Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) for Infant Meningococcal Vaccines
Evidence of benefits, harms, values and preferences, and cost-effectiveness were reviewed in accordance with GRADE methods.10 The primary policy question was “Should meningococcal vaccines be administered routinely to all infants for prevention of meningococcal disease?”. The evidence for two meningococcal vaccines licensed for use in infants (Hib-MenCY-TT and MenACWY-D) were evaluated to answer the questions: “Should the meningococcal vaccine Hib-MenCY-TT be administered routinely to all infants at 2, 4, 6, and 12 months of age for prevention of meningococcal disease?” and “Should the meningococcal vaccine MenACWY-D be administered to all infants at 9 and 12 months of age for prevention of meningococcal disease?”. The benefits outcomes considered for each vaccine included short-term vaccine efficacy (1 month after vaccination) and long-term efficacy (1, 3, and 5 years after vaccination). The harms outcomes considered for each vaccine included occurrence of serious adverse events (SAE) after vaccination and interference with other co-administered vaccines. Data from nine randomized controlled trials (RCT) were reviewed for Hib-MenCY-TT1-9; data from four unpublished observational studies (Obs) and 1 unpublished RCT were reviewed for MenACWY-D. The evidence type for each outcome was derived through a review of study design, risk of bias, inconsistency, indirectness, imprecision, and other considerations (Tables 1 and 2).Evidence Type 1: Randomized controlled trials, or overwhelming evidence from observational studies. Evidence Type 2: Randomized controlled trials with important limitations, or exceptionally strong evidence from observational studies. Evidence Type 3: Observational studies. Evidence Type 4: Clinical experience and observations, observational studies, or randomized controlled trials with notable limitations.10
Tables for GRADE: Infant Meningococcal Vaccines
MenACWY-D Summary: Vaccine is immunogenic in the short-term and safe. Low meningococcal disease burden lowers overall benefits.
Benefits Evidence Type: 3
Harms Evidence Type: 3
Overall Evidence Type: 3
HibMenCY-TT Summary: Vaccine is safe and immunogenic for Hib and MenCY in the short-term and 5 years post-vaccination. Low meningococcal disease burden lowers overall benefits for MenCY components.
Benefits Evidence Type: 2
Harms Evidence Type: 2
Overall Evidence Type: 2
- Bryant KA, Marshall GS, Marchant CD, et al. Immunogenicity and Safety of H. influenzae Type b-N meningitidis C/Y Conjugate Vaccine in Infants. Pediatrics 2011;127:e1375.
- Marchant CD, Miller JM, Marshall GS, et al. Randomized Trial to Assess Immunogenicity and Safety of Haemophilus influenzae Type B and Neisseria meningitidis Serogroups C and Y-Tetanus Toxoid Conjugate Vaccine in Infants. The Pediatric Infectious Diseases Journal 2010;29:48-52.
- Marshall GS, Marchant CD, Blatter M, et al. Immune Response and One-Year Antibody Persistence after a Fourth Dose of a Novel Haemophilus influenzae Type B and Neisseria Meningitidis Serogroups C and Y-Tetanus Toxoid Conjugate Vaccine (HibMenCY) at 12 to 15 Months of Age. The Pediatric Infectious Diseases Journal 2010;29:469-71.
- Marshall GS, Marchant CD, Blatter M, Friedland LR, Aris E, Miller JM. Co-administration of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine dose not interfere with the immune response to antigens contained in infant vaccines routinely used in the United States. Human Vaccines 2011;7:258-64.
- Marshall GS, Mesaros N, Aris E, Marchant CD, Blatter M, Miller JM. Persistence of Immunity Three Years after an Investigational Haemophilus influenzae type b and Neisseria meningitidis Serogroups C and Y Tetanus Toxoid (HibMenCY-TT) Conjugate Vaccine. 45th National Immunization Conference (NIC); March 28-31, 2011; Washington, D.C.
- Marshall, G. Mesaros, N., Aris, E. et al. Antibody Persistence 5 Years after the Fourth Dose of an Investigational Haemophilus influenzae Type b and Neisseria meningitidis Serogroups C and Y Tetanus Toxoid (HibMenCY-TT) Conjugate Vaccine. IDWeek 2012; October 18, 2012; San Diego, CA.
- Nolan T, Lambert S, Roberton D, et al. A novel combined Haemophilus influenzae type b-Neisseria meningitids serogroups C and Y-tetanus-toxoid conjugate vaccine is immogenic and induces immune memory when co-administered with DTPa-HBV-IPV and conjugate pneumococcal vaccines in infants. Vaccine 2007;25:8487-99.
- Nolan T, Richmond P, Marshall H, et al. Immunogenicity and Safety of an Investigational Combined Haemophilus influenzae Type B-Neisseria meningitidis Serogouprs C and Y-Tetanus Toxoid Conjugate Vaccine. The Pediatric Infectious Diseases Journal 2011;30:190-6.
- Rinderknecht S, Bryant KA, Nolan T, et al. The safety profile of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vacine (HibMenCY). Human Vaccines and Immunotherapeutics 2012;8:1-8.
- Ahmed F, Temte J, Campos-Outcalt D, Schunemann H, ACIP Evidence Based Recommendations Work Group. Methods for developing evidence-based recommendations by the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC). Vaccine 2011;29:9171-6.
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