A Randomized, Blind, parallel controlled trials to evaluate the safety and immunogenicity of freeze-dried group ACYW135 meningococcal conjugate vaccine

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-PPR-15006591

Enrollment

Unknown

Registered

2015-06-14

Start date

2015-11-09

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

2-6 month old children:freeze-dried group ACYW135 meningococcal conjugate vaccine 4ug dosage

2-6 month old children:freeze-dried group ACYW135 meningococcal conjugate vaccine 8ug dosage

3-5 month old children:freeze-dried group ACYW135 meningococcal conjugate vaccine 4ug dosage

3-5 month old children:freeze-dried group ACYW135 meningococcal conjugate vaccine 8ug dosage

3-5 month old children:control vaccine (A+C conjugate vaccine)

Eligibility

Sex/Gender

All

Age

No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1. 2-month (61-90 days) years old and 3-month (91-120 days) years old healthy infants unimmunized Group A&C meningococcal conjugate vaccine; 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.

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. Acute febrile diseases and infectious diseases; 6. History of labor abnormalities, choking rescue, congenital malformations, developmental disorders or serious chronic disease patients; 7. Had a severe allergic reaction of vaccination in the past; 8. Took oral steroids more than 14 days in last month; 9. Had high fever (axillary temperature>=38.0 degree C or higher) in the past three days; 10. attend any other drug clinical study; 11. Meningococcal vaccine contraindications and any situation which researchers think that may affect test evaluation.

Design outcomes

Primary

Measure	Time frame
Adverse reaction rate;Group specific complement mediated bactericidal antibody titers;	—

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