NCT03537508

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,627 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 42 Days – 89 Days
• Healthy volunteers: Accepted

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.

Detailed description

The duration of each subject's participation in the trial was approximately 16 to 19 months (Subgroup 1a) and 19 to 22 months (Subgroup 1b and Group 2), which included a safety follow up contact at 6 months after the last vaccinations.

Conditions

• Healthy Volunteers (Meningococcal Infection)

Interventions

Type	Name	Description
BIOLOGICAL	MenACYW conjugate vaccine	Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular
BIOLOGICAL	MenACYW-135 conjugate vaccine	Meningococcal (Groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine, 0.5 mL, intramuscular
BIOLOGICAL	DTaP-IPV//Hib vaccine	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
BIOLOGICAL	Pneumococcal 13-valent conjugate vaccine	Pneumococcal vaccine at 2, 4, 6, and 12 months of age, Intramuscular
BIOLOGICAL	Pentavalent rotavirus vaccine	Rotavirus vaccine at 2, 4, and 6 months of age, oral solution
BIOLOGICAL	Hepatitis B vaccine	Hepatitis B vaccine at 2 and 6 months of age, Intramuscular
BIOLOGICAL	Measles, mumps, rubella (MMR) vaccine	MMR vaccine at 12 months of age, Subcutaneous
BIOLOGICAL	Varicella vaccine	Varicella vaccine at 12 months of age
BIOLOGICAL	Hepatitis A vaccine	Hepatitis A vaccine at 15 to 18 months of age

Timeline

• Start date: 2018-04-25
• Primary completion: 2023-09-22
• Completion: 2023-09-22
• First posted: 2018-05-25
• Last updated: 2024-10-15
• Results posted: 2024-10-15

Locations

70 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study