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

NCT01580033 | Completed Phase 3

• 1 other identifier: JSVCT009
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Meningitis; Influenza

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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).

  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)

  4 weeks (28±3 days) after the infant series

Secondary Outcomes (5)

• adverse reactions after the first vaccination in infants aged 3-5 months

  7 days after the first vaccination

• adverse reactions after the second vaccination in infants aged 3-5 months

  7 days after the second vaccination

• adverse reactions after the third vaccination in infants aged 3-5 months

  7 days after the third vaccination

• GMT of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months

  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

  4 weeks (28±3 days) after the infant series

Study Arms (2)

A+C+hib Conjugate Vaccine

EXPERIMENTAL

600 infants aged 3-5 months, will be vaccinated on day0, 28, 56

Biological: A+C+hib Conjugate Vaccine; Biological: Placebo

Walvax AC vaccine, Pasteur Hib vaccine

ACTIVE COMPARATOR

300 infants aged 3-5 months, will be vaccinated on day0, 28, 56

Biological: A+C Vaccine; Biological: Hib vaccine

Interventions

A+C+hib Conjugate Vaccine BIOLOGICAL

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

A+C+hib Conjugate Vaccine

Placebo BIOLOGICAL

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

A+C+hib Conjugate Vaccine

A+C Vaccine BIOLOGICAL

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

Walvax AC vaccine, Pasteur Hib vaccine

Hib vaccine BIOLOGICAL

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

Walvax AC vaccine, Pasteur Hib vaccine

Eligibility Criteria

• Age: 3 Months - 5 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead
• Royal (Wuxi) Biological Co., LTD: collaborator

Study Sites (1)

Funing county Center for Disease Control and Prevention

Yancheng, Jiangsu, China

Location

MeSH Terms

Conditions

Meningitis; Influenza, Human

Interventions

HibTITER protein, Haemophilus influenzae

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Vaccine Clinical Evaluation Center in Jiangsu Province Centers for Disease Control and Prevention

Study Record Dates

• First Submitted: April 17, 2012
• First Posted: April 18, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 8, 2013

Record last verified: 2013-05

Locations

CN (1)