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Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine.
Vaccine. 2017 12 14; 35(49 Pt B):6879-6884.V

Abstract

BACKGROUND

Menactra® vaccine (MenACWY-D) was licensed in the United States in 2005 for persons 11-55years of age. The aim of this study was to assess the safety of MenACWY-D administered as part of routine clinical care to patients at Kaiser Permanente Northern California (KPNC).

METHODS

This was an observational, retrospective study that included all KPNC members who received MenACWY-D during the study period. We monitored all vaccine recipients for non-elective hospitalizations, emergency department visits, and selected outcomes captured in the clinic setting (Bell's palsy, seizures, neuritis, Guillain-Barré syndrome, encephalopathy, encephalitis, epilepsy, transverse myelitis, multiple sclerosis, hypersensitivity reactions, idiopathic thrombocytopenic purpura, diabetes, arthritis, hemolytic anemia, collagen-vascular disease) through 6months after vaccination. Using vaccine recipients as their own controls, we calculated incidence rate ratios (IRRs) of outcomes during the post-vaccination risk interval and compared these with rates during a comparison interval more remote from vaccination. We also compared rates of outcomes in MenACWY-D recipients with those in matched controls who received selected vaccines in the prior year. We reviewed medical records for selected outcomes.

RESULTS

From April 2005 through April 2006, 31,561 KPNC patients (>99% of whom were 11-55years of age) received MenACWY-D. Overall, there were 21 outcomes with significantly elevated IRRs and 44 outcomes with significantly reduced IRRs. Medical record review of outcomes with significantly elevated IRRs did not suggest any relationship with MenACWY-D. Two serious adverse events were considered possibly related to vaccination by the study investigator.

CONCLUSIONS

This study did not detect any safety concerns following MenACWY-D and provides reassurance that MenACWY-D administered as part of routine care was not associated with unexpected safety risks. ClinicalTrials.gov Identifier is NCT00254995.

Authors+Show Affiliations

Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza 16B, Oakland, CA 94612, USA. Electronic address: john.hansen@kp.org.Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza 16B, Oakland, CA 94612, USA.Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza 16B, Oakland, CA 94612, USA.Sanofi Pasteur, 1 Discovery Drive, Swiftwater, PA 18370, USA.Sanofi Pasteur, 1 Discovery Drive, Swiftwater, PA 18370, USA; Department of Health Policy, Vanderbilt University School of Medicine, Nashville, TN 37212, USA.Sanofi Pasteur, 1 Discovery Drive, Swiftwater, PA 18370, USA; Department of Pediatrics, University of Pittsburgh School of Medicine, 3550 Terrace St., Pittsburgh, PA 15213, USA.Sanofi Pasteur, 1 Discovery Drive, Swiftwater, PA 18370, USA.Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza 16B, Oakland, CA 94612, USA.

Pub Type(s)

Clinical Trial, Phase IV
Journal Article
Observational Study

Language

eng

PubMed ID

28941623

Citation

Hansen, J, et al. "Post-licensure Safety Surveillance Study of Routine Use of Quadrivalent Meningococcal Diphtheria Toxoid Conjugate Vaccine." Vaccine, vol. 35, no. 49 Pt B, 2017, pp. 6879-6884.
Hansen J, Zhang L, Klein NP, et al. Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine. Vaccine. 2017;35(49 Pt B):6879-6884.
Hansen, J., Zhang, L., Klein, N. P., Robertson, C. A., Decker, M. D., Greenberg, D. P., Bassily, E., & Baxter, R. (2017). Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine. Vaccine, 35(49 Pt B), 6879-6884. https://doi.org/10.1016/j.vaccine.2017.09.032
Hansen J, et al. Post-licensure Safety Surveillance Study of Routine Use of Quadrivalent Meningococcal Diphtheria Toxoid Conjugate Vaccine. Vaccine. 2017 12 14;35(49 Pt B):6879-6884. PubMed PMID: 28941623.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine. AU - Hansen,J, AU - Zhang,L, AU - Klein,N P, AU - Robertson,C A, AU - Decker,M D, AU - Greenberg,D P, AU - Bassily,E, AU - Baxter,R, Y1 - 2017/09/21/ PY - 2017/06/20/received PY - 2017/09/01/revised PY - 2017/09/10/accepted PY - 2017/9/25/pubmed PY - 2018/8/1/medline PY - 2017/9/25/entrez KW - Meningitis KW - Meningococcal infections KW - Meningococcal vaccines SP - 6879 EP - 6884 JF - Vaccine JO - Vaccine VL - 35 IS - 49 Pt B N2 - BACKGROUND: Menactra® vaccine (MenACWY-D) was licensed in the United States in 2005 for persons 11-55years of age. The aim of this study was to assess the safety of MenACWY-D administered as part of routine clinical care to patients at Kaiser Permanente Northern California (KPNC). METHODS: This was an observational, retrospective study that included all KPNC members who received MenACWY-D during the study period. We monitored all vaccine recipients for non-elective hospitalizations, emergency department visits, and selected outcomes captured in the clinic setting (Bell's palsy, seizures, neuritis, Guillain-Barré syndrome, encephalopathy, encephalitis, epilepsy, transverse myelitis, multiple sclerosis, hypersensitivity reactions, idiopathic thrombocytopenic purpura, diabetes, arthritis, hemolytic anemia, collagen-vascular disease) through 6months after vaccination. Using vaccine recipients as their own controls, we calculated incidence rate ratios (IRRs) of outcomes during the post-vaccination risk interval and compared these with rates during a comparison interval more remote from vaccination. We also compared rates of outcomes in MenACWY-D recipients with those in matched controls who received selected vaccines in the prior year. We reviewed medical records for selected outcomes. RESULTS: From April 2005 through April 2006, 31,561 KPNC patients (>99% of whom were 11-55years of age) received MenACWY-D. Overall, there were 21 outcomes with significantly elevated IRRs and 44 outcomes with significantly reduced IRRs. Medical record review of outcomes with significantly elevated IRRs did not suggest any relationship with MenACWY-D. Two serious adverse events were considered possibly related to vaccination by the study investigator. CONCLUSIONS: This study did not detect any safety concerns following MenACWY-D and provides reassurance that MenACWY-D administered as part of routine care was not associated with unexpected safety risks. ClinicalTrials.gov Identifier is NCT00254995. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/28941623/Post_licensure_safety_surveillance_study_of_routine_use_of_quadrivalent_meningococcal_diphtheria_toxoid_conjugate_vaccine_ DB - PRIME DP - Unbound Medicine ER -