 and 4 months of age with either an acellular pertussis, diphtheria, tetanus, inactivated poliovirus, Haemophilus influenzae type b (DT(5)aP-IPV-Hib; Pediacel) or a whole-cell pertussis (DTwP//Hib+oral poliomyelitis vaccine [OPV]) combination vaccine, given concomitantly with meningococcal serogroup C conjugate (MCC) vaccine, followed by a Hib booster at approximately 15 months of age...

Phase I safety and immunogenicity study of a candidate meningococcal disease vaccine based on Neisseria lactamica outer membrane vesicles. [2009.08]
Natural immunity to meningococcal disease in young children is associated epidemiologically with carriage of commensal Neisseria species, including Neisseria lactamica.

Phase III comparison of an investigational quadrivalent meningococcal conjugate vaccine with the licensed meningococcal ACWY conjugate vaccine in adolescents. [2009.07.01]
BACKGROUND: Neisseria meningitidis is an important cause of invasive bacterial infection in the United States, and disease rates are higher for adolescents than for the general population. Quadrivalent meningococcal conjugate vaccine is recommended for routine vaccination of adolescents and high-risk groups. This study compares the safety and immunogenicity of the Novartis Vaccines investigational quadrivalent meningococcal CRM(197) conjugate vaccine, MenACWY-CRM, with the licensed meningococcal conjugate vaccine, Menactra... CONCLUSIONS: MenACWY-CRM vaccine is well tolerated in adolescents and generates a stronger immune response than Menactra for all 4 serogroups. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT00450437 .

Investigation of different group A immunoassays following one dose of meningococcal group A conjugate vaccine or A/C polysaccharide vaccine in adults. [2009.07]
A double-blind, randomized, controlled phase I study to assess the safety, immunogenicity, and antibody persistence of a new group A conjugate vaccine (PsA-TT) in volunteers aged 18 to 35 years was previously performed... The correlation between hSBA and group A-specific IgG was higher for the PsA-TT group than for the PsA/C group.

Immunogenicity and tolerability in infants of a New Zealand epidemic strain meningococcal B outer membrane vesicle vaccine. [2009.05]
BACKGROUND: An outer membrane vesicle meningococcal vaccine (MeNZB), was developed for the New Zealand epidemic strain of Neisseria meningitidis B:4:P1.7-2,4... CONCLUSIONS: In this group of New Zealand infants, 4 MeNZB doses were required to demonstrate titers comparable with those achieved after 3 doses in older children. MeNZB was safe when used concomitantly with routine New Zealand immunizations to 5 months of age.

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Clinical Trials Related to Menomune (Meningococcal Polysaccharide Vaccine)

Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years [Recruiting]

Immunogenicity & Safety Study of a Meningococcal Serogroup B Vaccine Given in a 3 Dose Schedule to Healthy Adolescents Aged 12-18 Yrs [Completed]
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of 3 doses of the meningococcal serogroup B vaccine when given, using either a 0-2-4 month or a 0-1-6 month schedule, to healthy adolescents aged 12-18 years; a control group will receive 2 doses of Havrix™ (0-6 months) and Meningitec™ (month 1).

Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age [Recruiting]

Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age [Completed]

3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age [Completed]
This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age. Antibody persistence and immune responses to booster vaccinations were additionally assessed at 12 to 18 months of age.

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