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

Meningitis Clinical Trial

Official title:

Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine in Healthy Subjects 2 Months to 6 Years of Age in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003495
• Other study ID #: 2013L01041
• Secondary ID: 2013L01041
• Status: Completed
• Phase: Phase 3
• First received: December 3, 2013
• Last updated: September 19, 2015
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: September 2015
• Source: Beijing Minhai Biotechnology Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2195
• Est. completion date: October 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 6 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningitis

Intervention

Biological:
• 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

Locations

Country	Name	City	State
China	Henan Provincial Center for Disease Control and Prevention	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Minhai Biotechnology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects exhibiting a >= 4fold increase in rSBA titers level from pre-vaccination to post-vaccination		28 days after vaccination	No
Secondary	to evaluate the adverse reactions after vaccination		Within 28 days after vaccination	Yes