NCT03630705

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

Safety and Immunogenicity of a 3-Dose Schedule of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 525 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 2 Months – 12 Months
• Healthy volunteers: Accepted

Summary

Primary Objective: 1. To describe the vaccine seroprotection (antibody titer greater than or equal to \[\>=\] 1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine or Menveo® measured by serum bactericidal assay using human complement (hSBA), for Groups 1 and 2 when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico. 2. To describe the vaccine seroprotection (antibody titer \>=1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine measured by hSBA, for Group 3, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in the Russian Federation. Secondary Objective: 1. To describe hSBA vaccine seroresponse to the antigens (meningococcal serogroups A, C, Y, and W) 30 days after the last vaccination of the infant series, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico and Russian Federation (RF). 2. To describe immunogenicity profile of routine pediatric vaccines when administered concomitantly with MenACYW Conjugate vaccine or Menveo®; or when administered alone. 3. To describe hSBA antibody responses against meningococcal serogroups A, C, Y, and W when MenACYW Conjugate vaccine and Menveo® are administered concomitantly with routine pediatric vaccines in Mexico and RF. 4. To describe antibody titers to the antigens present in MenACYW Conjugate vaccine and Menveo®, before the first vaccination and 30 days after the last vaccination of the infant series and in the second year of life, when administered concomitantly with routine pediatric vaccines in a subset of participants in Mexico and RF.

Detailed description

Study duration per participant was approximately 12 months.

Conditions

• Healthy Volunteers (Meningococcal Infection)

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine	Pharmaceutical form: Liquid solution Route of administration : Intramuscular
BIOLOGICAL	Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine	Pharmaceutical form: Lyophilized powder combined with liquid component Route of administration : Intramuscular
BIOLOGICAL	Measles, Mumps, and Rubella Virus Vaccine Live	Pharmaceutical form: Lyophilized live virus vaccine Route of administration : Subcutaneous
BIOLOGICAL	Pneumococcal 13-valent Conjugate Vaccine	Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
BIOLOGICAL	Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine	Pharmaceutical form: Powder and suspension for injection Route of administration: Intramuscular
BIOLOGICAL	Hepatitis B Vaccine	Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
BIOLOGICAL	Rotavirus Vaccine, Live, Pentavalent	Pharmaceutical form: Oral solution Route of administration: Oral
BIOLOGICAL	Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine	Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

Timeline

• Start date: 2018-10-17
• Primary completion: 2022-02-18
• Completion: 2022-02-18
• First posted: 2018-08-15
• Last updated: 2023-10-19
• Results posted: 2023-10-19

Locations

11 sites across 2 countries: Mexico, Russia

Regulatory

• FDA-regulated drug study