Article Text

other Versions

PDF
A novel combined Hib-MenC-TT glycoconjugate vaccine as a booster dose for toddlers: a Phase 3 open randomised controlled trial
  1. David Pace (dpace{at}mail.global.net.mt)
  1. University of Oxford, United Kingdom
    1. Matthew D Snape (matthew.snape{at}paediatrics.ox.ac.uk)
    1. University of Oxford, United Kingdom
      1. Sharon Westcar (sharon.westcar{at}paediatrics.ox.ac.uk)
      1. University of Oxford, United Kingdom
        1. Claire Oluwalana (c_olulana{at}hotmail.com)
        1. University of Oxford, United Kingdom
          1. Ly-Mee Yu (ly-mee.yu{at}cancer.org.uk)
          1. University of Oxford, United Kingdom
            1. Norman Begg (norman.t.begg{at}gsk.com)
            1. GlaxoSmithKline, Biologicals, Belgium
              1. Jacek Wysocki (jawysocki{at}pro.onet.pl)
              1. Poznan University of Medical Sciences & Specialist Team of Care over Mother and Child, Dispensary Me, Poland
                1. Hanna Czajka (mczajka{at}rpr.krakow.pl)
                1. Cracow Specialist Hospital, under the name of John Paul II, Vaccination Centre, Krakow, Poland, Poland
                  1. Gudrun Maechler (gudrun.g.maechler{at}gskbio.com)
                  1. GlaxoSmithKline, Biologicals, Belgium
                    1. Dominique Boutriau (dominique.boutriau{at}gskbio.com)
                    1. GlaxoSmithKline, Biologicals, Belgium
                      1. Andrew J Pollard (andrew.pollard{at}paediatrics.ox.ac.uk)
                      1. University of Oxford, United Kingdom

                        Abstract

                        Objective: To study the immunogenicity and reactogenicity of a combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine (Hib-MenC-TT), when administered as a booster dose in combination with a measles, mumps and rubella vaccine (MMR).

                        Design: A phase 3 open randomised controlled trial.

                        Setting: One centre in Oxford, UK and nine centres in Poland

                        Subjects: 12-15 month old healthy children

                        Interventions: In the primary stage of the study 500 healthy, 6-12 week old infants were randomised in a 3:1 ratio to receive Hib-MenC-TT + DTPa-IPV or MenC-CRM197 vaccine + DTPa-IPV-Hib. In the booster stage 476 of participants, 190 in the UK and 286 in Poland, were vaccinated with Hib-MenC-TT and MMR.

                        Main outcome measures: The proportion of children with protective serum antibody levels against MenC and Hib, 6 weeks following a Hib-MenC-TT booster dose.

                        Results: The co-primary objectives were met: the Hib-MenC-TT booster dose induced protective antibody titres in children who were vaccinated with a combination of Hib-MenC-TT + DTPa-IPV or MenC-CRM197 + DTPa-IPV-Hib at 2, 3 and 4 months of age. 94.8% (LL 95%CI 92.4) of participants had rSBA-MenC ≥1:128 and 100% (LL 95%CI 99.2) achieved anti-PRP concentrations ≥1.0μg/ml. The percentage of toddlers with a post boost rSBA-MenC of 1:128 was significantly higher after priming with Hib-MenC-TT (97.7%) than after MenC-CRM197 (86%) (difference: 11.7%; 95%CI 6.2 to 19.4).

                        Conclusion: The waning antibody titres against Hib and MenC following primary immunisation can be boosted to protective levels by administering a dose of the Hib-MenC-TT vaccine at 12-15 months of age, supporting the recent introduction of this vaccine in the UK immunisation schedule to sustain protection of children against Hib and MenC disease. Trial registration: Clinical trials.gov, NCT00258700. Study ID: 103974.

                        Statistics from Altmetric.com

                        Request permissions

                        If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

                        Linked Articles

                        • Atoms
                          Howard Bauchner