Healthy PopulationPhase 3NCT06314659
Immunogenicity and Safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in Volunteers Aged 3-5 Months
A Phase 3 study testing Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Zhifei Lvzhu), Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Walvax) and Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Olymvax) in people with Healthy Population, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to evaluate the immunogenicity and safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 to 5 months old. Read more about this study
- Who is it for?
- Ages 3 to 5 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Population
- What is being tested?
- Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Zhifei Lvzhu), Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Walvax) and Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Olymvax)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 1 siteChina
- Study dates
- 17 Sep 2021to 30 Dec 2024
- 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 3 to 5 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For primary immunization stage
- Subjects aged 3-5 months;
- Subjects should be full-term (37-42 weeks of gestation) and their birth weight should meet the requirements (2500g ≤ body weight ≤ 4000g);
- Axillary body temperature ≤ 37.0 ℃;
- The guardian signs the informed consent form;
- The guardian and his family agree to comply with the requirements of the clinical trial protocol;
Show all 12Show fewer
- Subjects who have not been vaccinated with meningococcal group A and C conjugate vaccine;
- Subjects who had no history of other live vaccines within 14 days before vaccination and no history of other inactivated vaccines within 7 days;
- For booster immunization and immune persistence stage
- Infants in the experimental group who have completed primary immunization in this clinical trial and reach the age of 18 months;
- Infants and young children who have completed primary or booster immunization in this clinical trial;
- According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.
Who cannot join
- For primary immunization stage
- Test-tube baby who is suffering from perianal abscess, severe eczema or pathological jaundice;
- History of severe allergic reactions requiring medical intervention (such as swelling of mouth and throat, dyspnea, hypotension or shock);
- A clearly diagnosed history of thrombocytopenia or other coagulation disorders that may cause contraindications to intramuscular injection;
- History of severe abnormal labor and delivery, asphyxia rescue, congenital malformation, serious developmental disorder, serious genetic defect, serious malnutrition or serious chronic disease;
- Suffering from serious cardiovascular diseases (pulmonary heart disease, pulmonary edema), serious liver and kidney diseases, and diabetes with complications;
Show all 20Show fewer
- Has been diagnosed as infectious diseases, such as tuberculosis, viral hepatitis or their parents infected with human immunodeficiency virus (HIV);
- History or family history of encephalopathy, epilepsy, convulsions or seizures, and other progressive neurological diseases;
- Suffering from acute illness or in the acute phase of chronic illness, or using antipyretic, analgesic, and antiallergic drugs (such as acetaminophen, ibuprofen, aspirin, etc.) three days before vaccination;
- Long term treatment with immunosuppressants, such as long-term (continuous for more than 2 weeks) use of glucocorticoids (such as prednisone or inhaled steroids (budesonide, fluticasone) and similar drugs);
- History of using immunoglobulins and / or any blood products (except hepatitis B immunoglobulin) within 3 months before enrollment;
- Plan to participate or be participating in any other drug clinical research;
- Plan to move out of the local area before the end of the study or leave for a long time during the scheduled study visit period;
- According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.
- For booster immunization and immune persistence stage
- Has been vaccinated with any meningococcal vaccine after primary immunization and before blood collection of booster immunization;
- Has been vaccinated with any meningococcal vaccine after booster immunization and before blood collection of immune persistence;
- Has been known or suspected to have immunological defects since participating in this clinical trial, including being treated with immunosuppressants (such as chemotherapy, corticosteroids, antimetabolics, cytotoxic drugs, etc.) and HIV infection;
- History of using immunoglobulins and / or any blood products within 3 months before booster immunization;
- According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Nanning, Guangxi, 530028
About this study
Official title: A Single-center, Randomized, Blind, Positive Control Phase III Clinical Trial to Evaluate Immunogenicity and Safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in Volunteers Aged 3-5 Months
The purpose of this study is to evaluate the immunogenicity and safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 to 5 months old.
Read the detailed description
This is a Phase III, single center, randomized, blind, positive control clinical trial conducted in Guangxi Province, China. The purpose of this study is to evaluate the immunogenicity and safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 to 5 months old. A total of 630 subjects were included and randomly assigned to the experimental group and control group in a 1:1 ratio.
- Conditions
- Healthy Population
- Being tested
- Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Zhifei Lvzhu), Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Walvax), Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Olymvax)
- Keywords
- Group A and C Meningococcal Polysaccharide Conjugate Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Zhifei Lvzhu)Biological
Performed primary immunization following a 0-1-2-month schedule at the aged from 3 to 5 months and booster immunization at 18 months of age.
Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Walvax)Biological
Performed primary immunization following a 0-1-2-month schedule at the aged from 3 to 5 months.
Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Olymvax)Biological
Performed booster immunization at 18 months of age.
| Study group | Role | What they receive |
|---|---|---|
| Basic immunization | Experimental | Perform basic immunization with a program of 0, 1, and 2 months, booster vaccination with 1 dose at 18 months of age. Receives: Biological: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Zhifei Lvzhu); Biological: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Walvax) |
| Booster immunization | Active comparator | Perform booster vaccination with 1 dose at 18 months of age. Receives: Biological: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Zhifei Lvzhu); Biological: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Olymvax) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of antibody positivity conversion rate of serogroup A
The proportion of people with pre-immunization antibody titer against serogroup A meningococcus <1:8 who achieve an antibody titer ≥1:8 after immunization.
Measured: 30 day after primary immunization
Analysis of antibody positivity conversion rate of serogroup C
The proportion of people with pre-immunization antibody titer against serogroup C meningococcus <1:8 who achieve an antibody titer ≥1:8 after immunization.
Measured: 30 day after primary immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start17 Sep 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PopulationStudies 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
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Du, Study chair, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314659
- Sponsor's protocol ID
- 2020020C
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Blind, Positive Control Phase III Clinical Trial to Evaluate Immunogenicity and Safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in Volunteers Aged 3-5 Months
- ClinicalTrials.gov ID
- NCT06314659
- Acronym / sponsor ID
- 2020020C
- Conditions
- Healthy Population
- Keywords
- Group A and C Meningococcal Polysaccharide Conjugate Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 18 Mar 2024 (actual)
- 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 study is to evaluate the immunogenicity and safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 to 5 months old.
Detailed description
This is a Phase III, single center, randomized, blind, positive control clinical trial conducted in Guangxi Province, China. The purpose of this study is to evaluate the immunogenicity and safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 to 5 months old. A total of 630 subjects were included and randomly assigned to the experimental group and control group in a 1:1 ratio.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basic immunization | Experimental | Biological: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Zhifei Lvzhu), Biological: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Walvax)Perform basic immunization with a program of 0, 1, and 2 months, booster vaccination with 1 dose at 18 months of age. |
| Booster immunization | Active comparator | Biological: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Zhifei Lvzhu), Biological: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Olymvax)Perform booster vaccination with 1 dose at 18 months of age. |
Who may qualify
- Ages
- 3 to 5 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- For primary immunization stage
- Subjects aged 3-5 months;
- Subjects should be full-term (37-42 weeks of gestation) and their birth weight should meet the requirements (2500g ≤ body weight ≤ 4000g);
- Axillary body temperature ≤ 37.0 ℃;
- The guardian signs the informed consent form;
Key exclusion criteria (20 listed)
- For primary immunization stage
- Test-tube baby who is suffering from perianal abscess, severe eczema or pathological jaundice;
- History of severe allergic reactions requiring medical intervention (such as swelling of mouth and throat, dyspnea, hypotension or shock);
- A clearly diagnosed history of thrombocytopenia or other coagulation disorders that may cause contraindications to intramuscular injection;
- History of severe abnormal labor and delivery, asphyxia rescue, congenital malformation, serious developmental disorder, serious genetic defect, serious malnutrition or serious chronic disease;
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 A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Zhifei Lvzhu)Performed primary immunization following a 0-1-2-month schedule at the aged from 3 to 5 months and booster immunization at 18 months of age. | Biological | Basic immunization, Booster immunization |
| Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Walvax)Performed primary immunization following a 0-1-2-month schedule at the aged from 3 to 5 months. | Biological | Basic immunization |
| Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Olymvax)Performed booster immunization at 18 months of age. | Biological | Booster immunization |
Primary outcome
Analysis of antibody positivity conversion rate of serogroup A
Time frame: 30 day after primary immunization
The proportion of people with pre-immunization antibody titer against serogroup A meningococcus <1:8 who achieve an antibody titer ≥1:8 after immunization.
Analysis of antibody positivity conversion rate of serogroup C
Time frame: 30 day after primary immunization
The proportion of people with pre-immunization antibody titer against serogroup C meningococcus <1:8 who achieve an antibody titer ≥1:8 after immunization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
Related trials for Healthy Population
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
Not yet recruitingPhase 1
A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)
Healthy, Renal Impairment
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
Recruiting
Developing a Support Application for Food Pantries (SAFPAS) to Improve Client Access to Healthy Foods & Enhance Emergency Preparedness
Improving Healthy Food Access in Food Insecurity Populations in Normal and Emergency Situations
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
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.
Lin Du 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 3 study testing Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Zhifei Lvzhu), Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Walvax) and Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Olymvax) in people with Healthy Population, 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 12 inclusion and 20 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 3 Apr 2024. 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 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?
Results are not available in the source record.
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?
Analysis of antibody positivity conversion rate of serogroup A (time frame: 30 day after primary immunization). 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 3 Apr 2024.