A Phase 3 interventional study of A+C+hib Conjugate Vaccine and Placebo in Meningitis and Influenza, sponsored by Jiangsu Province Centers for Disease Control and Prevention. Completed at 1 site in China. Open to participants aged 3 Months to 5 Months. Per ClinicalTrials.gov, last updated 2013-05-08.
Sponsored by Jiangsu Province Centers for Disease Control and Prevention · Phase 3, Interventional, and Prevention
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.
381 studies on the registry are indexed under Meningitis; 33 are open to participants now.
This study's enrollment of 900 is above the median of 215 across 262 interventional studies indexed under Meningitis.
Browse Meningitis studies →Jiangsu Province Centers for Disease Control and Prevention is the lead sponsor of 77 studies on the registry; 5 are open to participants now.
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Exclusion Criteria for the first vaccination:
Exclusion Criteria for the second or third vaccination:
600 infants aged 3-5 months, will be vaccinated on day0, 28, 56
Biological: A+C+hib Conjugate Vaccine · Biological: Placebo
300 infants aged 3-5 months, will be vaccinated on day0, 28, 56
Biological: A+C Vaccine · Biological: Hib vaccine
The group A, C polysaccharide meningococcal and type b haemophilus influenzal conjugate vaccine (Wuxi Royal Biological Co., LTD, 20110101) will be administered on one arm, intramuscularly, per 0.5ml dose
Placebo will be administered intramuscularly on the other arm, intramuscularly, per 0.5ml dose
The group A, C polysaccharide meningococcal vaccine (Yunnan Walvax Biotechnology Co., LTD, 20101202) will be administered intramuscularly on one arm, per 0.5ml dose
The type b haemophilus influenzal vaccine (Sanofi Pasteur Limited) will be administered intramuscularly on the other arm, per 0.5ml dose
The seroconversion rate of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months
the seroconversion rate of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months when measured 4 weeks (28±3 days) after the infant series (three doses, 28 day apart).
Time frame: 4 weeks (28±3 days) after the infant series
The seroconversion rate of antibody against type b haemophilus influenza in infants aged 3-5 months
the seroconversion rate of antibody against type b haemophilus Influenza in infants aged 3-5 months when measured 4 weeks (28±3 days) after the infant series (three doses, 28 day apart)
Time frame: 4 weeks (28±3 days) after the infant series
adverse reactions after the first vaccination in infants aged 3-5 months
adverse reactions of the investigational vaccines in healthy infants aged 3-5 months for 7 days after the first vaccination
Time frame: 7 days after the first vaccination
adverse reactions after the second vaccination in infants aged 3-5 months
adverse reactions of the investigational vaccines in healthy infants aged 3-5 months for 7 days after the second vaccination
Time frame: 7 days after the second vaccination
adverse reactions after the third vaccination in infants aged 3-5 months
adverse reactions of the investigational vaccines in healthy infants aged 3-5 months for 7 days after the third vaccination
Time frame: 7 days after the third vaccination
GMT of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months
GMT of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months 4 weeks (28±3 days) after the infant series (three doses, 28 day apart)
Time frame: 4 weeks (28±3 days) after the infant series
GMT of antibody against type b haemophilus Influenza in serum in infants aged 3-5 months
GMT of antibody against type b haemophilus Influenza in infants aged 3-5 months 4 weeks (28±3 days) after the infant series (three doses, 28 day apart)
Time frame: 4 weeks (28±3 days) after the infant series
The record gives a start of Apr 2012, a primary completion of Sep 2012 and a completion of Nov 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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Jiangsu Province Centers for Disease Control and Prevention