MeningitisPhase 2NCT01661738

Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 002

A Phase 2 study testing Group ACYW135 Meningococcal Polysaccharide Vaccine in people with Meningitis, run by Hualan Biological Engineering, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The clinical trial was designed to evaluate the safety and immunogenicity 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: 360 participants
Where: No sites listed yet
Study dates: May 2006to Jun 2006
Phase: Phase 2
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;

Show all 15Show fewer

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 II Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine

The clinical trial was designed to evaluate the safety and immunogenicity 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 II clinical trial of Group ACYW135 Meningococcal Polysaccharide Vaccine to evaluate the safety and immunogenicity of the experimental vaccine.

The safety end points were the presence of any systemic, local and adverse reaction. Evaluation indicators of immunogenicity were bacteriocin levels of groups A, C, Y and W135 respectively in the serum after the whole vaccination.

Conditions: Meningitis
Being tested: Group ACYW135 Meningococcal Polysaccharide Vaccine
Keywords: Group ACYW135 Meninigococcal 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
360 subjects were divided into three groups (120 subjects in each group), children (2~6 years of age), early youth (7~15 years of age) and adult (16~30 years of age) to receive Group ACYW135 Meningococcal Polysaccharide Vaccine, 0.5 ml, one dose regime

Study groups in NCT01661738
Study group	Role	What they receive
Group ACYW135 Meningococcal Polysaccharide Vaccine	Experimental	0.5 ml/ 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
Systemic and local adverse reactions after the vaccination; adverse events
Measured: Day 28 after vaccination

Secondary outcomes (1)

Immunogenicity
4-fold (seroconversion) and 8-fold increase of bactericidin; GMT and bactericidin increase after immunization
Measured: The 4th week after immunization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2006Jun 2006

First posted9 Aug 2012 (estimated)
Study startMay 2006
Primary completionMay 2006
Study completionJun 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 2
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 360 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01661738
Sponsor's protocol ID: Hualanbio-Meningococcal CT 002
Other IDs: Hualanbio-phase II CT
Status last verified: Aug 2012
First submitted: 2 Aug 2012
Last updated: 9 Aug 2012
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
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Cryptococcal Infection, Cryptococcal Pneumonia
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Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia
Idiopathic CD4+ Lymphocytopenia, Cryptococcal Meningitis
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Acute Treatment and Long-term Assessment of Adult Infectious Meningitis
Viral Meningitis, Bacterial Meningitis
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Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Cysticercosis, Neurocysticercosis

All Meningitis trials

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 II Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine
ClinicalTrials.gov ID: NCT01661738
Acronym / sponsor ID: Hualanbio-Meningococcal CT 002
Conditions: Meningitis
Keywords: Group ACYW135 Meninigococcal Polysaccharide Vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 360 participants (actual)
Lead sponsor: Hualan Biological Engineering, Inc.Industry (pharma, biotech, devices)
Study start: May 2006
Primary completion: May 2006 (actual)
Study completion: Jun 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 and immunogenicity against Group ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of age and older.

Detailed description

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 Vaccine0.5 ml/ 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 Bio360 subjects were divided into three groups (120 subjects in each group), children (2~6 years of age), early youth (7~15 years of age) and adult (16~30 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
Systemic and local adverse reactions after the vaccination; adverse events

1 secondary outcome

Immunogenicity
Time frame: The 4th week after immunization

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.

Related trials for Meningitis

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingObservational study
Fungal Infection Susceptibility
Cryptococcal Infection, Cryptococcal Pneumonia
RecruitingObservational study
Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia
Idiopathic CD4+ Lymphocytopenia, Cryptococcal Meningitis
RecruitingObservational study
Acute Treatment and Long-term Assessment of Adult Infectious Meningitis
Viral Meningitis, Bacterial Meningitis
RecruitingObservational study
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Cysticercosis, Neurocysticercosis

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 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

On the ClinicalTrials.gov record for NCT01661738.

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; AzTrials last refreshed its copy on 8 Nov 2026.