NCT01962207

The Long-term Antibody Persistence of MenACWY-TT Vaccine (PF-06866681) Versus Meningitec(Registered) or Mencevax(Registered) ACWY in Healthy Adolescents and Adults and a Booster Dose of MenACWY-TT Administered 10 Years Post Primary Vaccination

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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).

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal vaccine GSK134612	One dose administered intramuscularly (IM) in the deltoid of the non-dominant arm

Timeline

• Start date: 2013-10-01
• Primary completion: 2017-12-01
• Completion: 2018-06-01
• First posted: 2013-10-14
• Last updated: 2019-06-07
• Results posted: 2019-06-07

Locations

9 sites across 1 country: Finland