Meningococcal Disease
Conditions
Keywords
conjugate vaccine, phase IV clinical trial, Neisseria meningitidis
Brief summary
A multicenter, single arm, post-marketing surveillance study. This study is a postlicensure requirement of the Korea Food and Drug Administration (KFDA) to provide continued safety evaluation of MenACWY in the Korean population from 2 months to 55 years of age, receiving MenACWY-CRM vaccination according to routine clinical practice and prescribing information.
Interventions
BIOLOGICALMenACWY-CRM (Menveo)
One dose administered intramuscularly preferably into the anterolateral aspect of the thigh in infants or into the deltoid muscle in children, adolescents and adults.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Individuals eligible for enrolment in this study are those: 1. male and female subjects from 2 months to 55 years of the age at the time of Visit 1 (including all 55 years old subjects, up to one day before their 56th year birthday), who are scheduled to receive vaccination with MenACWY-CRM conjugate vaccine, according to the local prescribing information and routine clinical practice; 2. to whom the nature of the study has been described and the subject or subject's parent/legal representative has provided written informed consent; 3. whom the investigator believes that the subject can and will comply with the requirements of the protocol (e.g., completion of the Diary Card); 4. who are in good health as determined by the outcome of medical history, physical assessment and clinical judgment of the investigator.
Exclusion criteria
1\. Contraindication, special warnings and/or precautions, as evaluated by the investigators, reported in the MenACWY-CRM conjugate vaccine Korean prescribing information. In particular, should not be included in the study a subject who has ever had: * an allergic reaction to the active substances or any of the other ingredients of the study vaccine; an allergic reaction to diphtheria toxoid; * an illness with high fever; however, a mild fever or upper respiratory infection (for example cold) itself is not a reason to delay vaccination. Special care should be taken for subjects having haemophilia or any other problem that may stop your blood from clotting properly, such as persons receiving blood thinners (anticoagulants).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | From Day 1 of vaccination to Day 7 post vaccination | Assessed solicited local AEs include: injection site erythema, injection site induration, injection site tenderness, injection site pain. Assessed solicited systemic AEs include: change in eating habits, sleepiness, irritability, rash, vomiting, diarrhea, fever, chills, nausea, malaise, generalized myalgia, generalized arthralgia, headache. Any is defined as any report of the specified symptom irrespective of intensity grade. Subjects from 2 months to 55 years of age were evaluated for the outcome measure. |
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | From Day 1 of vaccination to Day 7 post vaccination | An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. All unsolicited AEs reported from day 1 to day 7 post vaccination were assessed. Any is defined as any report of the specified symptom irrespective of intensity grade. Subjects from 2 months to 55 years of age were evaluated for the outcome measure. |
| Number of Subjects Reporting Medically Attended AEs (MAAEs) | From Day 1 of vaccination to study termination (Day 29/early termination) | MAAEs are defined as events that require a physician's visit or an emergency room visit. All reported MAAEs from day 1 to day 29 were assessed. Subjects from 2 months to 55 years of age were evaluated for the outcome measure. |
| Number of Subjects Reporting Serious AEs (SAEs) | From Day 1 of vaccination to study termination (Day 29/early termination) | An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening (i.e., the subject was, in the opinion of the investigator, at immediate risk of death from the event as it occurred); it does not refer to an event which hypothetically might have caused death if it were more severe, requires or prolongs subject's hospitalization, results in persistent or significant disability/incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions), results in a congenital anomaly/birth defect, is an important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. Subjects from 2 months to 55 years of age were evaluated for the outcome measure. |
Countries
South Korea
Participant flow
Recruitment details
Healthy subjects from 2 months to 55 years of age were enrolled in 46 centres in South Korea.
Pre-assignment details
Out of the 3,948 subjects enrolled, only 3,939 subjects were exposed to vaccination as 1 subject did not receive a study vaccination and 8 subjects did not provide post vaccination safety data. Among 3939 subjects, 15 subjects are in the ≥ 56 age category (outside the range defined as per the protocol).
Participants by arm
| Arm | Count |
|---|---|
| MenACWY-CRM Group Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care. | 3,939 |
| Total | 3,939 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Inappropriate enrollment | 18 |
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Withdrawal and inappropriate enrollment | 1 |
| Overall Study | Withdrawal by Subject | 22 |
Baseline characteristics
| Characteristic | MenACWY-CRM Group |
|---|---|
| Age, Continuous | 18.37 Years STANDARD_DEVIATION 15.4 |
| Age, Customized 11-18 years | 433 Participants |
| Age, Customized 19-34 years | 1286 Participants |
| Age, Customized 2-10 years | 890 Participants |
| Age, Customized 2- 23 months | 654 Participants |
| Age, Customized 2-5 years | 551 Participants |
| Age, Customized 35 - 55 years | 661 Participants |
| Age, Customized ≥ 56 years | 15 Participants |
| Age, Customized 6-10 years | 339 Participants |
| Race/Ethnicity, Customized Asian | 3937 Participants |
| Race/Ethnicity, Customized Caucasian | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants |
| Sex: Female, Male Female | 2181 Participants |
| Sex: Female, Male Male | 1758 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3,939 |
| other Total, other adverse events | 1,379 / 3,939 |
| serious Total, serious adverse events | 8 / 3,939 |
Outcome results
Primary
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Assessed solicited local AEs include: injection site erythema, injection site induration, injection site tenderness, injection site pain. Assessed solicited systemic AEs include: change in eating habits, sleepiness, irritability, rash, vomiting, diarrhea, fever, chills, nausea, malaise, generalized myalgia, generalized arthralgia, headache. Any is defined as any report of the specified symptom irrespective of intensity grade. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.
Time frame: From Day 1 of vaccination to Day 7 post vaccination
Population: This analysis was performed on the Safety per protocol set, which included enrolled subjects aged from 2 months to 55 years, who signed an informed consent, underwent screening, received a subject number and received a study vaccination and provided post vaccination data. Excluding 19 subjects from safety set with protocol violations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any irritability, 2 - 23 months | 219 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any chills, 11 - 18 years | 9 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any injection site induration, 35 - 55 years | 6 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any injection site tenderness, 2 - 23 months | 67 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any injection site erythema, 2 - 23 months | 32 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any injection site induration, 2 - 23 months | 28 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any change in eating habbits, 2 - 23 months | 110 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any sleepiness, 2 - 23 months | 126 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any injection site tenderness, 6 - 10 years | 108 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any injection site erythema, 6 - 10 years | 53 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any injection site induration, 6 - 10 years | 45 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any chills, 6 - 10 years | 7 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any nausea, 6 - 10 years | 7 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any malaise, 6 - 10 years | 5 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any vomiting, 2 - 23 months | 66 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any diarrhea, 2 - 23 months | 82 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any rash, 2 - 23 months | 20 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any fever, 2 - 23 months | 57 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any injection site tenderness, 2 - 5 years | 135 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any injection site erythema, 2 - 5 years | 71 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any injection site induration, 2 - 5 years | 49 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any change in eating habits, 2 - 5 years | 22 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any sleepiness, 2 - 5 years | 17 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any irritability, 2 - 5 years | 35 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any vomiting, 2 - 5 years | 4 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any diarrhea, 2 - 5 years | 7 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any rash, 2 - 5 years | 18 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any fever, 2 - 5 years | 12 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any myalgia, 6 - 10 years | 6 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any arthralgia, 6 - 10 years | 6 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any headache, 6 - 10 years | 11 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any rash, 6 - 10 years | 10 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any fever, 6 - 10 years | 9 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any injection site tenderness, 11 - 18 years | 91 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any fever, 19 - 34 years | 3 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any injection site erythema, 11 - 18 years | 17 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any injection site induration, 11 - 18 years | 21 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any nausea, 11 - 18 years | 4 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any malaise, 11 - 18 years | 9 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any fever, 11 - 18 years | 4 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any injenction site tenderness, 19 - 34 years | 214 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any injection site erythema, 19 - 34 years | 14 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any injection site induration, 19 - 34 years | 9 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any chills, 19 - 34 years | 7 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any nausea, 19 - 34 years | 6 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any injection site tenderness, 35 - 55 years | 174 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any malaise, 19 - 34 years | 20 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any myalgia, 19 - 34 years | 21 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any arthralgia, 19 - 34 years | 8 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any headache, 19 - 34 years | 29 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any rash, 19 - 34 years | 13 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any injection site erythema, 35 - 55 years | 7 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any chills, 35 - 55 years | 7 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any nausea, 35 - 55 years | 9 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any malaise, 35 - 55 years | 16 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any myalgia, 35 - 55 years | 23 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any arthralgia, 35 - 55 years | 15 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any headache, 35 - 55 years | 19 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any rash, 35 - 55 years | 6 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any fever, 35 - 55 years | 2 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any myalgia, 11 - 18 years | 12 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any arthralgia, 11 - 18 years | 5 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any headache, 11 - 18 years | 12 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) | Any rash, 11 - 18 years | 6 Participants |
Primary
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. All unsolicited AEs reported from day 1 to day 7 post vaccination were assessed. Any is defined as any report of the specified symptom irrespective of intensity grade. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.
Time frame: From Day 1 of vaccination to Day 7 post vaccination
Population: This analysis was performed on the Safety per protocol set, which included all enrolled subjects who signed an informed consent,underwent screening, received a subject number, received a study vaccination and provided post vaccination data. Excluding 19 subjects from safety set with protocol violations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenACWY-CRM Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 2 - 23 Months | 82 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 2 - 5 Years | 56 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 6 - 10 Years | 18 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 11 - 18 Years | 8 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 19 - 34 Years | 17 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 35 - 55 Years | 5 Participants |
Primary
Number of Subjects Reporting Medically Attended AEs (MAAEs)
MAAEs are defined as events that require a physician's visit or an emergency room visit. All reported MAAEs from day 1 to day 29 were assessed. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.
Time frame: From Day 1 of vaccination to study termination (Day 29/early termination)
Population: This analysis was performed on the Safety per protocol set, which included all enrolled subjects who signed an informed consent, underwent screening, received a subject number, received a study vaccination and provided post vaccination data. Excluding 19 subjects from safety set with protocol violations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenACWY-CRM Group | Number of Subjects Reporting Medically Attended AEs (MAAEs) | 2 - 23 Months | 238 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Medically Attended AEs (MAAEs) | 2 - 5 Years | 120 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Medically Attended AEs (MAAEs) | 6 - 10 Years | 28 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Medically Attended AEs (MAAEs) | 11 - 18 Years | 20 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Medically Attended AEs (MAAEs) | 19 - 34 Years | 16 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Medically Attended AEs (MAAEs) | 35 - 55 Years | 5 Participants |
Primary
Number of Subjects Reporting Serious AEs (SAEs)
An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening (i.e., the subject was, in the opinion of the investigator, at immediate risk of death from the event as it occurred); it does not refer to an event which hypothetically might have caused death if it were more severe, requires or prolongs subject's hospitalization, results in persistent or significant disability/incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions), results in a congenital anomaly/birth defect, is an important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.
Time frame: From Day 1 of vaccination to study termination (Day 29/early termination)
Population: This analysis was performed on the Safety per protocol set, which included all enrolled subjects who signed an informed consent, underwent screening, received a subject number, received a study vaccination and provided post vaccination data. Excluding 19 subjects from safety set with protocol violations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenACWY-CRM Group | Number of Subjects Reporting Serious AEs (SAEs) | 35 - 55 Years | 0 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Serious AEs (SAEs) | 2 - 23 Months | 3 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Serious AEs (SAEs) | 2 - 5 Years | 3 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Serious AEs (SAEs) | 6 - 10 Years | 0 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Serious AEs (SAEs) | 11 - 18 Years | 2 Participants |
| MenACWY-CRM Group | Number of Subjects Reporting Serious AEs (SAEs) | 19 - 34 Years | 0 Participants |