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

This study has been completed.
Sponsor:
Collaborator:
Royal (Wuxi) Biological Co., LTD
Information provided by (Responsible Party):
Fengcai Zhu, Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01580033
First received: April 17, 2012
Last updated: May 7, 2013
Last verified: May 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Meningitis
Central Nervous System Diseases
Central Nervous System Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on November 20, 2014