Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine in Healthy Subjects 2 Months to 6 Years of Age in China
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 2,195
- Locations
- 1
- Primary Endpoint
- Percentage of subjects exhibiting a >= 4fold increase in rSBA titers level from pre-vaccination to post-vaccination
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Months to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: MCV-ACYW135 Vaccine Group (Biological)
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
Intervention: MPV-ACYW135 Vaccine Group (Biological)
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.
Intervention: MPV-A Vaccine Group (Biological)
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.
Intervention: MCV-AC Vaccine Group (Biological)
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.
Intervention: Hib Vaccine Group (Biological)
Outcomes
Primary Outcomes
Percentage of subjects exhibiting a >= 4fold increase in rSBA titers level from pre-vaccination to post-vaccination
Time Frame: 28 days after vaccination
Secondary Outcomes
- to evaluate the adverse reactions after vaccination(Within 28 days after vaccination)