HealthyPhase 1NCT01406509
Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Children
A Phase 1 study testing 0.5ml/dose for a person in people with Healthy, 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
- Healthy
- What is being tested?
- 0.5ml/dose for a person
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Dec 2011
- Phase
- Phase 1
- 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 6 months to 5years 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 experimental 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
Show all 13Show fewer
- 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
- 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
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, 210009
About this study
Official title: A Phase I Clinical Trial for Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in 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, 90-99% of children will produce antibody of protection after 3 doses. 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.
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
- Healthy
- Being tested
- 0.5ml/dose for a person
- Keywords
- Safety, Conjugate vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5ml/dose for a personBiological
group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine of 0.5ml/dose for a person, on day0
0.5ml/dose for a personBiological
group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine of 0.5ml/dose for a person, on day0, 28
| Study group | Role | What they receive |
|---|---|---|
| children aged 2-5 years (1 dose) | Experimental | group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccines of 0.5ml/dose for a person in 20 children aged 2-5 years, on day 0 Receives: Biological: 0.5ml/dose for a person |
| children aged 6-23months (2 doses) | Experimental | group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccines of 0.5ml/dose for a person in 20 children aged 6-23 months old, on day 0, 28 Receives: Biological: 0.5ml/dose for a person |
What is being measured
The primary outcome is the main question the study is designed to answer.
The adverse reactions in healthy children (2-5 years) after the first vaccination
to evaluate the adverse reactions of the group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine in healthy children (2-5 years) after the first vaccination
Measured: 7 days after the first vaccination
The adverse reactions in healthy children (6-23 months) after the first vaccination
to evaluate the adverse reactions of the group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine in healthy children (6-23 months) after the first vaccination
Measured: 7 days after the first vaccination
The adverse reactions in healthy children (6-23 months) after the second vaccination
to evaluate the adverse reactions of the group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine in healthy children (6-23 months) after the second vaccination
Measured: 7 days after the second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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
- Principal investigator, Fengcai Zhu, Jiangsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406509
- Sponsor's protocol ID
- JSVCT006
- Status last verified
- Apr 2012
- First submitted
- 26 Jul 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 I Clinical Trial for Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Children
- ClinicalTrials.gov ID
- NCT01406509
- Acronym / sponsor ID
- JSVCT006
- Conditions
- Healthy
- Keywords
- Safety, Conjugate vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Royal (Wuxi) Biological Co., LTD
- Study start
- Aug 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 1 Aug 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, 90-99% of children will produce antibody of protection after 3 doses. 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.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children aged 2-5 years (1 dose) | Experimental | Biological: 0.5ml/dose for a persongroup A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccines of 0.5ml/dose for a person in 20 children aged 2-5 years, on day 0 |
| children aged 6-23months (2 doses) | Experimental | Biological: 0.5ml/dose for a persongroup A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccines of 0.5ml/dose for a person in 20 children aged 6-23 months old, on day 0, 28 |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy subjects aged from 6 months to 5years 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 experimental 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 (13 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 |
|---|---|---|
| 0.5ml/dose for a persongroup A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine of 0.5ml/dose for a person, on day0 | Biological | children aged 2-5 years (1 dose) |
| 0.5ml/dose for a persongroup A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine of 0.5ml/dose for a person, on day0, 28 | Biological | children aged 6-23months (2 doses) |
Primary outcome
The adverse reactions in healthy children (2-5 years) after the first vaccination
Time frame: 7 days after the first vaccination
to evaluate the adverse reactions of the group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine in healthy children (2-5 years) after the first vaccination
The adverse reactions in healthy children (6-23 months) after the first vaccination
Time frame: 7 days after the first vaccination
to evaluate the adverse reactions of the group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine in healthy children (6-23 months) after the first vaccination
The adverse reactions in healthy children (6-23 months) after the second vaccination
Time frame: 7 days after the second vaccination
to evaluate the adverse reactions of the group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine in healthy children (6-23 months) after the second 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.
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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 1 study testing 0.5ml/dose for a person in people with Healthy, 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 6 inclusion and 13 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 adverse reactions in healthy children (2-5 years) after the first vaccination (time frame: 7 days after the first vaccination). The study lists 3 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.