None listed
Conditions
Interventions
Intervention1: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine: Solution for injection
Intramuscular, 0.5 mL
Single Dose
Control Intervention1: Menactra®
Menin
Sponsors
Sanofi Pasteur Inc
Sanofi Healthcare India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Z-score of >= -2 standard deviations (SD) on the Weight-for-height table of the World Health Organization (WHO) Child Growth Standards 1.1 For children : 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 2. Informed consent obtained 2.1 For adults: Informed consent form has been signed and dated by the subject and by an independent witness, if required by local regulations 2.1.1 For 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 3. Able to attend all scheduled visits and to comply with all trial procedures 3.1 For adults: Able to attend all scheduled visits and to comply with all trial procedures 3.2 For children and adolescents: Participants and parent / legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
Exclusion criteria: 1. Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile 2. Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure 3. Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following vaccination except for oral poliovirus vaccine (OPV) in India, received during national immunization days. In India, OPV may be received with a gap of at least 2 weeks before the study vaccine. This exception includes monovalent and bivalent OPV. 4. Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C,Y, or W; or meningococcal B serogroup containing vaccine)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the non-inferiority of immunogenicity of a single dose of MenACYW conjugate vaccine compared to Menactra® in adolescents and children aged 2 to 17 years in terms of serum bactericidal assay using human complement (hSBA) titers.Timepoint: Day 30 (plus 14 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| To describe the antibody titers to the meningococcal serogroups A, C, Y, and W before and at Day (D) D30 (plus 14 days) after vaccination with MenACYW conjugate vaccine or a licensed meningococcal vaccine in adults in India aged 18 to 55 years (Menactra) or more than equal to 56 years (Quadri Meningo)Timepoint: Day 0 and Day 30 | — |
Countries
India, South Africa
Contacts
Public ContactDr Kuharaj Mahenthiran
Sanofi Healthcare India Private Limited
Outcome results
None listed