MeningitisPhase 1NCT01661725
Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 001
A Phase 1 study testing Group ACYW135 Meningococcal Polysaccharide Vaccine in people with Meningitis, run by Hualan Biological Engineering, Inc..
Trial summary
The clinical trial was designed to evaluate the safety against Group ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of age and older. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Meningitis
- What is being tested?
- Group ACYW135 Meningococcal Polysaccharide Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to May 2006
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy permanent residence 2 years of age and older, the subjects (or their guardians) are able to understand and sign the informed consent;
- Healthy male or female by oral history, physical examination and clinical judgment and who complies with vaccination of this product;
- Be able to comply with the requirements of clinical trial protocol and immunogenicity examination;
- Have no history of vaccination within the past 3 months and vaccination with other products within the last 2 weeks;
- Axillary temperature ≤37.0℃.
Who cannot join
- Any acute disease, such as: tumor, autoimmunity disease, progressive atherosclerotic disease or diabetes with complication, chronic obstructive pulmonary disease need oxygen uptake, acute or progressive hepatopathy or nephropathy, congestive heart-failure, etc.;
- Allergic to vaccines or drugs (history of allergy to any vaccine in the past);
- History of neurologic symptom or signs;
- Known or suspected (or high risk) impaired or abnormal immune function, e.g.: receive immunosuppressant or immunopotentiator therapy, take immunoglobulin or blood product or plasma extract (except the gastrointestinal tract) within the past 3 months, HIV infection or related disease, etc.;
- History of meningitis infection or vaccination of meningococcal vaccine within the past 3 months;
- History of receiving other vaccines or immunoglobulin injection or any research drugs;
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- Any acute disease needing application of antibiotics or anti-virus treatment in the whole body within the past 1 week;
- History of fever within the past 3 days (axillary temperature ≥38.0℃);
- Participating in another clinical trial;
- History of allergy, eclampsia, epilepsy, encephalopathy and mental disease or family disease;
- Thrombopenia or other coagulopathy that may cause contraindication to intramuscular injection;
- Acute chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, Guillain-Barre Syndrome);
- Known or suspected diseases, including: respiratory system disease, acute infection or active stage of chronic disease, SBAV infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc.;
- Pregnancy;
- Any condition that, in the judgment of investigator, may affect trial assessment.
About this study
Official title: Phase I Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine
The clinical trial was designed to evaluate the safety against Group ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of age and older.
Read the detailed description
Complying with requirements of the approval letter of clinical trial issued by SFDA (Approval Letter No.: 2006L01017), Hualan conducted phase I clinical trial of Group ACYW135 Meningococcal Polysaccharide Vaccine. The safety end points were the presence of any systemic, local and adverse reaction.
- Conditions
- Meningitis
- Being tested
- Group ACYW135 Meningococcal Polysaccharide Vaccine
- Keywords
- Group ACYW135 Meningococcal Polysaccharide Vaccine
- Medical subject headings
- Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ACYW135 Meningococcal Polysaccharide VaccineBiological
Also called Hualan Bio
60 subjects were divided into three groups (20 subjects each group), adult (16~30 years of age), early youth (7~15 years of age) and children (2~6 years of age) to receive Group ACYW135 Meningococcal Polysaccharide Vaccine, 0.5 ml, one dose regime
| Study group | Role | What they receive |
|---|---|---|
| Group ACYW135 Meningococcal Polysaccharide Vaccine | Experimental | 0.5ml/ vial Receives: Biological: Group ACYW135 Meningococcal Polysaccharide Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
All systemic and local adverse reactions and related adverse events on day 28 after the vaccination
Measured: Day 28 after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startApr 2006
- Primary completionApr 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hualan Biological Engineering, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fubao Ma, Bachelor, Principal investigator, Immunization Program Institute of Jiangsu Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661725
- Sponsor's protocol ID
- Hualanbio-Meningococcal CT 001
- Other IDs
- Hualanbio-phase I CT
- Status last verified
- Aug 2012
- First submitted
- 2 Aug 2012
- Last updated
- 9 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine
- ClinicalTrials.gov ID
- NCT01661725
- Acronym / sponsor ID
- Hualanbio-Meningococcal CT 001
- Conditions
- Meningitis
- Keywords
- Group ACYW135 Meningococcal Polysaccharide Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hualan Biological Engineering, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Apr 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 9 Aug 2012 (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.
The clinical trial was designed to evaluate the safety against Group ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of age and older.
Detailed description
Complying with requirements of the approval letter of clinical trial issued by SFDA (Approval Letter No.: 2006L01017), Hualan conducted phase I clinical trial of Group ACYW135 Meningococcal Polysaccharide Vaccine. The safety end points were the presence of any systemic, local and adverse reaction.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group ACYW135 Meningococcal Polysaccharide Vaccine | Experimental | Biological: Group ACYW135 Meningococcal Polysaccharide Vaccine0.5ml/ vial |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy permanent residence 2 years of age and older, the subjects (or their guardians) are able to understand and sign the informed consent;
- Healthy male or female by oral history, physical examination and clinical judgment and who complies with vaccination of this product;
- Be able to comply with the requirements of clinical trial protocol and immunogenicity examination;
- Have no history of vaccination within the past 3 months and vaccination with other products within the last 2 weeks;
- Axillary temperature ≤37.0℃.
Key exclusion criteria (15 listed)
- Any acute disease, such as: tumor, autoimmunity disease, progressive atherosclerotic disease or diabetes with complication, chronic obstructive pulmonary disease need oxygen uptake, acute or progressive hepatopathy or nephropathy, congestive heart-failure, etc.;
- Allergic to vaccines or drugs (history of allergy to any vaccine in the past);
- History of neurologic symptom or signs;
- Known or suspected (or high risk) impaired or abnormal immune function, e.g.: receive immunosuppressant or immunopotentiator therapy, take immunoglobulin or blood product or plasma extract (except the gastrointestinal tract) within the past 3 months, HIV infection or related disease, etc.;
- History of meningitis infection or vaccination of meningococcal vaccine within the past 3 months;
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 |
|---|---|---|
| Group ACYW135 Meningococcal Polysaccharide VaccineAlso: Hualan Bio60 subjects were divided into three groups (20 subjects each group), adult (16~30 years of age), early youth (7~15 years of age) and children (2~6 years of age) to receive Group ACYW135 Meningococcal Polysaccharide Vaccine, 0.5 ml, one dose regime | Biological | Group ACYW135 Meningococcal Polysaccharide Vaccine |
Primary outcome
Safety
Time frame: Day 28 after vaccination
All systemic and local adverse reactions and related adverse events on day 28 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 9 Aug 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.
Fubao Ma, Bachelor principal investigator
Immunization Program Institute of Jiangsu Provincial Center for Disease Control and Prevention
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Group ACYW135 Meningococcal Polysaccharide Vaccine in people with Meningitis, run by Hualan Biological Engineering, Inc..
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 5 inclusion and 15 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 9 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Safety (time frame: Day 28 after vaccination). 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 9 Aug 2012.