VaccinePhase 4NCT04638985
Evaluation of Immunogenicity and Safety of Combined Immunization of sIPV, DTaP and MMR
A Phase 4 study testing sIPV+DTaP+MMR, sIPV and DTaP in people with Vaccine, run by China National Biotec Group Company Limited at 3 sites in China.
Trial summary
Eligible,healthy infants who have finished the 3-dose-schedule of sIPV+DTaP combined vaccination clinical trial (NCT04054882) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows: Group 1: sIPV + DTaP + MMR, Group 2: sIPV only, Group 3: DTaP only, Group 4: MMR… Read more about this study
- Who is it for?
- Ages 18 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Vaccine
- What is being tested?
- sIPV+DTaP+MMR, sIPV and DTaP
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesChina
- Study dates
- 13 Nov 2020to Dec 2021
- Phase
- Phase 4
- 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 18 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects must have participated the clinical trial titled "Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP" (NCT04054882) in 2019, and have finished 3 doses of combined immunization of sIPV and DTaP;
- Subjects aged 18 months old at the date of recruitment;
- With informed consent form (ICF) signed by parent(s) or guardian(s);
- Parent(s) or guardian(s) are able to attend all planned clinical appointments and obey/follow all study instructions;
- Subjects have been vaccinated with a first dose of MMR, but have not been vaccinated with the 2nd dose of MMR and the booster (4th) dose of sIPV and DTaP;
- No less than 14 days since the last dose of vaccination;
- Axillary temperature ≤37.0℃.
Who cannot join
- With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
- Allergic to any ingredient of vaccine or with allergy history to any vaccine;
- Subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);
- Administration of immunoglobulins within 30 days prior to this study;
- Acute febrile disease(temperature ≥ 37.0°C) or infectious disease;
- With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection;
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- With any serious chronic illness, acute infectious diseases, or respiratory diseases;
- With severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;
- With any kind of infectious, purulent, or allergic skin diseases;
- With any other factor that makes the investigator determines the subject is unsuitable for this study.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Not yet recruiting
Sichuan Center for Disease Control and Prevention
Chengdu, Sichuan, 610041
Xiaoping Zhu, +86-852-85596863, xiaopingzhu98@163.com
- Recruiting
Anhui Provincial Center for Disease Control and Prevention
Hefei, Anhui, 230601
Binbing Wang, +86-551-63674927, 250267563@qq.com
- Recruiting
Jiangsu Province Centers for Disease Control and Prevention
Nanjing, Jiangsu, 210009
Fenyang Tang, +86-25-83759423, tfyepi@163.com
About this study
Official title: A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Immunogenicity and Safety of Combined Immunization of Sabin-strain Inactivated Polio Vaccine (sIPV), Diphtheria, Tetanus, Pertussis Vaccine (DTaP) and Measles, Moms and Rubella Vaccine (MMR)
Eligible,healthy infants who have finished the 3-dose-schedule of sIPV+DTaP combined vaccination clinical trial (NCT04054882) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows:
Group 1: sIPV + DTaP + MMR, Group 2: sIPV only, Group 3: DTaP only, Group 4: MMR only.
The immunogenicity and safety of the 4 groups will be compared and analyzed before and 30 days after vaccination.
Read the detailed description
Following the clinical trial of "Combined Immunization of sIPV and DTaP" in 2019, this study recruits 600 18-month-old subjects who have received 3 doses of sIPV + DTaP, and gives them a 4th dose of vaccination (booster immunization). They are divided into 4 different groups, with 150 subjects in each group, and are innoculated with different vaccines.
To be specific, group 1 receives sIPV (0.5ml)+ DTaP (0.5ml)+ MMR(0.5ml); group 2 receives sIPV (0.5ml); group 3 receives DTaP (0.5ml); group 4 receives MMR (0.5ml).
Blood samples will be collected before vaccination and 30 days after this booster immunization. Neutralization antibody will be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will be monitored as well.
- Conditions
- Vaccine
- Being tested
- sIPV+DTaP+MMR, sIPV, DTaP, MMR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sIPV+DTaP+MMRBiological
sIPV+DTaP+MMR at the age of 18 month old
sIPVBiological
sIPV at the age of 18 month old
DTaPBiological
DTaP at the age of 18 month old
MMRBiological
MMR at the age of 18 month old
| Study group | Role | What they receive |
|---|---|---|
| group 1 (sIPV+DTaP+MMR) | Experimental | 150 subjects; simultaneously administration of sIPV+DTaP+MMR as booster immunization at the age of 18 months old, 0.5 ml each, respectively Receives: Biological: sIPV+DTaP+MMR |
| group 2 (sIPV) | Active comparator | 150 subjects; vaccination of 0.5 ml sIPV as booster immunization at the age of 18 months old Receives: Biological: sIPV |
| group 3 (DTaP) | Active comparator | 150 subjects; vaccination of 0.5 ml DTaP as booster immunization at the age of 18 months old Receives: Biological: DTaP |
| group 4 (MMR) | Active comparator | 150 subjects; vaccination of 0.5 ml MMR as booster immunization at the age of 18 months old Receives: Biological: MMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate (sIPV)
determine the rate of positive seroconversion against poliovirus type I, II and III of the subjectsdetermine the rate of positive seroconversion against poliovirus type I, II and III of the subjects
Measured: Baseline (before vaccination) results
Seroconversion rate (sIPV)
determine the rate of positive seroconversion against poliovirus type I, II and III of the subjectsdetermine the rate of positive seroconversion against poliovirus type I, II and III of the subjects
Measured: Results obtained 30 days after vaccination
Seroconversion rate (DTaP)
determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Measured: Baseline (before vaccination) results
Seroconversion rate (DTaP)
determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Measured: Results obtained 30 days after vaccination
Seroconversion rate (MMR)
determine the positive seroconversion rate of measles, mumps, rubella antibodies of the subjects
Measured: Baseline (before vaccination) results
Seroconversion rate (MMR)
determine the positive seroconversion rate of measles, mumps, rubella antibodies of the subjects
Measured: Results obtained 30 days after vaccination
Geometric Mean Concentration (GMC) (sIPV)
GMCs of poliovirus type I, II and III of the subjects
Measured: Baseline (before vaccination) results
Geometric Mean Concentration (GMC) (sIPV)
GMCs of poliovirus type I, II and III of the subjects
Measured: Results obtained 30 days after vaccination
Geometric Mean Concentration (GMC) (DTaP)
GMCs of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Measured: Baseline (before vaccination) results
Geometric Mean Concentration (GMC) (DTaP)
GMCs of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Measured: Results obtained 30 days after vaccination
Geometric Mean Concentration (GMC) (MMR)
GMCs of measles, mumps, rubella antibodies of the subjects
Measured: Baseline (before vaccination) results
Geometric Mean Concentration (GMC) (MMR)
GMCs of measles, mumps, rubella antibodies of the subjects
Measured: Results obtained 30 days after vaccination
Secondary outcomes (1)
Adverse Events Following Immunization (AEFI)
analyse the incidence of adverse events following immunization, both solicited and unsolicited
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start13 Nov 2020
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccineStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Biotec Group Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Province Centers for Disease Control and Prevention, Anhui Provincial Center for Disease Control and Prevention, Sichuan Center for Disease Control and Prevention, Beijing Institute of Biological Products Co Ltd., Chengdu Institute of Biological Products Co.,Ltd., Peking University, National Institutes for Food and Drug Control, China
- Responsible party
- Sponsor
- Investigators
- Fenyang Tang, Principal investigator, Jiangsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638985
- Sponsor's protocol ID
- sIPV-DTaP-MMR-2020
- Status last verified
- Dec 2020
- First submitted
- 17 Nov 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Immunogenicity and Safety of Combined Immunization of Sabin-strain Inactivated Polio Vaccine (sIPV), Diphtheria, Tetanus, Pertussis Vaccine (DTaP) and Measles, Moms and Rubella Vaccine (MMR)
- ClinicalTrials.gov ID
- NCT04638985
- Acronym / sponsor ID
- sIPV-DTaP-MMR-2020
- Conditions
- Vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Jiangsu Province Centers for Disease Control and Prevention, Anhui Provincial Center for Disease Control and Prevention, Sichuan Center for Disease Control and Prevention, Beijing Institute of Biological Products Co Ltd., Chengdu Institute of Biological Products Co.,Ltd., Peking University, National Institutes for Food and Drug Control, China
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 20 Nov 2020 (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.
Eligible,healthy infants who have finished the 3-dose-schedule of sIPV+DTaP combined vaccination clinical trial (NCT04054882) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows:
Group 1: sIPV + DTaP + MMR, Group 2: sIPV only, Group 3: DTaP only, Group 4: MMR only.
The immunogenicity and safety of the 4 groups will be compared and analyzed before and 30 days after vaccination.
Detailed description
Following the clinical trial of "Combined Immunization of sIPV and DTaP" in 2019, this study recruits 600 18-month-old subjects who have received 3 doses of sIPV + DTaP, and gives them a 4th dose of vaccination (booster immunization). They are divided into 4 different groups, with 150 subjects in each group, and are innoculated with different vaccines.
To be specific, group 1 receives sIPV (0.5ml)+ DTaP (0.5ml)+ MMR(0.5ml); group 2 receives sIPV (0.5ml); group 3 receives DTaP (0.5ml); group 4 receives MMR (0.5ml).
Blood samples will be collected before vaccination and 30 days after this booster immunization. Neutralization antibody will be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will be monitored as well.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1 (sIPV+DTaP+MMR) | Experimental | Biological: sIPV+DTaP+MMR150 subjects; simultaneously administration of sIPV+DTaP+MMR as booster immunization at the age of 18 months old, 0.5 ml each, respectively |
| group 2 (sIPV) | Active comparator | Biological: sIPV150 subjects; vaccination of 0.5 ml sIPV as booster immunization at the age of 18 months old |
| group 3 (DTaP) | Active comparator | Biological: DTaP150 subjects; vaccination of 0.5 ml DTaP as booster immunization at the age of 18 months old |
| group 4 (MMR) | Active comparator | Biological: MMR150 subjects; vaccination of 0.5 ml MMR as booster immunization at the age of 18 months old |
Who may qualify
- Ages
- 18 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Subjects must have participated the clinical trial titled "Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP" (NCT04054882) in 2019, and have finished 3 doses of combined immunization of sIPV and DTaP;
- Subjects aged 18 months old at the date of recruitment;
- With informed consent form (ICF) signed by parent(s) or guardian(s);
- Parent(s) or guardian(s) are able to attend all planned clinical appointments and obey/follow all study instructions;
- Subjects have been vaccinated with a first dose of MMR, but have not been vaccinated with the 2nd dose of MMR and the booster (4th) dose of sIPV and DTaP;
Key exclusion criteria (10 listed)
- With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
- Allergic to any ingredient of vaccine or with allergy history to any vaccine;
- Subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);
- Administration of immunoglobulins within 30 days prior to this study;
- Acute febrile disease(temperature ≥ 37.0°C) or infectious 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 |
|---|---|---|
| sIPV+DTaP+MMRsIPV+DTaP+MMR at the age of 18 month old | Biological | group 1 (sIPV+DTaP+MMR) |
| sIPVsIPV at the age of 18 month old | Biological | group 2 (sIPV) |
| DTaPDTaP at the age of 18 month old | Biological | group 3 (DTaP) |
| MMRMMR at the age of 18 month old | Biological | group 4 (MMR) |
Primary outcome
Seroconversion rate (sIPV)
Time frame: Baseline (before vaccination) results
determine the rate of positive seroconversion against poliovirus type I, II and III of the subjectsdetermine the rate of positive seroconversion against poliovirus type I, II and III of the subjects
Seroconversion rate (sIPV)
Time frame: Results obtained 30 days after vaccination
determine the rate of positive seroconversion against poliovirus type I, II and III of the subjectsdetermine the rate of positive seroconversion against poliovirus type I, II and III of the subjects
Seroconversion rate (DTaP)
Time frame: Baseline (before vaccination) results
determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Seroconversion rate (DTaP)
Time frame: Results obtained 30 days after vaccination
determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Seroconversion rate (MMR)
Time frame: Baseline (before vaccination) results
determine the positive seroconversion rate of measles, mumps, rubella antibodies of the subjects
Seroconversion rate (MMR)
Time frame: Results obtained 30 days after vaccination
determine the positive seroconversion rate of measles, mumps, rubella antibodies of the subjects
Geometric Mean Concentration (GMC) (sIPV)
Time frame: Baseline (before vaccination) results
GMCs of poliovirus type I, II and III of the subjects
Geometric Mean Concentration (GMC) (sIPV)
Time frame: Results obtained 30 days after vaccination
GMCs of poliovirus type I, II and III of the subjects
Geometric Mean Concentration (GMC) (DTaP)
Time frame: Baseline (before vaccination) results
GMCs of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Geometric Mean Concentration (GMC) (DTaP)
Time frame: Results obtained 30 days after vaccination
GMCs of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Geometric Mean Concentration (GMC) (MMR)
Time frame: Baseline (before vaccination) results
GMCs of measles, mumps, rubella antibodies of the subjects
Geometric Mean Concentration (GMC) (MMR)
Time frame: Results obtained 30 days after vaccination
GMCs of measles, mumps, rubella antibodies of the subjects
1 secondary outcome
Adverse Events Following Immunization (AEFI)
Time frame: 0-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Fenyang Tang principal investigator
Jiangsu Province Centers for Disease Control and Prevention
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sIPV+DTaP+MMR, sIPV and DTaP in people with Vaccine, run by China National Biotec Group Company Limited at 3 sites 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 7 inclusion and 10 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 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Fenyang Tang (+86-25-83759419, tfyepi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion rate (sIPV) (time frame: Baseline (before vaccination) results). The study lists 12 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 10 Dec 2020.