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Status unknownNCT02869672Updated Aug 18, 2016

Safety and Immunogenicity Study of ACYW135 Meningococcal Polysaccharide Vaccine Aged 2-50 Years Old

A Phase 3 interventional study of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine and Hualan Biology ACYW135 meningococcal polysaccharide vaccine in ACYW135 Meningococcal Polysaccharide Vaccine, sponsored by Beijing Chaoyang District Centre for Disease Control and Prevention. Status unknown. Open to participants aged 2 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-18.

Sponsored by Beijing Chaoyang District Centre for Disease Control and Prevention · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
2 Years to 50 Years
Sex
All
01

Study summary

This study evaluates the safety and immunogenicity of the ACYW135 Meningococcal Polysaccharide Vaccine in population aged 2-50 years old. Subjects will be divided into 3 group according to their age, receiving the test vaccine and the control vaccine at the proportion of 1:1 randomly. Each age group has 400 subjects, 1200 in total.

02

Conditions studied

  • ACYW135 Meningococcal Polysaccharide Vaccine

Keywords

  • safety
  • immunogenicity
  • vaccine
03

In context

Lead sponsor

Beijing Chaoyang District Centre for Disease Control and Prevention is the lead sponsor of 11 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
2 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • With the subject (or his guardian's) informed consent and signed the informed consent;
  • The history, physical examination and clinical judgement were determined to be healthy and in accordance with the vaccination age of the product;
  • The Subject or his guardian could comply with the clinical study protocol;
  • Have not been inoculated with Meningococcal vaccine in the past six months and A + C meningococcal polysaccharide vaccine in the past two years;
  • Have not been inoculated with other preventive biological products;
  • Axillary temperature≤37.0 ℃.

Exclusion criteria

Exclusion Criteria:

  • Children with the history of Neisseria meningitis;
  • Had allergies or serious adverse reactions of previous vaccination, such as allergies, urticaria, dyspnea, edema, abdominal pain, etc;
  • Had immune inhibitor therapy and cytotoxic therapy, inhaled corticosteroids in the past 6 months (not including allergic rhinitis corticosteroid aerosol therapy, patients with acute non concurrent dermatitis surface corticosteroid therapy);
  • Have been accepted blood products in the past 3 months;
  • Have been inoculated with other research drugs or vaccines in the past month;
  • Have been inoculated with attenuated live vaccine in the past 14 days;
  • Have been inoculated with subunit or inactivated vaccine in the past 7 days;
  • Had any acute illness, the need for systemic application of antibiotics or antiviral treatment in the past 7 days;
  • Had fever in the past 3 days (axillary temperature≥38.0℃) ;
  • Have been diagnosed with abnormal coagulation function (such as the lack of coagulation factors, coagulation disorders and abnormal blood platelet), obvious bruises or coagulation disorders by physician diagnosis;
  • Had the history of thyroid resection or the need for treatment of thyroid diseases in the past 12 months;
  • Asplenia, functional asplenia and asplenia or splenectomy of any situation;
  • Had epilepsy, convulsions, encephalopathy, mental illness or family history;
  • Suffering from serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia, neurological disorders or Guillain-Barre syndrome);
  • Suffering from known or suspected concurrent diseases including: respiratory diseases, acute or chronic infection of the activities, children's mother or the subject had HIV infection, cardiovascular disease, high blood pressure, during cancer treatment period, skin diseases;
  • The female during her pregnant and lactation period or who plan to become pregnant during the trial.
  • The subject of any other factors that are not suitable to participate in clinical trials according to the researcher's judgment.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,200 participants (estimated)

Study arms

  • Experimental
    age of 18-50 years old, experimental

    0.5 ml of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine will be given.

    Biological: Tiantan Biology ACYW135 meningococcal polysaccharide vaccine

  • Active comparator
    age of 18-50 years old, control

    0.5 ml of Hualan Biology ACYW135 meningococcal polysaccharide vaccine will be given.

    Biological: Hualan Biology ACYW135 meningococcal polysaccharide vaccine

  • Experimental
    age of 7-17 years old,experimental

    0.5 ml of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine will be given.

    Biological: Tiantan Biology ACYW135 meningococcal polysaccharide vaccine

  • Active comparator
    age of 7-17 years old, control

    0.5 ml of Hualan Biology ACYW135 meningococcal polysaccharide vaccine will be given.

    Biological: Hualan Biology ACYW135 meningococcal polysaccharide vaccine

  • Experimental
    age of 2-6 years old,experimental

    0.5 ml of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine will be given.

    Biological: Tiantan Biology ACYW135 meningococcal polysaccharide vaccine

  • Active comparator
    age of 2-6 years old,control

    0.5 ml of Hualan Biology ACYW135 meningococcal polysaccharide vaccine will be given.

    Biological: Hualan Biology ACYW135 meningococcal polysaccharide vaccine

Interventions

  • BiologicalTiantan Biology ACYW135 meningococcal polysaccharide vaccine

    Tiantan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml

  • BiologicalHualan Biology ACYW135 meningococcal polysaccharide vaccine

    Hualan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml

06

What researchers measure

Primary outcomes

  1. Evaluate serum antibody titers of quadrivalent influenza Vaccine in healthy people.

    The serum antibody titers will be evaluated at 28 days after vaccination.

    Time frame: 28 days

  2. Evaluate the Rate of Adverse reactions of quadrivalent influenza Vaccine in healthy people.

    Adverse reactions associated with vaccine will be observed in subjects after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy.

    Time frame: 28 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02869672
Lead sponsor
Beijing Chaoyang District Centre for Disease Control and Prevention
Responsible party
Sponsor
First posted
Aug 17, 2016
Start date
Jul 2016
Primary completion
Dec 2016 (estimated)
Last update
Aug 18, 2016
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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