Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine
NCT ID: NCT02003495
Last Updated: 2015-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2195 participants
INTERVENTIONAL
2013-10-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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MCV-ACYW135 Vaccine Group
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.
MCV-ACYW135 Vaccine Group
0.5ml, intramuscular
MPV-ACYW135 Vaccine Group
Participants at age 2 to 6 years of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine
MPV-ACYW135 Vaccine Group
0.5ml, intramuscular
MPV-A Vaccine Group
Participants at age 6 to 23 months of enrollment will receive 2 doses on Group A Meningococcal Polysaccharide vaccine at 3 months apart.
MPV-A Vaccine Group
0.5ml, intramuscular
MCV-AC Vaccine Group
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.
MCV-AC Vaccine Group
0.5ml, intramuscular
Hib Vaccine Group
Participants at age 2 to 5 months of enrollment will receive 3 doses on Haemophilus Influenzae Type b Conjugate Vaccine at 2 months apart.
Hib Vaccine Group
0.5ml, intramuscular
Interventions
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MCV-ACYW135 Vaccine Group
0.5ml, intramuscular
MPV-ACYW135 Vaccine Group
0.5ml, intramuscular
MPV-A Vaccine Group
0.5ml, intramuscular
MCV-AC Vaccine Group
0.5ml, intramuscular
Hib Vaccine Group
0.5ml, intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
2 Months
6 Years
ALL
Yes
Sponsors
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Beijing Minhai Biotechnology Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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shengli xia
Role: PRINCIPAL_INVESTIGATOR
Henan Provincial Center for Disease Control and Prevention
Locations
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Henan Provincial Center for Disease Control and Prevention
Zhengzhou, Henan, China
Countries
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Other Identifiers
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2013L01041
Identifier Type: REGISTRY
Identifier Source: secondary_id
2013L01041
Identifier Type: -
Identifier Source: org_study_id
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