Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01428908 | Immunogenicity and Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Infants and Children | PHASE3 | COMPLETED | 2,394 | — | — | Sep 1, 2011 | Jan 1, 2012 | Apr 19, 2012 | 1 | China |
to evaluate the seroconversion rate of antibody against group A, C polysaccharide meningitis in children when measured 4 weeks (28±3 days) after the vaccination
to evaluate the seroconversion rate of antibody against group A, C polysaccharide meningitis in infants when measured 4 weeks (28±3 days) after the infant series (two times, 28 day apart).
to evaluate the seroconversion rate of antibody against type b haemophilus Influenza in children when measured 4 weeks (28±3 days) after the vaccination
to evaluate the seroconversion rate of antibody against type b haemophilus Influenza in infants when measured 4 weeks (28±3 days) after the infant series (two times, 28 day apart)
| Arm | Type | Description |
|---|---|---|
| children group A | EXPERIMENTAL | 600 children aged 2-5 years old, will be vaccinated on day0 |
| infants group A | EXPERIMENTAL | 600 infants aged 6-23 months old, will be vaccinated on day0, 28 |
| children group B | ACTIVE_COMPARATOR | 600 children aged 2-5 years old, will be vaccinated on day0 |
| infants group B | ACTIVE_COMPARATOR | 600 infants aged 6-23 months old, will be vaccinated on day0, 28 |
| Name | Type | Description |
|---|---|---|
| A+C+hib Conjugate Vaccine | BIOLOGICAL | The group A, C polysaccharide meningococcal and type b haemophilus influenzal conjugate vaccine (Wuxi Royal Biological Co., LTD, 20110101) will be administered intramuscularly on one arm, per 0.5ml dose |
| Placebo | BIOLOGICAL | Placebo will be administered intramuscularly on the other arm, per 0.5ml dose |
| A+C Vaccine | BIOLOGICAL | The group A, C polysaccharide meningococcal vaccine (Wuxi Royal Biological Co., LTD, 20101202) will be administered intramuscularly on one arm, per 0.5ml dose |
| Hib vaccine | BIOLOGICAL | The type b haemophilus influenzal vaccine (Sanofi Pasteur Limited) will be administered intramuscularly on the other arm, per 0.5ml dose |
For the children (aged from 2 to 5 years old) Inclusion Criteria: * Healthy subjects aged from 2 to 5 years old of normal intelligence. * The subjects' guardians are able to understand and sign the informed consent. * Subjects established as healthy after medical history questioning, physical exam...