A Single-center, open trials to evaluate the safety of freeze-dried group ACYW135 meningococcal conjugate vaccine

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-PPR-15006569

Enrollment

Unknown

Registered

2015-06-12

Start date

2015-06-03

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningococcal meningitis

Interventions

18-55 years old:freeze-dried group ACYW135 meningococcal conjugate vaccine 4ug dosage

18-55 years old:freeze-dried group ACYW135 meningococcal conjugate vaccine 8ug dosage

7-17 years old:freeze-dried group ACYW135 meningococcal conjugate vaccine 4ug dosage

7-17 years old:freeze-dried group ACYW135 meningococcal conjugate vaccine 8ug dosage

1-6 years old:freeze-dried group ACYW135 meningococcal conjugate vaccine 4ug dosage

1-6 years old:freeze-dried group ACYW135 meningococcal conjugate vaccine 8ug dosage

7-10 months old:freeze-dried group ACYW135 meningococcal conjugate vaccine 4ug dosage

7-10 months old:freeze-dried group ACYW135 meningococcal conjugate vaccine 8ug dosage

2 months old:freeze-dried group ACYW135 meningococcal conjugate vaccine 4ug dosage

2 months old:freeze-dried group ACYW135 meningococcal conjugate vaccine 8ug dosage

Eligibility

Sex/Gender

All

Age

No minimum to 55 Years

Inclusion criteria

Inclusion criteria: 1. Healthy infants unimmunized Group A&C meningococcal conjugate vaccine or Group A meningococcal polysaccharide vaccine which is above 2~11 months-old, and healthy toddler more than 1-year-old without booster immunization; 2. The guardian or himself informed consent, and signed the informed consent form; 3. The guardian and family agreed to abide by the requirements of clinical trial scheme; 4. Participants has no history of immunoglobulin vaccination in the last 2 months / 2 months-old infants has no history of immunoglobulin vaccination after born, there is no history of other live vaccine inoculation before vaccination in 14 days, within 7 days without other inactivated vaccine immunization history; 5. the axillary temperature < 37.1 degree C; 6. 2-months-old group in the age of 61-90 days; 7. 7-months-old group in the age of 211-300 days; 8. 1-year-old group in age of one full year of life.

Exclusion criteria

Exclusion criteria: 1. Have allergies, convulsions, seizures, encephalopathy and psychiatric history or family history; 2. Neomycin, streptomycin and polymyxin B allergies; 3. With immunodeficiency, immunosuppressant therapy; 4. History of meningitis; 5. Women in lactation or pregnant; 6. Acute febrile diseases and infectious diseases; 7. History of labor abnormalities, choking rescue, congenital malformations, developmental disorders or serious chronic disease patients; 8. Had a severe allergic reaction of vaccination in the past; 9. Took oral steroids more than 14 days in last month; 10. Had high fever (axillary temperature>=38.0 degree or higher)in the past three days; 11. Prepare to attend or is in any other drug clinical study; 12. Meningococcal vaccine contraindications and any situation which researchers think that may affect test evaluation.

Design outcomes

Primary

Measure	Time frame
systemic and local reactions 30 days after full-course vaccination;	—

Countries

China

Contacts

Public ContactZhan Faxian

zhanfx@163.com+86 13908639947

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026