A tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when co-administered with Twinrix(®) in subjects aged 11-17 years: an open, randomised, controlled trial

Lars Østergaard; Sven-Arne Silfverdal; Johan Berglund; Carl-Erik Flodmark; Christina West; Veronique Bianco; Yaela Baine; Jacqueline M Miller

doi:10.1016/j.vaccine.2011.11.051

A tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when co-administered with Twinrix(®) in subjects aged 11-17 years: an open, randomised, controlled trial

Vaccine. 2012 Jan 17;30(4):774-83. doi: 10.1016/j.vaccine.2011.11.051. Epub 2011 Nov 19.

Authors

Lars Østergaard¹, Sven-Arne Silfverdal, Johan Berglund, Carl-Erik Flodmark, Christina West, Veronique Bianco, Yaela Baine, Jacqueline M Miller

Affiliation

¹ Department of Infectious Diseases, Aarhus University Hospital, Brendstrupgaardsvej, 8200 Aarhus N, Denmark. [email protected]

PMID: 22107850
DOI: 10.1016/j.vaccine.2011.11.051

Abstract

The co-administration of the tetravalent meningococcal conjugate vaccine, MenACWY-TT, with a licensed hepatitis A and B vaccine, HepA/B (Twinrix(®)), was compared to their separate administration in this open, randomised, controlled study. Healthy subjects 11-17 years of age (n=611) were randomised (3:1:1) to receive both vaccines, MenACWY-TT alone or HepA/B alone. The co-administration of both vaccines was shown to be non-inferior to their individual administration. At seven months after the first vaccination, 99.4-100% of the subjects who received both vaccines co-administered showed seroprotection against all meningococcal serogroups and at least 99.1% of them were seropositive for hepatitis A and seroprotected against hepatitis B. This study suggests that MenACWY-TT vaccine could be co-administered with HepA/B without adversely impacting the immunogenicity, safety and reactogenicity of either of the vaccines.

Trial registration: ClinicalTrials.gov NCT00465816.

Publication types

Comparative Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Antibodies, Bacterial / blood
Child
Female
Hepatitis A Antibodies / blood
Hepatitis A Vaccines / administration & dosage*
Hepatitis A Vaccines / adverse effects
Hepatitis A Vaccines / immunology*
Hepatitis B Antibodies / blood
Hepatitis B Vaccines / administration & dosage*
Hepatitis B Vaccines / adverse effects
Hepatitis B Vaccines / immunology*
Humans
Male
Meningococcal Vaccines / administration & dosage*
Meningococcal Vaccines / adverse effects
Meningococcal Vaccines / immunology*
Tetanus Toxoid / administration & dosage*
Tetanus Toxoid / adverse effects
Tetanus Toxoid / immunology*
Vaccination / adverse effects
Vaccination / methods*
Vaccines, Combined / administration & dosage
Vaccines, Combined / adverse effects
Vaccines, Combined / immunology
Vaccines, Conjugate / administration & dosage
Vaccines, Conjugate / adverse effects
Vaccines, Conjugate / immunology

Substances

Antibodies, Bacterial
Hepatitis A Antibodies
Hepatitis A Vaccines
Hepatitis B Antibodies
Hepatitis B Vaccines
MenACWY
Meningococcal Vaccines
Tetanus Toxoid
Vaccines, Combined
Vaccines, Conjugate
twinrix

Associated data

ClinicalTrials.gov/NCT00465816