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Vaccine. 2014 Feb 12;32(8):965-72. doi: 10.1016/j.vaccine.2013.12.034. Epub 2014 Jan 4.

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.

Author information

1
Instituto de Atención Pediatrica, Apdo 607-1150 La Uruca, San Jose, Costa Rica.
2
Wee Care Pediatrics, 2084N 1700W Suite A, Layton, UT, United States.
3
Guanchipelin, San Rafael, Escazu, Heredia, Costa Rica.
4
Centro de Investigaciones en Pediatría, Guatemala City, Guatemala.
5
Department of Pediatrics, Mackay Memorial Hospital, 92, Sec. 2, Zhongshan N. Rd., Zhongshan District, Taipei City 104, Taiwan.
6
Department of Pediatrics, Chang Gung Children's Hospital, Chang Gung University College of Medicine, No.199, Tunghwa Rd., Taipei, Taiwan.
7
Instituto de Investigación Nutricional, Av. La Molina 1885, Lima 12, Peru.
8
Hospital Materno Infantil José Domingo de Obaldía, Ciudad de David, Chiriqui, Panama.
9
Novartis Vaccines and Diagnostics, Inc., 350 Massachusetts Avenue, Cambridge, MA 02139, United States.
10
Novartis Vaccines and Diagnostics, Inc., 350 Massachusetts Avenue, Cambridge, MA 02139, United States. Electronic address: peter.dull@novartis.com.

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.

KEYWORDS:

AE; Adverse events; DTaP; H. influenzae type b [vaccine]; Hib; IM; IMD; IPV; Infant; MenACWY-CRM; Meningococcal; SAE; Safety; Vaccine; adverse event; diphtheria, tetanus, pertussis [vaccine]; inactivated polio vaccine; intramuscular; invasive meningococcal disease; serious adverse event

PMID:
24397906
DOI:
10.1016/j.vaccine.2013.12.034
[Indexed for MEDLINE]

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