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Safety and immunogenicity of a novel quadrivalent meningococcal CRM-conjugate vaccine given concomitantly with routine vaccinations in infants.
Pediatr Infect Dis J. 2012 Jan; 31(1):64-71.PI

Abstract

BACKGROUND

In phase II studies, MenACWY-CRM elicited robust immunologic responses in young infants. We now present results from our pivotal phase III infant immunogenicity/safety study.

METHODS

In this open-label phase III study, we randomized full-term 2-month-old infants to 4 doses of MenACWY-CRM coadministered with routine vaccines at 2, 4, 6, and 12 months of age or with routine vaccines alone. We monitored for local and systemic reactions and serious adverse events among all study participants and evaluated for sufficiency of the immune responses to MenACWY-CRM through serum bactericidal activity assay with human complement.

RESULTS

Bactericidal antibodies were present in 94% to 100% of subjects against each of the serogroups in MenACWY-CRM after the 4-dose series and were 67% to 97% after the first 3 doses. Geometric mean titers were higher after the fourth dose of MenACWY-CRM compared with a single dose of MenACWY-CRM at 12 months of age for all serogroups (range of ratios, 4.5-38). Responses to 3 doses of routine vaccines coadministered with MenACWY-CRM were noninferior to routine vaccinations alone, except for small differences in pneumococcal serotype 6B responses after dose 3 but not dose 4 and pertactin after dose 3. Inclusion of MenACWY-CRM did not affect the safety or reactogenicity profiles of the routine infant vaccine series.

CONCLUSIONS

A 4-dose series of MenACWY-CRM was highly immunogenic and well tolerated in young infants, and it can be coadministered with routine infant vaccines. Substantial immunity was conferred after the first 3 doses administered at 2, 4, and 6 months of age.

Authors+Show Affiliations

Kaiser Permanente Vaccine Study Center, Oakland, CA 94612, USA. Nicola.Klein@kp.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22094635

Citation

Klein, Nicola P., et al. "Safety and Immunogenicity of a Novel Quadrivalent Meningococcal CRM-conjugate Vaccine Given Concomitantly With Routine Vaccinations in Infants." The Pediatric Infectious Disease Journal, vol. 31, no. 1, 2012, pp. 64-71.
Klein NP, Reisinger KS, Johnston W, et al. Safety and immunogenicity of a novel quadrivalent meningococcal CRM-conjugate vaccine given concomitantly with routine vaccinations in infants. Pediatr Infect Dis J. 2012;31(1):64-71.
Klein, N. P., Reisinger, K. S., Johnston, W., Odrljin, T., Gill, C. J., Bedell, L., & Dull, P. (2012). Safety and immunogenicity of a novel quadrivalent meningococcal CRM-conjugate vaccine given concomitantly with routine vaccinations in infants. The Pediatric Infectious Disease Journal, 31(1), 64-71. https://doi.org/10.1097/INF.0b013e31823dce5c
Klein NP, et al. Safety and Immunogenicity of a Novel Quadrivalent Meningococcal CRM-conjugate Vaccine Given Concomitantly With Routine Vaccinations in Infants. Pediatr Infect Dis J. 2012;31(1):64-71. PubMed PMID: 22094635.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and immunogenicity of a novel quadrivalent meningococcal CRM-conjugate vaccine given concomitantly with routine vaccinations in infants. AU - Klein,Nicola P, AU - Reisinger,Keith S, AU - Johnston,William, AU - Odrljin,Tatjana, AU - Gill,Christopher J, AU - Bedell,Lisa, AU - Dull,Peter, PY - 2011/11/19/entrez PY - 2011/11/19/pubmed PY - 2012/5/4/medline SP - 64 EP - 71 JF - The Pediatric infectious disease journal JO - Pediatr Infect Dis J VL - 31 IS - 1 N2 - BACKGROUND: In phase II studies, MenACWY-CRM elicited robust immunologic responses in young infants. We now present results from our pivotal phase III infant immunogenicity/safety study. METHODS: In this open-label phase III study, we randomized full-term 2-month-old infants to 4 doses of MenACWY-CRM coadministered with routine vaccines at 2, 4, 6, and 12 months of age or with routine vaccines alone. We monitored for local and systemic reactions and serious adverse events among all study participants and evaluated for sufficiency of the immune responses to MenACWY-CRM through serum bactericidal activity assay with human complement. RESULTS: Bactericidal antibodies were present in 94% to 100% of subjects against each of the serogroups in MenACWY-CRM after the 4-dose series and were 67% to 97% after the first 3 doses. Geometric mean titers were higher after the fourth dose of MenACWY-CRM compared with a single dose of MenACWY-CRM at 12 months of age for all serogroups (range of ratios, 4.5-38). Responses to 3 doses of routine vaccines coadministered with MenACWY-CRM were noninferior to routine vaccinations alone, except for small differences in pneumococcal serotype 6B responses after dose 3 but not dose 4 and pertactin after dose 3. Inclusion of MenACWY-CRM did not affect the safety or reactogenicity profiles of the routine infant vaccine series. CONCLUSIONS: A 4-dose series of MenACWY-CRM was highly immunogenic and well tolerated in young infants, and it can be coadministered with routine infant vaccines. Substantial immunity was conferred after the first 3 doses administered at 2, 4, and 6 months of age. SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/22094635/Safety_and_immunogenicity_of_a_novel_quadrivalent_meningococcal_CRM_conjugate_vaccine_given_concomitantly_with_routine_vaccinations_in_infants_ DB - PRIME DP - Unbound Medicine ER -