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

Who is this study for? Infant patients with Meningococcal Meningitis
What treatments are being studied? MenACYW Vaccine
Status: Active, not recruiting
Location: See all (22) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Primary objective is to demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of a 3-dose series of MenACYW conjugate vaccine compared to a 3-dose series of a licensed meningococcal vaccine when each vaccine is given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b [DTaP-IPV-HB-Hib vaccine]) to infants and toddlers 6 weeks to 18 months old Secondary objectives are: To demonstrate the non-inferiority of the antibody (Ab) response against meningococcal serogroups A, C, Y, and W following the administration of 2 doses in infancy of MenACYW conjugate vaccine compared to 2 doses of a licensed meningococcal vaccine when each vaccine is given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and DTaP-IPV-HB-Hib vaccine) to infants and toddlers 6 weeks to 18 months old. To describe the Ab responses against meningococcal groups A, C, Y, and W and the antigens of the routine pediatric vaccines administered in the study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 2 months
Healthy Volunteers: Accepts Healthy Volunteers
View:

• Aged ≥ 42 to ≤ 89 days on the day of the first study visit

• Healthy infants as determined by medical history, physical examination and judgment of the Investigator

• Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative

• Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all study procedures

• Covered by health insurance according to local regulations

Locations
Other Locations
Finland
Investigational Site Number :2462007
Espoo
Investigational Site Number :2462003
Helsinki
Investigational Site Number :2462004
Helsinki
Investigational Site Number :2462001
Järvenpää
Investigational Site Number :2462006
Kokkola
Investigational Site Number :2462005
Oulu
Investigational Site Number :2462002
Pori
Investigational Site Number :2462009
Seinajoki
Investigational Site Number :2462010
Tampere
Investigational Site Number :2462011
Tampere
Investigational Site Number :2462008
Turku
Italy
Investigational Site Number :3803002
Milano
Poland
Investigational Site Number :6167002
Bydgoszcz
Investigational Site Number :6167003
Siemianowice Slaskie
Investigational Site Number :6167006
Torun
Investigational Site Number :6167004
Trzebnica
Romania
Investigational Site Number :6424002
Calarasi
Investigational Site Number :6424006
Caracal
Spain
Investigational Site Number :7245002
Madrid
Investigational Site Number :7245003
Madrid
Investigational Site Number :7245001
Santiago De Compostela
Investigational Site Number :7245006
Sevilla
Time Frame
Start Date: December 14, 2018
Estimated Completion Date: October 20, 2023
Participants
Target number of participants: 1652
Treatments
Experimental: Group 1
MenACYW conjugate vaccine, 3 doses, co-administered with routine vaccines (10-valent pneumococcal vaccine, DTaP-IPV-HB-Hib vaccine, and measles, mumps, and rubella [MMR] vaccine) at 2, 4 and 12 to 18 months of age
Active Comparator: Group 2
Licensed meningococcal vaccine (Nimenrix®), 3 doses, co-administered with routine vaccines (10-valent pneumococcal vaccine, DTaP-IPV- HB-Hib vaccine, and MMR vaccine) at 2, 4 and 12 to 18 months of age
Experimental: Group 3
MenACYW conjugate vaccine, 3 doses, co-administered with routine vaccines (13-valent pneumococcal vaccine, DTaP-IPV-HB-Hib vaccine, and MMR vaccine) at 2, 4 and 12 to 18 months of age
Experimental: Group 4
MenACYW conjugate vaccine, 4 doses, co-administered with routine vaccines (13-valent pneumococcal vaccine, DTaP-IPV-HB-Hib vaccine, and MMR vaccine) at 2, 4, and 12 to 18 months of age and administered alone at 6 months of age
Sponsors
Leads: Sanofi Pasteur, a Sanofi Company

This content was sourced from clinicaltrials.gov

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