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Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine administered concomitantly with measles, mumps, rubella, varicella vaccine in healthy toddlers.
Vaccine. 2012 Jun 06; 30(26):3929-36.V

Abstract

BACKGROUND

Invasive meningococcal disease can have devastating outcomes, especially in high-risk groups such as infants. As infants are recommended to receive multiple vaccines during a single office visit, this phase 3 study assessed the safety and immune response to MenACWY-CRM at alternative visits in older infants and concomitant use with measles, mumps, rubella, varicella vaccine (MMRV) at 12 months of age.

METHODS

Two age groups were concurrently enrolled: 7- to 9-month-old infants who received 2 doses of MenACWY-CRM at 7-9 and 12 months and were randomized 1:1 to receive MenACWY-CRM with or without MMRV at 12 months, and 12-month-old infants who received MMRV only at 12 months. Using predefined non-inferiority criteria, immune responses to the antigens in MMRV were compared between those who did and did not receive MenACWY-CRM; immune responses to MenACWY-CRM as measured by the percentage of subjects with human serum bactericidal activity (hSBA) titers ≥ 8, were compared between those who did and did not receive concomitant MMRV. Adequacy of the immune response to 2 doses of MenACWY-CRM administered at 7-9 and 12 months was also assessed. Local and systemic reactions, adverse events resulting in withdrawal or requiring medical attention and serious adverse events were monitored.

RESULTS

Concomitant administration of MMRV with MenACWY-CRM did not affect the immune response to either vaccine. The 2-dose series of MenACWY-CRM induced adequate immune response to all 4 serogroups. No increased reactogenicity was observed with MenACWY-CRM+MMRV compared with MMRV alone, and there were no study-related serious adverse events.

CONCLUSIONS

Concomitant administration of MenACWY-CRM with MMRV vaccinations at 12 months was well-tolerated, without safety concerns. Robust immune responses to all components of both vaccines were produced and all criteria for non-inferiority were met, supporting the use of a 2-dose regimen of MenACWY-CRM in this age group.

Authors+Show Affiliations

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

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

22504039

Citation

Klein, Nicola P., et al. "Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Measles, Mumps, Rubella, Varicella Vaccine in Healthy Toddlers." Vaccine, vol. 30, no. 26, 2012, pp. 3929-36.
Klein NP, Shepard J, Bedell L, et al. Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine administered concomitantly with measles, mumps, rubella, varicella vaccine in healthy toddlers. Vaccine. 2012;30(26):3929-36.
Klein, N. P., Shepard, J., Bedell, L., Odrljin, T., & Dull, P. (2012). Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine administered concomitantly with measles, mumps, rubella, varicella vaccine in healthy toddlers. Vaccine, 30(26), 3929-36. https://doi.org/10.1016/j.vaccine.2012.03.080
Klein NP, et al. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Measles, Mumps, Rubella, Varicella Vaccine in Healthy Toddlers. Vaccine. 2012 Jun 6;30(26):3929-36. PubMed PMID: 22504039.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine administered concomitantly with measles, mumps, rubella, varicella vaccine in healthy toddlers. AU - Klein,Nicola P, AU - Shepard,Julie, AU - Bedell,Lisa, AU - Odrljin,Tatjana, AU - Dull,Peter, Y1 - 2012/04/10/ PY - 2011/12/19/received PY - 2012/03/23/revised PY - 2012/03/26/accepted PY - 2012/4/17/entrez PY - 2012/4/17/pubmed PY - 2012/9/13/medline SP - 3929 EP - 36 JF - Vaccine JO - Vaccine VL - 30 IS - 26 N2 - BACKGROUND: Invasive meningococcal disease can have devastating outcomes, especially in high-risk groups such as infants. As infants are recommended to receive multiple vaccines during a single office visit, this phase 3 study assessed the safety and immune response to MenACWY-CRM at alternative visits in older infants and concomitant use with measles, mumps, rubella, varicella vaccine (MMRV) at 12 months of age. METHODS: Two age groups were concurrently enrolled: 7- to 9-month-old infants who received 2 doses of MenACWY-CRM at 7-9 and 12 months and were randomized 1:1 to receive MenACWY-CRM with or without MMRV at 12 months, and 12-month-old infants who received MMRV only at 12 months. Using predefined non-inferiority criteria, immune responses to the antigens in MMRV were compared between those who did and did not receive MenACWY-CRM; immune responses to MenACWY-CRM as measured by the percentage of subjects with human serum bactericidal activity (hSBA) titers ≥ 8, were compared between those who did and did not receive concomitant MMRV. Adequacy of the immune response to 2 doses of MenACWY-CRM administered at 7-9 and 12 months was also assessed. Local and systemic reactions, adverse events resulting in withdrawal or requiring medical attention and serious adverse events were monitored. RESULTS: Concomitant administration of MMRV with MenACWY-CRM did not affect the immune response to either vaccine. The 2-dose series of MenACWY-CRM induced adequate immune response to all 4 serogroups. No increased reactogenicity was observed with MenACWY-CRM+MMRV compared with MMRV alone, and there were no study-related serious adverse events. CONCLUSIONS: Concomitant administration of MenACWY-CRM with MMRV vaccinations at 12 months was well-tolerated, without safety concerns. Robust immune responses to all components of both vaccines were produced and all criteria for non-inferiority were met, supporting the use of a 2-dose regimen of MenACWY-CRM in this age group. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/22504039/Immunogenicity_and_safety_of_a_quadrivalent_meningococcal_conjugate_vaccine_administered_concomitantly_with_measles_mumps_rubella_varicella_vaccine_in_healthy_toddlers_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(12)00488-4 DB - PRIME DP - Unbound Medicine ER -