Immunogenicity and Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Infants and Children

NCT ID: NCT01428908

Last Updated: 2012-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2394 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-01-31

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.

According to the present immunization schedule, to reach the median level of antibody levels there are at least 4 doses in need. So it is meaningful to improving vaccine immunogenicity, to provide high levels of long-term protection and to reduce the number of injections.

After the phase I study which was conducted in August, 2011, the safety profile of this vaccine is proved to be acceptable. 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.

Conditions

Group A, C Polysaccharide Meningitis; Type b Haemophilus Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

children group A

600 children aged 2-5 years old, will be vaccinated on day0

Group Type: EXPERIMENTAL

A+C+hib Conjugate Vaccine

Intervention Type: 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

Intervention Type: BIOLOGICAL

Placebo will be administered intramuscularly on the other arm, per 0.5ml dose

infants group A

600 infants aged 6-23 months old, will be vaccinated on day0, 28

Group Type: EXPERIMENTAL

A+C+hib Conjugate Vaccine

Intervention Type: 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

Intervention Type: BIOLOGICAL

Placebo will be administered intramuscularly on the other arm, per 0.5ml dose

children group B

600 children aged 2-5 years old, will be vaccinated on day0

Group Type: ACTIVE_COMPARATOR

A+C Vaccine

Intervention Type: 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

Intervention Type: BIOLOGICAL

The type b haemophilus influenzal vaccine (Sanofi Pasteur Limited) will be administered intramuscularly on the other arm, per 0.5ml dose

infants group B

600 infants aged 6-23 months old, will be vaccinated on day0, 28

Group Type: ACTIVE_COMPARATOR

A+C Vaccine

Intervention Type: 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

Intervention Type: BIOLOGICAL

The type b haemophilus influenzal vaccine (Sanofi Pasteur Limited) will be administered intramuscularly on the other arm, per 0.5ml dose

Interventions

A+C+hib Conjugate Vaccine

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

Intervention Type: BIOLOGICAL

Placebo

Placebo will be administered intramuscularly on the other arm, per 0.5ml dose

Intervention Type: BIOLOGICAL

A+C Vaccine

The group A, C polysaccharide meningococcal vaccine (Wuxi Royal Biological Co., LTD, 20101202) will be administered intramuscularly on one arm, per 0.5ml dose

Intervention Type: BIOLOGICAL

Hib vaccine

The type b haemophilus influenzal vaccine (Sanofi Pasteur Limited) will be administered intramuscularly on the other arm, per 0.5ml dose

Intervention Type: BIOLOGICAL

Eligibility Criteria

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 examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine.
• Subjects who can comply with the requirements of the clinical trial program according to the researcher's views.
• Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine.
• Subjects with temperature <37°C on axillary setting.

• Healthy subjects aged from 6 months to 23 months 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 examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine.
• Subjects who can comply with the requirements of the clinical trial program according to the researcher's views.
• Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine.
• Subjects with temperature<37°C on axillary setting.

Exclusion Criteria

• Subject who has a medical history of Meningitis;
• Subject that has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on;
• Subject who is allergic with tetanus toxoid components;
• Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection;
• Subject who has a history of allergic reactions;
• Any known immunological dysfunction;
• Had received gamma globulin or immune globulin, in the past two weeks
• Subject suffering from congenital malformations, dysgenopathy or serious chronic disease;
• Any acute infections
• Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

For the infants (aged from 6 to 23 months old)

• Subject who has a medical history of Meningitis;
• Subject that has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on;
• Subject who is allergic with tetanus toxoid components;
• Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection;
• Subject who has a history of allergic reactions;
• Any known immunological dysfunction;
• Had received gamma globulin or immune globulin, in the past two weeks
• Subject suffering from congenital malformations, dysgenopathy or serious chronic disease;
• Any acute infections
• Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

• Had any Grade 3 or Grade 4 adverse reactions or events occurred since the first vaccination
• Any condition the investigator believed may affect the evaluation of the vaccine.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal (Wuxi) Biological Co., LTD

OTHER

Sponsor Role: collaborator

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Funing county Center for Disease Control and Prevention

Funing County, Jiangsu, China

Countries

China

Other Identifiers

JSVCT007

Identifier Type: -

Identifier Source: org_study_id