Phase 3 Study of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine - 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.

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.

Condition	Intervention	Phase
Meningitis 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:	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

Resource links provided by NLM:

MedlinePlus related topics: Flu Haemophilus Infections 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 infants aged 3-5 months [ Time Frame: 4 weeks (28±3 days) after the infant series ] [ Designated as safety issue: No ]
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).
The seroconversion rate of antibody against type b haemophilus influenza in infants aged 3-5 months [ Time Frame: 4 weeks (28±3 days) after the infant series ] [ Designated as safety issue: No ]
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)

Secondary Outcome Measures:

adverse reactions after the first vaccination in infants aged 3-5 months [ Time Frame: 7 days after the first vaccination ] [ Designated as safety issue: Yes ]
adverse reactions of the investigational vaccines in healthy infants aged 3-5 months for 7 days after the first vaccination
adverse reactions after the second vaccination in infants aged 3-5 months [ Time Frame: 7 days after the second vaccination ] [ Designated as safety issue: Yes ]
adverse reactions of the investigational vaccines in healthy infants aged 3-5 months for 7 days after the second vaccination
adverse reactions after the third vaccination in infants aged 3-5 months [ Time Frame: 7 days after the third vaccination ] [ Designated as safety issue: Yes ]
adverse reactions of the investigational vaccines in healthy infants aged 3-5 months for 7 days after the third vaccination
GMT of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months [ Time Frame: 4 weeks (28±3 days) after the infant series ] [ Designated as safety issue: No ]
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)
GMT of antibody against type b haemophilus Influenza in serum in infants aged 3-5 months [ Time Frame: 4 weeks (28±3 days) after the infant series ] [ Designated as safety issue: No ]
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)

Enrollment:	900
Study Start Date:	April 2012
Study Completion Date:	November 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A+C+hib Conjugate Vaccine 600 infants aged 3-5 months, will be vaccinated on day0, 28, 56	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 on one arm, intramuscularly, per 0.5ml dose Biological: Placebo Placebo will be administered intramuscularly on the other arm, intramuscularly, per 0.5ml dose
Active Comparator: Walvax AC vaccine, Pasteur Hib vaccine 300 infants aged 3-5 months, will be vaccinated on day0, 28, 56	Biological: A+C Vaccine The group A, C polysaccharide meningococcal vaccine (Yunnan Walvax Biotechnology 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:	3 Months to 5 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Healthy subjects aged 3 to 5 months, normal intelligence.
The subjects' guardians are able to understand and sign the informed consent.
Healthy subjects confirmed by 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 who 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
Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
Any acute infections in last 7 days
Any prior administration of immunodepressant or corticosteroids in last 6month
Any prior administration of other research medicines in last 1 month
Any prior administration of attenuated live vaccine in last 28 days
Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
Subject suffering from congenital malformations, developmental delay 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 or third vaccination:

Had any Grade 3 or Grade 4 adverse reactions or events associated with investigational vaccine occurred since the vaccination
Any situation meets 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: NCT01580033

Locations

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

Sponsors and Collaborators

Jiangsu Province Centers for Disease Control and Prevention

Royal (Wuxi) Biological Co., LTD

More Information

No publications provided

Responsible Party:	Fengcai Zhu, Director of Vaccine Clinical Evaluation Center in Jiangsu Province Centers for Disease Control and Prevention, Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT01580033 History of Changes
Other Study ID Numbers:	JSVCT009
Study First Received:	April 17, 2012
Last Updated:	May 7, 2013
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

Additional relevant MeSH terms:

Influenza, Human
Meningitis
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 June 17, 2013