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Immunogenicity and Safety of Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine

Primary Purpose

Meningitis

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Group T

Group C

About this trial

This is an interventional prevention trial for Meningitis focused on measuring safety, immunogenicity, Meningococcal Polysaccharide Vaccine

Eligibility Criteria

2 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
Healthy permanent residence 2-30 years old.
Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures.
Axillary temperature ≤37.0 ℃.

Exclusion Criteria:

History of meningitis infection or vaccination of meningococcal vaccine within the past 6 months.
Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia.
Patients administered with immunosuppressive agents, cytotoxicity factor or corticosteroids in the 6 months preceding the vaccine trial.
Receipt of blood or blood-derived products in the 3 months preceding vaccination.
Participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination.
Receipt of any live virus vaccine in the 15 days preceding vaccination.
Receipt of any subunit vaccine and inactivated vaccine in the 7 days before vaccination.
Febrile illness (temperature ≥ 38°C) in the 3 days or any acute illness/infection in the 7 days preceding vaccination.
Thrombocytopenia.
History of thyroid gland excision or treatment for thyroid gland disease in last 12 months.
Functional or anatomic asplenia.
History of eclampsia, epilepsy, encephalopathy and mental disease or family disease.
Chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, Guillain-Barre Syndrome).
Known or suspected diseases, including: respiratory system disease, acute infection or active stage of chronic disease, HIV infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc.
In pregnancy or lactation or pregnant women during the test plan
Any condition that, in the judgment of investigator, may affect trial assessment.

Sites / Locations

Chaoyang District Centre for Disease Prevention and Control

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group T

Group C

Arm Description

Participants of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine.

Outcomes

Primary Outcome Measures

Percentage of subjects exhibiting a >=4 fold increase in rSBA titers level from pre-vaccination to post-vaccination

Secondary Outcome Measures

to evaluate the adverse reactions after vaccination

Full Information

NCT ID

NCT02003313

First Posted

November 28, 2013

Last Updated

September 19, 2015

Sponsor

Beijing Minhai Biotechnology Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02003313

Brief Title

Immunogenicity and Safety of Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine

Official Title

Immunogenicity and Safety of Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine in More Than 2 Years Old Children and Adults

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beijing Minhai Biotechnology Co., Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this double-blind study is to evaluate the safety, reactogenicity and immunogenicity of Group A,C,Y and W135 Meningococcal Polysaccharide Vaccine in 2 to 30 years-old Children and Adults. All subjects will receive 1 dose of Group A,C,Y and W135 Meningococcal Polysaccharide Vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meningitis

Keywords

safety, immunogenicity, Meningococcal Polysaccharide Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1260 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group T

Arm Type

Experimental

Arm Description

Participants of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine.

Arm Title

Group C

Arm Type

Active Comparator

Arm Description

Participants of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine.

Intervention Type

Biological

Intervention Name(s)

Group T

Other Intervention Name(s)

vaccine made by Beijing Minhai Biotechnology Co., Ltd

Intervention Description

0.5ml, Intramuscular

Intervention Type

Biological

Intervention Name(s)

Group C

Other Intervention Name(s)

vaccine made by Hualan Biological Engineering, INC

Intervention Description

0.5ml, Intramuscular

Primary Outcome Measure Information:

Title

Percentage of subjects exhibiting a >=4 fold increase in rSBA titers level from pre-vaccination to post-vaccination

Time Frame

28 days after vaccination

Secondary Outcome Measure Information:

Title

to evaluate the adverse reactions after vaccination

Time Frame

within 28 days after vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study. Healthy permanent residence 2-30 years old. Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures. Axillary temperature ≤37.0 ℃. Exclusion Criteria: History of meningitis infection or vaccination of meningococcal vaccine within the past 6 months. Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia. Patients administered with immunosuppressive agents, cytotoxicity factor or corticosteroids in the 6 months preceding the vaccine trial. Receipt of blood or blood-derived products in the 3 months preceding vaccination. Participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination. Receipt of any live virus vaccine in the 15 days preceding vaccination. Receipt of any subunit vaccine and inactivated vaccine in the 7 days before vaccination. Febrile illness (temperature ≥ 38°C) in the 3 days or any acute illness/infection in the 7 days preceding vaccination. Thrombocytopenia. History of thyroid gland excision or treatment for thyroid gland disease in last 12 months. Functional or anatomic asplenia. History of eclampsia, epilepsy, encephalopathy and mental disease or family disease. Chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, Guillain-Barre Syndrome). Known or suspected diseases, including: respiratory system disease, acute infection or active stage of chronic disease, HIV infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc. In pregnancy or lactation or pregnant women during the test plan Any condition that, in the judgment of investigator, may affect trial assessment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

nianmin shi

Organizational Affiliation

Beijing chaoyang district center for disease control and prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chaoyang District Centre for Disease Prevention and Control

City

Beijing

ZIP/Postal Code

100021

Country

China

12. IPD Sharing Statement

Learn more about this trial

Immunogenicity and Safety of Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine

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