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Safety of a quadrivalent meningococcal serogroups A, C, W and Y conjugate vaccine (MenACWY-CRM) administered with routine infant vaccinations: results of an open-label, randomized, phase 3b controlled study in healthy infants.
Vaccine. 2014 Feb 12; 32(8):965-72.V

Abstract

BACKGROUND

The highest risk for invasive meningococcal disease (IMD) is in infants aged <1 year. Quadrivalent meningococcal conjugate vaccination has the potential to prevent IMD caused by serogroups A, C, W and Y. This phase 3b, multinational, open-label, randomized, parallel-group, multicenter study evaluated the safety of a 4-dose series of MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, concomitantly administered with routine vaccinations to healthy infants.

METHODS

Two-month-old infants were randomized 3:1 to receive MenACWY-CRM with routine vaccines or routine vaccines alone at ages 2, 4, 6 and 12 months. Adverse events (AEs) that were medically attended and serious adverse events (SAEs) were collected from all subjects from enrollment through 18 months of age. In a subset, detailed safety data (local and systemic solicited reactions and all AEs) were collected for 7 days post vaccination. The primary objective was a non-inferiority comparison of the percentages of subjects with ≥1 severe systemic reaction during Days 1-7 after any vaccination of MenACWY-CRM plus routine vaccinations versus routine vaccinations alone (criterion: upper limit of 95% confidence interval [CI] of group difference <6%).

RESULTS

A total of 7744 subjects were randomized with 1898 in the detailed safety arm. The percentage of subjects with severe systemic reactions was 16% after MenACWY-CRM plus routine vaccines and 13% after routine vaccines alone (group difference 3.0% (95% CI -0.8, 6.4%). Although the non-inferiority criterion was not met, post hoc analysis controlling for significant center and group-by-center differences revealed that MenACWY-CRM plus routine vaccinations was non-inferior to routine vaccinations alone (group difference -0.1% [95% CI -4.9%, 4.7%]). Rates of solicited AEs, medically attended AEs, and SAEs were similar across groups.

CONCLUSION

In a large multinational safety study, a 4-dose series of MenACWY-CRM concomitantly administered with routine vaccines was clinically acceptable with a similar safety profile to routine vaccines given alone.

Authors+Show Affiliations

Instituto de Atención Pediatrica, Apdo 607-1150 La Uruca, San Jose, Costa Rica.Wee Care Pediatrics, 2084N 1700W Suite A, Layton, UT, United States.Guanchipelin, San Rafael, Escazu, Heredia, Costa Rica.Centro de Investigaciones en Pediatría, Guatemala City, Guatemala.Department of Pediatrics, Mackay Memorial Hospital, 92, Sec. 2, Zhongshan N. Rd., Zhongshan District, Taipei City 104, Taiwan.Department of Pediatrics, Chang Gung Children's Hospital, Chang Gung University College of Medicine, No.199, Tunghwa Rd., Taipei, Taiwan.Instituto de Investigación Nutricional, Av. La Molina 1885, Lima 12, Peru.Hospital Materno Infantil José Domingo de Obaldía, Ciudad de David, Chiriqui, Panama.Novartis Vaccines and Diagnostics, Inc., 350 Massachusetts Avenue, Cambridge, MA 02139, United States.Novartis Vaccines and Diagnostics, Inc., 350 Massachusetts Avenue, Cambridge, MA 02139, United States.Novartis Vaccines and Diagnostics, Inc., 350 Massachusetts Avenue, Cambridge, MA 02139, United States.Novartis Vaccines and Diagnostics, Inc., 350 Massachusetts Avenue, Cambridge, MA 02139, United States.Novartis Vaccines and Diagnostics, Inc., 350 Massachusetts Avenue, Cambridge, MA 02139, United States. Electronic address: peter.dull@novartis.com.

Pub Type(s)

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

Language

eng

PubMed ID

24397906

Citation

Abdelnour, Arturo, et al. "Safety of a Quadrivalent Meningococcal Serogroups A, C, W and Y Conjugate Vaccine (MenACWY-CRM) Administered With Routine Infant Vaccinations: Results of an Open-label, Randomized, Phase 3b Controlled Study in Healthy Infants." Vaccine, vol. 32, no. 8, 2014, pp. 965-72.
Abdelnour A, Silas PE, Lamas MR, et al. Safety of a quadrivalent meningococcal serogroups A, C, W and Y conjugate vaccine (MenACWY-CRM) administered with routine infant vaccinations: results of an open-label, randomized, phase 3b controlled study in healthy infants. Vaccine. 2014;32(8):965-72.
Abdelnour, A., Silas, P. E., Lamas, M. R., Aragón, C. F., Chiu, N. C., Chiu, C. H., Acuña, T. H., Castrejón, T. d. e. . L., Izu, A., Odrljin, T., Smolenov, I., Hohenboken, M., & Dull, P. M. (2014). Safety of a quadrivalent meningococcal serogroups A, C, W and Y conjugate vaccine (MenACWY-CRM) administered with routine infant vaccinations: results of an open-label, randomized, phase 3b controlled study in healthy infants. Vaccine, 32(8), 965-72. https://doi.org/10.1016/j.vaccine.2013.12.034
Abdelnour A, et al. Safety of a Quadrivalent Meningococcal Serogroups A, C, W and Y Conjugate Vaccine (MenACWY-CRM) Administered With Routine Infant Vaccinations: Results of an Open-label, Randomized, Phase 3b Controlled Study in Healthy Infants. Vaccine. 2014 Feb 12;32(8):965-72. PubMed PMID: 24397906.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety of a quadrivalent meningococcal serogroups A, C, W and Y conjugate vaccine (MenACWY-CRM) administered with routine infant vaccinations: results of an open-label, randomized, phase 3b controlled study in healthy infants. AU - Abdelnour,Arturo, AU - Silas,Peter E, AU - Lamas,Marta Raquel Valdés, AU - Aragón,Carlos Fernándo Grazioso, AU - Chiu,Nan-Chang, AU - Chiu,Cheng-Hsun, AU - Acuña,Teobaldo Herrera, AU - Castrejón,Tirza De León, AU - Izu,Allen, AU - Odrljin,Tatjana, AU - Smolenov,Igor, AU - Hohenboken,Matthew, AU - Dull,Peter M, Y1 - 2014/01/04/ PY - 2013/07/01/received PY - 2013/12/03/revised PY - 2013/12/12/accepted PY - 2014/1/9/entrez PY - 2014/1/9/pubmed PY - 2014/8/16/medline KW - AE KW - Adverse events KW - DTaP KW - H. influenzae type b [vaccine] KW - Hib KW - IM KW - IMD KW - IPV KW - Infant KW - MenACWY-CRM KW - Meningococcal KW - SAE KW - Safety KW - Vaccine KW - adverse event KW - diphtheria, tetanus, pertussis [vaccine] KW - inactivated polio vaccine KW - intramuscular KW - invasive meningococcal disease KW - serious adverse event SP - 965 EP - 72 JF - Vaccine JO - Vaccine VL - 32 IS - 8 N2 - BACKGROUND: The highest risk for invasive meningococcal disease (IMD) is in infants aged <1 year. Quadrivalent meningococcal conjugate vaccination has the potential to prevent IMD caused by serogroups A, C, W and Y. This phase 3b, multinational, open-label, randomized, parallel-group, multicenter study evaluated the safety of a 4-dose series of MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, concomitantly administered with routine vaccinations to healthy infants. METHODS: Two-month-old infants were randomized 3:1 to receive MenACWY-CRM with routine vaccines or routine vaccines alone at ages 2, 4, 6 and 12 months. Adverse events (AEs) that were medically attended and serious adverse events (SAEs) were collected from all subjects from enrollment through 18 months of age. In a subset, detailed safety data (local and systemic solicited reactions and all AEs) were collected for 7 days post vaccination. The primary objective was a non-inferiority comparison of the percentages of subjects with ≥1 severe systemic reaction during Days 1-7 after any vaccination of MenACWY-CRM plus routine vaccinations versus routine vaccinations alone (criterion: upper limit of 95% confidence interval [CI] of group difference <6%). RESULTS: A total of 7744 subjects were randomized with 1898 in the detailed safety arm. The percentage of subjects with severe systemic reactions was 16% after MenACWY-CRM plus routine vaccines and 13% after routine vaccines alone (group difference 3.0% (95% CI -0.8, 6.4%). Although the non-inferiority criterion was not met, post hoc analysis controlling for significant center and group-by-center differences revealed that MenACWY-CRM plus routine vaccinations was non-inferior to routine vaccinations alone (group difference -0.1% [95% CI -4.9%, 4.7%]). Rates of solicited AEs, medically attended AEs, and SAEs were similar across groups. CONCLUSION: In a large multinational safety study, a 4-dose series of MenACWY-CRM concomitantly administered with routine vaccines was clinically acceptable with a similar safety profile to routine vaccines given alone. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/24397906/Safety_of_a_quadrivalent_meningococcal_serogroups_A_C_W_and_Y_conjugate_vaccine__MenACWY_CRM__administered_with_routine_infant_vaccinations:_results_of_an_open_label_randomized_phase_3b_controlled_study_in_healthy_infants_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(13)01765-9 DB - PRIME DP - Unbound Medicine ER -