NCT03691610

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

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 950 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months – 19 Months
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with routine pediatric vaccines to infants and toddlers 6 to 7 months of age and 12 to 13 months of age. The secondary objectives of the study are: * To demonstrate the non-inferiority of the percentage of participants with antibody titers to meningococcal serogroups A, C, Y, and W ≥ 1:8 following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with pediatric routine vaccines to infants and toddlers at 6 to 7 months of age and 12 to 13 months of age. * To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 12 to 13 months of age with MenACYW conjugate vaccine or MENVEO®. * To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days and 6 months after the first vaccination at 6 to 7 months of age with MenACYW conjugate vaccine or MENVEO®. * To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 20 to 23 months of age with MenACYW conjugate vaccine or Menactra®.

Detailed description

Study duration per participant is approximately 1 year in Group 1 and Group 2, and 10 months in Group 3 and Group 4. This duration includes a safety follow-up contact at 6 months after the last vaccination.

Conditions

• Healthy Volunteers (Meningococcal Infection)

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine	Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
BIOLOGICAL	Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine	Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
BIOLOGICAL	Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine	Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
BIOLOGICAL	Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine	Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
BIOLOGICAL	Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine	Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
BIOLOGICAL	Haemophilus b Conjugate Vaccine	Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
BIOLOGICAL	Pneumococcal 13-valent Conjugate Vaccine	Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
BIOLOGICAL	Rotavirus Vaccine, Live, Oral, Pentavalent	Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL
BIOLOGICAL	Hepatitis B Vaccine	Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
BIOLOGICAL	Measles, Mumps, and Rubella Virus Vaccine Live	Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL
BIOLOGICAL	Varicella Virus Vaccine Live	Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL

Timeline

• Start date: 2018-10-04
• Primary completion: 2023-10-20
• Completion: 2023-10-20
• First posted: 2018-10-02
• Last updated: 2024-06-25
• Results posted: 2024-06-25

Locations

47 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study