Healthy PopulationPhase 3NCT06314685
Immunogenicity and Safety of MCV4 in Volunteers Aged 6 Months-5 Years
A Phase 3 study testing Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine, Group A and C Meningococcal Polysaccharide Vaccine and Group ACYW135 Meningococcal Polysaccharide Vaccine 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 ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old. Read more about this study
- Who is it for?
- Ages 6 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Population
- What is being tested?
- Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine, Group A and C Meningococcal Polysaccharide Vaccine and Group ACYW135 Meningococcal Polysaccharide Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,450 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2021to 30 Aug 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 6 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For primary immunization stage:
- Subjects aged 6 months-5 years;
- 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 of the subject voluntarily agrees to the child's participation in the study and signs an informed consent form;
- The guardians of the subjects have the ability to understand the research procedures and participate in all planned follow-up visits;
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- Infants and young children aged 6 to 23 months have not received the meningococcal conjugate vaccine. If they have been vaccinated with group A meningococcal polysaccharide vaccine, the interval between vaccination and the previous dose should exceed 3 months;
- Children aged 2-5 who have not been vaccinated with meningococcal conjugate vaccine, if they have been vaccinated with meningococcal polysaccharide vaccine (including group A meningococcal polysaccharide vaccine, group A and C meningococcal polysaccharide vaccine, and group ACYW135 meningococcal polysaccharide vaccine), the interval between the last dose should exceed 12 months;
- Subjects had no vaccination history of other live attenuated vaccines (such as BCG vaccine, live attenuated polio vaccine, rotavirus vaccine, etc.) within 14 days before vaccination, and no vaccination history of other non live vaccines (such as hepatitis B vaccine, inactivated polio vaccine, DPT vaccine, etc.) within 7 days.
- Subjects who have not been vaccinated with meningococcal group A and C conjugate vaccine at the aged of 3-5 months;
- 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 stage (applicable to the 6-11 month age group):
- Infants and young children who have been enrolled in this clinical trial between 6 and 11 months of age and have reached the age of 18 months;
- Infants and young children who have completed basic immunization in this clinical trial;
- According to the opinions of the researchers, the subjects and their guardians are able to comply with the requirements of the clinical trial protocol.
- For immune persistence stage (applicable to the 12-23 month age group):
- Children who have been enrolled in this clinical trial at 12-23 months of age and have completed basic immunization for 12 months; According to the researcher's opinion, the subjects and their guardians are able to comply with the requirements of the clinical trial protocol.
Who cannot join
- For primary immunization stage:
- Have a history of severe allergic reactions that require medical intervention; Have a history of allergies to vaccines or vaccine ingredients (such as lactose, sodium chloride, tetanus toxoids, etc.), and other serious adverse reactions to vaccines;
- Has contraindications for intramuscular injection such as thrombocytopenia, any coagulation dysfunction, or undergoing anticoagulant therapy;
- Has severely abnormal labor (dystocia, instrumental delivery, excluding cesarean section), or history of asphyxia, neurological damage, in vitro fertilization or multiple pregnancy, pathological jaundice (only applicable to infants and young children aged 6-11 months);
- Suffering from serious congenital malformations or chronic diseases that may interfere with the progress or completion of the study (including but not limited to Down's syndrome, thalassemia (the first degree relatives in the family are thalassemia or gene carriers of thalassemia), heart disease, kidney disease, diabetes, autoimmune diseases (repeated perianal abscesses), hereditary allergies, Guillain Barre syndrome, etc.);
- Infectious diseases with clinical or serological evidence, such as tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection or HIV infected parents;
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- Any situation resulting in splenomegaly, splenectomy, or functional splenomegaly;
- Has a history of convulsions, epilepsy, encephalopathy, and mental illness (including family history);
- Within 3 days prior to the first dose of the vaccine, there was an acute illness or acute exacerbation of a chronic disease, or the use of antipyretic, analgesic, and anti allergic drugs (such as acetaminophen, ibuprofen, aspirin, etc.);
- Congenital or acquired immunodeficiency; Or receive systemic corticosteroid treatment (any medication route, ≥ 2mg/kg/day) for ≥ 14 days within 3 months prior to enrollment, such as prednisone, inhaled steroids budesonide, fluticasone, etc; Or being using other immunosuppressants such as cyclosporine, tacrolimus, etc. before enrollment;
- Has given immunoglobulin and/or any blood products (except hepatitis B immunoglobulin) within 3 months before enrollment;
- Plan to move before the end of the study visit or leave the local area for a long time during the scheduled study visit;
- Plan to participate or be participating in any other drug clinical research;
- According to the researcher's judgment, there are any other factors that are not suitable for the subjects to participate in the clinical trial.
- For booster immunization stage (applicable to the 6-11 month age group) and immune persistence stage (applicable to the 12-23 month age group):
- Subjects in the experimental group aged 6-11 months received any meningococcal vaccine before blood serum collection at 18 months old after completing basic immunization;
- Subjects in the 12-23 month age group were vaccinated with any meningococcal vaccine before completing blood collection at 12 month post-completion of primary immunization schedule;
- After participating in this clinical trial, the subjects are known or suspected to have immunological deficiencies, including being treated with immunosuppressants (such as radiation therapy, chemotherapy, corticosteroids, anti metabolic drugs, cytotoxic drugs, etc.) and HIV infection;
- Subjects in the experimental group aged 6-11 month old were given immunoglobulin and/or any blood products (except hepatitis B immunoglobulin) within 3 months before the booster immunization.
- According to the researcher's judgment, there are any other factors that are not suitable for the subjects to participate in the clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
Hunan Center for Disease Control and Prevention
Changsha, Hunan, 410005
About this study
Official title: A Single-center, Randomized, Blind, Positive Control Phase III Clinical Trial to Evaluate Immunogenicity and Safety of Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged From 6 Months to 5 Years
The purpose of this study is to evaluate the immunogenicity and safety of Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old.
Read the detailed description
This is a Phase III, single center, randomized, blind, positive control clinical trial conducted in Hunan Province, China. The purpose of this study is to evaluate the immunogenicity and safety of Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old. A total of 2450 subjects were included, divided into three age groups: 6-11 months old (700 subjects), 12-23 months old (1050 subjects), and 2-5 years old (700 subjects).
- Conditions
- Healthy Population
- Being tested
- Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine, Group A and C Meningococcal Polysaccharide Vaccine, Group ACYW135 Meningococcal Polysaccharide Vaccine
- Keywords
- Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine, MCV4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ACYW135 Meningococcal Polysaccharide Conjugate VaccineBiological
As a experimental vaccine for 6 months to 5 years old.
Group A and C Meningococcal Polysaccharide VaccineBiological
As a control vaccine for ages 6-11 months and 12-23 months.
Group ACYW135 Meningococcal Polysaccharide VaccineBiological
As a control vaccine for ages 2-5 years.
| Study group | Role | What they receive |
|---|---|---|
| 6~11 months old | Experimental | For children aged 6-11 months, they was randomly assigned in a 1:1 ratio to the experimental group and control group, and basic immunization was performed following a 0,1-month schedule. And the experimental group received one dose of booster immunization at 18 months old; Receives: Biological: Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine; Biological: Group A and C Meningococcal Polysaccharide Vaccine |
| 12~23 months old | Experimental | For infants aged 12-23 months, they was randomly assigned in a 1:1:1 ratio to the two-dose experimental group, one-dose experimental group, and two-dose control group. For the 12-23 month-olds in the two-dose group, they received two doses of immunization according to a 0, 1-month schedule; while those in the one-dose group receive a single dose of immunization. Receives: Biological: Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine; Biological: Group A and C Meningococcal Polysaccharide Vaccine |
| 2~5 years old | Experimental | For children aged 2-5 years, they were randomly assigned in a 1:1 ratio to the experimental group and control group and received a single dose of immunization. Receives: Biological: Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine; Biological: Group ACYW135 Meningococcal Polysaccharide Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody positive conversion rate
Immunogenicity study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by positive conversion rate (4-fold increase)
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 start10 Dec 2021
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 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
- 2,450 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
- NCT06314685
- Sponsor's protocol ID
- 2020040C-2
- Status last verified
- Feb 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 ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged From 6 Months to 5 Years
- ClinicalTrials.gov ID
- NCT06314685
- Acronym / sponsor ID
- 2020040C-2
- Conditions
- Healthy Population
- Keywords
- Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine, MCV4
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,450 participants (actual)
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 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 ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old.
Detailed description
This is a Phase III, single center, randomized, blind, positive control clinical trial conducted in Hunan Province, China. The purpose of this study is to evaluate the immunogenicity and safety of Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old. A total of 2450 subjects were included, divided into three age groups: 6-11 months old (700 subjects), 12-23 months old (1050 subjects), and 2-5 years old (700 subjects).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 6~11 months old | Experimental | Biological: Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine, Biological: Group A and C Meningococcal Polysaccharide VaccineFor children aged 6-11 months, they was randomly assigned in a 1:1 ratio to the experimental group and control group, and basic immunization was performed following a 0,1-month schedule. And the experimental group received one dose of booster immunization at 18 months old; |
| 12~23 months old | Experimental | Biological: Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine, Biological: Group A and C Meningococcal Polysaccharide VaccineFor infants aged 12-23 months, they was randomly assigned in a 1:1:1 ratio to the two-dose experimental group, one-dose experimental group, and two-dose control group. For the 12-23 month-olds in the two-dose group, they received two doses of immunization according to a 0, 1-month schedule; while those in the one-dose group receive a single dose of immunization. |
| 2~5 years old | Experimental | Biological: Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine, Biological: Group ACYW135 Meningococcal Polysaccharide VaccineFor children aged 2-5 years, they were randomly assigned in a 1:1 ratio to the experimental group and control group and received a single dose of immunization. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- Subjects aged 6 months-5 years;
- 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 of the subject voluntarily agrees to the child's participation in the study and signs an informed consent form;
- The guardians of the subjects have the ability to understand the research procedures and participate in all planned follow-up visits;
Key exclusion criteria (20 listed)
- Have a history of severe allergic reactions that require medical intervention; Have a history of allergies to vaccines or vaccine ingredients (such as lactose, sodium chloride, tetanus toxoids, etc.), and other serious adverse reactions to vaccines;
- Has contraindications for intramuscular injection such as thrombocytopenia, any coagulation dysfunction, or undergoing anticoagulant therapy;
- Has severely abnormal labor (dystocia, instrumental delivery, excluding cesarean section), or history of asphyxia, neurological damage, in vitro fertilization or multiple pregnancy, pathological jaundice (only applicable to infants and young children aged 6-11 months);
- Suffering from serious congenital malformations or chronic diseases that may interfere with the progress or completion of the study (including but not limited to Down's syndrome, thalassemia (the first degree relatives in the family are thalassemia or gene carriers of thalassemia), heart disease, kidney disease, diabetes, autoimmune diseases (repeated perianal abscesses), hereditary allergies, Guillain Barre syndrome, etc.);
- Infectious diseases with clinical or serological evidence, such as tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection or HIV infected parents;
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 Conjugate VaccineAs a experimental vaccine for 6 months to 5 years old. | Biological | 12~23 months old, 2~5 years old, 6~11 months old |
| Group A and C Meningococcal Polysaccharide VaccineAs a control vaccine for ages 6-11 months and 12-23 months. | Biological | 12~23 months old, 6~11 months old |
| Group ACYW135 Meningococcal Polysaccharide VaccineAs a control vaccine for ages 2-5 years. | Biological | 2~5 years old |
Primary outcome
Antibody positive conversion rate
Time frame: 30 day after primary immunization
Immunogenicity study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by positive conversion rate (4-fold increase)
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.
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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.
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 ACYW135 Meningococcal Polysaccharide Conjugate Vaccine, Group A and C Meningococcal Polysaccharide Vaccine and Group ACYW135 Meningococcal Polysaccharide Vaccine 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 17 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?
Antibody positive conversion rate (time frame: 30 day after primary immunization). 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.