Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects From 2 Months to 55 Years of Age in the Republic of South Korea
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT01766206
Collaborator
(none)
3,948
54
1
58.3
73.1
1.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
3948 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Multicenter Post Marketing Surveillance Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ACWY Conjugate Vaccine(MenACWY-CRM) Administered According to the Prescribing Information to Healthy Subjects From 2 Months to 55 Years of Age in the Republic of South Korea.
Actual Study Start Date
:
Mar 15, 2013
Actual Primary Completion Date
:
Jan 22, 2018
Actual Study Completion Date
:
Jan 22, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Biological: MenACWY-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.
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Months
to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
Individuals eligible for enrolment in this study are those:
-
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;
-
to whom the nature of the study has been described and the subject or subject's parent/legal representative has provided written informed consent;
-
whom the investigator believes that the subject can and will comply with the requirements of the protocol (e.g., completion of the Diary Card);
-
who are in good health as determined by the outcome of medical history, physical assessment and clinical judgment of the investigator.
Exclusion Criteria:
- 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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Ansan | Korea, Republic of | 15381 | |
| 2 | GSK Investigational Site | Anyang | Korea, Republic of | 431 062 | |
| 3 | GSK Investigational Site | Bucheon | Korea, Republic of | 14610 | |
| 4 | GSK Investigational Site | Busan | Korea, Republic of | ||
| 5 | GSK Investigational Site | Changwon | Korea, Republic of | 51503 | |
| 6 | GSK Investigational Site | Daegu | Korea, Republic of | 706 090 | |
| 7 | GSK Investigational Site | DaeJeon | Korea, Republic of | 34189 | |
| 8 | GSK Investigational Site | Daejeon | Korea, Republic of | 34944 | |
| 9 | GSK Investigational Site | Donghae | Korea, Republic of | 25768 | |
| 10 | GSK Investigational Site | Gimhae-si | Korea, Republic of | 51004 | |
| 11 | GSK Investigational Site | Goyang-si, Gyeonggi-do | Korea, Republic of | 10503 | |
| 12 | GSK Investigational Site | Goyang-si | Korea, Republic of | 10589 | |
| 13 | GSK Investigational Site | Guro Gu | Korea, Republic of | 152703 | |
| 14 | GSK Investigational Site | Gwangmyeong-si | Korea, Republic of | 14250 | |
| 15 | GSK Investigational Site | Gwangmyeong | Korea, Republic of | 484 5 | |
| 16 | GSK Investigational Site | Gyeonggi do | Korea, Republic of | 158 774 | |
| 17 | GSK Investigational Site | Gyeonggi-do | Korea, Republic of | 16481 | |
| 18 | GSK Investigational Site | Gyeonggi-do | Korea, Republic of | 463 707 | |
| 19 | GSK Investigational Site | Gyeonggi-do | Korea, Republic of | ||
| 20 | GSK Investigational Site | Incheon | Korea, Republic of | 22214 | |
| 21 | GSK Investigational Site | Incheon | Korea, Republic of | 22397 | |
| 22 | GSK Investigational Site | Incheon | Korea, Republic of | 22736 | |
| 23 | GSK Investigational Site | JeJu | Korea, Republic of | 63070 | |
| 24 | GSK Investigational Site | Jeollanam Do | Korea, Republic of | 530822 | |
| 25 | GSK Investigational Site | Kyeonggido | Korea, Republic of | ||
| 26 | GSK Investigational Site | Pyeongtaek | Korea, Republic of | 450 832 | |
| 27 | GSK Investigational Site | Seoul | Korea, Republic of | 02598 | |
| 28 | GSK Investigational Site | Seoul | Korea, Republic of | 02717 | |
| 29 | GSK Investigational Site | Seoul | Korea, Republic of | 03966 | |
| 30 | GSK Investigational Site | Seoul | Korea, Republic of | 04143 | |
| 31 | GSK Investigational Site | Seoul | Korea, Republic of | 04154 | |
| 32 | GSK Investigational Site | Seoul | Korea, Republic of | 04168 | |
| 33 | GSK Investigational Site | Seoul | Korea, Republic of | 06591 | |
| 34 | GSK Investigational Site | Seoul | Korea, Republic of | 100 032 | |
| 35 | GSK Investigational Site | Seoul | Korea, Republic of | 110746 | |
| 36 | GSK Investigational Site | Seoul | Korea, Republic of | 130 702 | |
| 37 | GSK Investigational Site | Seoul | Korea, Republic of | 130-702 | |
| 38 | GSK Investigational Site | Seoul | Korea, Republic of | 130-711 | |
| 39 | GSK Investigational Site | Seoul | Korea, Republic of | 132-703 | |
| 40 | GSK Investigational Site | Seoul | Korea, Republic of | 135 244 | |
| 41 | GSK Investigational Site | Seoul | Korea, Republic of | 135720 | |
| 42 | GSK Investigational Site | Seoul | Korea, Republic of | 135951 | |
| 43 | GSK Investigational Site | Seoul | Korea, Republic of | 137 873 | |
| 44 | GSK Investigational Site | Seoul | Korea, Republic of | 138 162 | |
| 45 | GSK Investigational Site | Seoul | Korea, Republic of | 138201 | |
| 46 | GSK Investigational Site | Seoul | Korea, Republic of | 140 887 | |
| 47 | GSK Investigational Site | Seoul | Korea, Republic of | 143729 | |
| 48 | GSK Investigational Site | Seoul | Korea, Republic of | 156-070 | |
| 49 | GSK Investigational Site | Seoul | Korea, Republic of | 156755 | |
| 50 | GSK Investigational Site | Seoul | Korea, Republic of | 158 885 | |
| 51 | GSK Investigational Site | Seoul | Korea, Republic of | ||
| 52 | GSK Investigational Site | Ulsan | Korea, Republic of | 683380 | |
| 53 | GSK Investigational Site | Ulsan | Korea, Republic of | ||
| 54 | GSK Investigational Site | Yangju-si, Gyeonggi-do | Korea, Republic of | 11440 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
More Information
Publications
- Al-Tawfiq JA, Clark TA, Memish ZA. Meningococcal disease: the organism, clinical presentation, and worldwide epidemiology. J Travel Med. 2010 Sep-Oct;17 Suppl:3-8. doi: 10.1111/j.1708-8305.2010.00448.x.
- Bae SM, Kang YH. Serological and genetic characterization of meningococcal isolates in Korea. Jpn J Infect Dis. 2008 Nov;61(6):434-7.
- Cho HK, Lee H, Kang JH, Kim KN, Kim DS, Kim YK, Kim JS, Kim JH, Kim CH, Kim HM, Park SE, Oh SH, Chung EH, Cha SH, Choi YY, Hur JK, Hong YJ, Lee HJ, Kim KH. The causative organisms of bacterial meningitis in Korean children in 1996-2005. J Korean Med Sci. 2010 Jun;25(6):895-9. doi: 10.3346/jkms.2010.25.6.895. Epub 2010 May 24.
- Deasy A, Read RC. Challenges for development of meningococcal vaccines in infants and children. Expert Rev Vaccines. 2011 Mar;10(3):335-43. doi: 10.1586/erv.11.3. Review.
- Hill DJ, Griffiths NJ, Borodina E, Virji M. Cellular and molecular biology of Neisseria meningitidis colonization and invasive disease. Clin Sci (Lond). 2010 Feb 9;118(9):547-64. doi: 10.1042/CS20090513. Review.
- Lee JH, Cho HK, Kim KH, Kim CH, Kim DS, Kim KN, Cha SH, Oh SH, Hur JK, Kang JH, Kim JH, Kim YK, Hong YJ, Chung EH, Park SE, Choi YY, Kim JS, Kim HM, Choi EH, Lee HJ. Etiology of invasive bacterial infections in immunocompetent children in Korea (1996-2005): a retrospective multicenter study. J Korean Med Sci. 2011 Feb;26(2):174-83. doi: 10.3346/jkms.2011.26.2.174. Epub 2011 Jan 24.
- Moon SY, Chung DR, Kim SW, Chang HH, Lee H, Jung DS, Kim YS, Jung SI, Ryu SY, Heo ST, Moon C, Ki HK, Son JS, Kwon KT, Shin SY, Lee JS, Lee SS, Rhee JY, Lee JA, Joung MK, Cheong HS, Peck KR, Song JH. Changing etiology of community-acquired bacterial meningitis in adults: a nationwide multicenter study in Korea. Eur J Clin Microbiol Infect Dis. 2010 Jul;29(7):793-800. doi: 10.1007/s10096-010-0929-8. Epub 2010 May 1.
- Obaro SK, Madhi SA. Bacterial pneumonia vaccines and childhood pneumonia: are we winning, refining, or redefining? Lancet Infect Dis. 2006 Mar;6(3):150-61. Review.
- Rouphael NG, Stephens DS. Neisseria meningitidis: biology, microbiology, and epidemiology. Methods Mol Biol. 2012;799:1-20. doi: 10.1007/978-1-61779-346-2_1. Review.
- Trotter CL, Andrews NJ, Kaczmarski EB, Miller E, Ramsay ME. Effectiveness of meningococcal serogroup C conjugate vaccine 4 years after introduction. Lancet. 2004 Jul 24-30;364(9431):365-7.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01766206
Other Study ID Numbers:
- 205341
- V59_62
First Posted:
Jan 11, 2013
Last Update Posted:
Sep 21, 2018
Last Verified:
Jul 1, 2018
Studies a U.S. FDA-regulated Drug Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Healthy subjects from 2 months to 55 years of age were enrolled in 46 centres in South Korea. |
|---|---|
| Pre-assignment Detail | 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). |
| Arm/Group Title | MenACWY-CRM Group |
|---|---|
| Arm/Group Description | Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care. |
| Period Title: Overall Study | |
| STARTED | 3939 |
| COMPLETED | 3888 |
| NOT COMPLETED | 51 |
Baseline Characteristics
| Arm/Group Title | MenACWY-CRM Group |
|---|---|
| Arm/Group Description | Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care. |
| Overall Participants | 3939 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
18.37
(15.4)
|
| Age, Customized (Number) [Number] | |
| 2- 23 months |
654
16.6%
|
| 2-10 years |
890
22.6%
|
| 2-5 years |
551
14%
|
| 6-10 years |
339
8.6%
|
| 11-18 years |
433
11%
|
| 19-34 years |
1286
32.6%
|
| 35 - 55 years |
661
16.8%
|
| ≥ 56 years |
15
0.4%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
2181
55.4%
|
| Male |
1758
44.6%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| Asian |
3937
99.9%
|
| Caucasian |
1
0%
|
| Hispanic |
1
0%
|
Outcome Measures
| Title | Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | MenACWY-CRM Group |
|---|---|
| Arm/Group Description | Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care. |
| Measure Participants | 3920 |
| Any injection site tenderness, 2 - 23 months |
67
1.7%
|
| Any injection site erythema, 2 - 23 months |
32
0.8%
|
| Any injection site induration, 2 - 23 months |
28
0.7%
|
| Any change in eating habbits, 2 - 23 months |
110
2.8%
|
| Any sleepiness, 2 - 23 months |
126
3.2%
|
| Any irritability, 2 - 23 months |
219
5.6%
|
| Any vomiting, 2 - 23 months |
66
1.7%
|
| Any diarrhea, 2 - 23 months |
82
2.1%
|
| Any rash, 2 - 23 months |
20
0.5%
|
| Any fever, 2 - 23 months |
57
1.4%
|
| Any injection site tenderness, 2 - 5 years |
135
3.4%
|
| Any injection site erythema, 2 - 5 years |
71
1.8%
|
| Any injection site induration, 2 - 5 years |
49
1.2%
|
| Any change in eating habits, 2 - 5 years |
22
0.6%
|
| Any sleepiness, 2 - 5 years |
17
0.4%
|
| Any irritability, 2 - 5 years |
35
0.9%
|
| Any vomiting, 2 - 5 years |
4
0.1%
|
| Any diarrhea, 2 - 5 years |
7
0.2%
|
| Any rash, 2 - 5 years |
18
0.5%
|
| Any fever, 2 - 5 years |
12
0.3%
|
| Any injection site tenderness, 6 - 10 years |
108
2.7%
|
| Any injection site erythema, 6 - 10 years |
53
1.3%
|
| Any injection site induration, 6 - 10 years |
45
1.1%
|
| Any chills, 6 - 10 years |
7
0.2%
|
| Any nausea, 6 - 10 years |
7
0.2%
|
| Any malaise, 6 - 10 years |
5
0.1%
|
| Any myalgia, 6 - 10 years |
6
0.2%
|
| Any arthralgia, 6 - 10 years |
6
0.2%
|
| Any headache, 6 - 10 years |
11
0.3%
|
| Any rash, 6 - 10 years |
10
0.3%
|
| Any fever, 6 - 10 years |
9
0.2%
|
| Any injection site tenderness, 11 - 18 years |
91
2.3%
|
| Any injection site erythema, 11 - 18 years |
17
0.4%
|
| Any injection site induration, 11 - 18 years |
21
0.5%
|
| Any chills, 11 - 18 years |
9
0.2%
|
| Any nausea, 11 - 18 years |
4
0.1%
|
| Any malaise, 11 - 18 years |
9
0.2%
|
| Any myalgia, 11 - 18 years |
12
0.3%
|
| Any arthralgia, 11 - 18 years |
5
0.1%
|
| Any headache, 11 - 18 years |
12
0.3%
|
| Any rash, 11 - 18 years |
6
0.2%
|
| Any fever, 11 - 18 years |
4
0.1%
|
| Any injenction site tenderness, 19 - 34 years |
214
5.4%
|
| Any injection site erythema, 19 - 34 years |
14
0.4%
|
| Any injection site induration, 19 - 34 years |
9
0.2%
|
| Any chills, 19 - 34 years |
7
0.2%
|
| Any nausea, 19 - 34 years |
6
0.2%
|
| Any malaise, 19 - 34 years |
20
0.5%
|
| Any myalgia, 19 - 34 years |
21
0.5%
|
| Any arthralgia, 19 - 34 years |
8
0.2%
|
| Any headache, 19 - 34 years |
29
0.7%
|
| Any rash, 19 - 34 years |
13
0.3%
|
| Any fever, 19 - 34 years |
3
0.1%
|
| Any injection site tenderness, 35 - 55 years |
174
4.4%
|
| Any injection site erythema, 35 - 55 years |
7
0.2%
|
| Any injection site induration, 35 - 55 years |
6
0.2%
|
| Any chills, 35 - 55 years |
7
0.2%
|
| Any nausea, 35 - 55 years |
9
0.2%
|
| Any malaise, 35 - 55 years |
16
0.4%
|
| Any myalgia, 35 - 55 years |
23
0.6%
|
| Any arthralgia, 35 - 55 years |
15
0.4%
|
| Any headache, 35 - 55 years |
19
0.5%
|
| Any rash, 35 - 55 years |
6
0.2%
|
| Any fever, 35 - 55 years |
2
0.1%
|
| Title | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | MenACWY-CRM Group |
|---|---|
| Arm/Group Description | Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care. |
| Measure Participants | 3920 |
| 2 - 23 Months |
82
2.1%
|
| 2 - 5 Years |
56
1.4%
|
| 6 - 10 Years |
18
0.5%
|
| 11 - 18 Years |
8
0.2%
|
| 19 - 34 Years |
17
0.4%
|
| 35 - 55 Years |
5
0.1%
|
| Title | Number of Subjects Reporting Medically Attended AEs (MAAEs) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | MenACWY-CRM Group |
|---|---|
| Arm/Group Description | Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care. |
| Measure Participants | 3920 |
| 2 - 23 Months |
238
6%
|
| 2 - 5 Years |
120
3%
|
| 6 - 10 Years |
28
0.7%
|
| 11 - 18 Years |
20
0.5%
|
| 19 - 34 Years |
16
0.4%
|
| 35 - 55 Years |
5
0.1%
|
| Title | Number of Subjects Reporting Serious AEs (SAEs) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | MenACWY-CRM Group |
|---|---|
| Arm/Group Description | Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care. |
| Measure Participants | 3920 |
| 2 - 23 Months |
3
0.1%
|
| 2 - 5 Years |
3
0.1%
|
| 6 - 10 Years |
0
0%
|
| 11 - 18 Years |
2
0.1%
|
| 19 - 34 Years |
0
0%
|
| 35 - 55 Years |
0
0%
|
Adverse Events
| Time Frame | Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination). | |
|---|---|---|
| Adverse Event Reporting Description | Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category). | |
| Arm/Group Title | MenACWY-CRM Group | |
| Arm/Group Description | Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care. | |
All Cause Mortality |
||
| MenACWY-CRM Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/3939 (0%) | |
Serious Adverse Events |
||
| MenACWY-CRM Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 8/3939 (0.2%) | |
| General disorders | ||
| Pyrexia | 1/3939 (0%) | 1 |
| Infections and infestations | ||
| Bronchiolitis | 1/3939 (0%) | 1 |
| Pneumonia | 4/3939 (0.1%) | 4 |
| Tonsillitis | 1/3939 (0%) | 1 |
| Nervous system disorders | ||
| Dizziness | 1/3939 (0%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| MenACWY-CRM Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 1379/3939 (35%) | |
| Blood and lymphatic system disorders | ||
| Lymphadentitis | 1/3939 (0%) | 1 |
| Anaemia | 1/3939 (0%) | 1 |
| Iron deficiency anaemia | 1/3939 (0%) | 1 |
| Lymphadenitis | 1/3939 (0%) | 1 |
| Ear and labyrinth disorders | ||
| Ear pain | 1/3939 (0%) | 1 |
| Eye disorders | ||
| Conjunctivitis allergic | 1/3939 (0%) | 1 |
| Eye discharge | 1/3939 (0%) | 1 |
| Ocular hyperaemia | 1/3939 (0%) | 1 |
| Conjunctivitis allergic | 1/3939 (0%) | 1 |
| Keratitis | 1/3939 (0%) | 1 |
| Gastrointestinal disorders | ||
| Vomiting | 70/3939 (1.8%) | 70 |
| Enteritis | 5/3939 (0.1%) | 5 |
| Diarrhoea | 6/3939 (0.2%) | 6 |
| Vomiting | 5/3939 (0.1%) | 5 |
| Constipation | 2/3939 (0.1%) | 2 |
| Stomatitis | 2/3939 (0.1%) | 2 |
| Abdominal pain | 4/3939 (0.1%) | 4 |
| Colitis | 1/3939 (0%) | 1 |
| Dental caries | 1/3939 (0%) | 1 |
| Gastritis erosive | 1/3939 (0%) | 1 |
| Gastrooesophageal reflux disease | 1/3939 (0%) | 1 |
| Enteritis | 22/3939 (0.6%) | 23 |
| Diarrhoea | 7/3939 (0.2%) | 7 |
| Vomiting | 8/3939 (0.2%) | 8 |
| Constipation | 7/3939 (0.2%) | 7 |
| Stomatitis | 7/3939 (0.2%) | 7 |
| Gastritis | 6/3939 (0.2%) | 6 |
| Abdominal pain | 2/3939 (0.1%) | 2 |
| Colitis | 3/3939 (0.1%) | 3 |
| Chronic gastritis | 1/3939 (0%) | 1 |
| Dental caries | 1/3939 (0%) | 1 |
| Gastritis erosive | 1/3939 (0%) | 1 |
| Gastrooesophageal reflux disease | 1/3939 (0%) | 1 |
| Irritable bowel syndrome | 1/3939 (0%) | 1 |
| General disorders | ||
| Injection site tenderness | 202/3939 (5.1%) | 202 |
| Injection site pain | 592/3939 (15%) | 592 |
| Injection site erythema | 195/3939 (5%) | 195 |
| Injection site induration | 158/3939 (4%) | 158 |
| Diarrhea | 89/3939 (2.3%) | 89 |
| Chills | 31/3939 (0.8%) | 31 |
| Nausea | 28/3939 (0.7%) | 28 |
| Malaise | 53/3939 (1.3%) | 53 |
| Myalgia | 64/3939 (1.6%) | 64 |
| Arthralgia | 34/3939 (0.9%) | 34 |
| Fever | 87/3939 (2.2%) | 87 |
| Pyrexia | 8/3939 (0.2%) | 8 |
| Injection site erythema | 9/3939 (0.2%) | 9 |
| Injection site induration | 7/3939 (0.2%) | 7 |
| Injection site pruritus | 7/3939 (0.2%) | 7 |
| Injection site pain | 2/3939 (0.1%) | 2 |
| Injection site warmth | 2/3939 (0.1%) | 2 |
| Oedema peripheral | 2/3939 (0.1%) | 2 |
| Chest pain | 1/3939 (0%) | 1 |
| Injection site bruising | 1/3939 (0%) | 1 |
| Injection site swelling | 1/3939 (0%) | 1 |
| Pyrexia | 15/3939 (0.4%) | 17 |
| Injection site erythema | 1/3939 (0%) | 1 |
| Injection site pruritus | 1/3939 (0%) | 1 |
| Oedema peripheral | 2/3939 (0.1%) | 2 |
| Chest pain | 1/3939 (0%) | 1 |
| Injection site rash | 1/3939 (0%) | 1 |
| Injection site swelling | 1/3939 (0%) | 1 |
| Immune system disorders | ||
| Atopy | 1/3939 (0%) | 1 |
| Infections and infestations | ||
| Bronchitis | 21/3939 (0.5%) | 21 |
| Nasopharyngitis | 31/3939 (0.8%) | 31 |
| Pharyngitis | 13/3939 (0.3%) | 13 |
| Gastroenteritis | 5/3939 (0.1%) | 5 |
| Bronchiolitis | 11/3939 (0.3%) | 11 |
| Otitis media | 6/3939 (0.2%) | 6 |
| Pneumonia | 3/3939 (0.1%) | 3 |
| Rhinitis | 6/3939 (0.2%) | 6 |
| Conjunctivitis | 4/3939 (0.1%) | 4 |
| Tonsillitis | 6/3939 (0.2%) | 6 |
| Upper respiratory tract infection | 3/3939 (0.1%) | 3 |
| Influenza | 2/3939 (0.1%) | 2 |
| Cellulitis | 4/3939 (0.1%) | 4 |
| Acute sinusitis | 2/3939 (0.1%) | 2 |
| Herpangina | 2/3939 (0.1%) | 2 |
| Laryngitis | 2/3939 (0.1%) | 2 |
| Viral pharyngitis | 1/3939 (0%) | 1 |
| Cystitis | 2/3939 (0.1%) | 2 |
| Oral herpes | 1/3939 (0%) | 1 |
| Periodontitis | 1/3939 (0%) | 1 |
| Pharyngitis streptococcal | 1/3939 (0%) | 1 |
| Sinusitis | 1/3939 (0%) | 1 |
| Bronchitis | 94/3939 (2.4%) | 100 |
| Nasopharyngitis | 82/3939 (2.1%) | 93 |
| Pharyngitis | 40/3939 (1%) | 42 |
| Gastroenteritis | 30/3939 (0.8%) | 31 |
| Bronchiolitis | 28/3939 (0.7%) | 29 |
| Otitis media | 22/3939 (0.6%) | 22 |
| Pneumonia | 15/3939 (0.4%) | 16 |
| Rhinitis | 13/3939 (0.3%) | 13 |
| Conjunctivitis | 12/3939 (0.3%) | 12 |
| Tonsillitis | 17/3939 (0.4%) | 17 |
| Upper respiratory tract infection | 11/3939 (0.3%) | 11 |
| Influenza | 8/3939 (0.2%) | 8 |
| Cellulitis | 6/3939 (0.2%) | 6 |
| Acute sinusitis | 5/3939 (0.1%) | 5 |
| Impetigo | 5/3939 (0.1%) | 5 |
| Herpes dermatitis | 4/3939 (0.1%) | 4 |
| Otitis media acute | 4/3939 (0.1%) | 4 |
| Hand-foot-and-mouth disease | 3/3939 (0.1%) | 3 |
| Herpangina | 3/3939 (0.1%) | 3 |
| Laryngitis | 3/3939 (0.1%) | 3 |
| Oral candidiasis | 3/3939 (0.1%) | 3 |
| Viral pharyngitis | 3/3939 (0.1%) | 3 |
| Cystitis | 2/3939 (0.1%) | 2 |
| Oral herpes | 2/3939 (0.1%) | 2 |
| Pharyngitis bacterial | 2/3939 (0.1%) | 2 |
| Pharyngotonsillitis | 2/3939 (0.1%) | 2 |
| Tracheitis | 2/3939 (0.1%) | 2 |
| Bacterial infection | 1/3939 (0%) | 1 |
| Croup infectious | 1/3939 (0%) | 1 |
| Exanthema subitum | 1/3939 (0%) | 1 |
| Gastrointestinal infection | 1/3939 (0%) | 1 |
| Hordeolum | 1/3939 (0%) | 1 |
| Periodontitis | 1/3939 (0%) | 1 |
| Pharyngitis streptococcal | 1/3939 (0%) | 1 |
| Sinusitis | 1/3939 (0%) | 1 |
| Urinary tract infection | 1/3939 (0%) | 1 |
| Injury, poisoning and procedural complications | ||
| Arthropod bite | 1/3939 (0%) | 1 |
| Laceration | 1/3939 (0%) | 2 |
| Nail injury | 1/3939 (0%) | 1 |
| Arthropod bite | 1/3939 (0%) | 1 |
| Contusion | 2/3939 (0.1%) | 2 |
| Laceration | 1/3939 (0%) | 2 |
| Ligament sprain | 1/3939 (0%) | 1 |
| Muscle strain | 1/3939 (0%) | 1 |
| Skin abrasion | 1/3939 (0%) | 1 |
| Metabolism and nutrition disorders | ||
| Vitamin D deficiency | 1/3939 (0%) | 1 |
| Vitamin D deficiency | 1/3939 (0%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Myalgia | 2/3939 (0.1%) | 2 |
| Arthralgia | 2/3939 (0.1%) | 2 |
| Neck pain | 1/3939 (0%) | 1 |
| Nervous system disorders | ||
| Sleepiness | 143/3939 (3.6%) | 143 |
| Headache | 73/3939 (1.9%) | 73 |
| Headache | 1/3939 (0%) | 1 |
| Burning sensation | 1/3939 (0%) | 1 |
| Dizziness | 1/3939 (0%) | 1 |
| Somnolence | 1/3939 (0%) | 1 |
| sleepiness | 1/3939 (0%) | 1 |
| Psychiatric disorders | ||
| Eating disorder | 132/3939 (3.4%) | 132 |
| Irritability | 254/3939 (6.4%) | 254 |
| Eating disorder | 6/3939 (0.2%) | 6 |
| Irritability | 4/3939 (0.1%) | 4 |
| Eating disorder | 3/3939 (0.1%) | 3 |
| Irritability | 1/3939 (0%) | 1 |
| Renal and urinary disorders | ||
| Haematuria | 1/3939 (0%) | 1 |
| Renal cyst | 1/3939 (0%) | 1 |
| Tubulointerstitial nephritis | 1/3939 (0%) | 1 |
| Haematuria | 1/3939 (0%) | 1 |
| Renal cyst | 1/3939 (0%) | 1 |
| Tubulointerstitial nephritis | 1/3939 (0%) | 1 |
| Reproductive system and breast disorders | ||
| Prostatic cyst | 1/3939 (0%) | 1 |
| Prostatic cyst | 1/3939 (0%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Rhinitis allergic | 6/3939 (0.2%) | 6 |
| Asthma | 1/3939 (0%) | 1 |
| Cough | 4/3939 (0.1%) | 4 |
| Rhinorrhoea | 2/3939 (0.1%) | 2 |
| Nasal congestion | 1/3939 (0%) | 1 |
| Productive cough | 1/3939 (0%) | 1 |
| Oropharyngeal pain | 1/3939 (0%) | 1 |
| Rhinitis allergic | 18/3939 (0.5%) | 18 |
| Asthma | 8/3939 (0.2%) | 8 |
| Cough | 2/3939 (0.1%) | 2 |
| Rhinorrhoea | 3/3939 (0.1%) | 3 |
| Nasal congestion | 2/3939 (0.1%) | 2 |
| Productive cough | 1/3939 (0%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Rash | 74/3939 (1.9%) | 74 |
| Dermatitis atopic | 7/3939 (0.2%) | 7 |
| Dermatitis | 5/3939 (0.1%) | 5 |
| Urticaria | 5/3939 (0.1%) | 5 |
| Dermatitis contact | 2/3939 (0.1%) | 2 |
| Dermatitis allergic | 1/3939 (0%) | 1 |
| Rash | 2/3939 (0.1%) | 2 |
| Cold sweat | 1/3939 (0%) | 1 |
| Dyshidrotic eczema | 1/3939 (0%) | 1 |
| Eczema | 1/3939 (0%) | 1 |
| Generalised erythema | 1/3939 (0%) | 1 |
| Pruritus | 1/3939 (0%) | 1 |
| Dermatitis atopic | 20/3939 (0.5%) | 20 |
| Dermatitis | 11/3939 (0.3%) | 11 |
| Urticaria | 10/3939 (0.3%) | 12 |
| Dermatitis contact | 8/3939 (0.2%) | 8 |
| Blister | 1/3939 (0%) | 1 |
| Dermatitis allergic | 2/3939 (0.1%) | 2 |
| Dermatitis diaper | 2/3939 (0.1%) | 2 |
| Eczema | 1/3939 (0%) | 1 |
| Generalised erythema | 1/3939 (0%) | 1 |
| Miliaria | 1/3939 (0%) | 1 |
| Seborrhoeic dermatitis | 1/3939 (0%) | 1 |
| Vascular disorders | ||
| Orthostatic hypotension | 1/3939 (0%) | 1 |
| Orthostatic hypotension | 1/3939 (0%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
| sss42438@gsk.com |
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01766206
Other Study ID Numbers:
- 205341
- V59_62
First Posted:
Jan 11, 2013
Last Update Posted:
Sep 21, 2018
Last Verified:
Jul 1, 2018