NCT01428908

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,394

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

April 19, 2012

Status Verified

April 1, 2012

Enrollment Period

3 months

First QC Date

September 2, 2011

Last Update Submit

April 17, 2012

Conditions

Group A, C Polysaccharide MeningitisType b Haemophilus Influenza

Keywords

immunogenicitysafetygroup A, C polysaccharide meningitistype b haemophilus Influenzaconjugate vaccine

Outcome Measures

Primary Outcomes (4)

  • The seroconversion rate of antibody against group A, C polysaccharide meningitis in children after vaccination

    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

    4 weeks (28±3 days) after the vaccination

  • The seroconversion rate of antibody against group A, C polysaccharide meningitis in infants after infant series

    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).

    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

    to evaluate the seroconversion rate of antibody against type b haemophilus Influenza in children when measured 4 weeks (28±3 days) after the vaccination

    4 weeks (28±3 days) after the vaccination

  • The seroconversion rate of antibody against type b haemophilus influenza in infants after infant series

    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)

    4 weeks (28±3 days) after the infant series (two times, 28 day apart)

Secondary Outcomes (6)

  • Injection-site reactions and systemic events after the vaccination in children

    7 days after the vaccination

  • Injection-site reactions and systemic events after the first vaccination in infants

    7 days after the first vaccination

  • Injection-site reactions and systemic events after the second vaccination in infants

    7 days after the second vaccination

  • GMT of antibody against group A, C polysaccharide meningitis in children after the vaccination

    4 weeks (28±3 days) after the vaccination

  • GMT of antibody against group A, C polysaccharide meningitis in infants after the infant series

    4 weeks (28±3 days) after the infant series (two times, 28 day apart)

  • +1 more secondary outcomes

Study Arms (4)

children group A

EXPERIMENTAL

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

Biological: A+C+hib Conjugate VaccineBiological: Placebo

infants group A

EXPERIMENTAL

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

Biological: A+C+hib Conjugate VaccineBiological: Placebo

children group B

ACTIVE COMPARATOR

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

Biological: A+C VaccineBiological: Hib vaccine

infants group B

ACTIVE COMPARATOR

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

Biological: A+C VaccineBiological: Hib vaccine

Interventions

A+C+hib Conjugate VaccineBIOLOGICAL

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

children group Ainfants group A
PlaceboBIOLOGICAL

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

children group Ainfants group A
A+C VaccineBIOLOGICAL

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

children group Binfants group B
Hib vaccineBIOLOGICAL

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

children group Binfants group B

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • 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.
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Funing county Center for Disease Control and Prevention

Funing County, Jiangsu, 224400, China

Location

MeSH Terms

Interventions

HibTITER protein, Haemophilus influenzae

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
SPONSOR

Study Record Dates

First Submitted

September 2, 2011

First Posted

September 5, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

April 19, 2012

Record last verified: 2012-04

Locations

CN(1)