Format

Send to

Choose Destination
Vaccine. 2015 Feb 11;33(7):933-41. doi: 10.1016/j.vaccine.2014.08.027. Epub 2014 Aug 21.

Quadrivalent meningococcal (MenACWY-TT) conjugate vaccine or a fourth dose of H. influenzae-N. meningitidis C/Y conjugate vaccine (HibMenCY-TT) is immunogenic in toddlers who previously received three doses of HibMenCY-TT in infancy.

Author information

1
Palmetto Pediatrics, 2781 Tricom St, North Charleston, SC 29406, United States. Electronic address: mikeyleonardi@yahoo.com.
2
ACC Pediatric Research, Oak Thicket Shopping Center, 1025 Highway 80 East Haughton, Bossier City, LA 71037, United States.
3
Division of General Academic Pediatrics, University of Texas Medical Branch at Galveston, 301 University Blvd, Galveston, TX 77555, United States.
4
Baptist Health Lexington, 1740 Nicholasville Road, Lexington, KY 40503, United States.
5
Dixie Pediatrics, 1240 E 100 S Suite 14, Saint George, UT 84790, United States.
6
Jordan Valley Medical Center, 3580 West 9000 South, West Jordan, UT 84088, United States.
7
30 E Hickman Road, Waukee, IA 50263, United States.
8
Saint Clair Hospital, 1000 Bower Hill Road, Pittsburgh, PA 15243, United States.
9
GlaxoSmithKline Vaccines, Rue Fleming 20, Wavre 1300, Belgium.
10
GlaxoSmithKline Vaccines, 2301 Renaissance Blvd, RN0220, King of Prussia, PA 19406, United States.

Abstract

BACKGROUND:

Immunogenicity and safety of a single dose of MenACWY-TT or a fourth dose of HibMenCY-TT were evaluated in the second year of life in HibMenCY-TT-primed toddlers.

METHODS:

Healthy infants were randomized (5:1) and primed at 2, 4 and 6 months of age with HibMenCY-TT and diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus (DTaP-HBV-IPV) vaccine; or Hib-TT and DTaP-HBV-IPV (control). Recipients of HibMenCY-TT+DTaP-HBV-IPV were re-randomized (2:2:1) to receive MenACWY-TT at 12-15 months and DTaP at 15-18 months; MenACWY-TT co-administered with DTaP at 15-18 months; or HibMenCY-TT at 12-15 months and DTaP at 15-18 months. Controls received DTaP only at 15-18 months due to Hib conjugate vaccine shortage. Serum bactericidal activity using human complement (hSBA) and safety were assessed one month after meningococcal vaccination.

RESULTS:

After vaccination with MenACWY-TT at 12-15 months or MenACWY-TT+DTaP at 15-18 months, all subjects previously primed for serogroups C/Y had hSBA ≥1:8 for these serogroups. At least 96.1% also had hSBA ≥1:8 for serogroups A/W. All subjects in the HibMenCY-TT group had hSBA ≥1:8 for serogroups C/Y. All pre-defined statistical criteria for meningococcal immunogenicity were satisfied. All vaccination regimens had acceptable safety profiles.

CONCLUSION:

Children primed with three doses of HibMenCY-TT who then received a single dose of MenACWY-TT or a fourth dose of HibMenCY-TT had robust increases in hSBA titers for serogroups C/Y. These data provide support that MenACWY-TT, given with or without the fourth scheduled dose of DTaP could be administered as an alternative to a fourth dose of HibMenCY-TT in the second year of life. This study (110870/110871) is registered at www.clinicaltrials.gov NCT00614614.

KEYWORDS:

ACWY; Conjugate vaccine; HibMenCY; Quadrivalent meningococcal vaccine; Serum bactericidal activity

PMID:
25152325
DOI:
10.1016/j.vaccine.2014.08.027
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center