Infections, Meningococcal Clinical Trial
Official title:
A PHASE IIIB, OPEN, MULTI-CENTER STUDY TO EVALUATE THE LONG-TERM ANTIBODY PERSISTENCE AT 6, 7, 8, 9 AND 10 YEARS AFTER THE ADMINISTRATION OF ONE DOSE OF THE MENINGOCOCCAL CONJUGATE VACCINE MENACWY-TT VERSUS ONE DOSE OF MENINGITEC(REGISTERED) VACCINE OR ONE DOSE OF THE MENINGOCOCCAL POLYSACCHARIDE VACCINE MENCEVAX(REGISTERED) ACWY, AND TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A BOOSTER DOSE OF MENACWY-TT VACCINE ADMINISTERED 10 YEARS AFTER PRIMARY VACCINATION OF 1-10 YEAR OLD SUBJECTS WITH MENACWY-TT, MENINGITEC(REGISTERED) OR MENCEVAX(REGISTERED) ACWY.
The purpose of this study is to evaluate the long-term antibody persistence 6, 7, 8, 9 and 10 years after receiving a primary vaccination of meningococcal conjugate vaccine MenACWY-TT versus Meningitec™ or Mencevax™ ACWY, and the safety and immunogenicity of a booster dose of MenACWY-TT administered 10 years after the primary vaccination. All subjects received a primary vaccination at 1 to 10 years of age in study 108658 (NCT00427908). No new subjects will be enrolled in this booster study.
The study aims to evaluate the antibody persistence post primary vaccination with active
control, safety and immunogenicity of a booster dose uncontrolled post primary vaccination
during different phases:
Persistence phase: Long-term persistence 6, 7, 8, 9 and 10 years after primary vaccination
with MenACWY-TT or Meningitec or Mencevax ACWY, in study MenACWY-TT-027.
Booster phase: One month post booster vaccination with MenACWY-TT vaccine ten years after
primary vaccination.
The subjects in this study will be allocated to the same groups as in the vaccination study
MenACWY-TT-027 (NCT00427908).
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