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Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine

Primary Purpose

Meningitis

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

MCV-ACYW135 Vaccine Group

MPV-ACYW135 Vaccine Group

MPV-A Vaccine Group

MCV-AC Vaccine Group

Hib Vaccine Group

About this trial

This is an interventional prevention trial for Meningitis focused on measuring Immunogenicity, Safety, Meningococcal Conjugate Vaccine

Eligibility Criteria

2 Months - 6 Years (Child)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 months to 6 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.
Any condition that, in the judgment of investigator, may affect trial assessment.

Sites / Locations

Henan Provincial Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

MCV-ACYW135 Vaccine Group

MPV-ACYW135 Vaccine Group

MPV-A Vaccine Group

MCV-AC Vaccine Group

Hib Vaccine Group

Arm Description

Participants at age 2 to 6 years of enrollment will receive 1 dose on Meningococcal ( A, C, Y and W 135) conjugate vaccine. Participants at age 6 to 23 months of enrollment will receive 2 doses on Meningococcal ( A, C, Y and W 135) conjugate vaccine at 3 months apart. Participants at age 3 to 5 months of enrollment will receive 3 doses on Meningococcal ( A, C, Y and W 135) conjugate vaccine at 1 month apart. Participants at age 2 to 5 months of enrollment will receive 3 doses on Meningococcal ( A, C, Y and W 135) conjugate vaccine at 2 months apart.

Participants at age 2 to 6 years of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine

Participants at age 6 to 23 months of enrollment will receive 2 doses on Group A Meningococcal Polysaccharide vaccine at 3 months apart.

Participants at age 3 to 5 months of enrollment will receive 3 doses on Group A and C Meningococcal conjugate vaccine at 1 month apart.

Participants at age 2 to 5 months of enrollment will receive 3 doses on Haemophilus Influenzae Type b Conjugate Vaccine at 2 months apart.

Outcomes

Primary Outcome Measures

Percentage of subjects exhibiting a >= 4fold 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

NCT02003495

First Posted

December 3, 2013

Last Updated

September 19, 2015

Sponsor

Beijing Minhai Biotechnology Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02003495

Brief Title

Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine

Official Title

Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine in Healthy Subjects 2 Months to 6 Years of Age in China

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

October 2014 (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 observer-blind study is to evaluate the safety, reactogenicity and immunogenicity of Meninggococcal (A,C,Y and W135) Conjugate Vaccine in 2 months to 6 years-old children.

6. Conditions and Keywords

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

Meningitis

Keywords

Immunogenicity, Safety, Meningococcal Conjugate Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2195 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MCV-ACYW135 Vaccine Group

Arm Type

Experimental

Arm Description

Arm Title

MPV-ACYW135 Vaccine Group

Arm Type

Active Comparator

Arm Description

Participants at age 2 to 6 years of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine

Arm Title

MPV-A Vaccine Group

Arm Type

Active Comparator

Arm Description

Participants at age 6 to 23 months of enrollment will receive 2 doses on Group A Meningococcal Polysaccharide vaccine at 3 months apart.

Arm Title

MCV-AC Vaccine Group

Arm Type

Active Comparator

Arm Description

Participants at age 3 to 5 months of enrollment will receive 3 doses on Group A and C Meningococcal conjugate vaccine at 1 month apart.

Arm Title

Hib Vaccine Group

Arm Type

Placebo Comparator

Arm Description

Participants at age 2 to 5 months of enrollment will receive 3 doses on Haemophilus Influenzae Type b Conjugate Vaccine at 2 months apart.

Intervention Type

Biological

Intervention Name(s)

MCV-ACYW135 Vaccine Group

Other Intervention Name(s)

Meningococcal ( A, C, Y and W 135) conjugate vaccine

Intervention Description

0.5ml, intramuscular

Intervention Type

Biological

Intervention Name(s)

MPV-ACYW135 Vaccine Group

Other Intervention Name(s)

Group A, C, Y and W-135 Meningococcal Polysaccharide Vaccine

Intervention Description

0.5ml, intramuscular

Intervention Type

Biological

Intervention Name(s)

MPV-A Vaccine Group

Other Intervention Name(s)

Group A Meningococcal Polysaccharide vaccine

Intervention Description

0.5ml, intramuscular

Intervention Type

Biological

Intervention Name(s)

MCV-AC Vaccine Group

Other Intervention Name(s)

Group A and C Meningococcal conjugate vaccine

Intervention Description

0.5ml, intramuscular

Intervention Type

Biological

Intervention Name(s)

Hib Vaccine Group

Other Intervention Name(s)

Haemophilus Influenzae Type b Conjugate Vaccine

Intervention Description

0.5ml, intramuscular

Primary Outcome Measure Information:

Title

Percentage of subjects exhibiting a >= 4fold 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 Months

Maximum Age & Unit of Time

6 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 months to 6 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. Any condition that, in the judgment of investigator, may affect trial assessment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

shengli xia

Organizational Affiliation

Henan Provincial Center for Disease Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Henan Provincial Center for Disease Control and Prevention

City

Zhengzhou

State/Province

Henan

Country

China

12. IPD Sharing Statement

Learn more about this trial

Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine

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