Group A, C Polysaccharide MeningitisPhase 3NCT01428908
Immunogenicity and Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Infants and Children
A Phase 3 study testing A+C+hib Conjugate Vaccine, A+C Vaccine and Hib vaccine in people with Group A, C Polysaccharide Meningitis and Type b Haemophilus Influenza, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Group A, C Polysaccharide Meningitis, Type b Haemophilus Influenza
- What is being tested?
- A+C+hib Conjugate Vaccine, A+C Vaccine and Hib vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,394 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Jan 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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)
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Funing county Center for Disease Control and Prevention
Funing County, Jiangsu, 224400
About this study
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.
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.
Read more
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.
- Being tested
- A+C+hib Conjugate Vaccine, Placebo, A+C Vaccine, Hib vaccine
- Keywords
- immunogenicity, safety, group A, C polysaccharide meningitis, type b haemophilus Influenza, conjugate vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboBiological
Placebo will be administered intramuscularly on the other arm, per 0.5ml dose
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
Hib vaccineBiological
The type b haemophilus influenzal vaccine (Sanofi Pasteur Limited) will be administered intramuscularly on the other arm, per 0.5ml dose
| Study group | Role | What they receive |
|---|---|---|
| children group A | Experimental | 600 children aged 2-5 years old, will be vaccinated on day0 Receives: Biological: A+C+hib Conjugate Vaccine; Biological: Placebo |
| infants group A | Experimental | 600 infants aged 6-23 months old, will be vaccinated on day0, 28 Receives: Biological: A+C+hib Conjugate Vaccine; Biological: Placebo |
| children group B | Active comparator | 600 children aged 2-5 years old, will be vaccinated on day0 Receives: Biological: A+C Vaccine; Biological: Hib vaccine |
| infants group B | Active comparator | 600 infants aged 6-23 months old, will be vaccinated on day0, 28 Receives: Biological: A+C Vaccine; Biological: Hib vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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).
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
to evaluate the seroconversion rate of antibody against type b haemophilus Influenza in children when measured 4 weeks (28±3 days) after the vaccination
Measured: 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)
Measured: 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
to evaluate the injection-site reactions and systemic events of the investigational vaccines in healthy children for 7 days after the vaccination
Measured: 7 days after the vaccination
Injection-site reactions and systemic events after the first vaccination in infants
to evaluate the injection-site reactions and systemic events of the investigational vaccines in healthy infants for 7 days after the first vaccination
Measured: 7 days after the first vaccination
Injection-site reactions and systemic events after the second vaccination in infants
to evaluate the injection-site reactions and systemic events of the investigational vaccines in healthy infants for 7 days after the second vaccination
Measured: 7 days after the second vaccination
GMT of antibody against group A, C polysaccharide meningitis in children after the vaccination
to evaluate the GMT of antibody against group A, C polysaccharide meningitis in children 4 weeks (28±3 days) after the vaccination
Measured: 4 weeks (28±3 days) after the vaccination
GMT of antibody against group A, C polysaccharide meningitis in infants after the infant series
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)
Measured: 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
to evaluate the GMT of antibody against type b haemophilus Influenza in children 4 weeks (28±3 days) after the vaccination
Measured: 4 weeks (28±3 days) after the vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Group A, C Polysaccharide MeningitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2,394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- Royal (Wuxi) Biological Co., LTD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428908
- Sponsor's protocol ID
- JSVCT007
- Status last verified
- Apr 2012
- First submitted
- 2 Sep 2011
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01428908
- Acronym / sponsor ID
- JSVCT007
- Keywords
- immunogenicity, safety, group A, C polysaccharide meningitis, type b haemophilus Influenza, conjugate vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,394 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Royal (Wuxi) Biological Co., LTD
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 5 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| children group A | Experimental | Biological: A+C+hib Conjugate Vaccine, Biological: Placebo600 children aged 2-5 years old, will be vaccinated on day0 |
| infants group A | Experimental | Biological: A+C+hib Conjugate Vaccine, Biological: Placebo600 infants aged 6-23 months old, will be vaccinated on day0, 28 |
| children group B | Active comparator | Biological: A+C Vaccine, Biological: Hib vaccine600 children aged 2-5 years old, will be vaccinated on day0 |
| infants group B | Active comparator | Biological: A+C Vaccine, Biological: Hib vaccine600 infants aged 6-23 months old, will be vaccinated on day0, 28 |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A+C+hib Conjugate VaccineThe 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 | children group A, infants group A |
| PlaceboPlacebo will be administered intramuscularly on the other arm, per 0.5ml dose | Biological | children group A, infants group A |
| A+C VaccineThe group A, C polysaccharide meningococcal vaccine (Wuxi Royal Biological Co., LTD, 20101202) will be administered intramuscularly on one arm, per 0.5ml dose | Biological | children group B, infants group B |
| Hib vaccineThe type b haemophilus influenzal vaccine (Sanofi Pasteur Limited) will be administered intramuscularly on the other arm, per 0.5ml dose | Biological | children group B, infants group B |
Primary outcome
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
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)
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
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)
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)
6 secondary outcomes
Injection-site reactions and systemic events after the vaccination in children
Time frame: 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
Injection-site reactions and systemic events after the second vaccination in infants
Time frame: 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
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing A+C+hib Conjugate Vaccine, A+C Vaccine and Hib vaccine in people with Group A, C Polysaccharide Meningitis and Type b Haemophilus Influenza, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2012.