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.
Phase: PHASE4
Conditions: Meningococcal Disease
Sponsor: GlaxoSmithKline

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13 JUN 12 Version 1.0 
Protocol V59_62 
Page 1 of 37 
Confidential 
A Multicenter Post Marketing Surveillance Study to Monitor the Safety of Novartis 
Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) Administered 
According to the Prescribing Information to Healthy Subjects from 11 to 55 Years of 
Age in the Republic of South Korea 
CLINICAL STUDY PROTOCOL V59_62 
Property of Novartis Vaccines and Diagnostics 
Confidential 
May not be used, divulged, published or otherwise disclosed without written 
consent of Novartis Vaccines and Diagnostics. 

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Confidential 
PROTOCOL SYNOPSIS V59_62 
Name of Sponsor 
Novartis Vaccines 
and Diagnostics 
Protocol number: 
V59_62 
Date of Protocol 
Synopsis: 
22 NOV 11 
Title of Study: A Multicenter Post Marketing Surveillance Study to Monitor the Safety 
of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) 
Administered According to the Prescribing Information to Healthy Subjects from 11 to 
55 Years of Age in the Republic of South Korea. 
Publication (reference): None 
Study Period: 29 days 
Clinical Phase: Post Marketing Surveillance 
Rationale: 
Neisseria meningitidis is a leading cause of bacterial meningitis and sepsis with a 
fatality rate of 5% to 15%; the fatality rate can be as high as 20% to 40% in 
meningococcal septicemia. 
In Korea meningococcal disease is a notifiable disease and any confirmed case is 
reported to the Korea Centers for Disease Control and Prevention. The disease has been 
regarded as a rare infection. However, during the period from 2002 to 2003 the number 
of reported cases in Korea dramatically increased, suggesting that the burden of 
meningococcal disease should be taken in serious consideration in this Country. 
Limited data are available about the incidence of meningococcal disease among age 
groups in Korea. Military personnel are considered to have a higher risk for the disease, 
probably due to the crowded living conditions. A specific group that has several 
characteristics in common with the military personnel is college students, especially 
dormitory residents. Nevertheless, one report, aiming to the serological characterization 
of 11 meningococcal isolates in Korea, shows an even distribution of cases among age 
groups (0-5 years: 2 subjects; 6-10 years: 2 subjects; 11-17 years: 2 subjects; 18-30 
years: 2 subjects; 31-55: 2 subjects; >56 years: 1 subject). 
Novartis Vaccines and Diagnostics (NVD) has developed a conjugate meningococcal 
ACWY (MenACWY-CRM) vaccine containing bacterial capsular oligosaccharides for 
serogroups A, C, W, and Y conjugated to a protein carrier CRM197 (a non-toxic mutant 
of diphtheria toxin). MenACWY-CRM is currently licensed in many Countries 
including Korea. Over 35,000 subjects have been enrolled in more than 30 clinical 
studies with over 25,000 receiving at least one dose of MenACWY-CRM. 
This is a post-marketing surveillance study to monitor the safety of MenACWY-CRM 
in Korean individuals from 11 to 55 years of age receiving MenACWY-CRM 
vaccination according to routine clinical practice and prescribing information. The study 

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Protocol V59_62 
Page 3 of 37 
Confidential 
 
Name of Sponsor 
Novartis Vaccines 
and Diagnostics 
Protocol number: 
V59_62 
Date of Protocol 
Synopsis: 
22 NOV 11 
is a post-licensure requirement of the Korea Food and Drug Administration (KFDA) to 
provide continued safety evaluation in the Korean population from 11 to 55 years of 
age. 
Study Agent: 
MenACWY-CRM Conjugate Vaccine (Menveo), one 0.5 mL dose to be administered 
by intramuscular injection in the deltoid area of (preferably) the non-dominant arm. 
Objectives: 
Immunogenicity and efficacy objectives 
No immunogenicity or efficacy objectives will be measured in this study. 
Safety objectives 
The primary objective of the study is to monitor the safety of a single dose of 
MenACWY-CRM vaccine in subjects from 11 to 55 years of age , as evaluated by: 
• Local and systemic solicited reactions reported from study Day 1 (day of 
vaccination) through study Day 7 post-vaccination; 
• All unsolicited adverse events (AEs) reported from study Day 1 (day of vaccination) 
through study Day 7 post-vaccination; 
• Medically attended adverse events reported from study Day 1 to study termination 
(Day 29/early termination); 
• All Serious adverse events (SAEs) reported from study Day 1 to study termination 
(Day 29/early termination). 
Methodology: 
This is a multicenter post marketing surveillance study to monitor the safety of 
MenACWY-CRM (Menveo) administered according to the prescribing information to 
3,300 healthy subjects from 11 to 55 years of age in Korea. 
 
Subjects will be enrolled at the time of their visit to a participating clinic or hospital for 
vaccination with MenACWY-CRM according to routine clinical practice. 
Visit No. 
1 
/ 
Age 
(years) 
# of Subjects 
Day 1 
Day 29 
(-4/+7 days) 
11-55 
years 
3,300 
Menveo 
Safety 

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Name of Sponsor 
Novartis Vaccines 
and Diagnostics 
Protocol number: 
V59_62 
Date of Protocol 
Synopsis: 
22 NOV 11 
At Visit 1 (Day 1) the informed consent will be obtained from the subjects or subject’s 
parent/legal representative. The vaccination will be administered. Subjects will remain 
under observation for at least 30 minutes in the clinic after study immunization; during 
this period subjects will be evaluated for any immediate hypersensitivity reactions and 
other adverse events. 
The subjects or subject’s parent/legal representative will then be instructed to complete 
the Diary Card daily for 7 days, reporting local and systemic reactions and all AEs 
occurring within 7 days following immunization, and all medically attended AEs and 
SAEs occurring up to Day 29. 
Subjects will also be instructed to return the completed diaries to the study site at Day 
29 as follows: 
• During a visit at the study center or 
• Using the provided pre-addressed stamped envelope (PASE). 
At the discretion of the investigator, the subject or subject’s parent/legal representative 
will be reminded of the date of the study termination by a phone call at Day 29. If any 
clarification is required after Diary Card retrieval the site staff will follow up by phone, 
and any additional finding will be recorded on the subject’s medical record. 
In case the Diary Card is not retrieved within 10 days after Day 29, subject or subject’s 
parent/legal representative will be contacted by phone to assess the occurrence of 
adverse events, determine the subject’s clinical status and complete study termination. 
All information will be recorded by the site staff on the subject’s medical record and 
collected in the appropriate section of the CRF. 
All SAEs will be monitored until resolution and/or the cause is identified. If a SAE 
remains unresolved at study termination, a clinical assessment will be made by the 
investigator and the NVD medical monitor to determine whether continued follow up of 
the SAE is needed. 
Safety Assessment Table 
The following table summarizes relevant safety assessments: 
Medical History: 
All significant past diagnoses including all allergies, 
major surgeries requiring inpatient hospitalization, 
other significant injuries or hospitalizations, any 
conditions requiring prescription or chronic medication 
(i.e., >2 weeks in duration), or other significant 
medical conditions based on the investigator’s 
From birth, collected at 
clinic Visit Day 1 

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Name of Sponsor 
Novartis Vaccines 
and Diagnostics 
Protocol number: 
V59_62 
Date of Protocol 
Synopsis: 
22 NOV 11 
judgment. 
Immediate reactions: 
Subjects will be assessed for immediate 
hypersensitivity reactions. 
For at least 30 minutes after 
vaccination 
Local reactions: 
Erythema, induration, pain. 
Days 1-7 after vaccination 
Systemic reactions: 
Chills, nausea, malaise, myalgia, arthralgia, headache, 
rash, fever. 
Days 1-7 after vaccination 
All unsolicited AEs will be collected 
Days 1-7 after vaccination 
Medically attended Adverse Events: 
Events that require a physician’s visit or an emergency 
room visit (events that are managed by telephone or 
means other than a face-to-face evaluation by a 
clinician do not qualify as medically attended AEs). 
From Day 1 to study 
termination (Day 29/early 
termination) 
Serious AEs: 
All SAEs will be collected. 
From Day 1 to study 
termination (Day 29/early 
termination) 
Medications: 
Any medications used to treat any solicited local and 
systemic reaction and unsolicited AE be collected. 
From Day 1 to Day 7 
Medications: 
Any medications used to treat any medically attended 
AE or SAE will be collected. 
From Day 1 to study 
termination (Day 29/early 
termination) 
Number of Subjects Planned: 
A total of approximately 3,300 subjects are planned for enrolment into this study, within 
a 6 years period. Assuming a 10% drop-out rate, this should provide approximately 
3,000 evaluable subjects, in compliance with KFDA requirements. 
Clinics and hospitals including pediatricians and family doctors will be involved in the 
study. 
Subject Population: 
Healthy male and female subjects from 11 to 55 years of age will be enrolled. They will 
be identified among subjects attending to participating clinics or hospitals for 
vaccination with MenACWY-CRM according to routine clinical practice. 
Subject Characteristics and Main Criteria for Inclusion and Exclusion: 
A detailed list of criteria is included in protocol section 4.0 
Inclusion criteria: Male and female subjects, of from 11 to 55 years of age (including 

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Name of Sponsor 
Novartis Vaccines 
and Diagnostics 
Protocol number: 
V59_62 
Date of Protocol 
Synopsis: 
22 NOV 11 
all 55 years old subjects, up to one day before their 56th year birthday), who are 
scheduled to receive MenACWY-CRM conjugate vaccine according to the Korean 
prescribing information, who or whose legally acceptable representative have given 
written informed consent at the time of enrollment, and who are able to comply with all 
study procedure. 
Exclusion criteria: Contraindication, special warnings and/or precautions, as evaluated 
by the investigators, reported in the MenACWY-CRM conjugate vaccine Korean 
prescribing information. 
Vaccines: 
MenACWY-CRM conjugate vaccine (Menveo). 
The vaccine will not be provided by the sponsor. Commercial supplies used in routine 
clinical practice will be utilized in this study. 
There is no placebo or test vaccine being evaluated in this study. 
Safety Endpoints: 
Safety will be assessed after administration of study vaccine in terms of the number and 
percentage of subjects with: 
• Local and systemic solicited reactions reported from study Day 1 (day of 
vaccination) through study Day 7 post-vaccination; 
• Unsolicited AEs reported from study Day 1 (day of vaccination) through study Day 
7 post-vaccination; 
• Medically attended AEs reported from study Day 1 to study termination (Day 
29/early termination); 
• SAEs reported from study Day 1 to study termination (Day 29/early termination). 
Statistical Considerations: 
All analyses will be run descriptively; no statistical (null) hypothesis is associated with 
the primary safety objective. 
A total of approximately 3,300 subjects are planned for enrolment into this study. 
Assuming a 10% drop-out rate, this should provide approximately 3,000 evaluable 
subjects. This sample size meets the post-licensure requirements of the KFDA to 
provide continued safety monitoring in the Korean population. 
Interim Analysis: 
NVD will provide biannual (every 6 months) study status reports during the first two 
years, and annual reports from the third to the sixth year, in compliance with KFDA 
requirements. 
Data Monitoring Committee: No Data Monitoring Committee will be convened for 
this study. 

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TABLE OF CONTENTS 
PROTOCOL SYNOPSIS V59_62 ....................................................................................... 2 
TABLE OF CONTENTS ..................................................................................................... 7 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS .................................... 10 
1.0 
BACKGROUND AND RATIONALE .................................................................. 11 
2.0 
OBJECTIVES ........................................................................................................ 12 
3.0 
STUDY DESIGN AND INVESTIGATIONAL PLAN ........................................ 12 
3.1 
Overview of Study Design ................................................................................. 12 
3.2 
Discussion of Overall Study Design .................................................................. 14 
3.3 
Study Procedures and Flowchart ....................................................................... 14 
3.3.1 
Data Required by KFDA: Survey Item .......................................................... 19 
3.3.2 
Subject Selection Method .............................................................................. 20 
3.3.3 
Subject Numbering ........................................................................................ 20 
3.3.4 
Method of Assignment to Study Groups ........................................................ 20 
3.3.5 
Blinding procedures ....................................................................................... 20 
3.3.6 
Vaccine Supply, Storage, Tracking and Labeling .......................................... 20 
3.3.7 
Processing, Labeling and Storage of Serum Samples for Serology ............... 20 
3.4 
Duration of Subject’s Expected Participation in the Entire Study ..................... 21 
3.5 
Stopping/Pausing Rules ..................................................................................... 21 
4.0 
SELECTION OF STUDY POPULATION ........................................................... 21 
4.1 
Inclusion Criteria ............................................................................................... 21 
4.2 
Exclusion Criteria .............................................................................................. 21 
4.3 
Withdrawal of Subjects from Therapy or Assessment ...................................... 22 
5.0 
TREATMENT OF SUBJECTS ............................................................................. 22 
5.1 
MenACWY Vaccine .......................................................................................... 22 
5.2 
Control Vaccines ................................................................................................ 23 
5.3 
Concomitant Vaccines or Treatment ................................................................. 23 
5.4 
Vaccines Preparation and Administration ......................................................... 23 
5.5 
Other Concomitant Treatment or Vaccines ....................................................... 24 
5.6 
Vaccination Compliance .................................................................................... 24 

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6.0 
EFFICACY/IMMUNOGENICITY AND SAFETY ASSESSMENTS ................. 24 
6.1 
Appropriateness of Measurements ..................................................................... 24 
6.1.1 
Efficacy/Immunogenicity............................................................................... 24 
6.1.2 
Methods, Criteria and Timing for Assessing and Recording 
Efficacy/Immunogenicity Parameters ........................................................................ 25 
6.2 
Safety Parameters ............................................................................................... 25 
6.2.1 
Immediate Hypersensitivity Reactions .......................................................... 25 
6.2.2 
Local and Systemic Reactions ....................................................................... 25 
6.2.3 
Adverse Events .............................................................................................. 26 
6.2.4 
Serious Adverse Events ................................................................................. 27 
6.2.5 
Methods and Timing for Assessing and Recording Safety Parameters ......... 27 
6.2.6 
Pregnancies .................................................................................................... 29 
6.3 
Data Monitoring Committee .............................................................................. 29 
7.0 
STATISTICAL PLAN ........................................................................................... 29 
7.1 
Statistical Hypothesis ......................................................................................... 29 
7.2 
Sample Size and Power Considerations ............................................................. 30 
7.3 
Population for Analysis ..................................................................................... 30 
7.4 
Analysis of Demographic and Baseline Characteristics .................................... 30 
7.5 
Analysis of Efficacy/Immunogenicity Endpoints .............................................. 30 
7.5.1 Description of Response Variables ................................................................ 30 
7.5.2 Statistical Methods for Efficacy/Immunogenicity Variables ......................... 30 
7.6 
Analysis of Safety (Endpoints) and Reactogenicity .......................................... 30 
7.6.1 Analysis of Extent of Exposure ..................................................................... 31 
7.6.2 Analysis of Local and Systemic Reactions .................................................... 31 
7.6.3 Analysis of Other Adverse Events ................................................................. 31 
7.7 
Planned Interim Analysis ................................................................................... 32 
8.0 
STUDY MONITORING, AUDITING AND DOCUMENTATION .................... 32 
8.1 
Study Monitoring ............................................................................................... 32 
8.2 
Source Data Verification.................................................................................... 32 
9.0 
DATA MANAGEMENT ....................................................................................... 33 
9.1 
Data Handling Procedures ................................................................................. 33 

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9.2 
Documentation of Study Findings ..................................................................... 34 
9.3 
Data Protection .................................................................................................. 34 
10.0 
RECORD RETENTION ........................................................................................ 34 
11.0 
USE OF INFORMATION AND PUBLICATION ................................................ 34 
12.0 
ETHICS.................................................................................................................. 35 
12.1 
Regulatory and Ethical Compliance .................................................................. 35 
12.2 
Informed Consent Procedures ............................................................................ 35 
12.3 
Responsibilities of the Investigator and IRB/EC ............................................... 35 
12.4 
Protocol Adherence ............................................................................................ 36 
12.5 
Protocol Amendments ........................................................................................ 36 
13.0 
REFERENCE LIST ............................................................................................... 37 

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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviations 
AE 
Adverse Event 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
DCF 
Data Clarification Form 
EC 
Ethics Committee 
EP 
European Pharmacopea 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
ICD 
International Classification of Diseases 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IM 
Intramuscular 
IRB 
Institutional Review Board 
KFDA 
Korean Food and Drug Administration 
MedDRA 
Medical Dictionary for Regulatory Activities 
NCR 
No carbon required 
NVD 
Novartis Vaccines and Diagnostics 
PMS 
Post Marketing Surveillance 
SAE 
Serious Adverse Event 
PASE 
Pre Addressed Stamped Envelope 
VSAE 
Vaccine Serious Adverse Event 
WHO 
World Health Organization 

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1.0 
BACKGROUND AND RATIONALE 
Neisseria meningitidis is a leading cause of bacterial meningitis and sepsis with a fatality 
rate of 5% to 15%; the fatality rate can be as high as 20% to 40% in meningococcal 
septicemia [Rouphael and Stephens 2012, Al-Tawfiq et al 2010, Hill et al 2010, Deasy 
and Read 2011]. In addition, 12% to 19% of survivors develop long-term neurologic 
sequelae [Al-Tawfiq et al 2010]. Most cases of N. meningitidis infection are caused by 
close contact with carriers of the infectious agent, with nearly 15% of adolescents [Al- 
Tawfiq et al 2010] and 10%-35% of adults [Hill et al 2010] acting as carriers. Young 
children are at the highest risk for invasive disease, with peaks in incidence in children 
under 4 years and young adults 15-19 years [Deasy and Read 2011]. 
In Korea meningococcal disease is a notifiable disease and any confirmed case is reported 
to the Korea Centers for Disease Control and Prevention [Song-Mee and Yeon-Ho 2008]. 
The disease has been regarded as a rare infection [Song-Mee and Yeon-Ho 2008]. 
However, during the period from 2002 to 2003 the number of reported cases in Korea 
dramatically increased [Korea Center for Disease Control and Prevention 2007], 
suggesting that the burden of meningococcal disease may be significant in this Country. 
Limited data are available about the incidence of meningococcal disease among age 
groups in Korea. In retrospective surveys of several hospitals in Korea from 1996 to 
2005, N. meningitidis accounted for 24% to 37% of bacterial meningitis cases in children 
aged over 5 years, with a case fatality rate of 15% to 26% [Lee et al 2011, Cho et al 
2011]. Another survey of adults with community-acquired bacterial meningitis reported 
that N. meningitidis was the causative organism in 2.6% of cases from 1998 to 2008 in 
Korea [Moon et al 2010]. Military personnel are considered to have a higher risk for the 
disease, probably due to the crowded living conditions [Al-Tawfiq et al 2010]. A specific 
group that has several characteristics in common with the military personnel is college 
students, especially dormitory residents. Nevertheless, one report, aiming to the 
serological characterization of 11 meningococcal isolates in Korea, shows an even 
distribution of cases among age groups (0-5 years: 2/11 subjects; 6-10 years: 2/11 
subjects; 11-17 years: 2/11 subjects; 18-30 years: 2/11 subjects; 31-55: 2/11 subjects; >56 
years: 1/11 subject) [Song-Mee and Yeon-Ho 2008]. 
Novartis Vaccines and Diagnostics (NVD) has developed a conjugate meningococcal 
ACWY (MenACWY-CRM) vaccine [Trotter et al 2004, Obaro et al 2006] containing 
bacterial capsular oligosaccharides for serogroups A, C, W, and Y conjugated to a protein 
carrier CRM197 (a non-toxic mutant of diphtheria toxin). MenACWY-CRM is currently 
licensed in many countries including Korea. Over 35,000 subjects have been enrolled in 
more than 30 clinical studies with over 25,000 receiving at least one dose of MenACWY- 
CRM. 
This is a post-marketing surveillance (PMS) study to monitor the safety of MenACWY- 
CRM in Korean individuals from 11 to 55 years of age receiving MenACWY-CRM 

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vaccination according to routine clinical practice and prescribing information. The study 
is a post-licensure requirement of the Korea Food and Drug Administration (KFDA) to 
provide continued safety evaluation in the Korean population. The post-marketing 
surveillance study will be performed in accordance with the principles outlined by 
KFDA. 
2.0 
OBJECTIVES 
Immunogenicity Objectives: 
No immunogenicity or efficacy objectives will be measured in this study. 
Safety objectives: 
The primary objective of the study is to monitor the safety of a single dose of 
MenACWY-CRM vaccine in subjects from 11 to 55 years of age, as evaluated by: 
▫ Local and systemic solicited reactions reported from study Day 1 (day of 
vaccination) through study Day 7 post-vaccination; 
▫ All unsolicited Adverse Events (AEs) reported from study Day 1 (day of 
vaccination) through study Day 7 post-vaccination; 
▫ Medically attended Adverse Events reported from study Day 1 to study termination 
(Day 29/early termination). 
▫ All Serious Adverse Events (SAEs) reported from study Day 1 to study termination 
(Day 29/early termination). 
3.0 
STUDY DESIGN AND INVESTIGATIONAL PLAN 
3.1 
Overview of Study Design 
This is a multicenter post marketing surveillance study to monitor the safety of 
MenACWY-CRM administered according to the prescribing information to 3,300 healthy 
subjects from 11 to 55 years of age in Korea. 
Subjects will be enrolled at the time of their visit to a participating clinic or hospital for 
vaccination with MenACWY-CRM according to the routine clinical care. 
At Visit 1 (Day 1), after obtaining consent from the subjects or subjects’ parents/legal 
representative, the vaccination will be administered. Subjects will remain under 
observation for at least 30 minutes in the clinic after study immunization. 
The subjects or subject’s parent/legal representative will be then instructed to complete 
the Diary Card daily, reporting local and systemic reaction and all other AEs occurring 

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within 7 days following immunizations, and medically attended AEs or SAEs occurring 
up to Day 29. 
Subjects will also be instructed to return the completed diaries to the study site at Day 29 
as follows: 
• During a visit at the study center or 
• Using the provided pre-addressed stamped envelope (PASE). 
At the investigator discretion, the subject or subject’s parent/legal representative will be 
reminded of the date of the study termination by a phone call at Day 29. If any 
clarification is required after Diary Card retrieval the site staff will follow up by phone, 
and any additional finding will be recorded on the subject’s medical record. 
In case the Diary Card is not retrieved within 10 days after Day 29, subject or subject’s 
parent/legal representative will be contacted by phone to assess the occurrence of adverse 
events, determine the subject’s clinical status and complete study termination. All 
information will be recorded by the site staff on the subject’s medical record and 
collected in the appropriate section of the CRF. 
All SAEs will be monitored until resolution and/or the cause is identified. If a SAE 
remains unresolved at study termination, a clinical assessment will be made by the 
investigator and the NVD regional physician to determine whether continued follow up of 
the SAE is needed. 
Table 3.1-1: Safety Assessment Table 
Medical History: 
All significant past diagnoses including all 
allergies, major surgeries requiring inpatient 
hospitalization, other significant injuries or 
hospitalizations, any conditions requiring 
prescription or chronic medication (i.e., >2 weeks 
in duration), or other significant medical 
conditions based on the investigator’s judgment. 
From birth, collected at 
clinic visit Day 1 
Immediate reactions: 
Subjects will be assessed for immediate 
hypersensitivity reactions. 
For at least 30 minutes after 
vaccination 
Local reactions: 
Erythema, induration, pain. 
Days 1-7 after vaccination 
Systemic reactions: 
Chills, nausea, malaise, myalgia, arthralgia, 
headache, rash, fever. 
Days 1-7 after vaccination 
All unsolicited AEs will be collected 
Days 1-7 after vaccination 
Medically attended Adverse Events: 
Events that require a physician’s visit or an 
emergency room visit (events that are managed by 
From Day 1 to study 
termination (Day 29/early 
termination) 

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telephone or means other than a face-to-face 
evaluation by a clinician do not qualify as 
medically attended AEs). 
Serious AEs: 
All SAEs will be collected. 
From Day 1 to study 
termination (Day 29/early 
termination) 
Medications: 
Any medications used to treat any solicited local 
and systemic reaction and unsolicited AE be 
collected. 
From Day 1 to Day 7 
Medications: 
Any medications used to treat any medically 
attended AE or SAE will be collected. 
From Day 1 to study 
termination (Day 29/early 
termination) 
3.2 
Discussion of Overall Study Design 
This is a multicenter post-marketing surveillance study to monitor the safety of 
MenACWY-CRM in Korean individuals from 11 to 55 years of age receiving 
MenACWY-CRM vaccination according to routine clinical practice and prescribing 
information. 
A total of approximately 3,300 subjects are planned for enrolment into this study, within a 
6 years period. Assuming a 10% drop-out rate, this should provide approximately 3,000 
evaluable subjects, in compliance with KFDA requirements. Clinics and hospitals 
including pediatricians and family doctors will be involved in the study. 
The study is a post-licensure requirement of the KFDA to provide continued safety 
evaluation after immunization with MenACWY-CRM in the Korean population. 
3.3 
Study Procedures and Flowchart 
Study subjects or subjects’ parent/legal representative will be informed by study staff of 
the possibility for enrollment in the PMS study while attending a visit at the participating 
clinic or hospital, for the purpose of vaccination with MenACWY-CRM according to the 
local routine clinical care. 
Informed consent must be obtained from the subject, or where applicable, the subject's 
parent(s) or legally acceptable representative(s) prior to the performance of any study 
related procedures. 
At the visit, for each subject, data will be collected on the respective source document and 
then recorded on the appropriate section of the CRF. 

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Visit 1 - Day 1 
▫ Written informed consent from the subject or subject’s parents/legal representative, 
will be obtained. 
▫ It will be checked whether subject conforms to inclusion and exclusion criteria (see 
section 4.0). 
▫ Medical history will be collected and recorded on the Medical History CRF. 
▫ A physical exam/assessment, including height, weight and body temperature 
(preferably axillary) will be performed and results recorded before vaccination. 
▫ Demographic data will be collected and recorded. 
▫ The study vaccine will be administered intramuscularly in the deltoid, preferably of 
the non-dominant arm. If the investigator determines that the subject’s health on the 
day of vaccination temporarily precludes vaccination, according to the indication 
reported in the vaccine leaflet, the visit may be rescheduled. 
▫ The subject will be observed closely for at least 30 minutes in the clinic after 
vaccination, with appropriate medical treatment readily available in case of a rare 
anaphylactic reaction following the administration of vaccines. Any local or 
systemic reaction observed within 30 minutes post vaccination will be recorded in 
the Adverse Event CRF. 
▫ All subjects, or, where applicable, the subject’s parents/legal representative, will be 
dispensed a Diary Card with instructions on how to complete it: 
- 
Days 1-7: record all local (erythema, induration, pain) and systemic (chills, 
nausea, malaise, myalgia, arthralgia, headache, rash, fever) reactions, all 
other AEs and SAEs, and all medications used to treat them; 
- 
Days 8-29: record all medically attended AEs and SAEs and all medications 
used to treat them. 
▫ The subjects, or, where applicable, the subject’s parent/legal representative, will be 
instructed to contact the investigator immediately should the subject manifest any 
signs or symptoms they perceive as serious. 
▫ The subject or subject’s parent/legal representative will be informed of the date of 
the study termination by a phone call at Day 29, if deemed necessary by the 
investigator. 
/ 
- Day 29 
□ 
If Diary Cards are returned during a routine visit at the study center, the investigator 
will review local and systemic reactions, AEs and SAEs with the subject or 
subject’s parent/legal representative. Any new and/or clarified findings, additional 

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to what was already reported in the Diary Card, will be documented in the subject’s 
medical record; 
□ 
If Diary Cards are returned using the PASE, the site staff should carefully review 
and assess the entries on the Diary Card; for all AEs and SAEs throughout the 28 
days following vaccination the site staff should follow up by phone with the subject 
or subject’s parent/legal representative; any new and/or clarified findings should be 
documented in the subject’s medical record. 
▫ All local and systemic reactions noted by the subject or subject’s parent/legal 
representative will be reviewed and recorded on subject’s medical record and on the 
appropriate Local and Systemic Reaction CRF. 
▫ All AEs and SAEs will be collected, reviewed and recorded on the Adverse Events 
CRF. 
▫ All concomitant medications used to treat AEs and SAEs during the trial will be 
collected and recorded. 
All SAEs will be monitored until resolution and/or the cause is identified. If a SAE 
remains unresolved at study termination, a clinical assessment will be made by the 
investigator and the NVD regional physician to determine whether continued follow up of 
the SAE is required. 
Should the Diary Card not be retrieved within 10 days after Day 29, subject or subject’s 
parent/legal representative will be contacted by phone to assess the occurrence of 
adverse events, determine the subject’s clinical status and complete study termination. All 
information will be recorded by the site staff on the subject’s medical record and 
collected in the appropriate section of the CRF. 
At least three phone contact attempts (at three subsequent days) will be made by the study 
staff to reach the subject or subject’s parent/legal representative. 
▫ Study termination will be completed for all subjects and noted on the CRF. 

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Table 3.3-1: Times and Events Table 
Visit Type 
Clinic Visit 
/ 
 
Study Day 
Day 1 
Day 29 
Study Visit Window 
n/a 
-4/+7 
ICF 
X 
Exclusion/Inclusion 
X 
Medical history 
X 
Physical exam/assessmenta 
X 
Study vaccine administered 
X 
Immediate hypersensitivity reactionsb 
X 
Diary Card Dispensed 
X 
Diary Card Collected and/or Reviewedc 
X 
Assess/review Local/Systemic Reactionsd 
X 
Assess/review AEs and SAEse 
X 
Concomitant medicationsf 
X 
X 
Study Terminationg 
X 
a. 
Physical examination must be performed by a qualified health professional designated within the Site 
Responsibility Delegation Log. 
b. Data on immediate reactions will be collected by the study personnel for all subjects for 30 minutes 
post-injection. 
c. 
Diary card review at Day 29 will be performed over the phone or during a routine visit at the study 
center. Please refer to protocol Section 3.3. 
d. Subject’s parents/legal representative will record local and systemic solicited reactions on the Diary 
Card daily for 7 days after each study vaccination. 
e. 
Assess AEs and SAEs according to Safety Assessment Table in the Protocol (Table 3.1-1). All SAEs 
will be monitored until resolution and/or cause identified. If an SAE remains unresolved at study 
termination, a clinical assessment will be made by the investigator and the NVD regional physician to 
determine whether continued follow up of the SAE is needed. 
f. 
Collect concomitant medications according to Safety Assessment Table in the Protocol (Table 3.1-1) 
g. Any subject who terminates the study during the Post-Vaccination period is recommended to undergo 
Day 29 study-related procedures. 

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Figure 3.3-1: Study Procedure Flowchart - detailed 
Day 1 
Day 29 (-4/+7) 
 
• ICF 
• Inclusion/Exclusion 
• Medical History 
• Physical Examination 
• Vaccine administration 
• 30’ Reactions 
• Diary Card (dispensation) 
• Reminder to return Diary Card 
to site either in person or by post 
• Diary Card (review) 
• Local/Systemic solicited Reactions and 
unsolicited AEs up to Day 7 (review/assess) 
• Medically attended AEs and SAEs up to Day 
29 (review/assess) 
• Study Termination 
Visit 1 
/ 

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3.3.1 
Data Required by KFDA: Survey Item 
The following subject data will be collected and recorded in each subject CRF. 
A. Subject Baseline Information 
1. Subject Number 
2. Demographics: Date of Birth, Sex, Weight, Height 
3. Inclusion/Exclusion Criteria 
4. Medical History 
B. Vaccination Record 
1. Pre-Vaccination Body Temperature 
2. Date of Vaccination 
3. MenACWY-CRM Dose 
4. Injection Site 
C. Adverse Events 
1. Adverse Event 
2. Seriousness 
3. Date of Onset 
4. Date of Resolution 
5. Frequency 
6. Severity 
7. Actions Taken 
8. Outcome 
9. Relationship to Study Vaccine 
D. Concomitant Medications & Vaccine Therapy 
1. Name of Drug 
2. Route 
3. Start and End Date of Therapy 
4. Indication for Treatment 
E. Study Termination 
1. Reason(s) for ending study participation 
2. Reason(s) for early termination 

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3.3.2 
Subject Selection Method 
In order to obtain information on Regulatory PMS data after market launch, NVD or 
delegate will create the Regulatory PMS contract with the relevant clinics/hospitals and 
the physician in charge of the survey shall implement this Regulatory PMS in subjects 
that receive MenACWY-CRM in the relevant hospital/clinic since the contract date until 
the number of contracted survey cases, without omission, is reached. 
3.3.3 
Subject Numbering 
In agreement with GCP, each subject will be unambiguously identified by a code, which 
allows the identification of all the data reported for each subject. In NVD, the code is a 6- 
digit number resulting from the combination of the site number (first 3 digits) and the 
subject code (last 3 digits). The site number is assigned by NVD to the investigative site. 
The digits identifying the subject within the site are assigned sequentially, such as 001, 
002, etc. corresponding to the first subject enrolled at each site. 
The subject number/identifier is assigned by the investigator after the subject or subject’s 
parent/legal representative has signed the informed consent form and the investigator has 
confirmed the eligibility criteria. The investigator must keep track of the names of the 
subjects enrolled and their identifying number in a Subject Identification Code List. 
Once assigned to a subject a number cannot be reused. 
3.3.4 
Method of Assignment to Study Groups 
A subject who fulfills all of the inclusion criteria and none of the exclusion criteria is 
given a subject number/identifier as described above. 
3.3.5 
Blinding procedures 
The study is planned as a single-arm, open-label study for safety monitoring. Study staff 
and subjects will not be blinded to vaccine administration. 
3.3.6 
Vaccine Supply, Storage, Tracking and Labeling 
The investigational vaccine is MenACWY-CRM conjugate vaccine (Menveo). The 
vaccine will not be provided by the sponsor. Commercial supplies used in routine clinical 
practice will be utilized in this study. 
The vaccine must be stored by the study centers according to the instructions specified on 
the labels. 
3.3.7 
Processing, Labeling and Storage of Serum Samples for Serology 
There will be no blood drawn from the subjects during this study. 

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3.4 
Duration of Subject’s Expected Participation in the Entire Study 
Expected subject trial participation interval: 29 days. 
3.5 
Stopping/Pausing Rules 
There are no predetermined stopping rules other than circumstances for which subjects 
may be removed from study according to investigator’s discretion, as described in section 
4.3. 
NVD, or the investigator (following consultation with NVD) has the right to discontinue 
this study at any time. If the study is prematurely terminated, the investigator is to 
promptly inform the study subjects and should assure appropriate therapy and follow-up 
for the subjects. All procedures and requirements pertaining to the archiving of the 
documents should be followed. All other study materials must be returned to the sponsor. 
4.0 
SELECTION OF STUDY POPULATION 
4.1 
Inclusion Criteria 
Individuals eligible for enrolment in this study are those: 
1. male and female subjects from 11 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. 
4.2 
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; 

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• 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). 
4.3 
Withdrawal of Subjects from Therapy or Assessment 
The subject, or where applicable, the subject’s parent/legal representative can withdraw 
consent for participation in the study at any time without penalty or loss of benefit to 
which the subject is otherwise entitled. The investigator can withdraw a subject if, in his 
or her clinical judgment, it is in the best interest of the subject or if the subject cannot 
comply with the protocol. 
If a subject withdraws from the study, the reason for withdrawal should be documented in 
the subject’s medical record and reported in the CRF. If the withdrawal of a subject 
resulted from an AE, the information should be recorded in the CRF. 
Withdrawn subjects will not be replaced. 
5.0 
TREATMENT OF SUBJECTS 
All subjects will be vaccinated with one dose of MenACWY-CRM197 (Menveo) on Day 
1. 
5.1 
MenACWY Vaccine 
The MenACWY vaccine is supplied as a: 
 Vial containing the MenA Lyophilised Conjugate Component as a white to off 
white powder;
 Vial containing the MenCWY Liquid Conjugate Component as clear solution.
The contents of the two components are to be mixed prior to vaccination providing 1 
dose of 0.5 ml. 
After reconstitution, one dose of MenACWY will have the following composition per 0,5 
mL of injectable solution: 
Active substances 
 Meningococcal group A oligosaccharide 10 micrograms (Corynebacterium 
diphtheriae CRM197 protein 16.7 to 33.3 micrograms)
 Meningococcal group C oligosaccharide 5 micrograms (Corynebacterium 
diphtheriae CRM197 protein 7.1 to 12.5 micrograms)

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 Meningococcal group W135 oligosaccharide 5 micrograms (Corynebacterium 
diphtheriae CRM197 protein 3.3 to 8.3 micrograms)
 Meningococcal group Y oligosaccharide 5 micrograms (Corynebacterium 
diphtheriae CRM197 protein 5.6 to 10.0 micrograms)
Stabilizing agent: 
Sucrose (EP) - 12.5 mg 
Isotonic agent: 
Sodium chloride (EP) - 4.5 mg 
Buffering agent: 
Potassium dihydrogen phosphate (EP) - 5 mM 
Sodium dihydrogen phosphate monohydrate (EP) - 2.5 mM 
Disodium phosphate dihydrate (EP) - 7.5 mM 
Diluent: 
Water for injections (EP) - 0.5 ml 
Following reconstitution the vaccine is a clear, colourless to light yellow solution. 
One 0.5 mL dose of MenACWY-CRM will be administered by intramuscular (IM) 
injection in the deltoid area of nondominant arm (preferably). 
5.2 
Control Vaccines 
No control vaccine will be administered during this study. 
5.3 
Concomitant Vaccines or Treatment 
All concomitant medications and concomitant vaccines should be taken by/administered 
to the subject in accordance with the indication reported in the package leaflet. 
Concomitant medication and vaccines administered to treat any AE or SAE must be 
documented on the Concomitant Medications CRF. 
5.4 
Vaccines Preparation and Administration 
The vaccine must be prepared according to the package insert before use. 
The principal investigator or designee will be responsible for the administration of the 
vaccine to subjects enrolled into the study according to the indications reported in 
package leaflet. The vaccine will be administered only by personnel qualified to perform 
that function according to the routine clinical practice and under applicable local laws and 
regulations for the specific study site. 
PRECAUTIONS TO BE OBSERVED IN ADMINISTERING STUDY VACCINE: 
The vaccination site should be disinfected with a skin disinfectant (e.g., 70% alcohol). 
Before vaccination, the skin must be dry. DO NOT inject intravascularly. 

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Standard immunization practices should be observed and care should be taken to 
administer the injection intramuscularly in the deltoid of the non-dominant arm, 
preferably. As with all injectable vaccines, appropriate medical treatment and supervision 
should be readily available in case of anaphylactic reactions following administration of 
the study vaccine. Epinephrine 1:1000 and diphenhydramine, or locally approved 
medications, should be available in case of any anaphylactic reactions. 
Study vaccines should not be administered to individuals with known hypersensitivity to 
any component of the vaccines. 
Vaccination must not be administered to any subject with a clinically significant active 
infection (as assessed by the investigator) or measured body temperature ≥ 38°C/100.4ºF 
within 3 days of the intended date of vaccination. If either of these is observed, 
vaccination should be postponed until the subject’s temperature remains below 
38.0°C/100.4°F for at least 3 days or the investigator feels that the subject’s illness has 
stabilized, as appropriate. 
5.5 
Other Concomitant Treatment or Vaccines 
Medication taken by the subject prior to the start of the study will not be collected. Other 
concomitant treatment used during the study period to treat any AE or SAE should be 
recorded in CRF. 
5.6 
Vaccination Compliance 
The investigator or designee will administer the study vaccine following the indications 
reported in the package leaflet. The date, dosage, and time of the vaccination must be 
recorded. 
6.0 
EFFICACY/IMMUNOGENICITY AND SAFETY ASSESSMENTS 
As this is a post-marketing safety monitoring study, efficacy and immunogenicity will not 
be assessed. 
6.1 
Appropriateness of Measurements 
The measures of safety used in this study are routine clinical procedures. They include a 
close vigilance for, and stringent reporting of, selected local and systemic reactions 
routinely monitored in vaccine clinical trials as indicators of reactogenicity. 
6.1.1 
Efficacy/Immunogenicity 
Not applicable. 

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6.1.2 
Methods, Criteria and Timing for Assessing and Recording 
Efficacy/Immunogenicity Parameters 
Not applicable. 
6.2 
Safety Parameters 
A brief medical history will be obtained and physical examination performed for each 
subject entered into the study. 
Local and systemic reactions and other adverse events will be collected throughout the 
study, as detailed in sections 6.2.1 to 6.2.5. 
6.2.1 
Immediate Hypersensitivity Reactions 
The occurrence of immediate hypersensitivity reactions up to 30 minutes after 
vaccination will be recorded on the Adverse Events CRF. 
6.2.2 
Local and Systemic Reactions1 
The occurrence of selected indicators of reactogenicity (listed below), which by 
definition, can only occur up to 7 days post vaccination, will be recorded on the “Local 
and Systemic Reactions” appropriate CRF. These will be summarized in the final report 
under the category “solicited adverse events” to differentiate them from other adverse 
events which were not solicited. 
▫ Local Reactions: erythema, induration and pain. 
▫ Systemic Reactions: chills, nausea, malaise, myalgia, arthralgia, headache, rash, 
fever. 
Subjects or subjects’ parent/legal representative will be asked to measure body 
temperature and record all solicited local and systemic reactions and unsolicited AEs for 
7 days following vaccination on a Diary Card. The study site will then collect the Diary 
Card after Day 29 by mail using PASE provided, or at a subsequent clinic or hospital 
visit. If the Diary Card will not be returned, telephone contacts will be made to solicit 
assess the occurrence of solicited reactions and adverse event and determine the subjects 
clinical status. 
All other medically attended AEs and associated concomitant medications will be 
recorded throughout the 29 day follow-up period. 
1 Local and systemic reactogenicity is referred to as “solicited adverse events” to differentiate those events 
that were solicited on a checklist from other adverse events collected during the trial. 

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Site staff should consult the MenACWY-CRM Korean prescribing information for 
additional information concerning contraindications, hypersensitivity, adverse reactions, 
special warnings and precautions for use. 
6.2.3 
Adverse Events2 
An adverse event (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. An AE can, 
therefore be any unfavorable and unintended sign (including an abnormal laboratory 
finding, for example), symptom, or disease temporally associated with the use of an 
investigational product, whether or not considered related to the investigational product. 
This definition includes intercurrent illnesses or injuries and exacerbation of pre-existing 
conditions. 
An unexpected adverse event is one that is not listed in Package Leaflet or an event that is 
by nature more specific or more severe than a listed event. 
The severity of events reported on the “Adverse Events” CRF will be determined by the 
investigator as: 
Mild: 
transient with no limitation in normal daily activity. 
Moderate: 
some limitation in normal daily activity. 
Severe: 
unable to perform normal daily activity. 
The relationship of the study treatment to an AE will be determined by the investigator 
based on the following definitions: 
1. Not Related 
The AE is not related if exposure to the investigational vaccine has not occurred, or the 
occurrence of the AE is not reasonably related in time, or the AE is considered unlikely 
to be related to use of the investigational vaccine, i.e. there are no facts (evidence) or 
arguments to suggest a causal relationship. 
2. Possibly Related 
The administration of the investigational vaccine and AE are considered reasonably 
related in time and the AE could be explained by causes other than exposure to the 
investigational vaccine. 
2 Adverse Events collected in this study and that are not solicited on a checklist may also be referred to as 
“unsolicited Adverse Event” in the Clinical Study Report. 

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3. Probably Related 
Exposure to the investigational vaccine and AE are reasonably related in time and the 
investigational vaccine is more likely than other causes to be responsible for the AE, or is 
the most likely cause of the AE. 
The relationship of the study treatment to an AE will be determined by the investigator. 
6.2.4 
Serious Adverse Events 
A serious adverse event (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. 
Adverse events which do not fall into these categories are defined as non-serious. 
It should be noted that a severe adverse event need not be serious in nature and that a 
serious adverse event need not, by definition, be severe. 
In addition, a pre-existing event or condition that results in hospitalization should be 
recorded on the Medical History CRF. If the onset of an event occurred before the subject 
entered the trial (e.g., any pre-planned hospitalization for conditions like cosmetic 
treatments or for non-emergency routine visits for a pre-existing condition), the 
hospitalization would not lead to an AE being classified as serious unless, in the view of 
the investigator, hospitalization was prolonged as a result of participation in the clinical 
trial or was necessary due to a worsening of the pre-existing condition. 
6.2.5 
Methods and Timing for Assessing and Recording Safety Parameters 
All study subjects will be observed for at least 30 minutes after a vaccination for evidence 
of immediate reactions in general and in particular for symptoms of allergic phenomena 

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(such as rashes, itching, or other allergic manifestations). Each subject, or where 
applicable, the subjects’ parent/legal representative will be instructed to complete a Diary 
Card for 28 days following vaccine administration, describing: local reactions, systemic 
reactions, and all AEs for 7 days after vaccination; medically attended AEs, SAEs and 
associated concomitant medications throughout 28 days following vaccination. If a local 
and systemic reaction continues beyond 7 days after vaccination, the subject or subject’s 
parent/legal representative should note this on the Diary Card and note the start and stop 
dates of the event and any medications used as treatment. When this information is 
collected by the site, the site staff will record it on the subject’s medical record. 
The period of observation for adverse events extends from the time the subject receives 
vaccination until he or she completes the safety follow up period (Day 29) or terminates 
the study earlier. 
Any medical event that occurs after the informed consent form is signed, but prior to 
receiving study vaccine and is related to a study procedure, will be documented as an 
adverse event and recorded on the Adverse Events CRF. Any medical event that occurs 
after the informed consent form is signed, but prior to receiving study vaccine and is not 
related to a study procedure, will be documented as a pre-existing condition and will be 
recorded on the Medical History CRF. 
All adverse events, regardless of severity, will be monitored by the investigator until 
resolution or stabilization. All subjects experiencing adverse events - whether considered 
associated with the use of the study vaccine or not - must be monitored until symptoms 
subside and any abnormal laboratory values have returned to baseline, or until there is a 
satisfactory explanation for the changes observed, or until death, in which case a full 
pathologist’s report should be supplied, if possible. All findings must be reported on an 
“Adverse Events” CRF and on the “Vaccine Serious Adverse Event” form, if necessary, 
which is part of the investigator’s study file. All findings in subjects experiencing adverse 
events must be reported also in the subject's medical records. 
All SAEs which occur during the course of the trial, whether considered to be associated 
with the vaccination or not, must be reported within 24 hours or at the latest on the 
following working day by telephone or fax to NVD or designated representatives. Contact 
details for submitting SAEs to NVD or its designee and instructions for completion of 
documentation will be provided in a handout located in the Investigator Site File. 
All SAEs are also to be documented on the Adverse Events CRF. Any medication or 
other therapeutic measures used to treat the AE will be recorded on the appropriate 
CRF(s) in addition to the outcome of the AE. 
After receipt of the initial SAE report, representatives of NVD will contact the 
investigator if it is necessary to obtain further information for assessment of the event. 

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NVD will also comply with the applicable regulatory requirements related to the 
reporting of all SAEs to KFDA. 
All SAEs must be reported by the investigator to his/her EC/IRB in accordance with 
institutional policy/regulation requirements and adequate documentation of this 
notification must be provided to the sponsor. 
If required, a follow up report including all new information obtained on the serious 
adverse event must be prepared and sent to designated representatives by fax and marked 
as “Follow-up report.” 
Post-Study Events 
Any AE that occurs outside the protocol-specified observation period or after the end of 
the study but considered to be caused by the study vaccine must be reported to NVD. 
These AEs will be processed by the NVD Pharmacovigilance group. Instruction for how 
to submit these AEs will be provided in a handout in the Investigator File. 
6.2.6 
Pregnancies 
To ensure subjects’ safety, each pregnancy in a subject on study vaccine must be reported 
to NVD within 24 hours of the site learning of its occurrence. If the subject agrees to 
submit this information, the pregnancy must be followed to determine outcome, including 
spontaneous or voluntary termination, details of the birth, and the presence or absence of 
any birth defects, congenital abnormalities, or maternal and/or newborn complications. 
This follow-up should occur even if intended duration of safety follow-up for the study 
has ended. 
Pregnancy data must be recorded on a Pregnancy Report CRF (initial report) and 
Pregnancy Follow-Up CRF (outcome report) and reported to NVD. Contact details for 
submitting the case report forms will be described in the Investigator Site File. 
Any pregnancy outcome meeting the definition of a SAE (see section 6.2.4) must also be 
reported on the SAE Report Form. 
6.3 
Data Monitoring Committee 
No Data Monitoring Committee will be convened for this study. 
7.0 
STATISTICAL PLAN 
7.1 
Statistical Hypothesis 
All analyses will be run descriptively; no statistical (null) hypothesis is associated with 
the primary safety objective. 

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7.2 
Sample Size and Power Considerations 
A total of approximately 3,300 subjects are planned for enrolment into this study. 
Assuming a 10% drop-out rate, this should provide approximately 3,000 evaluable 
subjects. This sample size meets the post-licensure requirements of the KFDA to provide 
continued safety monitoring in the Korean population. 
7.3 
Population for Analysis 
Definition of populations to be analyzed: 
(a) All Enrolled Set 
All subjects who have signed an informed consent form, undergone screening 
procedure(s) and received a subject number. 
(b) Exposed Set 
All subjects in the enrolled set who receive a study vaccination. 
(c) Safety Set 
All subjects in the Exposed set who provide post vaccination safety data. 
7.4 
Analysis of Demographic and Baseline Characteristics 
Descriptive statistics (mean, standard deviation, median, minimum and maximum) for 
age, height and weight at enrollment will be calculated. Distributions of subjects by sex 
will be summarized. 
7.5 
Analysis of Efficacy/Immunogenicity Endpoints 
7.5.1 
Description of Response Variables 
Not applicable. 
7.5.2 
Statistical Methods for Efficacy/Immunogenicity Variables 
Not applicable. 
7.6 
Analysis of Safety (Endpoints) and Reactogenicity 
Analysis of safety criteria 

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All subjects who receive the immunization and provide some safety data will be 
considered evaluable for the safety analyses. The safety of the study vaccine will be 
assessed in terms of number of subjects exposed to study vaccine with reported local and 
systemic reactions, as well as the number of all subjects with reported AEs and/or SAEs 
for the specified time period. All SAEs and AEs will be judged by the Investigator as 
either probably related, possibly related, or not related to vaccine and will be tabulated. 
All SAEs and AEs resulting in withdrawal from the study will be summarized. 
The safety assessment of the study vaccine will be also performed after subject 
stratification according to age groups. In particular, the following age groups will be 
analyzed: 11 to 18 years of age; 19 to 34 years of age; 35 to 55 years of age. 
7.6.1 
Analysis of Extent of Exposure 
The number of subjects actually receiving vaccination will be summarized. 
7.6.2 
Analysis of Local and Systemic Reactions 
Frequencies and percentages of subjects experiencing each reaction will be presented for 
each symptom severity. Summary tables showing the occurrence of any local or systemic 
reaction overall and at each time point will also be presented. 
Post-vaccination reactions reported from Day 1 to Day 7 will be summarized by maximal 
severity. The severity of local reactions, including injection-site, erythema and induration 
will be categorized as: none (0), 1 to 25 mm; 26 to 50 mm, 51 to 100 mm, >100 mm. 
The severity of pain and systemic reactions (i.e., chills, nausea, malaise, myalgia, 
arthralgia, headache) occurring up to 7 days after each vaccination will be categorized as 
None, Mild (present but not interfering with daily activity), Moderate (some interference 
with daily activity), and Severe (prevents daily activity) except for rash, which will 
be categorized as None, Urticarial, or Other. 
Body temperature will be categorized as <38°C (no fever), ≥38°C (fever) and will 
summarized by 0.5°C increments from 36.0°C up to 40°C. Additionally, no fever vs. 
fever will be reported. 
Each local and systemic reaction will also be categorized as none vs. any. 
7.6.3 
Analysis of Other Adverse Events 
All the unsolicited AE occurring from Day 1 to Day 7, and medically attended AE 
occurring from Day 1 to Day 29 judged either as related to vaccination or not by the 
investigator, will be recorded as specified in section 6.2.5. The original verbatim terms 
used by investigators to identify adverse events in the CRFs will be mapped to preferred 
terms using the most recent MedDRA dictionary. The AEs will then be grouped by 

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MedDRA preferred terms into frequency tables according to system organ class. All 
reported adverse events, as well as adverse events judged by the investigator as at least 
possibly related to study vaccine, will be summarized according to system organ class and 
preferred term within system organ class. When an AE occurs more than once for a 
subject, the maximal severity and strongest relationship to the vaccine group will be 
counted. Additionally, three separate summaries will be produced: (i) serious adverse 
events, (ii) medically attended adverse events that are possibly or probably related to 
vaccine, and (iii) adverse events that are possibly or probably related to vaccine. Data 
listings of all adverse events will be provided by subject. In addition, a listing of subjects 
withdrawn from the study because of an adverse event will be presented. 
7.7 
Planned Interim Analysis 
NVD will provide biannual (every 6 months) study status reports during the first two 
years, and annual reports from the third to the sixth year, in compliance with KFDA 
requirements. 
8.0 
STUDY MONITORING, AUDITING AND DOCUMENTATION 
Study monitoring and auditing will be performed in accordance with the sponsor’s 
standard operating procedures and applicable regulatory requirements (e.g., KFDA, ICH 
and GCP guidelines). 
Investigators and/or their study staff will be trained on the study protocol and all 
applicable study procedures prior to subject enrollment. CRFs supplied by NVD must be 
completed for each enrolled subject. The data entries as well as study related documents 
will be checked by NVD and/or trained delegates of NVD. 
8.1 
Study Monitoring 
Study progress will be monitored by NVD or its representative (e.g. a CRO) as frequently 
as necessary to ensure the rights and well-being of study subjects are protected, to verify 
adequate, accurate and complete data collection, protocol compliance and to determine 
that the study is being conducted in conformance with applicable regulatory requirements. 
Arrangements for monitoring visits will be made in advance in accordance with the 
monitoring plan, except in case of emergency. 
8.2 
Source Data Verification 
Data recorded on the CRF will be verified by checking the CRF entries against source 
documents (i.e., all original records, laboratory reports, medical records, subjects diaries) 
in order to ensure data completeness and accuracy as required by study protocol. The 
investigator and/or site staff must make CRFs and source documents of subjects enrolled 
in this study available for inspection by NVD or its representative at the time of each 
monitoring visit. 

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At a minimum, source documentation must be available to substantiate subject 
identification, eligibility and participation, proper informed consent procedures, dates of 
visits, adherence to protocol procedures, adequate reporting and follow-up of adverse 
events, administration of concomitant medication, study vaccine administration 
information, and date of completion and reason. Specific items required as source 
documents will be reviewed with the investigator before the study. 
The source documents must also be available for inspection, verification and copying, as 
required by regulations, by officials of the regulatory health authorities (e.g. KFDA) 
and/or ECs/IRBs. The investigator and study site staff must comply with applicable 
privacy, data protection and medical confidentiality laws for use and disclosure of 
information related to the study and enrolled subjects. 
The subject or the subject’s parents or legally acceptable representative(s) must also allow 
access to the subject’s medical records. Each subject, or the subject’s parent(s) or legally 
acceptable representative(s), should be informed of this prior to the start of the study. 
9.0 
DATA MANAGEMENT 
Three-part “no carbon required” (NCR) paper CRFs will be provided for each subject by 
the sponsor. All appropriate subject data collected during the study will be recorded on 
these forms. One copy must be retained by the investigator, and all other copies 
(including the original copy) will be returned as directed by the sponsor. Instructions on 
how to complete these forms will be provided to the investigator. 
All study data must be entered by the investigator or delegate who will sign and date the 
CRFs. If the investigator delegates and authorizes other persons in his/her staff to make 
entries on the CRF, the names, positions, signatures and initials must be documented in 
writing (e.g., site delegation log). 
CRFs must be completed during/after each study visit. Arrangements will be made by the 
study monitor to collect the CRFs upon completion. No CRFs are to be mailed to the 
sponsor without specific authorization. 
Data from the CRFs are entered into the study database by a data management CRO staff 
member following the Data Management Plan that has been reviewed and approved by 
NVD. Contact details for the data management CRO are provided in the Data 
Management Plan. 
9.1 
Data Handling Procedures 
Coding of adverse events, Medical History, and Concomitant Medication will be 
performed using standard dictionaries as described in the Data Management Plan. 

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9.2 
Documentation of Study Findings 
If corrections are made to entries in the CRF by the investigator or designates, the words 
or figures must be crossed through, leaving the initial entry legible. The correction must 
then be dated and initialed. Incorrect entries must not be covered with correcting fluid, 
obliterated, or made illegible in any way. If further corrections are made to a previously 
reviewed and signed CRF page, the investigator must confirm the correction and endorse 
the changes by signing and dating the study termination CRF again. 
As part of the conduct of the trial, NVD or its representative (e.g. CRO) may have 
questions about the data after the CRFs are collected from the site. These questions will 
be documented using Data Clarification Forms (DCFs). The Investigator will provide 
follow-up clarification and/or resolution of data issues raised by the monitor or the data 
manager. 
An explanation must be provided and documented by the investigator for all missing data. 
9.3 
Data Protection 
NVD respects the subjects’ rights to privacy and will ensure the confidentiality of their 
medical information in accordance with all applicable laws and regulations. 
10.0 
RECORD RETENTION 
Investigators must retain all study records required by NVD and by the applicable KFDA 
regulations in a secure and safe facility. The investigator must consult a NVD 
representative before disposal of any study records, and must notify the sponsor of any 
change in the location, disposition, or custody of the study files. Essential documents for 
PMS in Korea must be retained for 3 years from completion of drug re-examination. 
Retention time can be prolonged upon KFDA or sponsor request. “Essential documents” 
are defined as documents that individually and collectively permit evaluation of the 
conduct of a trial and the quality of the data produced. These documents should be 
retained for a longer period however, if required by the applicable regulatory 
requirements or by an agreement with the sponsor, but not less that 15 years. It is the 
responsibility of the sponsor to inform the investigator/institution as to when these 
documents no longer need to be retained (ICH E6, 5.5.12). 
11.0 
USE OF INFORMATION AND PUBLICATION 
NVD assures that the key design elements of this protocol will be posted in a publicly 
accessible database such as clinicaltrials.gov. 
NVD also assures that key results of this study will be posted in a publicly accessible 
database within one year from the last subject’s last study visit (LSLV). 

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12.0 
ETHICS 
12.1 
Regulatory and Ethical Compliance 
This clinical study was designed and shall be implemented and reported in accordance 
with the ICH Harmonized Tripartite Guidelines for Good Clinical Practice, under KFDA 
regulations and with the ethical principles laid down in the Declaration of Helsinki. 
12.2 
Informed Consent Procedures 
Eligible subjects may only be included in the study after providing written (witnessed, 
where required by law or regulation), EC/IRB-approved informed consent, or, if 
incapable of doing so, after such consent has been provided by a legally acceptable 
representative of the subject. In cases where consent is given by the subject’s 
representative, the subject should be informed about the study to the extent possible given 
his/her understanding. 
Informed consent must be obtained before conducting any study-specific procedures (i.e. 
all of the procedures described in the protocol). The process of obtaining informed 
consent should be documented in the subject source documents. 
NVD will provide to investigators a separate document with a proposed informed consent 
form that complies with the ICH GCP guideline and regional regulatory requirements and 
is considered appropriate for this study. Any changes to the proposed consent form 
suggested by the investigator must be agreed to by NVD before submission to the 
EC/IRB, and a copy of the approved version must be provided to the NVD monitor or its 
representative (e.g. contract research organization) after EC/IRB approval. 
12.3 
Responsibilities of the Investigator and IRB/EC 
The protocol and the proposed informed consent form will be reviewed and approved by 
EC/IRB before study start. A signed and dated statement that the protocol and informed 
consent have been approved by the relevant EC/IRB must be given to NVD before study 
initiation. A copy of the informed consent must be maintained in the site’s study file. 
Prior to study start, the investigator is required to sign a protocol signature page 
confirming his/her agreement to conduct the study in accordance with these documents 
and all of the instructions and procedures found in this protocol and to give access to all 
relevant data and records to NVD monitors, auditors, Novartis Clinical Quality Assurance 
representatives, designated agents of NVD, ECs/IRBs, and regulatory authorities as 
required. If an inspection of the clinical site is requested by a regulatory authority, the 
investigator must inform NVD immediately that this request has been made. 

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12.4 
Protocol Adherence 
Investigators will apply due diligence to avoid protocol deviations. Under no 
circumstances should the investigator contact NVD or its agents, if any, monitoring the 
trial to request approval of a protocol deviation, as no authorized deviations are permitted. 
If the investigator feels a change to the protocol would improve the conduct of the study 
this must be considered a protocol amendment, and unless such an amendment is agreed 
upon by NVD and approved by the EC/IRB it cannot be implemented. All significant 
protocol deviations will be recorded and reported in the clinical study report. 
12.5 
Protocol Amendments 
An amendment is a written description of change(s) to or formal clarification of a study 
protocol which may impact on the conduct of the study, potential benefit of the study, or 
may affect subject safety, including changes of study objectives, study design, subject 
population, sample sizes, study procedures, or significant administrative aspects. An 
administrative change of a study protocol is a minor correction or clarification that has no 
significant impact on the way the study is to be conducted and no effect on subject safety 
(e.g., change of telephone number(s), logistical changes). Protocol amendments must be 
approved by NVD, Health Authorities, KFDA where required, and the relevant EC/IRB. 
In cases when the amendment is required in order to protect the subject safety, the 
amendment can be implemented prior to relevant EC/IRB approval. Notwithstanding the 
need for formal approval of a protocol amendment, the investigator is expected to take 
any immediate action required for the safety of any subject included in this study, even if 
this action represents a deviation from the protocol. In such cases, NVD should be 
notified of this action and the relevant EC/IRB at the study site should be informed within 
10 working in accordance with local regulations. 

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13.0 
REFERENCE LIST 
Al-Tawfiq JA, Clark TA and Memish ZA. Meningococcal disease: the organism, clinical 
presentation, and worldwide epidemiology. J Travel Med 2010; 17 Suppl:3-8. 
Cho HK et al. The causative organisms of bacterial meningitis in Korean children in 
1996-2005. J Korean Med Sci 2010; 25: 895-899. 
Deasy A and Read RC. Challenges for development of meningococcal vaccines in infants 
and children. Expert Rev. Vaccines 2011; 10: 335–343. 
Hill DJ, Griffiths NJ, Borodina E and Virji M. Cellular and molecular biology of 
Neisseria meningitidis colonization and invasive disease. Clinical Science 2010; 118: 
547–564. 
Korea Centers for Disease Control and Prevention. Communicable diseases monthly 
report (CDMR). 2007. Online at http://dis.mohw.go.kr/cdmr/cdmr.asp. 
Lee JH et al. Etiology of invasive bacterial infections in immunocompetent children in 
Korea (1996-2005): a retrospective multicenter study. J Korean Med Sci 2011; 26: 174- 
183. 
Moon SY et al. Changing etiology of community-acquired bacterial meningitis in adults: 
a nationwide multicenter study in Korea. Eur J Clin Microbiol Infect Dis 2010; 29: 793– 
800. 
Obaro S and Madhi S. Bacterial pneumonia vaccines and childhood pneumonia; are we 
winning, refining, or redefining? Lancet Infect Dis 2006; 6:150-161. 
Rouphael NG and Stephens DS. Neisseria meningitidis: Biology, Microbiology, and 
Epidemiology. Methods Mol Biol. 2012;799:1-20. 
Song-Mee Bae and Yeon-Ho Kang. Serological and Genetic Characterization of 
Meningococcal Isolates in Korea. Jpn J Infect Dis. 2008;61:434-437. 
Trotter C et al. Effectiveness of meningococcal serogroup C conjugate vaccine 4 years 
after introduction. Lancet 2004; 364: 365-367. 

Novartis Vaccines and Diagnostics 
22 MAY 13 
Clinical Study Protocol V59_62 Amendment 1 
Page 1 of 3 
Confidential 
CLINICAL STUDY PROTOCOL V59_62 
Amendment Number 1 
A Multicenter Post Marketing Surveillance Study to Monitor the Safety of Novartis 
Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) Administered 
According to the Prescribing Information to Healthy Subjects from 11 to 55 Years 
of Age in the Republic of South Korea 
Property of Novartis Vaccines and Diagnostics 
Confidential 
May not be used, divulged, published or otherwise disclosed without written 
consent of Novartis Vaccines and Diagnostics. 
The present amendment reflects changes to the protocol since the version 1 of the 
protocol. 
PRO-01 TEMP 08 / Atlas No. 293623 
Version No. 1 / Version Date: August 20, 2012 
Doc Number: 51742732 

Novartis Vaccines and Diagnostics 
22 MAY 13 
Clinical Study Protocol V59_62 Amendment 1 
Page 2 of 3 
Confidential 
DESCRIPTION OF CHANGE(S) AND RATIONALE: 
V59_62 is a post-marketing surveillance (PMS) study to monitor the safety of 
MenACWY-CRM in Korean individuals from 11 to 55 years of age receiving 
MenACWY-CRM vaccination according to routine clinical practice and prescribing 
information. The study is a post-licensure requirement of the Ministry of Food and Drug 
Safety (MFDS) to provide continued safety evaluation in the Korean population. MFDS 
recently approved (21 March 2013) Menveo indication in subjects 2-10 years of age. The 
protocol is amended to include these subjects in the PMS study. Solicited local and 
systemic adverse events are also revised accordingly, to include the definitions relevant to 
subjects 2 to 5 years of age. Of note, the solicited systemic adverse events reported within 
V59_62 protocol version 1 were modified as compared to the NVD mandatory standards 
to ensure consistency with the V59_39 Menveo registration study. NVD standard 
solicited local and systemic adverse events for subjects < 6 years of age are in included in 
V59_62 protocol version 2. 
V59_62 is conducted in accordance with the principles outlined by MFDS. PMS 
guidelines require only study protocol and CRF to be submitted for study approval. 
However, in compliance with NVD SOPs, ICF has also been submitted. Following 
MFDS approval, some of the IRBs required to provide also an Assent Form to be signed 
by minors (the age-range for collecting the Assent Form signature is specific for each 
IRB). The protocol is therefore amended to specify that the Assent Form will be provided 
to the sites where IRBs specifically requires it. 
V59_62 includes individuals receiving MenACWY-CRM vaccination according to 
routine clinical practice and prescribing information. Exclusion criteria within the 
protocol descriptively refer to the contraindication contained in the vaccine package 
leaflet. Exclusion criteria are collected in the database criteria per code, each code 
associated with a default description. To facilitate the collection of these data in the CDR, 
a single exclusion criteria referring to the package leaflet is included in the revised 
protocol. 
Korea Food and Drug Administration (KFDA) has changed its official name to Ministry 
of Food and Drug Safety (MFDS), the protocol is revised accordingly. 
PRO-01 TEMP 08 / Atlas No. 293623 
Version No. 1 / Version Date: August 20, 2012 
Doc Number: 51742732 

Novartis Vaccines and Diagnostics 
22 MAY 13 
Clinical Study Protocol V59_62 Amendment 1 
Page 3 of 3 
Confidential 
CHANGE 
LOCATIONS OF 
CHANGE 
RATIONALE FOR 
CHANGE 
Change in target population 
from 11-55 years of age to 2- 
55 years of age. 
Study title, synopsis, list 
of abbreviation and 
definition of terms, 
section 1, section 2, 
section 3, section 4, 
section 7. 
Approval for 2-10 years of 
age subjects granted by 
MFDS. 
Allow Assent Form to be 
provided to minors when 
requested by IRBs. 
Synopsis, section 3, 
section 4, section 12. 
Assent Form request by some 
IRBs. 
Change in the solicited local 
and systemic events 
description. 
Synopsis, section 3, 
section 6, section 7. 
Solicited local and systemic 
events to be described 
according to NVD standards 
including the distinction for 
>6 years and <6 years of age. 
Exclusion criteria numbered. 
Section 4. 
To facilitate data collection 
into the CDR. 
Change Korea Food and 
Drug Administration 
(KFDA) to Ministry of Food 
and Drug Safety (MFDS) 
Synopsis, section 1, 
section 3, section 4, 
section 6, section 7, 
section 8, section 10, 
section 12. 
Change of Regulatory 
Agency official name 
PRO-01 TEMP 08 / Atlas No. 293623 
Version No. 1 / Version Date: August 20, 2012 
Doc Number: 51742732 

 
PPD 
Novartis 
Document Approval Certificate / 
 
 
The individuals listed have approved this document for implementation using an electronic signature in the 
Atlas EDMS. / 
 
. 
 
 
 
UserName: PPD 
 
Title: Cluster Physician 
Date: Monday, 03 June 2013, 12:15 GMT 
Meaning: As an approver, I agree with the content and format of this document. 
================================================ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Novartis Vaccines 
22 OCT 14 
Clinical Study Protocol Amendment 2 
Page 1 of 4 
Confidential 
CLINICAL STUDY PROTOCOL AMENDMENT 
Study Number: V59_62 
A Multicenter Post Marketing Surveillance Study to Monitor the Safety of Novartis 
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 
Amendment Number 2 
Revised Protocol version 3.0 issued on 22 OCT 14 
The present amendment reflects changes to the Revised Protocol version 2.0 issued 
on 22 MAY 13 
Property of Novartis Vaccines 
Confidential 
May not be used, divulged, published or otherwise disclosed without written 
consent of Novartis Vaccines. 
PRO-01 TEMP 08 / Atlas No. 293623 
Version No. 2 / Version Date: May 5, 2014 
Doc Number: 67631572 

Novartis Vaccines 
22 OCT 14 
Clinical Study Protocol Amendment 2 
Page 2 of 4 
Confidential 
The purpose of this amendment is to add infants (2 to 24 months) according to 
MFDS requirements and add provide clarifications to the protocol. 
DESCRIPTION OF CHANGE(S) AND RATIONALE: 
CHANGES 1 (Synopsis) 
Previously reads: 
NA 
Now reads: 
Infant from 2 to 23 months of age may enroll if scheduled to receive MenACWY-CRM 
prophylaxis as part of vaccination series per routine standard of care. The infant may 
enroll at any point, for one injection only, in the vaccination series, including those 
subjects who may have already initiated the vaccination series. 
Rational for changes: Text has been added to clarify the procedure of infant vaccination. 
CHANGE 2 (Section 3.3) 
Previously reads: 
A physical exam/assessment, including height, weight and body temperature (preferably 
axillary) will be performed and results recorded before vaccination. 
Now reads: 
A physical exam/assessment, including height, weight and body temperature (preferably 
axillary for subjects from 2 to 55 years of age and tympanic for infants) will be 
performed and results recorded before vaccination. 
Rational for change: Inclusion of infants in standard temperature measurement. 
CHANGE 3 (Section 4.2, Exclusion Criteria) 
Previously reads: 
NA 
Now reads: 
1. Infants who were already enrolled in this trial for previous vaccination. 
PRO-01 TEMP 08 / Atlas No. 293623 
Version No. 2 / Version Date: May 5, 2014 
Doc Number: 67631572 

Novartis Vaccines 
22 OCT 14 
Clinical Study Protocol Amendment 2 
Page 3 of 4 
Confidential 
Rational for change: To ensure that infants are not enrolled more than once. 
CHANGE 4 (Section 6.2.5, Post Study Event) 
Previously reads: 
Any AE that occurs outside the protocol-specified observation period or after the end of 
the study but considered to be caused by the study vaccine must be reported to NVD. 
These AEs will be processed by the NVD Pharmaco-vigilance group. 
Now reads: 
Any AE that occurs outside the protocol-specified observation period or after the end of 
the study but considered to be caused by the study vaccine must be reported to the 
sponsor as spontaneous report as per the local practice. 
Rational for change: Spontaneous reporting to be applied to this PMS studies. 
CHANGE 5 (Section 6.2.6) 
Previously reads: 
Pregnancy data must be recorded on a Pregnancy Report CRF (initial report) and 
Pregnancy Follow-Up CRF (outcome report) and reported to NV. 
Now reads: 
Pregnancy data must be recorded on a Pregnancy Report CRF (initial report) and 
Pregnancy Follow-Up CRF (outcome report) and reported to study CRO. 
Rational for change: Procedure correction involving the CRO instead of NVD. 
CHANGE (Section 7.0, Statistical Plan) 
Previously reads: 
NA 
Now reads: 
The statistical plan to analyze and report data according to ICH requirement is described 
in the following section. A separate document will describe the statistical analysis plan 
(including population for analysis) according to MFDS. 
PRO-01 TEMP 08 / Atlas No. 293623 
Version No. 2 / Version Date: May 5, 2014 
Doc Number: 67631572 

Novartis Vaccines 
22 OCT 14 
Clinical Study Protocol Amendment 2 
Page 4 of 4 
Confidential 
Rational for change: To clarify that additional SAP will be performed to follow ICH 
requirements. 
Table 1: Other Changes 
CHANGE 
LOCATION(S) OF 
CHANGE 
RATIONALE FOR 
CHANGE 
Change in the location of 
the injection including 
infants. 
Synopsis 
Section 3.3 
Alignment with study 
population 
Menveo is to be 
administered as a single 
0.5 ml intramuscular 
injection, preferably into 
the anterolateral aspect of 
the thigh in infants or into 
the deltoid muscle (upper 
arm) in children, 
adolescents and adults. 
Section 5.1 
Section 5.4 
Change in the study 
population, adding infants 
from 2 to 23 months. 
Study title 
Synopsis 
Approval by KFDA 
Section 1; 2 ; 3.1; 3.2; 4.1; 
7.2; 7.6 
PRO-01 TEMP 08 / Atlas No. 293623 
Version No. 2 / Version Date: May 5, 2014 
Doc Number: 67631572 

PPD 
Novartis 
Document Approval Certificate / 
 
The individuals listed have approved this document for implementation using an electronic signature in the 
Atlas EDMS. / 
UserName: PPD 
 
Title: Cluster Physician 
Date: Tuesday, 28 October 2014, 13:46 GMT 
Meaning: As an approver, I agree with the content and format of this document. 
================================================ 
This signature certificate is only valid when accompanied by all the pages of the document. / 
PPD 
 
PPD 
Doc Number: 67631572 

Novartis Vaccines 
12 MAY 15 
Clinical Study Protocol Amendment 3 
Page 1 of 7 
Confidential 
CLINICAL STUDY PROTOCOL V59_62 
A Multicenter Post Marketing Surveillance Study to Monitor the Safety of Novartis 
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 
Amendment Number 3 
Revised Protocol version 4.0 issued on 12 May 2015 
The present amendment reflects changes to the Protocol version 3.0 
issued on 22 OCT 14 
Property of Novartis Vaccines 
Confidential 
May not be used, divulged, published or otherwise disclosed without written 
consent of Novartis Vaccines. 
The purpose of this amendment is to implement changes requested by Korean 
Health Authorities. 
PRO-01 TEMP 08 / Atlas No. 293623 
Version No. 2 / Version Date: May 5, 2014 
Doc Number: 72773581 

Novartis Vaccines 
12 MAY 15 
Clinical Study Protocol Amendment 3 
Page 2 of 7 
Confidential 
DESCRIPTION OF CHANGE(S) AND RATIONALE: 
CHANGE 1 
In the synopsis section, page 4, 3rd paragraph, following text was added. 
For subjects 2-23 months of age, the parents will also be asked to consent for surveillance 
after subsequent vaccinations. 
CHANGE 2 (PAGE 23, SECTION 3.3.2) 
Previously read: 
In order to obtain information on Regulatory PMS data after-market launch, NVD or 
delegate will create the Regulatory PMS contract with the relevant clinics/hospitals and 
the physician in charge of the survey shall implement this Regulatory PMS in subjects 
that receive MenACWY-CRM in the relevant hospital/clinic since the contract date until 
the number of contracted survey cases, without omission, is reached. 
Now reads: 
In order to obtain information on Regulatory PMS data after-market launch, NVD or 
delegate will create the Regulatory PMS contract with the relevant clinics/hospitals and 
the physician in charge of the survey shall implement this Regulatory PMS in subjects 
that receive MenACWY-CRM in the relevant hospital/clinic since the contract date until 
the number of contracted survey cases, without omission, is reached 
Subjects will be enrolled at the time of their visit to participating clinic or hospital for 
vaccination with MenACWY-CRM according to routine clinical practice: 
• Vaccine schedule for children from 2 to 23 months of age 
➢ In infants initiating vaccination from 2 to 6 months of age, three doses of 
Menveo, each of 0.5 ml, should be given with an interval of at least 2 
months; the fourth dose should be administered during the second year of 
life with an interval of at least 6 months after the third dose. 
➢ In unvaccinated children from 7 to 23 months of age, Menveo should be 
administered as two doses, each as a single dose (0.5 ml), with the second 
dose administered in the second year of life and at least three months after 
the first dose. 
PRO-01 TEMP 08 / Atlas No. 293623 
Version No. 2 / Version Date: May 5, 2014 
Doc Number: 72773581 

Novartis Vaccines 
12 MAY 15 
Clinical Study Protocol Amendment 3 
Page 3 of 7 
Confidential 
• Vaccine schedule for children, adolescents and adults 2 to 55 years of age 
➢ Menveo is to be administered as single dose (0.5 ml). 
Subjects 2 to 23 months of age may enroll at any vaccination time point in the vaccination 
series and will be followed up within the surveillance period for 29 days after vaccination. 
According to parental consent, these subjects may be followed up for 29 days within the 
surveillance period after subsequent vaccination(s) at the same study site. 
Rationale for Change: 
All texts have been changed to align with Korean Heath Authorities. 
PRO-01 TEMP 08 / Atlas No. 293623 
Version No. 2 / Version Date: May 5, 2014 
Doc Number: 72773581 

Novartis Vaccines 
12 MAY 15 
Clinical Study Protocol Amendment 3 
Page 4 of 7 
Confidential 
CHANGE 3 (SECTION 3.3.1) 
Previously read: 
Table 3.3-1: Times and Events Table 
Visit Type 
Clinic Visit 
Study Day 
Day 1 
Day 29 
Study Visit Window 
n/a 
-4/+7 
ICF/AFa 
X 
Exclusion/Inclusion 
X 
Medical history 
X 
Physical exam/assessmentb 
X 
Study vaccine administered 
X 
Immediate hypersensitivity eventsc 
X 
Diary Card Dispensed 
X 
Diary Card Collected and/or Reviewedd 
X 
Assess/review Local/Systemic Adverse Eventse 
X 
Assess/review AEs and SAEsf 
X 
Concomitant medicationsg 
X 
X 
Study Terminationh 
X 
PRO-01 TEMP 08 / Atlas No. 293623 
Version No. 2 / Version Date: May 5, 2014 
Doc Number: 72773581 

Novartis Vaccines 
12 MAY 15 
Clinical Study Protocol Amendment 3 
Page 5 of 7 
Confidential 
Now reads: 
Table 3.3-1: Times and Events Table (2 months through 55 years of age) 
Visit Type 
Clinic Visit 
Telephone 
or Clinic Visit 
Study Day 
Day 1 
Day 29 
Study Visit Window 
n/a 
-4/+7 
ICF/AFa 
X 
(Only at 1st 
vaccination 
) 
Exclusion/Inclusion 
X 
Medical history 
X 
Physical exam/assessmentb 
X 
Demographics 
X 
(Only at 1st 
vaccination 
) 
Study vaccine administered 
X 
Immediate hypersensitivity eventsc 
X 
Diary Card Dispensed 
X 
Diary Card Collected and/or Reviewedd 
X 
Assess/review Local/Systemic Adverse 
Eventse 
X 
Assess/review AEs and SAEsf 
X 
Concomitant medicationsg 
X 
X 
Study Terminationh 
X 
PRO-01 TEMP 08 / Atlas No. 293623 
Version No. 2 / Version Date: May 5, 2014 
Doc Number: 72773581 

Novartis Vaccines 
12 MAY 15 
Clinical Study Protocol Amendment 3 
Page 6 of 7 
Confidential 
Rational for changes: Table was modified to include infant subjects 
CHANGE 4 (SECTION 3.3.2) 
Previously read: 
Adverse events (Not related) 
Previously reads: 
The AE is not related if exposure to the investigational vaccine has not occurred, or the 
occurrence of the AE is not reasonably related in time, or the AE is considered unlikely to 
be related to use of the investigational vaccine, i.e. there are no facts (evidence) or 
arguments to suggest a causal relationship. 
Now reads: 
The AE is not related to an investigational vaccine if there is evidence that clearly 
indicates an alternative explanation. If the subject has not received the vaccine, the timing 
of the exposure to the vaccine and the onset of the AE are not reasonably related in time, 
or other facts, evidence or arguments exist that reasonably suggest an alternative 
explanation, then the AE is not related. 
Adverse Events (Possibly related) 
Previous reads: 
The administration of the investigational vaccine and AE are considered reasonably 
related in time and the AE could be explained by causes other than exposure to the 
investigational vaccine. 
Now reads: 
The administration of the investigational vaccine and AE are considered reasonably 
related in time and the AE could be explained by exposure to the investigational vaccine 
or by other causes. 
Adverse Events (Probably related) 
Previously reads: 
 
 
PRO-01 TEMP 08 / Atlas No. 293623 
Version No. 2 / Version Date: May 5, 2014 
Doc Number: 72773581 

Novartis Vaccines 
12 MAY 15 
Clinical Study Protocol Amendment 3 
Page 7 of 7 
Confidential 
Exposure to the investigational vaccine and AE are reasonably related in time and the 
investigational vaccine is more likely than other causes to be responsible for the AE, or is 
the most likely cause of the AE. 
Now reads: 
Exposure to the investigational vaccine and AE are reasonably related in time and no 
alternative explanation has been identified. 
Rational for changes: All texts have been changed to align with Korean Heath 
Authorities. 
CHANGE 5 (section 3.4) 
Previously reads: 
Expected subject trial participation interval: 29 days 
Now reads: 
Expected subject trial participation interval: approximately 29 days 
The safety will be followed up until the end of surveillance period, and the end date of 
surveillance will be informed by the sponsor. 
Rational for changes: To clarify study participation duration 
PRO-01 TEMP 08 / Atlas No. 293623 
Version No. 2 / Version Date: May 5, 2014 
Doc Number: 72773581 

PPD 
Novartis 
Document Approval Certificate / 
 
The individuals listed have approved this document for implementation using an electronic signature in the 
Atlas EDMS. / 
UserName: PPD 
 
Title: Cluster Physician 
Date: Monday, 01 June 2015, 10:41 GMT 
Meaning: As an approver, I agree with the content and format of this document. 
================================================ 
This signature certificate is only valid when accompanied by all the pages of the document. / 
PPD 
 
PPD 
Doc Number: 72773581 

GLAXOSMITHKLINE BIOLOGICALS S.A 
25 AUG 15 
Clinical Study Protocol Amendment 4 
Page 1 of 2 
Confidential 
CLINICAL STUDY PROTOCOL V59_62 
A Multicenter Post Marketing Surveillance Study to Monitor the Safety of GSK 
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 
Amendment Number 4 
Revised Protocol version 5.0 issued on 25 August 2015 
The present amendment reflects changes to the Protocol version 4.0 
Issued on 12 May 15 
Property of GSK 
Confidential 
May not be used, divulged, published or otherwise disclosed without written 
consent of GSK. 
PRO-01 TEMP 08 / Atlas No. 293623 
Version No. 2 / Version Date: May 5, 2014 
Doc Number: 74725146 

GLAXOSMITHKLINE BIOLOGICALS S.A 
25 AUG 15 
Clinical Study Protocol Amendment 4 
Page 2 of 2 
Confidential 
DESCRIPTION OF CHANGE(S) AND RATIONALE: 
CHANGE 1 
The entire document has been revised to ensure all instances where Novartis is 
mentioned are replaced with GSK. 
Rationale for Change: 
Due to change of Marketing Authorization Holder from Novartis Vaccines to GSK 
Vaccines, the document has been revised to change name of Sponsor. 
PRO-01 TEMP 08 / Atlas No. 293623 
Version No. 2 / Version Date: May 5, 2014 
Doc Number: 74725146 

PPD 
Novartis 
Document Approval Certificate / 
 
The individuals listed have approved this document for implementation using an electronic signature in the 
Atlas EDMS. / 
UserName: PPD 
 
Title: Cluster Physician 
Date: Thursday, 27 August 2015, 22:00 GMT 
Meaning: As an approver, I agree with the content and format of this document. 
================================================ 
This signature certificate is only valid when accompanied by all the pages of the document. / 
PPD 
 
PPD 
Doc Number: 74725146