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

Beijing Minhai Biotechnology

Status and phase: Completed; Phase 3

Conditions: Meningitis

Treatments: Biological: MCV-AC Vaccine Group; Biological: Hib Vaccine Group; Biological: MPV-A Vaccine Group; Biological: MPV-ACYW135 Vaccine Group; Biological: MCV-ACYW135 Vaccine Group

Study type: Interventional

Funder types: Industry

Identifiers

NCT02003495

2013L01041 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 2,195 patients

Sex: All

Ages: 2 months to 6 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,195 participants in 5 patient groups, including a placebo group

MCV-ACYW135 Vaccine Group

Experimental group

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.

Treatment:

Biological: MCV-ACYW135 Vaccine Group

MPV-ACYW135 Vaccine Group

Active Comparator group

Description:

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

Treatment:

Biological: MPV-ACYW135 Vaccine Group

MPV-A Vaccine Group

Active Comparator group

Description:

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

Treatment:

Biological: MPV-A Vaccine Group

MCV-AC Vaccine Group

Active Comparator group

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.

Treatment:

Biological: MCV-AC Vaccine Group

Hib Vaccine Group

Placebo Comparator group

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.

Treatment:

Biological: Hib Vaccine Group