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Menomune

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Menomune

CLINICAL PHARMACOLOGY

Mechanism Of Action

The presence of bactericidal anti-capsular meningococcal antibodies has been associated with protection from invasive meningococcal disease.11,12 Menomune - A/C/Y/W-135 vaccine induces the production of bactericidal antibodies specific to the capsular polysaccharides of serogroups A, C, Y, and W-135.

Non-Clinical Toxicology

Carcinogenesis, mutagenesis, impairment Of fertility

Menomune - A/C/Y/W-135 vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.

Clinical Studies

Effectiveness of Menomune - A/C/Y/W-135 vaccine was inferred by evaluating the proportion of children 2-10 years of age achieving a pre-specified level of serum bactericidal antibody and the proportion of persons 11-55 years of age achieving a 4-fold increase from baseline in serum bactericidal antibody, for each serogroup. Evidence for clinical efficacy against serogroupspecific meningococcal disease in school-age children and adults has been obtained from historical field trials and observational studies with other high molecular weight polysaccharide vaccines containing meningococcal serogroup A and/or C components.6 No studies have been conducted to evaluate the efficacy of meningococcal polysaccharide vaccines against disease due to serogroups Y and W-135.

Menomune - A/C/Y/W-135 vaccine was used as the control vaccine in three US, multi-center, clinical trials designed primarily to evaluate the immunogenicity and safety of Menactra vaccine in children (2-10 years old), adolescents (11-18 years old), and adults (18-55 years old), respectively. In these trials, participants in the control arm received a dose of Menomune - A/C/Y/W-135 vaccine. Sera were obtained before and approximately 28 days after vaccination. The Serum Bactericidal Assay (SBA) used to test sera contained an exogenous complement source that was either human (SBA-H) or, when correlated to SBA-H, baby rabbit (SBA-BR).13

Data on immune responses, as measured by SBA-H, following Menomune - A/C/Y/W-135 vaccine in a subset of children 2-10 years old are presented in Table 3. Data on immune responses, as measured by SBA-BR, following Menomune - A/C/Y/W-135 vaccine in adolescents and adults are presented in Table 4.

Table 3: Bactericidal Antibody Responses* to Menomune - A/C/Y/W-135 Vaccine 28 Days After Vaccination for Subsets of Participants Aged 2-3 and 4-10 Years

Menomune - A/C/Y/W-135 vaccine Aged 2-3 Years
N†=50-53
Menomune - A/C/Y/W-135 vaccine Aged 4-10 Years
N†=84
Serogroup     (95% CI) ‡ Serogroup     (95% CI) J
A % ≥ 1:8 64 50,77 A % ≥ 1:8 55 44,66
GMT 10 7,12 GMT 7 6,9
C % ≥ 1:8 38 25,53 C % ≥ 1:8 48 37,59
GMT 11 5,21 GMT 12 7,18
Y % ≥ 1:8 73 59,84 Y % ≥ 1:8 92 84,97
GMT 18 11,27 GMT 46 33,66
W-135 % ≥ 1:8 33 20,47 W-135 % ≥ 1:8 79 68,87
GMT 5 3,6 GMT 20 14,27
The study was designed to show the safety and immunogenicity of Menactra vaccine are non-inferior to that of Menomune - A/C/Y/W-135 vaccine. The table shows the immune response in Menomune - A/C/Y /W-135 vaccine participants from this study.
* Serum Bactericidal Assay with an exogenous human complement (SBA-H) source.
† N = Number of subset participants with at least one valid serology result at Day 0 and Day 28.
‡ The 95% CI for the Geometric Mean Titer (GMT) was calculated based on an approximation to the normal distribution.

In participants 2-3 years of age with undetectable pre-vaccination SBA titers (ie, < 4 at Day 0), rates of seroconversion (defined as SBA titer ≥ 8 at Day 28) following Menomune - A/C/Y/W- 135 vaccine were 55%, serogroup A (n=16/29); 30%, serogroup C (n=13/43); 57%, serogroup Y (n=17/30); 26%, serogroup W-135 (n=11/43).

In participants 4-10 years of age with undetectable pre-vaccination SBA titers (ie, < 4 at Day 0), rates of seroconversion (defined as SBA titer ≥ 8 at Day 28) following Menomune - A/C/Y/W- 135 vaccine were 48%, serogroup A (n=10/21); 38%, serogroup C (n=19/50); 84%, serogroup Y (n=38/45); 68%, serogroup W-135 (n=26/38).

Table 4: Bactericidal Antibody Responses* to Menomune - A/C/Y/W-135 Vaccine 28 Days After Vaccination for Participants Aged 11-18 and 18-55 Years

Menomune - A/C/Y/W-135 vaccine Aged 11-18 Years
N†=423
Menomune - A/C/Y/W-135 vaccine Aged 18-55 Years
N†=1098
Serogroup     (95% CI) ‡ Serogroup     (95% CI) ‡
A % ≥ 4-fold rise§ 92.4 (89.5, 94.8) A % > 4-fold rise§ 84.6 (82.3, 86.7)
GMT 3246 (2910, 3620) GMT 4114 (3832, 4417)
C % ≥ 4-fold rise§ 88.7 (85.2, 91.5) C % ≥ 4-fold rise§ 89.7 (87.8, 91.4)
GMT 1639 (1406,1911) GMT 3469 (3148,3823)
Y % ≥ 4-fold rise§ 80.1 (76.0, 83.8) Y % ≥ 4-fold rise§ 79.4 (76.9, 81.8)
GMT 1228 (1088, 1386) GMT 2449 (2237, 2680)
W-135 % ≥ 4-fold rise§ 95.3 (92.8, 97.1) W-135 % ≥ 4-fold rise§ 94.4 (92.8, 95.6)
GMT 1545 (1384, 1725) GMT 1871 (1723,2032)
Both studies (11-18 and 18-55 years of age) were designed to show the safety and immunogenicity of Menactra vaccine are non-inferior to that of Menomune - A/C/Y/W-135 vaccine. The table shows the immune response in Menomune - A/C/Y/W-135 vaccine participants from these studies.
* Serum Bactericidal Assay with baby rabbit complement (SBA-BR).
† N = Number of participants with valid serology results at Day 0 and Day 28.
‡ The 95% CI for the GMT was calculated based on an approximation to the normal distribution.
The proportion of subjects with a > 4-fold rise from baseline in SBA-BR titer for Nmeningitidis for each of the serogroups A, C, Y and W-135, 28 days following vaccination with Menomune - A/C/Y/W-135 vaccine.

In participants 11-18 years of age with undetectable pre-vaccination SBA titers (ie, < 8 at Day 0), rates of seroconversion (defined as a ≥ 4-fold rise in Day 28 SBA titers) following Menomune - A/C/Y/W-135 vaccine were 100%, serogroup A (n=93/93); 99%, serogroup C (n=151/152); 100%, serogroup Y (n=47/47); 99%, serogroup W-135 (n=138/139).

In participants 18-55 years of age with undetectable pre-vaccination SBA titers (ie, < 8 at Day 0), rates of seroconversion (defined as a ≥ 4-fold rise in Day 28 SBA titers) following Menomune - A/C/Y/W-135 vaccine were 99%, serogroup A (n=143/144); 98%, serogroup C (n=297/304); 97%, serogroup Y (n=221/228); 99%, serogroup W-135 (n=325/328).

REFERENCES

6 Granoff DM, et al. Meningococcal vaccines. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: WB Saunders Company; 2008:399-434.

11 Makela PH, et al. Evolution of conjugate vaccines. Expert Rev Vaccines 2002;1(3):399- 410.

12 Goldschneider I, et al. Human immunity to the meningococcus. I. The Role of Humoral Antibodies. J Exp Med 1969;129:1307-1326.

13 Maslanka SE, et al. Standardization and a Multilaboratory Comparison of Neisseria meningitidis Serogroup A and C Serum Bactericidal Assays. Clin and Diag Lab Immunol 1997;156-167.

Last reviewed on RxList: 9/18/2014
This monograph has been modified to include the generic and brand name in many instances.

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