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NCT Number: NCT06389513

Clinical Study of the Safety of Menhycia® in 3-Month-Old Infants

This study is an open, multicenter Phase IV clinical study to evaluate the safety of vaccination with Menhycia®. The study plan is to enroll approximately 3,000 infants at 3 months of age who have not been vaccinated with any epidemic encephalitis vaccine, and to administer a total of 3 doses of Menhycia®, with a minimum of 1 month between doses, and a booster dose of 1 dose of immunization is allowed at 12 months of age.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Epidemic Meningitis Bacterial Infections Bacterial Infections and Mycoses Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Gram-Negative Bacterial Infections Infections Meningitis Meningitis, Bacterial Meningitis, Meningococcal Meningococcal Infections Neisseriaceae Infections Nervous System Diseases Neuroinflammatory Diseases

Age range

3 month–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nanjing Luhe District Center for Disease Control and Prevention Center for Disease Control and Prevention

Nanjing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MCV4

Biological

4 doses of vaccine on Day 0, Day30, Day 60 and Month 12

Primary outcomes

  1. Incidence of localized adverse reactions in subjects

    Time frame: Within 7 days after each dose of vaccination

  2. Incidence of systemic adverse reactions in subjects

    Time frame: Within 7 days after each dose of vaccination

Secondary outcomes

  1. Incidence of adverse reactions in subjects

    Time frame: Within 30 days after each dose of vaccination

  2. Incidence of adverse events in subjects

    Time frame: Within 30 days after each dose of vaccination

  3. Incidence of severe adverse events

    Time frame: Through study completion, an average of 10 months

Sponsors and collaborators

Lead sponsor

CanSino Biologics Inc.

Industry

Registry information

Official study title

Phase IV Clinical Study of the Safety of Menhycia® in 3-Month-Old Infants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2024
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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