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CompletedNCT01661751Updated Aug 9, 2012

Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 003

A Phase 3 interventional study of ACYW135 Meningococcal Polysaccharide Vaccine and A+C Meningococcal Polysaccharide Vaccine in Meningitis, sponsored by Hualan Biological Engineering, Inc.. Completed. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-08-09.

Sponsored by Hualan Biological Engineering, Inc. · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
900
Allocation
Randomized
Ages
2 Years and older
Sex
All
01

Study summary

The clinical trial was designed to evaluate the safety and immunogenicity against Group ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of age and older.

Read the detailed description

Complying with requirements of the approval letter of clinical trial issued by SFDA (Approval Letter No.: 2006L01017), Hualan conducted phase III clinical trial of Group ACYW135 Meningococcal Polysaccharide Vaccine to evaluate the safety and immunogenicity of the experimental vaccine.

The safety end points were the presence of any systemic, local and adverse reaction. Evaluation indicators of immunogenicity were bacteriocin levels of groups A, C, Y and W135 respectively in the serum after the whole vaccination.

02

Conditions studied

  • Meningitis

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Keywords

  • Group ACYW135 Meninigococcal Polysaccharide Vaccine
03

In context

Meningitis

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

This study's enrollment of 900 is above the median of 215 across 262 interventional studies indexed under Meningitis.

Browse Meningitis studies →

Lead sponsor

Hualan Biological Engineering, Inc. is the lead sponsor of 7 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 and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy permanent residence 2 years of age and older, the subjects (or their guardians) are able to understand and sign the informed consent;
  • Healthy male or female by oral history, physical examination and clinical judgment and who complies with vaccination of this product;
  • Be able to comply with the requirements of clinical trial protocol and immunogenicity examination;
  • Have no history of vaccination within the past 3 months and vaccination with other products within the last 2 weeks;
  • Axillary temperature ≤37.0℃.

Exclusion criteria

Exclusion Criteria:

  • Any acute disease, such as: tumor, autoimmunity disease, progressive atherosclerotic disease or diabetes with complication, chronic obstructive pulmonary disease need oxygen uptake, acute or progressive hepatopathy or nephropathy, congestive heart-failure, etc.;
  • Allergic to vaccines or drugs (history of allergy to any vaccine in the past);
  • History of neurologic symptom or signs;
  • Known or suspected (or high risk) impaired or abnormal immune function, e.g.: receive immunosuppressant or immunopotentiator therapy, take immunoglobulin or blood product or plasma extract (except the gastrointestinal tract) within the past 3 months, HIV infection or related disease, etc.;
  • History of meningitis infection or vaccination of meningococcal vaccine within the past 3 months;
  • History of receiving other vaccines or immunoglobulin injection or any research drugs;
  • Any acute disease needing application of antibiotics or anti-virus treatment in the whole body within the past 1 week;
  • History of fever within the past 3 days (axillary temperature ≥38.0℃);
  • Participating in another clinical trial;
  • History of allergy, eclampsia, epilepsy, encephalopathy and mental disease or family disease;
  • Thrombopenia or other coagulopathy that may cause contraindication to intramuscular injection;
  • Acute 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, SBAV infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc.;
  • Pregnancy
  • 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
Double (Participant, Investigator)
Enrollment
900 participants (actual)

Study arms

  • Experimental
    ACYW135 Meningococcal Vaccine

    0.5 ml/ dose, containing 50 μg of each antigen; lot No.: 20040601, manufacturing date: June 9, 2004 and the expiration date: till June 2006

    Biological: ACYW135 Meningococcal Polysaccharide Vaccine

  • Active comparator
    A+C Meningococcal Vaccine

    0.5 ml/ dose; each ampoule or dose contains 100 μg (one single human dose) and 50 μg of each antigen; lot No.: 20050805 and the expiration date: Aug. 24, 2007

    Biological: A+C Meningococcal Polysaccharide Vaccine

Interventions

  • BiologicalACYW135 Meningococcal Polysaccharide Vaccine

    600 subjects were divided into three groups (200 subjects in each group), adult (16\~30 years of age), early youth (7\~15 years of age) and children (2\~6 years of age) to receive Group ACYW135 Meningococcal Polysaccharide Vaccine, 0.5 ml, one dose regime

    Also known as: Hualan Bio

  • BiologicalA+C Meningococcal Polysaccharide Vaccine

    300 subjects were divided into three groups (100 subjects in each group), adult (16\~30 years of age), early youth (7\~15 years of age) and children (2\~6 years of age) to receive Group AC Meningococcal Polysaccharide Vaccine, 0.5 ml, one dose regime

    Also known as: Lanzhou Institute

06

What researchers measure

Primary outcomes

  1. Safety

    Systemic and local adverse reactions after the vaccination; adverse events

    Time frame: Dat 28 after vaccination

Secondary outcomes

  1. Immunogenicity

    4-fold (seroconversion) and 8-fold increase of bactericidin; GMT and bactericidin increase after immunization

    Time frame: The 4th week after immunization

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 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01661751
Lead sponsor
Hualan Biological Engineering, Inc.
Responsible party
Sponsor
First posted
Aug 9, 2012
Start date
May 2006
Primary completion
May 2006
Completion
Aug 2006
Last update
Aug 9, 2012

Study contacts

Fubao Ma, Bachelor
principal investigator · Immunization Program Institute of Jiangsu Provincial Center for Disease Control and Prevention

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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