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

This study is currently recruiting participants.
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
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 April 17, 2014