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

Purpose

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.

Condition	Intervention	Phase
Group A, C Polysaccharide Meningitis Type b Haemophilus Influenza	Biological: A+C+hib Conjugate Vaccine Biological: Placebo Biological: A+C Vaccine Biological: Hib vaccine	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	A Phase III Clinical Trial the Immunogenicity and Safety Study of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Infants and Children.

Resource links provided by NLM:

MedlinePlus related topics: Flu Meningitis

U.S. FDA Resources

Further study details as provided by Jiangsu Province Centers for Disease Control and Prevention:

Primary Outcome Measures:

The seroconversion rate of antibody against group A, C polysaccharide meningitis in children after vaccination [ Time Frame: 4 weeks (28±3 days) after the vaccination ] [ Designated as safety issue: No ]
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
The seroconversion rate of antibody against group A, C polysaccharide meningitis in infants after infant series [ Time Frame: 4 weeks (28±3 days) after the infant series (two times, 28 day apart) ] [ Designated as safety issue: No ]
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).
The seroconversion rate of antibody against type b haemophilus influenza in children after the vaccination [ Time Frame: 4 weeks (28±3 days) after the vaccination ] [ Designated as safety issue: No ]
to evaluate the seroconversion rate of antibody against type b haemophilus Influenza in children when measured 4 weeks (28±3 days) after the vaccination
The seroconversion rate of antibody against type b haemophilus influenza in infants after infant series [ Time Frame: 4 weeks (28±3 days) after the infant series (two times, 28 day apart) ] [ Designated as safety issue: No ]
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)

Secondary Outcome Measures:

Injection-site reactions and systemic events after the vaccination in children [ Time Frame: 7 days after the vaccination ] [ Designated as safety issue: Yes ]
to evaluate the injection-site reactions and systemic events of the investigational vaccines in healthy children for 7 days after the vaccination
Injection-site reactions and systemic events after the first vaccination in infants [ Time Frame: 7 days after the first vaccination ] [ Designated as safety issue: Yes ]
to evaluate the injection-site reactions and systemic events of the investigational vaccines in healthy infants for 7 days after the first vaccination
Injection-site reactions and systemic events after the second vaccination in infants [ Time Frame: 7 days after the second vaccination ] [ Designated as safety issue: Yes ]
to evaluate the injection-site reactions and systemic events of the investigational vaccines in healthy infants for 7 days after the second vaccination
GMT of antibody against group A, C polysaccharide meningitis in children after the vaccination [ Time Frame: 4 weeks (28±3 days) after the vaccination ] [ Designated as safety issue: No ]
to evaluate the GMT of antibody against group A, C polysaccharide meningitis in children 4 weeks (28±3 days) after the vaccination
GMT of antibody against group A, C polysaccharide meningitis in infants after the infant series [ Time Frame: 4 weeks (28±3 days) after the infant series (two times, 28 day apart) ] [ Designated as safety issue: No ]
to evaluate the GMT of antibody against group A, C polysaccharide meningitis in infants 4 weeks (28±3 days) after the infant series (two times, 28 day apart)
GMT of antibody against type b haemophilus Influenza in serum in children after the vaccination [ Time Frame: 4 weeks (28±3 days) after the vaccination ] [ Designated as safety issue: No ]
to evaluate the GMT of antibody against type b haemophilus Influenza in children 4 weeks (28±3 days) after the vaccination

Enrollment:	2394
Study Start Date:	September 2011
Study Completion Date:	January 2012
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: children group A 600 children aged 2-5 years old, will be vaccinated on day0	Biological: 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 Biological: Placebo Placebo will be administered intramuscularly on the other arm, per 0.5ml dose
Experimental: infants group A 600 infants aged 6-23 months old, will be vaccinated on day0, 28	Biological: 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 Biological: Placebo Placebo will be administered intramuscularly on the other arm, per 0.5ml dose
Active Comparator: children group B 600 children aged 2-5 years old, will be vaccinated on day0	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 Biological: Hib vaccine The type b haemophilus influenzal vaccine (Sanofi Pasteur Limited) will be administered intramuscularly on the other arm, per 0.5ml dose
Active Comparator: infants group B 600 infants aged 6-23 months old, will be vaccinated on day0, 28	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 Biological: Hib vaccine The type b haemophilus influenzal vaccine (Sanofi Pasteur Limited) will be administered intramuscularly on the other arm, per 0.5ml dose

Eligibility

Ages Eligible for Study:	6 Months to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 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)

Inclusion Criteria:

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 for the first vaccination:

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

Exclusion Criteria for the second vaccination:

Had any Grade 3 or Grade 4 adverse reactions or events occurred since the first vaccination
Any situation meets the exclusion criteria stated in the exclusion criteria for first dose;
Any condition the investigator believed may affect the evaluation of the vaccine.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428908

Locations

China, Jiangsu
Funing county Center for Disease Control and Prevention
Funing county, Jiangsu, China, 224400

Sponsors and Collaborators

Jiangsu Province Centers for Disease Control and Prevention

Royal (Wuxi) Biological Co., LTD

More Information

No publications provided

Responsible Party:	Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT01428908 History of Changes
Other Study ID Numbers:	JSVCT007
Study First Received:	September 2, 2011
Last Updated:	April 17, 2012
Health Authority:	China: Food and Drug Administration

Keywords provided by Jiangsu Province Centers for Disease Control and Prevention:

immunogenicity
safety
group A, C polysaccharide meningitis
type b haemophilus Influenza
conjugate vaccine

Additional relevant MeSH terms:

Haemophilus Infections
Influenza, Human
Meningitis
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Orthomyxoviridae Infections

RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013