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Polysaccharide Conjugate Vaccine

Two-Dose Menactra Group for Meningitis

Phase 2
Waitlist Available
Research Sponsored by Sanofi Pasteur, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 (pre-vaccination) and day 30 post-vaccination
Awards & highlights

Summary

Study will evaluate the persistence of antibodies approximately three years after an initial dose of Menactra® vaccine in toddlers who participated in study MTA26 (NCT00643916) and age-matched Menactra naive participants. Objectives: * To assess the persistence of antibody responses three years after one or two doses of Menactra® vaccine in subjects who participated in study MTA26. * To describe the antibody responses to a single dose of Menactra® vaccine in subjects who had previously received one or two doses of Menactra® vaccine and in Menactra® vaccine-naïve subjects. * To describe the safety profile of a single dose of Menactra® vaccine in subjects.

Eligible Conditions
  • Meningitis
  • Meningococcal Sepsis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 (pre-vaccination) and day 30 post-vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 (pre-vaccination) and day 30 post-vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
Other outcome measures
Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®.
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®

Side effects data

From 2015 Phase 4 trial • 1394 Patients • NCT01659996
59%
Irritability
51%
Injection Site Tenderness
39%
Crying abnormal
35%
Appetite lost
31%
Injection Site Erythema
30%
Drowsiness
21%
Injection-site Swelling
12%
Fever
11%
Upper respiratory tract infection
10%
Vomiting
9%
Teething
7%
Cough
6%
Diarrhoea
6%
Otitis media
5%
Rhinorrhoea
5%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pentacel Vaccine Group
Menactra + Pentacel Vaccine Group
Menactra Vaccine Group

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Two-Dose Menactra GroupExperimental Treatment1 Intervention
Participants received two doses of Menactra® in Study MTA26
Group II: One-Dose Menactra GroupExperimental Treatment1 Intervention
Participants received one dose of Menactra® in Study MTA26
Group III: Menactra vaccine-naïve GroupActive Control1 Intervention
Participants had never received Menactra® vaccine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neisseria meningitidis group c capsular polysaccharide diphtheria toxoid conjugate antigen
FDA approved

Find a Location

Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor
412 Previous Clinical Trials
6,095,684 Total Patients Enrolled
44 Trials studying Meningitis
90,580 Patients Enrolled for Meningitis
Medical MonitorStudy DirectorSanofi Pasteur Inc.
1,673 Previous Clinical Trials
988,254 Total Patients Enrolled
12 Trials studying Meningitis
4,993 Patients Enrolled for Meningitis
~10 spots leftby Sep 2025
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