Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine
1 other identifier
interventional
2,195
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2013
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 3, 2013
CompletedFirst Posted
Study publicly available on registry
December 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedSeptember 22, 2015
September 1, 2015
10 months
December 3, 2013
September 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of subjects exhibiting a >= 4fold increase in rSBA titers level from pre-vaccination to post-vaccination
28 days after vaccination
Secondary Outcomes (1)
to evaluate the adverse reactions after vaccination
Within 28 days after vaccination
Study Arms (5)
MCV-ACYW135 Vaccine Group
EXPERIMENTALParticipants 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.
MPV-ACYW135 Vaccine Group
ACTIVE COMPARATORParticipants at age 2 to 6 years of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine
MPV-A Vaccine Group
ACTIVE COMPARATORParticipants at age 6 to 23 months of enrollment will receive 2 doses on Group A Meningococcal Polysaccharide vaccine at 3 months apart.
MCV-AC Vaccine Group
ACTIVE COMPARATORParticipants at age 3 to 5 months of enrollment will receive 3 doses on Group A and C Meningococcal conjugate vaccine at 1 month apart.
Hib Vaccine Group
PLACEBO COMPARATORParticipants at age 2 to 5 months of enrollment will receive 3 doses on Haemophilus Influenzae Type b Conjugate Vaccine at 2 months apart.
Interventions
0.5ml, intramuscular
0.5ml, intramuscular
0.5ml, intramuscular
0.5ml, intramuscular
0.5ml, intramuscular
Eligibility Criteria
You may qualify if:
- 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 ℃.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Henan Provincial Center for Disease Control and Prevention
Zhengzhou, Henan, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
shengli xia
Henan Provincial Center for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2013
First Posted
December 6, 2013
Study Start
October 1, 2013
Primary Completion
August 1, 2014
Study Completion
October 1, 2014
Last Updated
September 22, 2015
Record last verified: 2015-09