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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,480
1 dose of Menhycia (0.5ml) on Day 0, Intramuscular injection
1 dose of Menhycia (0.5ml) on Day 0, Intramuscular injection
1 dose of Menhycia (0.5ml) on Day 0, Intramuscular injection
1 dose of Menactra (0.5ml) on Day 0, Intramuscular injection
Husada Utama Hospital
Surabaya, Indonesia
The geometric mean titer (GMT) of serogroup A, C, Y and W135 meningococcal rSBA titer in all participants.
Time frame: Day 30 post vaccination
The seroconversion rate of serogroup A, C, Y, and W135 meningococcal rSBA titer.
Time frame: Day 30 post vaccination
The incidence of adverse reactions (ARs) in all participants.
Time frame: Within 7 days post vaccination
The geometric mean fold increase (GMI) of serogroup A, C, Y and W135 meningococcal rSBA titer in all participants.
Time frame: 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.
Time frame: Day 30 post vaccination
The incidence of ARs and adverse events (AEs) in all participants.
Time frame: Within 30 days post vaccination
The incidence of ARs in all participants.
Time frame: Within 30 min post vaccination
The incidence of serious adverse events (SAEs) in all participants.
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: Day 90, day 180 and day 365 post vaccination
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