Status and phase
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Study type
Funder types
Identifiers
About
The MEQ00074 study was a Phase III, open-label, single-center study aimed at describing the immunogenicity and safety of a single dose of investigational quadrivalent Meningococcal Polysaccharide (serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine (MenACYW conjugate vaccine) in participants aged 12 months and older in Vietnam.
The primary objectives of the study were:
Full description
The duration of each participant's participation was approximately 30 to 44 days.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Aged 12 months and above on the day of inclusion
Adults:
Aged 18 and above on the day of inclusion
A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applies:
A female participant of childbearing potential would have a negative highly sensitive pregnancy test (urine) within 1 week before the dose of study intervention.
Adolescents:
Aged 10 to 17 years on the day of inclusion
A female participant was eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
A female participant of childbearing potential would have a negative highly sensitive pregnancy test (urine) within 1 week before the dose of study intervention.
Children:
Toddlers
Exclusion criteria
Participants were excluded from the study if any of the following criteria apply:
Adults (aged 18 years and above), Adolescents (aged 10 to 17 years), Children (aged 2 to 9 years) and Toddlers (aged 12 to 23 months)
Adults (aged 18 years and above) and Adolescents (aged 10 to 17 years)
Children (aged 2 to 9 years)
Toddlers (aged 12 to 23 months)
Primary purpose
Allocation
Interventional model
Masking
447 participants in 1 patient group
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Central trial contact
Trial Transparency email recommended (Toll free for US & Canada)
Data sourced from clinicaltrials.gov
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