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CompletedNCT02003313Updated Sep 22, 2015

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

A Phase 3 interventional study of Group T and Group C in Meningitis, sponsored by Beijing Minhai Biotechnology Co., Ltd. Completed at 1 site in China. Open to participants aged 2 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-22.

Sponsored by Beijing Minhai Biotechnology Co., Ltd · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
1,260
Allocation
Randomized
Ages
2 Years to 30 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Meningitis

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Keywords

  • safety, immunogenicity, Meningococcal Polysaccharide Vaccine
03

In context

Meningitis

373 studies on the registry are indexed under Meningitis; 32 are open to participants now.

This study's enrollment of 1,260 is above the median of 211 across 257 interventional studies indexed under Meningitis.

Browse Meningitis studies →

Lead sponsor

Beijing Minhai Biotechnology Co., Ltd is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
1,260 participants (actual)

Study arms

  • Experimental
    Group T

    Participants of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine.

    Biological: Group T

  • Active comparator
    Group C

    Participants of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine.

    Biological: Group C

Interventions

  • BiologicalGroup T

    0.5ml, Intramuscular

    Also known as: vaccine made by Beijing Minhai Biotechnology Co., Ltd

  • BiologicalGroup C

    0.5ml, Intramuscular

    Also known as: vaccine made by Hualan Biological Engineering, INC

06

What researchers measure

Primary outcomes

  1. Percentage of subjects exhibiting a >=4 fold increase in rSBA titers level from pre-vaccination to post-vaccination

    Time frame: 28 days after vaccination

Secondary outcomes

  1. to evaluate the adverse reactions after vaccination

    Time frame: within 28 days after vaccination

07

Study locations

1 site
  • Chaoyang District Centre for Disease Prevention and Control
    Beijing, 100021, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02003313
Lead sponsor
Beijing Minhai Biotechnology Co., Ltd
Responsible party
Sponsor
First posted
Dec 6, 2013
Start date
Nov 2013
Primary completion
May 2015
Completion
Jul 2015
Last update
Sep 22, 2015

Study contacts

nianmin shi
principal investigator · Beijing chaoyang district center for disease control and prevention

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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