Evaluating the safety of Menhycia® vaccine in infants
Phase IV Clinical Study of the Safety of Menhycia® in 3-Month-Old Infants
PHASE4 · CanSino Biologics Inc. · NCT06389513
This study is testing the safety of the Menhycia® vaccine in infants who are 3 months old and have never had an epidemic encephalitis vaccine before.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | 3 Months to 3 Months |
| Sex | All |
| Sponsor | CanSino Biologics Inc. (industry) |
| Locations | 1 site (Nanjing) |
| Trial ID | NCT06389513 on ClinicalTrials.gov |
What this trial studies
This open, multicenter Phase IV clinical study aims to assess the safety of the Menhycia® vaccine in infants aged 3 months who have not previously received any epidemic encephalitis vaccine. Approximately 3,000 infants will be enrolled, and they will receive three doses of the vaccine, spaced at least one month apart, with a booster dose allowed at 12 months of age. The study will monitor the infants for any adverse effects following vaccination to ensure the vaccine's safety profile.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy infants who are 3 months old and have not received any prior epidemic encephalitis vaccinations.
Not a fit: Patients with congenital malformations, severe malnutrition, or a history of seizures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safe vaccination option for infants against epidemic meningitis.
How similar studies have performed: Other studies evaluating similar vaccines have shown promising safety profiles, suggesting that this approach is supported by previous research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants 3 months of age who had not received any epidemic encephalitis vaccine at the time of screening * The legal guardian or delegate has given informed consent, has voluntarily signed an informed consent form, and is able to comply with the requirements of the clinical study protocol Exclusion Criteria: First dose exclusion criteria * Fever before vaccination, axillary temperature \>37.0°C * Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. * History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders * Acute infections or active chronic diseases, severe infectious or allergic skin diseases * Known allergy to a component of the vaccine, especially to diphtheria toxoid, or to previous administration of the product * Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate Subsequent dose exclusion criteria * Severe allergic reactions after a previous dose of vaccine * Those with serious adverse reactions causally related to the previous dose of vaccination * Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate
Where this trial is running
Nanjing
- Nanjing Luhe District Center for Disease Control and Prevention Center for Disease Control and Prevention — Nanjing, China (RECRUITING)
Study contacts
- Study coordinator: Peng Wan
- Email: peng.wan@cansinotech.com
- Phone: 022-58213600-6051
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Epidemic Meningitis, Vaccine, ACYW135, CRM197, Safety, 3 months of age