CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 301 enrolled
Drug / intervention
Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine +1 morebiological
Likely dose
Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 Combined 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01732627
NCT01732627Phase 2Completed
CompareCT.gov

Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered in Subjects 56 Years of Age and Older

Sanofi Pasteur, a Sanofi Company·interventional·Posted Nov 26, 2012·Updated Apr 4, 2022

In Brief

A Phase 2 clinical trial evaluating Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine and Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 Combined for Meningitis and 3 related conditions. Completed, enrolled 301 participants across 12 sites.

Detailed Summary

Primary objectives: * To describe the antibody responses to meningococcal serogroups A, C, Y, and W 135, measured by serum bactericidal assay using human complement (hSBA) and baby rabbit complement (rSBA), induced by a single dose of Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein (MenACYW) Conjugate vaccine or Menomune® - A/C/Y/W 135. * To describe the safety profile of a single dose of MenACYW Conjugate vaccine or Menomune® - A/C/Y/W 135.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningitis, Meningococcal Meningitis, Meningococcal Infections, Invasive Meningococcal Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 26, 2012
Enrollment StartNov 12, 2012
Primary CompletionJan 17, 2013
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.6 years ago

Interventions

Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccinebiological

0.5 milliliter (mL), Intramuscular (IM)

Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 Combinedbiological

0.5 mL, Subcutaneous (SC)