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

Phase 3

Completed

• Conditions: Meningitis
• Interventions: Biological: MPV-A Vaccine Group; Biological: MCV-AC Vaccine Group; Biological: MCV-ACYW135 Vaccine Group; Biological: MPV-ACYW135 Vaccine Group; Biological: Hib Vaccine Group

• Registration Number: NCT02003495
• Lead Sponsor: Beijing Minhai Biotechnology Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-06
• Primary Completion: 2014-08
• Study Completion: 2014-10
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-19
• Last Update Posted: 2015-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2195

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MPV-A Vaccine Group	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.
MCV-AC Vaccine Group	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-ACYW135 Vaccine Group	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.
MPV-ACYW135 Vaccine Group	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
Hib Vaccine Group	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.

Primary Outcome Measures

Name	Time	Method
Percentage of subjects exhibiting a >= 4fold increase in rSBA titers level from pre-vaccination to post-vaccination	28 days after vaccination

Secondary Outcome Measures

Name	Time	Method
to evaluate the adverse reactions after vaccination	Within 28 days after vaccination

Trial Locations

Locations (1)

Henan Provincial Center for Disease Control and Prevention; 🇨🇳 Zhengzhou, Henan, China