Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at three study centres in Taiwan.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled subjects were included in the trial.

Reporting Groups

	Description
2-10 Years	Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
11-18 Years	Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.

Participant Flow:   Overall Study

	2-10 Years	11-18 Years
STARTED	173	168
COMPLETED	173	167
NOT COMPLETED	0	1
Withdrawal by Subject	0	1

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was done on all the enrolled subjects.

Reporting Groups

	Description
2-10 Years	Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
11-18 Years	Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
Total	Total of all reporting groups

Baseline Measures

	2-10 Years	11-18 Years	Total
Overall Participants Analyzed  [Units: Participants]	173	168	341
Age  [Units: Years] Mean (Standard Deviation)	6.3  (2.6)	14.0  (2.2)	10.1  (4.5)
Gender  [Units: Subjects]
Female	92	88	180
Male	81	80	161

1.  Primary:

Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination   [ Time Frame: Day 1 and Day 29 ]

2.  Secondary:

Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group   [ Time Frame: Day 1 and Day 29 ]

3.  Secondary:

Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination   [ Time Frame: Day 1 and 29 ]

4.  Secondary:

Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination   [ Time Frame: Day 1 and Day 29 ]

5.  Secondary:

Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination   [ Time Frame: Day 1 and 29 ]

6.  Secondary:

Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years   [ Time Frame: From day 1 through day 7 postvaccination ]

7.  Secondary:

Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years   [ Time Frame: From day 1 through day 7 postvaccination ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.