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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Beijing Minhai Biotechnology Co., Ltd
Sponsor:
Information provided by (Responsible Party):
Beijing Minhai Biotechnology Co., Ltd
ClinicalTrials.gov Identifier:
NCT02003495
First received: December 3, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Meningitis
Biological: MCV-ACYW135 Vaccine Group
Biological: MPV-ACYW135 Vaccine Group
Biological: MPV-A Vaccine Group
Biological: MCV-AC Vaccine Group
Biological: Hib Vaccine Group
Phase 3

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of subjects exhibiting a >= 4fold 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: 28 days after vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2195
Study Start Date: October 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MCV-ACYW135 Vaccine Group

Participants at age 2 to 6 years of enrollment will receive 1 doses 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 months 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.

Biological: MCV-ACYW135 Vaccine Group
0.5 mL, Intramuscular
Other Name: Meningococcal ( A, C, Y and W 135) conjugate vaccine
Active Comparator: MPV-ACYW135 Vaccine Group
Participants at age 2 to 6 years of enrollment will receive 1 doses on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine
Biological: MPV-ACYW135 Vaccine Group
0.5 mL, Intramuscular
Other Name: Group A, C, Y and W-135 Meningococcal Polysaccharide Vaccine
Active Comparator: 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.
Biological: MPV-A Vaccine Group
0.5 mL, Intramuscular
Other Name: Group A Meningococcal Polysaccharide vaccine
Active Comparator: 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 months apart.
Biological: MCV-AC Vaccine Group
0.5 mL, Intramuscular
Other Name: Group A and C Meningococcal conjugate vaccine
Placebo Comparator: 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.
Biological: Hib Vaccine Group
0.5 mL, Intramuscular
Other Name: Haemophilus Influenzae Type b Conjugate Vaccine

  Eligibility

Ages Eligible for Study:   2 Months to 6 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 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.
  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: NCT02003495

Contacts
Contact: Guifan Li 86-10-59613591 guifan@sohu.com

Locations
China, Henan
Center of henan province for Disease Control and Prevention Recruiting
Zhengzhou, Henan, China
Contact: shengli xia    86-371-68089128    xiasl@hncdc.com.cn   
Sponsors and Collaborators
Beijing Minhai Biotechnology Co., Ltd
Investigators
Principal Investigator: shengli xia center of Henan province for disease control and prevention
  More Information

No publications provided

Responsible Party: Beijing Minhai Biotechnology Co., Ltd
ClinicalTrials.gov Identifier: NCT02003495     History of Changes
Other Study ID Numbers: 2013L01041, 2013L01041
Study First Received: December 3, 2013
Last Updated: December 3, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Beijing Minhai Biotechnology Co., Ltd:
Immunogenicity, Safety, Meningococcal Conjugate Vaccine

Additional relevant MeSH terms:
Meningitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014