Immunogenicity and Safety of Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Beijing Minhai Biotechnology Co., Ltd
ClinicalTrials.gov Identifier:
NCT02003313
First received: November 28, 2013
Last updated: September 19, 2015
Last verified: September 2015
  Purpose
The purpose of this double-blind study is to evaluate the safety, reactogenicity and immunogenicity of Group A,C,Y and W135 Meningococcal Polysaccharide Vaccine in 2 to 30 years-old Children and Adults. All subjects will receive 1 dose of Group A,C,Y and W135 Meningococcal Polysaccharide Vaccine.

Condition Intervention Phase
Meningitis
Biological: Group T
Biological: Group C
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine in More Than 2 Years Old Children and Adults

Further study details as provided by Beijing Minhai Biotechnology Co., Ltd:

Primary Outcome Measures:
  • Percentage of subjects exhibiting a >=4 fold increase in rSBA titers level from pre-vaccination to post-vaccination [ Time Frame: 28 days after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to evaluate the adverse reactions after vaccination [ Time Frame: within 28 days after vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 1260
Study Start Date: November 2013
Study Completion Date: July 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group T
Participants of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine.
Biological: Group T
0.5ml, Intramuscular
Other Name: vaccine made by Beijing Minhai Biotechnology Co., Ltd
Active Comparator: Group C
Participants of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine.
Biological: Group C
0.5ml, Intramuscular
Other Name: vaccine made by Hualan Biological Engineering, INC

  Eligibility

Ages Eligible for Study:   2 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
  • Healthy permanent residence 2-30 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.
  • In pregnancy or lactation or pregnant women during the test plan
  • Any condition that, in the judgment of investigator, may affect trial assessment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02003313

Locations
China
Chaoyang District Centre for Disease Prevention and Control
Beijing, China, 100021
Sponsors and Collaborators
Beijing Minhai Biotechnology Co., Ltd
Investigators
Principal Investigator: nianmin shi Beijing chaoyang district center for disease control and prevention
  More Information

No publications provided

Responsible Party: Beijing Minhai Biotechnology Co., Ltd
ClinicalTrials.gov Identifier: NCT02003313     History of Changes
Other Study ID Numbers: 2012L02647  2012L02647 
Study First Received: November 28, 2013
Last Updated: September 19, 2015
Health Authority: China: Food and Drug Administration

Keywords provided by Beijing Minhai Biotechnology Co., Ltd:
safety, immunogenicity, Meningococcal Polysaccharide Vaccine

ClinicalTrials.gov processed this record on February 11, 2016