Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multicenter, randomized, double-blinded, positive controlled study to evaluate the lot-to-lot consistency, immunogenicity and safety of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) in adults aged 18 to 55 years. Subjects will be randomized to receive investigational Lot 1, Lot 2, Lot 3 vaccine or control vaccine in a 1:1:1:1 ratio, with the subjects in experimental group randomly and equally assigned to three different batches of MCV4 for single-dose vaccination.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| batch 1 of MCV4 | Experimental | 1 dose of Menhycia on Day 0 |
|
| batch 2 of MCV4 | Experimental | 1 dose of Menhycia on Day 0 |
|
| batch 3 of MCV4 | Experimental | 1 dose of Menhycia on Day 0 |
|
| Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine | Active Comparator | 1 dose of Menactra on Day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| batch 1 of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) (MCV4) | Biological | 1 dose of Menhycia (0.5ml) on Day 0, Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| The geometric mean titer (GMT) of serogroup A, C, Y and W135 meningococcal rSBA titer in all participants. | Day 30 post vaccination | |
| The seroconversion rate of serogroup A, C, Y, and W135 meningococcal rSBA titer. | Day 30 post vaccination | |
| The incidence of adverse reactions (ARs) in all participants. | Within 7 days post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The geometric mean fold increase (GMI) of serogroup A, C, Y and W135 meningococcal rSBA titer in all participants. | Day 30 post vaccination | |
| The proportion of GMT ≥ 1:128 of serogroup A, C, Y and W135 meningococcal rSBA titer on day 30 post vaccination in all participants. |
Not provided
Inclusion Criteria:
Participants aged 18-55 years old at the time of screening, who are in good health condition as determined by the study clinician.
Participants who have not been vaccinated with any meningococcal vaccines (including but not limited to meningococcal group A and C conjugate vaccine, meningococcal group A and C polysaccharide vaccine, Group ACYW135 Meningococcal polysaccharide/conjugate vaccine).
The participant or participant's legal guardian signs the informed consent form (ICF) and participant agrees to comply with the requirements of protocol and finish the 1-year follow-up.
Participants who are willing to discuss medical history with investigators or doctors and allow access to all medical records relevant to this trial.
Participants with child-bearing potential who are willing to practice adequate contraception methods from signing the ICF to 12 months after vaccination. This includes:
Be able to communicate well with the investigator, and to understand and comply with the requirements of this clinical trial.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Isti Suharjanti, Dr | Husada Utama Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Husada Utama Hospital | Surabaya | 60131 | Indonesia |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| batch 2 of MCV4 | Biological | 1 dose of Menhycia (0.5ml) on Day 0, Intramuscular injection |
|
|
| batch 3 of MCV4 | Biological | 1 dose of Menhycia (0.5ml) on Day 0, Intramuscular injection |
|
|
| Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine | Biological | 1 dose of Menactra (0.5ml) on Day 0, Intramuscular injection |
|
|
| Day 30 post vaccination |
| The incidence of ARs and adverse events (AEs) in all participants. | Within 30 days post vaccination |
| The incidence of ARs in all participants. | Within 30 min post vaccination |
| The incidence of serious adverse events (SAEs) in all participants. | Within 365 days post vaccination |
| The GMT of serogroup A, C, Y and W135 meningococcal antibodies in the 480 subjects (120 of each subgroup,Immunopersistence group) | Day 90, day 180 and day 365 post vaccination |
| The GMI of serogroup A, C, Y and W135 meningococcal antibodies in the 480 subjects (120 of each subgroup,Immunopersistence group). | Day 90, day 180 and day 365 post vaccination |
| The proportion of GMT ≥ 1:128 of serogroup A, C, Y and W135 meningococcal antibodies in the 480 subjects (120 of each subgroup,Immunopersistence group). | Day 90, day 180 and day 365 post vaccination |
| ID | Term |
|---|---|
| D008585 | Meningitis, Meningococcal |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D008589 | Meningococcal Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C028581 | CRM197 (non-toxic variant of diphtheria toxin) |
| D022401 | Meningococcal Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided