Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults, Adolescents, Children, and Toddlers in India and Healthy Adolescents and Children in the Republic of South Africa
Who is this study for? Patients with Meningococcal Infection
What treatments are being studied? Meningococcal Polysaccharide Vaccine
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This will be a Phase III, modified double-blind (open-label for toddlers in India), randomized, parallel-group, active-controlled, step-wise, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adults, adolescents, children, and toddlers in India and a modified double-blind, randomized, parallel-group, active-controlled, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adolescents and children in RSA.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: Accepts Healthy Volunteers
View:
• Age in the defined range on the day of inclusion: For Adults: Aged ≥ 18 years on the day of inclusion For Children and Adolescents: Aged 2 to 17 years on the day of inclusion For Toddlers: Aged 12 to 23 months† on the day of inclusion
• Z-score of ≥ -2 standard deviations (SD) on the Weight-for-height table of the World Health Organization (WHO) Child Growth Standards: For toddlers and children: Toddlers aged 12 to 23 months and Children aged 2 to 5 years must have a Z-score of ≥ -2 SD on the Weight-for-height table of the WHO Child Growth Standards
⁃ Informed consent obtained For adults: Informed consent form has been signed and dated by the subject and by an independent witness, if required by local regulations For toddlers, children, and adolescents: Assent form has been signed and dated by the subject (for subjects 7 to 17 years of age), and informed consent form has been signed and dated by the parent(s) or legally acceptable representative and by an independent witness, if required by local regulations
⁃ Able to attend all scheduled visits and to comply with all trial procedures For adults: Able to attend all scheduled visits and to comply with all trial procedures For toddlers, children, and adolescents: Participants and parent / legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
⁃ For Toddlers: All toddlers must be due to receive an age-recommended RPV on D0 - - - -
Locations
Other Locations
India
Investigational Site Number :3560002
Recruiting
Bangalore
Investigational Site Number :3560016
Recruiting
Belgaum
Investigational Site Number :3560015
Recruiting
Bhubaneswar
Investigational Site Number :3560007
Recruiting
Chennai
Investigational Site Number :3560004
Recruiting
Hyderabad
Investigational Site Number :3560011
Recruiting
Kolkata
Investigational Site Number :3560010
Recruiting
Ludhiana
Investigational Site Number :3560012
Recruiting
Mysore
Investigational Site Number :3560003
Recruiting
Pune
Investigational Site Number :3560008
Recruiting
Pune
South Africa
Investigational Site Number :7100007
Completed
Bloemfontein
Investigational Site Number :7100002
Completed
Cape Town
Investigational Site Number :7100005
Completed
Cape Town
Investigational Site Number :7100004
Completed
Johannesburg
Investigational Site Number :7100001
Completed
Middelburg
Investigational Site Number :7100006
Completed
Pretoria
Investigational Site Number :7100003
Completed
Soweto
Contact Information
Primary
Trial Transparency email recommended (Toll free number for US & Canada)
Contact-US@sanofi.com
Time Frame
Start Date:December 30, 2019
Estimated Completion Date:July 12, 2024
Participants
Target number of participants:1482
Treatments
Experimental: Group 1
MenACYW conjugate vaccine, 1 vaccination, adults in India aged 18 to 55 years
Active Comparator: Group 2
Menactra® conjugate vaccine, 1 vaccination, adults in India aged 18 to 55 years
Experimental: Group 3
MenACYW conjugate vaccine, 1 vaccination, adults in India aged ≥ 56 years
Active Comparator: Group 4
Quadri Meningo™, 1 vaccination, adults in India aged ≥ 56 years
Experimental: Group 5
MenACYW conjugate vaccine, 1 vaccination, children and adolescents in India aged 2 to 17 years
Active Comparator: Group 6
Menactra®, 1 vaccination, children and adolescents in India aged 2 to 17 years
Experimental: Group 7
MenACYW conjugate vaccine, 1 vaccination, children and adolescents in RSA aged 2 to 17 years
Active Comparator: Group 8
Menactra®, 1 vaccination, children and adolescents in RSA aged 2 to 17 years
Experimental: Group 9
MenACYW conjugate vaccine and age-recommended routine pediatric vaccine(s), toddlers aged 12 to 23 months in India
Active Comparator: Group 10
Age-recommended routine pediatric vaccine(s) (RPV) only, toddlers aged 12 to 23 months in India
Who is this study for: Patients with Meningococcal Infection
Enrollment Status: Recruiting
Publish Date: January 05, 2023
Intervention Type: Biological
Study Drugs: Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate Vaccine MenMeningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate VaccineMeningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate VaccineDiphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus and Haemophilus b Conjugate VaccineDiphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus VaccineHaemophilus b Conjugate VaccinePneumococcal 13-Valent Conjugate VaccineRotavirus Vaccine, Live, Oral, PentavalentHepatitis B VaccineMeasles, Mumps, and Rubella Virus Vaccine LiveVaricella Virus Vaccine Live