Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 001

Hualan Biological Engineering

Status and phase

Completed

Phase 1

Conditions

Meningitis

Treatments

Biological: Group ACYW135 Meningococcal Polysaccharide Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01661725

Hualanbio-Meningococcal CT 001

Hualanbio-phase I CT (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full description

Complying with requirements of the approval letter of clinical trial issued by SFDA (Approval Letter No.: 2006L01017), Hualan conducted phase I clinical trial of Group ACYW135 Meningococcal Polysaccharide Vaccine. The safety end points were the presence of any systemic, local and adverse reaction.

Enrollment

60 patients

Sex

All

Ages

2+ years old

Volunteers

Accepts Healthy Volunteers

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

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.