MeningitisPhase 3NCT02003495
Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine
A Phase 3 study testing MCV-ACYW135 Vaccine Group, MPV-ACYW135 Vaccine Group and MPV-A Vaccine Group in people with Meningitis, run by Beijing Minhai Biotechnology Co., Ltd at 1 site in China.
Trial summary
The purpose of this observer-blind study is to evaluate the safety, reactogenicity and immunogenicity of Meninggococcal (A,C,Y and W135) Conjugate Vaccine in 2 months to 6 years-old children. Read more about this study
- Who is it for?
- Ages 2 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningitis
- What is being tested?
- MCV-ACYW135 Vaccine Group, MPV-ACYW135 Vaccine Group and MPV-A Vaccine Group
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,195 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Oct 2014
- 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 2 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
- Healthy permanent residence 2 months to 6 years old.
- Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures.
- Axillary temperature ≤37.0 ℃.
Who cannot join
- History of meningitis infection or vaccination of meningococcal vaccine within the past 6 months.
- Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia.
- Patients administered with immunosuppressive agents, cytotoxicity factor or corticosteroids in the 6 months preceding the vaccine trial.
- Receipt of blood or blood-derived products in the 3 months preceding vaccination
- Participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination.
- Receipt of any live virus vaccine in the 15 days preceding vaccination.
Show all 15Show fewer
- Receipt of any subunit vaccine and inactivated vaccine in the 7 days before vaccination.
- Febrile illness (temperature ≥ 38°C) in the 3 days or any acute illness/infection in the 7 days preceding vaccination.
- Thrombocytopenia.
- History of thyroid gland excision or treatment for thyroid gland disease in last 12 months.
- Functional or anatomic asplenia.
- History of eclampsia, epilepsy, encephalopathy and mental disease or family disease.
- 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, HIV infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc.
- Any condition that, in the judgment of investigator, may affect trial assessment.
Trial locations and contacts
1 site in 1 country.
China1 site
Henan Provincial Center for Disease Control and Prevention
Zhengzhou, Henan
About this study
Official title: Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine in Healthy Subjects 2 Months to 6 Years of Age in China
The purpose of this observer-blind study is to evaluate the safety, reactogenicity and immunogenicity of Meninggococcal (A,C,Y and W135) Conjugate Vaccine in 2 months to 6 years-old children.
- Conditions
- Meningitis
- Being tested
- MCV-ACYW135 Vaccine Group, MPV-ACYW135 Vaccine Group, MPV-A Vaccine Group, MCV-AC Vaccine Group, Hib Vaccine Group
- Keywords
- Immunogenicity, Safety, Meningococcal Conjugate Vaccine
- Medical subject headings
- Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCV-ACYW135 Vaccine GroupBiological
Also called Meningococcal ( A, C, Y and W 135) conjugate vaccine
0.5ml, intramuscular
MPV-ACYW135 Vaccine GroupBiological
Also called Group A, C, Y and W-135 Meningococcal Polysaccharide Vaccine
0.5ml, intramuscular
MPV-A Vaccine GroupBiological
Also called Group A Meningococcal Polysaccharide vaccine
0.5ml, intramuscular
MCV-AC Vaccine GroupBiological
Also called Group A and C Meningococcal conjugate vaccine
0.5ml, intramuscular
Hib Vaccine GroupBiological
Also called Haemophilus Influenzae Type b Conjugate Vaccine
0.5ml, intramuscular
| Study group | Role | What they receive |
|---|---|---|
| MCV-ACYW135 Vaccine Group | Experimental | Participants at age 2 to 6 years of enrollment will receive 1 dose on Meningococcal ( A, C, Y and W 135) conjugate vaccine.
Participants at age 6 to 23 months of enrollment will receive 2 doses on Meningococcal ( A, C, Y and W 135) conjugate vaccine at 3 months apart.
Participants at age 3 to 5 months of enrollment will receive 3 doses on Meningococcal ( A, C, Y and W 135) conjugate vaccine at 1 month apart.
Participants at age 2 to 5 months of enrollment will receive 3 doses on Meningococcal ( A, C, Y and W 135) conjugate vaccine at 2 months apart. Receives: Biological: MCV-ACYW135 Vaccine Group |
| MPV-ACYW135 Vaccine Group | Active comparator | Participants at age 2 to 6 years of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine Receives: Biological: MPV-ACYW135 Vaccine Group |
| MPV-A Vaccine Group | Active comparator | Participants at age 6 to 23 months of enrollment will receive 2 doses on Group A Meningococcal Polysaccharide vaccine at 3 months apart. Receives: Biological: MPV-A Vaccine Group |
| MCV-AC Vaccine Group | Active comparator | Participants at age 3 to 5 months of enrollment will receive 3 doses on Group A and C Meningococcal conjugate vaccine at 1 month apart. Receives: Biological: MCV-AC Vaccine Group |
| Hib Vaccine Group | Placebo comparator | Participants at age 2 to 5 months of enrollment will receive 3 doses on Haemophilus Influenzae Type b Conjugate Vaccine at 2 months apart. Receives: Biological: Hib Vaccine Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects exhibiting a >= 4fold increase in rSBA titers level from pre-vaccination to post-vaccination
Measured: 28 days after vaccination
Secondary outcomes (1)
to evaluate the adverse reactions after vaccination
Measured: Within 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2014
- Study completionOct 2014
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Minhai Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- shengli xia, Principal investigator, Henan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003495
- Sponsor's protocol ID
- 2013L01041
- Other IDs
- 2013L01041
- Status last verified
- Sep 2015
- First submitted
- 3 Dec 2013
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine in Healthy Subjects 2 Months to 6 Years of Age in China
- ClinicalTrials.gov ID
- NCT02003495
- Acronym / sponsor ID
- 2013L01041
- Conditions
- Meningitis
- Keywords
- Immunogenicity, Safety, Meningococcal Conjugate Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,195 participants (actual)
- Lead sponsor
- Beijing Minhai Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 6 Dec 2013 (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 purpose of this observer-blind study is to evaluate the safety, reactogenicity and immunogenicity of Meninggococcal (A,C,Y and W135) Conjugate Vaccine in 2 months to 6 years-old children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MCV-ACYW135 Vaccine Group | Experimental | Biological: MCV-ACYW135 Vaccine GroupParticipants at age 2 to 6 years of enrollment will receive 1 dose on Meningococcal ( A, C, Y and W 135) conjugate vaccine. Participants at age 6 to 23 months of enrollment will receive 2 doses on Meningococcal ( A, C, Y and W 135) conjugate vaccine at 3 months apart. Participants at age 3 to 5 months of enrollment will receive 3 doses on Meningococcal ( A, C, Y and W 135) conjugate vaccine at 1 month apart. Participants at age 2 to 5 months of enrollment will receive 3 doses on Meningococcal ( A, C, Y and W 135) conjugate vaccine at 2 months apart. |
| MPV-ACYW135 Vaccine Group | Active comparator | Biological: MPV-ACYW135 Vaccine GroupParticipants at age 2 to 6 years of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine |
| MPV-A Vaccine Group | Active comparator | Biological: MPV-A Vaccine GroupParticipants at age 6 to 23 months of enrollment will receive 2 doses on Group A Meningococcal Polysaccharide vaccine at 3 months apart. |
| MCV-AC Vaccine Group | Active comparator | Biological: MCV-AC Vaccine GroupParticipants at age 3 to 5 months of enrollment will receive 3 doses on Group A and C Meningococcal conjugate vaccine at 1 month apart. |
| Hib Vaccine Group | Placebo comparator | Biological: Hib Vaccine GroupParticipants at age 2 to 5 months of enrollment will receive 3 doses on Haemophilus Influenzae Type b Conjugate Vaccine at 2 months apart. |
Who may qualify
- Ages
- 2 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
- Healthy permanent residence 2 months to 6 years old.
- Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures.
- Axillary temperature ≤37.0 ℃.
Key exclusion criteria (15 listed)
- History of meningitis infection or vaccination of meningococcal vaccine within the past 6 months.
- Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia.
- Patients administered with immunosuppressive agents, cytotoxicity factor or corticosteroids in the 6 months preceding the vaccine trial.
- Receipt of blood or blood-derived products in the 3 months preceding vaccination
- Participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination.
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 |
|---|---|---|
| MCV-ACYW135 Vaccine GroupAlso: Meningococcal ( A, C, Y and W 135) conjugate vaccine0.5ml, intramuscular | Biological | MCV-ACYW135 Vaccine Group |
| MPV-ACYW135 Vaccine GroupAlso: Group A, C, Y and W-135 Meningococcal Polysaccharide Vaccine0.5ml, intramuscular | Biological | MPV-ACYW135 Vaccine Group |
| MPV-A Vaccine GroupAlso: Group A Meningococcal Polysaccharide vaccine0.5ml, intramuscular | Biological | MPV-A Vaccine Group |
| MCV-AC Vaccine GroupAlso: Group A and C Meningococcal conjugate vaccine0.5ml, intramuscular | Biological | MCV-AC Vaccine Group |
| Hib Vaccine GroupAlso: Haemophilus Influenzae Type b Conjugate Vaccine0.5ml, intramuscular | Biological | Hib Vaccine Group |
Primary outcome
Percentage of subjects exhibiting a >= 4fold increase in rSBA titers level from pre-vaccination to post-vaccination
Time frame: 28 days after vaccination
1 secondary outcome
to evaluate the adverse reactions after vaccination
Time frame: Within 28 days after 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 22 Sep 2015.
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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.
shengli xia principal investigator
Henan Provincial Center for Disease Control and Prevention
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 MCV-ACYW135 Vaccine Group, MPV-ACYW135 Vaccine Group and MPV-A Vaccine Group in people with Meningitis, run by Beijing Minhai Biotechnology Co., Ltd 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 4 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 22 Sep 2015. 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. Some participants in this study may receive a placebo. 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?
Percentage of subjects exhibiting a >= 4fold increase in rSBA titers level from pre-vaccination to post-vaccination (time frame: 28 days 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 22 Sep 2015.