Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-01 @ 2:15 AM
Study NCT ID:
NCT01580033
Status:
COMPLETED
Last Update Posted:
2013-05-08
First Post:
2012-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 3 Study of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine
Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Organization:
Study Overview
Official Title:
Immunogenicity and Safety Study of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Aged 3-5 Months: A Phase 3 Clinical Trial
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Haemophilus influenzae is an important pathogen which can cause primary infection and respiratory viral infection in infants and leaded to secondary infections. The infection of haemophilus is a major cause of morbidity and mortality in infants and children. At present, the developed conjugant Hib vaccine is proved to be safe and effective. Because Hib vaccine can prevent meningitis, pneumonia, epiglottis inflammation and other serious infection caused by Hib bacteria, the WHO suggested that Hib vaccine should be included in the infant's normal immune programming.
Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus polysaccharide vaccine with a relatively poor immune response in the infants under the age of two, and the remaining 60% with a low antibody level and a short duration.
The immunogenicity and safety of this vaccine has been proved in older children aged 6-23 months and 2-5 years. And in the phase I study which was conducted in February, 2012, the safety profile of this vaccine is proved to be acceptable in infants aged 3-5 months. The phase III study is aimed to further evaluate the safety and the immunization of the vaccine. The objective of this study is to evaluate the safety of the group A, C polysaccharide meningococcal and type b haemophilus influenzal conjugate vaccine.
Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus polysaccharide vaccine with a relatively poor immune response in the infants under the age of two, and the remaining 60% with a low antibody level and a short duration.
The immunogenicity and safety of this vaccine has been proved in older children aged 6-23 months and 2-5 years. And in the phase I study which was conducted in February, 2012, the safety profile of this vaccine is proved to be acceptable in infants aged 3-5 months. The phase III study is aimed to further evaluate the safety and the immunization of the vaccine. The objective of this study is to evaluate the safety of the group A, C polysaccharide meningococcal and type b haemophilus influenzal conjugate vaccine.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: