NCT03537508|CompletedPhase 3ResultsFDA Drug

Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US

A Phase III, Partially Modified Double-blind, Randomized, Parallel-group, Active-controlled, Multi-center Study to Compare the Immunogenicity and Describe the Safety of MenACYW Conjugate Vaccine and MENVEO® When Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in the United States

Sanofi Pasteur, a Sanofi Company ClinicalTrials.gov

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3 other identifiers

MET42U1111-1183-63612018-001473-24

Study Type

interventional

Target

2,627

Locations

2 countries

Sites

Timeline

RegisteredMay 2018

StartedApr 2018

CompletionSep 2023

Brief Summary

The purpose of this study was to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers in the US.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

2,627

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Apr 2018

Longer than P75 for phase_3

Geographic Reach

2 countries

70 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.4 years study duration

Study Start

First participant enrolled

April 25, 2018

Completed

20 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2018

Completed

10 days until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed

5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2023

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

October 15, 2024

Completed

Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

5.4 years

First QC Date

May 15, 2018

Results QC Date

August 23, 2024

Last Update Submit

October 10, 2024

Conditions

Healthy Volunteers (Meningococcal Infection)

Keywords

Meningococcal meningitisMenACYW conjugate vaccineQuadrivalent meningococcal vaccine

Outcome Measures

Primary Outcomes (2)

Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Vaccine seroresponse was defined as a post 4th dose (Day 30 after 12-month) hSBA titer \>=1:16 for participants with pre 1st dose (Day 0 before 2-month) hSBA titer less than (\<) 1:8, or at least a 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8. Percentages are rounded off to the tenth decimal place.
Day 30 post 12-month vaccination (Month 13)
Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place.
Day 30 post 6-month vaccination (Month 7)

Secondary Outcomes (15)

Groups 1 and 2: Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 Milli-International Units Per Milliliter (mIU/mL) at Day 30 Post 6-Month Vaccination
Day 30 post 6-month vaccination (Month 7)
Groups 1 and 2: Percentage of Participants Who Achieved Anti-Polyribosyl-Ribitol (PRP) Antibody Concentrations >=0.15 and >=1.0 Microgram (mcg)/mL at Day 30 Post 6-Month Vaccination
Day 30 post 6-month vaccination (Month 7)
Groups 1 and 2: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 6-Month Vaccination
Day 30 post 6-month vaccination (Month 7)
Groups 1 and 2: Percentage of Participants Who Achieved Anti-Rotavirus Immunoglobulin A (IgA) Antibody Concentrations >=3-Fold Rise at Day 30 Post 6-Month Vaccination
Day 30 post 6-month vaccination (Month 7)
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Anti-Rotavirus IgA Antibodies at Day 30 Post 6-Month Vaccination
Day 30 post 6-month vaccination (Month 7)
+10 more secondary outcomes

Study Arms (4)

Group 1a

EXPERIMENTAL

MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age

Biological: MenACYW conjugate vaccineBiological: DTaP-IPV//Hib vaccineBiological: Pneumococcal 13-valent conjugate vaccineBiological: Pentavalent rotavirus vaccineBiological: Hepatitis B vaccineBiological: Measles, mumps, rubella (MMR) vaccineBiological: Varicella vaccine

Group 1b

EXPERIMENTAL

MenACYW conjugate vaccine at 2, 4, 6, and 15 to 18 months of age and routine vaccines at 2, 4, 6, 12 to 15 months of age, and 15 to 18 months of age

Group 2a

ACTIVE COMPARATOR

MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age

Biological: MenACYW-135 conjugate vaccineBiological: DTaP-IPV//Hib vaccineBiological: Pneumococcal 13-valent conjugate vaccineBiological: Pentavalent rotavirus vaccineBiological: Hepatitis B vaccineBiological: Measles, mumps, rubella (MMR) vaccineBiological: Varicella vaccine

Group 2b

ACTIVE COMPARATOR

MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age

Interventions

MenACYW conjugate vaccineBIOLOGICAL

Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular

Group 1aGroup 1b

MenACYW-135 conjugate vaccineBIOLOGICAL

Meningococcal (Groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine, 0.5 mL, intramuscular

Also known as: MENVEO®

Group 2aGroup 2b

DTaP-IPV//Hib vaccineBIOLOGICAL

DTaP-IPV//Hib vaccine at 2, 4, 6 and 12 to 15 (Group 1a)/15-18 (Group 1b and Group 2) months of age Intramuscular

Also known as: Pentacel®