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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}
  1. University of Oxford, United Kingdom
    1. Matthew D Snape (matthew.snape{at}
    1. University of Oxford, United Kingdom
      1. Sharon Westcar (sharon.westcar{at}
      1. University of Oxford, United Kingdom
        1. Claire Oluwalana (c_olulana{at}
        1. University of Oxford, United Kingdom
          1. Ly-Mee Yu (ly-mee.yu{at}
          1. University of Oxford, United Kingdom
            1. Norman Begg (norman.t.begg{at}
            1. GlaxoSmithKline, Biologicals, Belgium
              1. Jacek Wysocki (jawysocki{at}
              1. Poznan University of Medical Sciences & Specialist Team of Care over Mother and Child, Dispensary Me, Poland
                1. Hanna Czajka (mczajka{at}
                1. Cracow Specialist Hospital, under the name of John Paul II, Vaccination Centre, Krakow, Poland, Poland
                  1. Gudrun Maechler (gudrun.g.maechler{at}
                  1. GlaxoSmithKline, Biologicals, Belgium
                    1. Dominique Boutriau (dominique.boutriau{at}
                    1. GlaxoSmithKline, Biologicals, Belgium
                      1. Andrew J Pollard (andrew.pollard{at}
                      1. University of Oxford, United Kingdom


                        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, NCT00258700. Study ID: 103974.

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