Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers
CompletedPhase 2Results postedLast updated 4 April 2022
What this trial tests
Phase 2 trial testing Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine in Meningitis in 188 participants. Completed in 19 August 2015.
Adults 12 Months to 23 Months, any sex, with Meningitis or Meningococcal Meningitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®Primary· Day 0 up to Day 7 post-vaccination
A solicited reaction was defined as an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the case report form (CRF) and considered as related to vaccination. Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 solicited injection site reactions: Tenderness: cries when injected limb was moved or the movement of the injected limb was reduced; Erythema and Swelling: greater than or equal to (≥) 50
Any Injection site tenderness
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
28
Group 2: NIMENRIX®
31
Grade 3 Injection site tenderness
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
0
Group 2: NIMENRIX®
1
Any Injection site erythema
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
29
Group 2: NIMENRIX®
33
Grade 3 Injection site erythema
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
2
Group 2: NIMENRIX®
1
Any Injection site swelling
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
14
Group 2: NIMENRIX®
17
Grade 3 Injection site swelling
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
1
Group 2: NIMENRIX®
3
Any Fever
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
7
Group 2: NIMENRIX®
4
Grade 3 Fever
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
1
Group 2: NIMENRIX®
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of the study was to evaluate the immunogenicity and safety profile of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate vaccine when given alone compared to that of the licensed Meningococcal groups A, C, W 135 and Y (NIMENRIX®) Conjugate vaccine.
Observational objectives:
* To evaluate the antibody responses to the antigens (serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine and NIMENRIX® measured by serum bactericidal assay using baby rabbit complement (rSBA) and by serum bactericidal assay using human complement (hSBA)
* To evaluate the antibody responses against tetanus in participants who received MenACYW Conjugate vaccine or NIMENRIX® vaccine
* To evaluate the safety profile of MenACYW Conjugate vaccine and NIMENRIX®
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
Other trials of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Trials testing the same drug.
NCT05794230 — Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccine
· Phase 3
· completed
NCT03630705 — Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine
· Phase 3
· completed
NCT02955797 — Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers
· Phase 3
· completed
NCT02842853 — Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine
· Phase 3
· completed
NCT02842866 — Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults 56 Years and Olde
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sanofi Pasteur, a Sanofi Company
Last refreshed: 4 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03205358.