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A phase IIIb, open-label, randomised, multicentre study to evaluate the immunogenicity and safety of a booster dose of GlaxoSmithKline Biologicals’ dTpa-IPV vaccine (Boostrix Polio) compared with Sano...

Update Il y a 4 ans
Reference: EUCTR2008-006124-64

A phase IIIb, open-label, randomised, multicentre study to evaluate the immunogenicity and safety of a booster dose of GlaxoSmithKline Biologicals’ dTpa-IPV vaccine (Boostrix Polio) compared with Sanofi-Pasteur-MSD’s DTPa-IPV (Tetravac), when co-administered with MMRV (Priorix Tetra) in 5 to 6-year-old healthy children

Woman and Man

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Extract

To demonstrate that GSK Biologicals’ dTpa-IPV vaccine is non-inferior to Sanofi-Pasteur-MSD’s DTPa-IPV vaccine, in terms of seroprotection rates against diphtheria, tetanus and poliovirus types 1, 2 and 3, one month after vaccination.

Inclusion criteria

  • Booster immunisation of healthy preschool children against diphtheria, tetanus, pertussis, poliomyelitis, mumps, measles and rubella; and first or second immunisation of healthy preschool children against varicella

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