Article Text

  1. T Vesikari1,
  2. A Karvonen1,
  3. N Kitchin2,
  4. M Baudin3,
  5. S Thomas3,
  6. H Kroczynski3,
  7. A Fiquet3
  1. 1University of Tampere Medical School, Tampere, Finland
  2. 2Sanofi Pasteur MSD Ltd, Maiderhead, UK
  3. 3Sanofi Pasteur MSD SNC, Lyon, France


Background The 3-dose oral pentavalent rotavirus vaccine RotaTeq has been demonstrated to be efficacious, immunogenic and to have a good safety profile. Results from trials show good immunogenicity and safety when RotaTeq is used concomitantly with current childhood vaccines. Concomitant use with meningococcal group C conjugate vaccines (MCCV) has not been evaluated.

Objectives The primary objective was to demonstrate that RotaTeq can be co-administered with MCCV in healthy infants without impairing the seroprotective response to MCCV.

Methods 247 healthy infants, aged 6–7 weeks, were randomised (1:1) to receive 3 doses of RotaTeq and 2 doses of MCCV either concomitantly (Group 1) or alternating at separate visits, starting with RotaTeq (Group 2). Response to MCCV was measured by serum bactericidal antibody titres using rabbit complement (rSBA) and that for RotaTeq by serum anti-rotavirus IgA and serum neutralising antibody (SNA). Serious adverse events were recorded for 14 days following each vaccination; deaths and vaccine-related serious adverse events were recorded throughout the study.

Results Co-administration was non-inferior to sequential administration and the seroprotection rate to MCCV (rSBA >1:8) was 100% in both groups. Both the responses to MCCV (titre >1:128, 4-fold increase titres, and GMTs) and RotaTeq (IgA, SNA response to G1-4 and P1A, GMTs and >3-fold increase) were similar between groups, including 3-fold IgA increase for >95% in both groups. Both vaccines were well tolerated when administered concomitantly.

Conclusions The immunogenicity and safety of RotaTeq and MCCV supports their concomitant use. Thus RotaTeq can now be used concomitantly with all routine childhood vaccines.

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