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Immunogenicity and reactogenicity of Infanrix™ when co-administered with meningococcal MenACWY-TT conjugate vaccine in toddlers primed with MenHibrix™ and Pediarix™.
Vaccine. 2015 Feb 11; 33(7):924-32.V

Abstract

BACKGROUND

Co-administration of an investigational quadrivalent meningococcal serogroups A, C, W and Y tetanus toxoid conjugate vaccine (MenACWY-TT) with the fourth dose of diphtheria-tetanus-acellular pertussis vaccine (DTaP) at age 15-18 months was investigated in 3-dose Haemophilus influenzae type b-meningococcal serogroups C/Y conjugate vaccine (HibMenCY-TT)-primed toddlers.

METHODS

Infants were randomized (5:1) and primed at 2, 4 and 6 months of age with HibMenCY-TT and DTaP-hepatitis B-inactivated poliovirus (DTaP-HBV-IPV) vaccine, or Hib-TT and DTaP-HBV-IPV (Control). HibMenCY-TT+ DTaP-HBV-IPV vaccinees were re-randomized (2:2:1) to receive MenACWY-TT at 12-15 months and DTaP at 15-18 months (MenACWY-TT group); MenACWY-TT co-administered with DTaP at 15-18 months (Coad group); or HibMenCY-TT at 12-15 months and DTaP at 15-18 months (HibMenCY-TT group). Controls received DTaP at 15-18 months. Only children in the HibMenCY-TT group received a fourth dose of Hib conjugate vaccine due to Hib conjugate vaccine shortage at the time of the study. DTaP immunogenicity and reactogenicity were assessed one month post-vaccination.

RESULTS

Pre-defined statistical non-inferiority criteria between Coad and Control groups were met for diphtheria, tetanus and filamentous haemagglutinin but not pertussis toxoid and pertactin. Following vaccination ≥99% of children had anti-diphtheria/anti-tetanus concentrations ≥1.0 IU/ml. Pertussis GMCs were lower in all investigational groups versus Control. In post hoc analyses, pertussis antibody concentrations were above those in infants following 3-dose DTaP primary vaccination in whom efficacy against pertussis was demonstrated (Schmitt, von König, et al., 1996; Schmitt, Schuind, et al., 1996). The reactogenicity profile of the Coad group was similar to DTaP administered alone.

CONCLUSION

Routine booster DTaP was immunogenic with an acceptable safety profile when co-administered with MenACWY-TT vaccine in HibMenCY-TT-primed toddlers. These data support the administration of a fourth DTaP dose following a 4-dose HibMenCY-TT vaccination series, or co-administered with MenACWY-TT in HibMenCY-TT-primed children.

Authors+Show Affiliations

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

Pub Type(s)

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

Language

eng

PubMed ID

25305567

Citation

Leonardi, Michael, et al. "Immunogenicity and Reactogenicity of Infanrix™ when Co-administered With Meningococcal MenACWY-TT Conjugate Vaccine in Toddlers Primed With MenHibrix™ and Pediarix™." Vaccine, vol. 33, no. 7, 2015, pp. 924-32.
Leonardi M, Latiolais T, Sarpong K, et al. Immunogenicity and reactogenicity of Infanrix™ when co-administered with meningococcal MenACWY-TT conjugate vaccine in toddlers primed with MenHibrix™ and Pediarix™. Vaccine. 2015;33(7):924-32.
Leonardi, M., Latiolais, T., Sarpong, K., Simon, M., Twiggs, J., Lei, P., Rinderknecht, S., Blatter, M., Bianco, V., Baine, Y., Friedland, L. R., Baccarini, C., & Miller, J. M. (2015). Immunogenicity and reactogenicity of Infanrix™ when co-administered with meningococcal MenACWY-TT conjugate vaccine in toddlers primed with MenHibrix™ and Pediarix™. Vaccine, 33(7), 924-32. https://doi.org/10.1016/j.vaccine.2014.09.064
Leonardi M, et al. Immunogenicity and Reactogenicity of Infanrix™ when Co-administered With Meningococcal MenACWY-TT Conjugate Vaccine in Toddlers Primed With MenHibrix™ and Pediarix™. Vaccine. 2015 Feb 11;33(7):924-32. PubMed PMID: 25305567.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and reactogenicity of Infanrix™ when co-administered with meningococcal MenACWY-TT conjugate vaccine in toddlers primed with MenHibrix™ and Pediarix™. AU - Leonardi,Michael, AU - Latiolais,Thomas, AU - Sarpong,Kwabena, AU - Simon,Michael, AU - Twiggs,Jerry, AU - Lei,Paul, AU - Rinderknecht,Stephen, AU - Blatter,Mark, AU - Bianco,Veronique, AU - Baine,Yaela, AU - Friedland,Leonard R, AU - Baccarini,Carmen, AU - Miller,Jacqueline M, Y1 - 2014/10/08/ PY - 2014/06/06/received PY - 2014/08/21/revised PY - 2014/09/16/accepted PY - 2014/10/12/entrez PY - 2014/10/12/pubmed PY - 2015/10/20/medline KW - Co-administration KW - DTaP vaccine KW - HibMenCY-TT KW - MenACWY-TT KW - Quadrivalent meningococcal vaccine SP - 924 EP - 32 JF - Vaccine JO - Vaccine VL - 33 IS - 7 N2 - BACKGROUND: Co-administration of an investigational quadrivalent meningococcal serogroups A, C, W and Y tetanus toxoid conjugate vaccine (MenACWY-TT) with the fourth dose of diphtheria-tetanus-acellular pertussis vaccine (DTaP) at age 15-18 months was investigated in 3-dose Haemophilus influenzae type b-meningococcal serogroups C/Y conjugate vaccine (HibMenCY-TT)-primed toddlers. METHODS: Infants were randomized (5:1) and primed at 2, 4 and 6 months of age with HibMenCY-TT and DTaP-hepatitis B-inactivated poliovirus (DTaP-HBV-IPV) vaccine, or Hib-TT and DTaP-HBV-IPV (Control). HibMenCY-TT+ DTaP-HBV-IPV vaccinees were re-randomized (2:2:1) to receive MenACWY-TT at 12-15 months and DTaP at 15-18 months (MenACWY-TT group); MenACWY-TT co-administered with DTaP at 15-18 months (Coad group); or HibMenCY-TT at 12-15 months and DTaP at 15-18 months (HibMenCY-TT group). Controls received DTaP at 15-18 months. Only children in the HibMenCY-TT group received a fourth dose of Hib conjugate vaccine due to Hib conjugate vaccine shortage at the time of the study. DTaP immunogenicity and reactogenicity were assessed one month post-vaccination. RESULTS: Pre-defined statistical non-inferiority criteria between Coad and Control groups were met for diphtheria, tetanus and filamentous haemagglutinin but not pertussis toxoid and pertactin. Following vaccination ≥99% of children had anti-diphtheria/anti-tetanus concentrations ≥1.0 IU/ml. Pertussis GMCs were lower in all investigational groups versus Control. In post hoc analyses, pertussis antibody concentrations were above those in infants following 3-dose DTaP primary vaccination in whom efficacy against pertussis was demonstrated (Schmitt, von König, et al., 1996; Schmitt, Schuind, et al., 1996). The reactogenicity profile of the Coad group was similar to DTaP administered alone. CONCLUSION: Routine booster DTaP was immunogenic with an acceptable safety profile when co-administered with MenACWY-TT vaccine in HibMenCY-TT-primed toddlers. These data support the administration of a fourth DTaP dose following a 4-dose HibMenCY-TT vaccination series, or co-administered with MenACWY-TT in HibMenCY-TT-primed children. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/25305567/Immunogenicity_and_reactogenicity_of_Infanrix™_when_co_administered_with_meningococcal_MenACWY_TT_conjugate_vaccine_in_toddlers_primed_with_MenHibrix™_and_Pediarix™_ DB - PRIME DP - Unbound Medicine ER -