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

B

Beijing Minhai Biotechnology

Status and phase

Completed
Phase 3

Conditions

Meningitis

Treatments

Biological: Group C
Biological: Group T

Study type

Interventional

Funder types

Industry

Identifiers

NCT02003313
2012L02647 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

1,260 patients

Sex

All

Ages

2 to 30 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

1,260 participants in 2 patient groups

Group T
Experimental group
Description:
Participants of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine.
Treatment:
Biological: Group T
Group C
Active Comparator group
Description:
Participants of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine.
Treatment:
Biological: Group C

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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