## Protocol Section
### Identification Module
**NCT ID:** NCT01705379

**Brief Title:** Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects 2 Years of Age and Older

**Official Title:** A Multicenter, Single Arm, 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 2 Years of Age and Older in the Philippines

#### Organization Study ID Info
**ID:** V59_45OB
#### Organization
**Class:** INDUSTRY
**Full Name:** Novartis
### Status Module
#### Completion Date
**Date:** 2016-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-12-01

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-11-30

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2016-04

**Type:** ESTIMATED

#### Start Date
**Date:** 2013-03

**Status Verified Date:** 2016-11

#### Study First Post Date
**Date:** 2012-10-12
**Type:** ESTIMATED
**Study First Submit Date:** 2012-10-09
**Study First Submit QC Date:** 2012-10-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Novartis Vaccines

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** A multicenter, single arm, postmarketing surveillance study. This study is a postlicensure requirement of the Philippine Food and Drug Administration (FDA) to provide continued safety evaluation of MenACWY-CRM in Philippine individuals 2 years of age and older, receiving MenACWY-CRM vaccination according to routine clinical practice and prescribing information.

### Conditions Module

**Conditions:**

- Meningococcal Disease

**Keywords:**

- Neisseria meningitidis, conjugate vaccine, phase IV clinical trial

### Design Module

#### Enrollment Info

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 2 years of age and older

**Intervention Names:**

- Biological: Novartis Meningococcal ACWY Conjugate Vaccine

**Label:** MenACWY-CRM

### Interventions

#### Intervention 1

**Arm Group Labels:**

- MenACWY-CRM

**Description:** Immunization

**Name:** Novartis Meningococcal ACWY Conjugate Vaccine

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Measure:** All adverse events

**Time Frame:** Day 29

**Measure:** All serious adverse events

**Time Frame:** Day 29

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Individuals eligible for enrolment in this study are those:

1. who are of any gender, from the age of 2 and older, and to whom/whose parents or legally acceptable representatives the nature of the study has been described and the subject/subject's parent/legally acceptable representative has provided written informed consent.
2. who the investigator believes that the subject and/or his or her parent/legal representative can and will comply with the requirements of the protocol.
3. who are in good health as determined by clinical judgment of the investigator.

Exclusion Criteria:

Individuals not eligible to be enrolled in the study are those:

1. who are unwilling or unable to give written informed consent or assent to participate in the study.
2. who are perceived to be unreliable or unavailable for the duration of the study period.
3. who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
4. who have received any investigational or non-registered product (drug or vaccine) within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study.
5. who have received or who are planning to receive any vaccines (other than routine childhood vaccines) within 30 days before and after administration of study vaccine.

   (Exception: Influenza vaccine may be administered up to 15 days prior to study vaccination and at least 15 days after study vaccination)
6. who have behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
7. who are pregnant or breast feeding (female subjects of appropriate age) or who plan to become pregnant during the course of the study.
8. who have any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition), who have epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
9. who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components.
10. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
11. who are included in study personnel or close family members of personnel conducting this study.

**Healthy Volunteers:** True

**Minimum Age:** 2 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Healthy male and female subjects 2 years of age and older

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000016870

- Term: Neisseriaceae Infections

- ID: D000016905

- Term: Gram-Negative Bacterial Infections

- ID: D000001424

- Term: Bacterial Infections

- ID: D000001423

- Term: Bacterial Infections and Mycoses

- ID: D000007239

- Term: Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11572

- Name: Meningococcal Infections

- Relevance: HIGH

- As Found: Meningococcal Disease

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19218

- Name: Neisseriaceae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M19249

- Name: Gram-Negative Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12136

- Name: Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: T3709

- Name: Meningococcal Infection

- Relevance: HIGH

- As Found: Meningococcal Disease

- ID: T4057

- Name: Neisseria Meningitidis Infection

- Relevance: HIGH

- As Found: Meningococcal Disease

### Condition Browse Module - Meshes

- ID: D000008589

- Term: Meningococcal Infections

### Intervention Browse Module - Ancestors

- ID: D000002400

- Term: Cathartics

- ID: D000005765

- Term: Gastrointestinal Agents

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

- ID: M239062

- Name: Lactitol

- Relevance: HIGH

- As Found: Cruciate Ligament

- ID: M27664

- Name: Laxatives

- Relevance: LOW

- As Found: Unknown

- ID: M5651

- Name: Cathartics

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000014635

- Term: Lactitol

### Misc Info Module

- Version Holder: 2024-05-24
