MeningitisPhase 1/2NCT02919293
Immunogenicity and Safety of Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age
A Phase 1/2 study testing Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free) and Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant) in people with Meningitis and Meningococcal Meningitis, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 1 site in China.
Trial summary
To evaluate Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age. Primary objective: To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C and Haemophilus influenzae type b… Read more about this study
- Who is it for?
- Ages 2 to 5 monthsHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- What is being tested?
- Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free) and Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to May 2017
- Phase
- Phase 1/2
- 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 to 5 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Health infants aged 2 to 5 months.
- Legal guardian has signed written informed consent.
- Guardian may finish the whole visit in the judgment of investigator.
- 2-5 months health infants who haven't immuned with any Meningococcal A and C Conjugate Vaccine or Haemophilus b Conjugate Vaccine.
- Subject who did't vaccinated with any live vaccine within 14 days or inactivated vaccine within 10 days before vaccination.
Who cannot join
- Fever, body temperature ≥37.1℃.
- History of severe allergic reaction that needs medical intervention including throat swelling, dyspnea, hypotension or shock; History of allergic reaction to vaccine or to any of the vaccine components especially to tetanus toxoid or history of other severe adverse reaction to vaccine.
- Clear diagnosis of thrombocytopenia or history of other coagulation disorders that may cause contraindications of intramuscular injection.
- Subject with history of abnormal labor, asphyxia rescue history,congenital malformations,eccyliosis or severe chronic disease.
- Severe cardiovascular or liver and kidney disease, active tuberculosis and HIV infection.
- Subject with encephalopathy, uncontrolled epilepsy and other progressive nervous system disease.
- Subject suffer from acute disease, severe chronic disease, acute episode of chronic disease and febrile illness (temperature ≥ 38°C) within 3 days.
- Any condition that, in the judgment of investigator, subject is not suitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Gaozhou Center for Disease Control and Prevention
Gaozhou, Guangdong, 525200
Zeng peiyu, Bachelor, 86-668-6578613, gzcdc6578613@163.com
About this study
Official title: Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age
To evaluate Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age.
Primary objective:
Read more
- To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C and Haemophilus influenzae type b following the administration of adjuvant-free MenAC-Hib conjugate vaccine compared to those observed following the administration of adjuvant MenAC-Hib conjugate vaccine.
- To describe the safety profile of adjuvant-free MenAC-Hib conjugate vaccine compared to that of adjuvant MenAC-Hib conjugate vaccine.
Secondary objective:
•To compare the antibody level of meningococcal serogroups A, C and Haemophilus influenzae type b following the administration of adjuvant-free MenAC-Hib conjugate vaccine to those observed following the administration of adjuvant MenAC-Hib conjugate vaccine.
- Being tested
- Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free), Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)
- Medical subject headings
- Meningitis, Meningitis, Meningococcal, Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free)Biological
Also called HibACon, MenAC-Hib
30μg /dose, Intramuscular
Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)Biological
Also called HibACon, MenAC-Hib
0.5ml /dose, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant-Free MenAC-Hib Conjugate Vaccine Group | Experimental | Participants randomized to receive adjuvant-free MenAC-Hib conjugate vaccine. Receives: Biological: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free) |
| Adjuvant MenAC-Hib Conjugate Vaccine Group | Active comparator | Participants randomized to receive adjuvant MenAC-Hib conjugate vaccine. Receives: Biological: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with seroresponse to meningococcal serogroups A,C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine
Measured: Day 30 post-vaccination
Occurrence of adverse events during a 30 day follow-up period after each vaccination
Measured: 30 day after each vaccination
Secondary outcomes (2)
Occurrence of severe adverse events within six months post-vaccination
Measured: six months post-vaccination
Geometric mean titer （GMT）of antibodies against meningococcal serogroups A, C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine
Measured: Day 30 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2017 (estimated)
- Study completionMay 2017 (estimated)
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangdong Center for Disease Prevention and Control, Guizhou Center for Disease Control and Prevention, National Institutes for Food and Drug Control, China, Air Force Military Medical University, China, Simoon Record Pharma Information Consulting Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Du lin, Master, Study chair, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919293
- Sponsor's protocol ID
- 085201602
- Status last verified
- Aug 2016
- First submitted
- 27 Sep 2016
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age
- ClinicalTrials.gov ID
- NCT02919293
- Acronym / sponsor ID
- 085201602
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Guangdong Center for Disease Prevention and Control, Guizhou Center for Disease Control and Prevention, National Institutes for Food and Drug Control, China, Air Force Military Medical University, China, Simoon Record Pharma Information Consulting Co., Ltd.
- Study start
- Aug 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 29 Sep 2016 (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.
To evaluate Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age.
Primary objective:
- To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C and Haemophilus influenzae type b following the administration of adjuvant-free MenAC-Hib conjugate vaccine compared to those observed following the administration of adjuvant MenAC-Hib conjugate vaccine.
- To describe the safety profile of adjuvant-free MenAC-Hib conjugate vaccine compared to that of adjuvant MenAC-Hib conjugate vaccine.
Secondary objective:
•To compare the antibody level of meningococcal serogroups A, C and Haemophilus influenzae type b following the administration of adjuvant-free MenAC-Hib conjugate vaccine to those observed following the administration of adjuvant MenAC-Hib conjugate vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant-Free MenAC-Hib Conjugate Vaccine Group | Experimental | Biological: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free)Participants randomized to receive adjuvant-free MenAC-Hib conjugate vaccine. |
| Adjuvant MenAC-Hib Conjugate Vaccine Group | Active comparator | Biological: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)Participants randomized to receive adjuvant MenAC-Hib conjugate vaccine. |
Who may qualify
- Ages
- 2 to 5 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Health infants aged 2 to 5 months.
- Legal guardian has signed written informed consent.
- Guardian may finish the whole visit in the judgment of investigator.
- 2-5 months health infants who haven't immuned with any Meningococcal A and C Conjugate Vaccine or Haemophilus b Conjugate Vaccine.
- Subject who did't vaccinated with any live vaccine within 14 days or inactivated vaccine within 10 days before vaccination.
Key exclusion criteria (8 listed)
- Fever, body temperature ≥37.1℃.
- History of severe allergic reaction that needs medical intervention including throat swelling, dyspnea, hypotension or shock; History of allergic reaction to vaccine or to any of the vaccine components especially to tetanus toxoid or history of other severe adverse reaction to vaccine.
- Clear diagnosis of thrombocytopenia or history of other coagulation disorders that may cause contraindications of intramuscular injection.
- Subject with history of abnormal labor, asphyxia rescue history,congenital malformations,eccyliosis or severe chronic disease.
- Severe cardiovascular or liver and kidney disease, active tuberculosis and HIV infection.
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 |
|---|---|---|
| Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free)Also: HibACon, MenAC-Hib30μg /dose, Intramuscular | Biological | Adjuvant-Free MenAC-Hib Conjugate Vaccine Group |
| Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)Also: HibACon, MenAC-Hib0.5ml /dose, Intramuscular | Biological | Adjuvant MenAC-Hib Conjugate Vaccine Group |
Primary outcome
Percentage of participants with seroresponse to meningococcal serogroups A,C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine
Time frame: Day 30 post-vaccination
Occurrence of adverse events during a 30 day follow-up period after each vaccination
Time frame: 30 day after each vaccination
2 secondary outcomes
Occurrence of severe adverse events within six months post-vaccination
Time frame: six months post-vaccination
Geometric mean titer （GMT）of antibodies against meningococcal serogroups A, C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine
Time frame: Day 30 post-vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
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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.
Du lin, Master study chair
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free) and Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant) in people with Meningitis and Meningococcal Meningitis, run by Beijing Zhifei Lvzhu Biopharmaceutical 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 29 Sep 2016. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeng peiyu, Bachelor (86-668-6578613, gzcdc6578613@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with seroresponse to meningococcal serogroups A,C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine (time frame: Day 30 post-vaccination). The study lists 2 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 29 Sep 2016.