DiphtheriaPhase 1NCT06184542
Phase I Clinical Trial of Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine
A Phase 1 study testing DTacP (one-dose booster), DTacP (three-dose primary vaccination) and DT (one-dose booster) in people with Diphtheria and Tetanus, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 3 sites in China.
Trial summary
This study is a randomized, blinded, active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine (DTacP) in subjects (aged 2 months to 6 years). Read more about this study
- Who is it for?
- Ages 2 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Pertussis
- What is being tested?
- DTacP (one-dose booster), DTacP (three-dose primary vaccination) and DT (one-dose booster)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 3 sitesChina
- Study dates
- 23 Dec 2023to 1 Nov 2026
- Phase
- Phase 1
- 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
- Age Requirement: children aged 6 years, toddlers aged 18-24 months, and infants aged 2-3 months at the time of enrollment
- Previous Vaccination Requirements: (a) Children (aged 6 years) enrolled in the study should have received four doses of the Diphtheria, Tetanus, and Pertussis combined vaccine, and not yet received the Diphtheria, Tetanus combined vaccine; (b) Toddlers (aged 18-24 months) enrolled in the study should have received three doses of Diphtheria, Tetanus, and Pertussis combined vaccine as well as three doses of the Polio vaccine, and not yet received the booster dose of Diphtheria, Tetanus, and Pertussis combined vaccine and the Polio vaccine; (c) Infants (aged 3 months) enrolled in the study should not have received diphtheria-tetanus-pertussis-containing vaccine, polio-containing vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine, Haemophilus influenzae type b conjugate vaccine, or meningococcal group A and C polysaccharide conjugate vaccine; (d) Infants (aged 2 months) enrolled in the study should not received diphtheria-tetanus-pertussis-containing vaccine, polio-containing vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine, or Haemophilus influenzae type b conjugate vaccine.
- Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
- Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.
- Birth Outcome Condition: Toddlers (aged 18-24 months) and Infants (aged 2-3 months) should be born at full term (37-42 weeks of gestation) with birth weight ≥2500g.
- Temperature Requirement: Axillary body temperature is no more than 37.3°C.
Who cannot join
- Subjects meeting any of the following exclusion criteria will be not eligible for enrollment.
- Previous Diagnosis: Subjects diagnosed with pertussis, tetanus, or diphtheria disease.
- Special Conditions for Toddlers (aged 18-24 months) and Infants (aged 2-3 months): Subjects have been with abnormal labor (dystocia, instrumental delivery) or a history of asphyxia, nervous system damage, or clinically confirmed pathological jaundice.
- Allergic History: Subjects have a history of allergies to any component of the vaccine (such as aluminum hydroxide), or previous allergy or suspected allergy to any vaccine, or other serious adverse reactions, such as anaphylactic shock, laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, local anaphylactic necrosis reaction, dyspnea, angioedema, systemic rash and/or urticaria.
- Vaccination History: Subjects received any inactivated vaccines or subunit vaccines within 7 days before vaccination (except COVID-19 vaccines) with the investigational vaccine, or any other live attenuated vaccines or COVID-19 vaccines within 14 days before vaccination
- Acute Illness: Subjects have acute illness (e.g., fever) or acute exacerbation of a chronic illness within 3 days before receipt of the first dose of the investigational vaccine
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- Neurological and Mental Health: Subjects have a history or family history of seizures, epilepsy, and other encephalopathy and psychiatric disorders.
- Health Condition: Subjects have a major congenital malformation, developmental disability, or congenital disease (e.g., Down syndrome, sickle cell anemia, congenital neurological disorders), or other clinically diagnosed serious chronic disease, including but not limited to, serious diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolic system, skeletal system and other system and malignant tumor history.
- Blood Disease: Subjects have genetic bleeding tendency or coagulopathy, or a history of bleeding disorders.
- Infectious Disease: Subjects diagnosed with infectious diseases that may interfere with the study, such as tuberculosis, viral hepatitis, human immunodeficiency virus (HIV) infection, etc.
- Special Condition: Subjects who cannot tolerate venipuncture or have a history of needle and blood sickness.
- Organ Removal History: Subjects with surgical removal of the spleen or other vital organs for any reason.
- Blood Condition: Subjects with blood loss (≥400 ml) and receipt of blood or blood products in the 3 months before receipt of the first dose of the investigational vaccine
- Immune Therapy: Subjects received treatment with an immunosuppressive agent, such as long-term systemic glucocorticoid therapy (treatment with systemic glucocorticoids, such as prednisone or a similar agent, for more than 2 consecutive weeks within 6 months before receipt of the first dose of an investigational vaccine), except topical agents (such as ointments, eye drops, inhalers, or nasal sprays) that do not exceed the recommended dose in the label or have any signs of systemic exposure
- Participation in Other Clinical Studies: Subjects use any investigational or unregistered product (drug, biologic product, or device) within 3 months before receipt of the first dose of the investigational vaccine, plan to use such product during the duration of this study, or were enrolled in another clinical trial before enrollment in this study.
- Physical Examination: (a) Subjects with abnormal vital signs with clinical significance; (b) Subjects abnormal blood routine, blood biochemistry, and urine routine test indicators with clinical significance
- Investigator's Discretion: The final exclusion criterion is the investigator's discretion to determine whether a subject is suitable for participation in the study.
- Contraindications of the second and third doses of the vaccine:
- Subjects meeting any of the following contraindications will be not eligible for the following doses.
- Serious Adverse Events: Subjects experienced serious adverse events related to vaccination after the previous dose.
- Vaccination with other vaccines during the study: (a) Subjects received other diphtheria, Tetanus, and acellular pertussis combined vaccines except for the investigational vaccine after the previous dose during the study period; (b) Infants (C3 subgroup and D3 subgroup) received other polio vaccines after the previous dose during the study period.
- Ineligibility: Subjects cannot be eligible or meet exclusion criteria after the previous dose of the investigational vaccine, and the qualification should be determined by the investigator.
- Investigator's Discretion: Subjects determined by the investigator as unsuitable for the following study period.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Dazhu Center for Disease Prevention and Control
Dazhou, Sichuan
Dongya Yuan, 0818-6250693 ext. +86, 784120008@qq.com
- Not yet recruiting
Cuiping Center for Disease Prevention and Control
Yibin, Sichuan
Hao Huang, 0831-8739062 ext. +86, 1183096649@qq.com
- Not yet recruiting
Xingwen Center for Disease Prevention and Control
Yibin, Sichuan
Shuang Liu, 0831-8830297 ext. +86, 3697922404@qq.com
About this study
Official title: To Evaluate Safety and Preliminary Immunogenicity of the Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine in Children Aged 2 Months to 6 Years: A Randomized, Blinded, Active-controlled Phase I Clinical Trial
This study is a randomized, blinded, active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine (DTacP) in subjects (aged 2 months to 6 years). Primary safety endpoints are the occurrence of solicited adverse events within 30 minutes after each dose, the occurrence of solicited adverse events within 7 days after each dose, the occurrence of unsolicited adverse events within 30 days after each dose, and the occurrence of adverse events 30 days after immunization. The secondary safety endpoint is the occurrence of serious adverse events (SAEs) within 12 months after immunization. Secondary immunogenicity endpoints are the geometric mean concentration (GMC), geometric mean fold increase (GMFI), seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 30 days after immunization. The exploratory endpoints are the GMC, GMFI, seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-PT, and anti-FHA neutralizing antibodies 30 days after immunization in all groups, the GMC and seropositive rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 12 months after primary immunization in the infant group, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 30 days after immunization in all groups, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 12 months after primary immunization in the infant group.
Read the detailed description
This is a randomized, blinded, active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity in 460 subjects (aged 2 months to 6 years). Then 40 children (aged 6 years), 60 toddlers (aged 18-24 months), and 360 infants (180 subjects aged 3 months and 180 subjects aged 2 months) are eligible for enrollment after assessing thorough medical history and physical examination according to the principle of age escalating from children to infants.
[First Stage] 40 Children (aged 6 years) in the first stage of the study will be randomly assigned to the vaccine cohort and DT cohort in a ratio of 1:1, that is, 20 subjects in such group will be injected with the DTacP vaccine while 20 subjects with the DT vaccine. All children will receive the injection in the deltoid muscle of the upper arm on Day 0. The safety evaluation will be conducted by the Data and Safety Monitoring Board (DSMB) through assessing the preliminary safety data between Day 0 and Day 7 after administration. If results given by DSMB meet the criterion (no more than 25% of participants experienced Grade 3 or above adverse events and/or laboratory abnormalities), the study will continue to the second stage.
[Second Stage] 60 Toddlers (aged 18-24 months) in the second stage of the study will be randomly assigned to the vaccine cohort, DTaP cohort, and Pentaxim cohort in a ratio of 1:1:1, that is, 20 subjects in such group will be injected with the DTacP vaccine, 20 subjects will be injected with the DTaP vaccine, and the 20 subjects will be injected with DTaP-IPV-Hib (Pentaxim). All toddlers will receive the injection in the deltoid muscle of the upper arm on Day 0. The safety evaluation will be conducted by the Data and Safety Monitoring Board (DSMB) through assessing the preliminary safety data between Day 0 and Day 7 after administration. If results given by DSMB meet the criterion (no more than 25% of participants experienced Grade 3 or above adverse events and/or laboratory abnormalities), the study will continue to the third stage.
[Third Stage] (1) 180 Children (aged 3 months) in the third stage of the study will be randomly assigned to the vaccine cohort, DTaP cohort, and Pentaxim cohort in a ratio of 1:1:1, that is, 60 subjects in such group will be injected with the DTacP vaccine, 60 subjects will be injected with the DTaP vaccine, and 60 subjects will be injected with DTaP-IPV-Hib (Pentaxim). The vaccine cohort will be randomly assigned to two sub-cohorts in a ratio of 1:1 according to different injection sites, that is, 30 subjects will receive three injections in the anterolateral midthigh while 30 subjects in the deltoid muscle of the upper arm on an M3-M4-M5 immunization schedule. The DTaP cohort will receive three injections in the deltoid muscle of the upper arm on an M3-M4-M5 immunization schedule. The Pentaxim cohort will receive three injections in the anterolateral midthigh on an M3-M4-M5 immunization schedule. (2) 180 Children (aged 2 months) in the third stage of the study will be randomly assigned to the vaccine cohort, and Pentaxim cohort in a ratio of 2:1, that is, 120 subjects in such group will be injected with the DTacP vaccine, and 60 subjects will be injected with DTaP-IPV-Hib (Pentaxim). The vaccine cohort will be randomly assigned to four sub-cohorts in a ratio of 1:1:1:1 according to different injection sites and immunization schedules, that is, 30 subjects will receive three injections in the anterolateral midthigh on an M2-M3-M4 immunization schedule, 30 subjects will receive three injections in the anterolateral midthigh on an M2-M4-M6 immunization schedule, 30 subjects will receive three injections in the deltoid muscle of the upper arm on an M2-M3-M4 immunization schedule, 30 subjects will receive three injections in the deltoid muscle of the upper arm on an M2-M4-M6 immunization schedule. The Pentaxim cohort will receive three injections in the anterolateral midthigh on an M2-M3-M4 immunization schedule.
The duration of children and toddlers for intervention is 1 day. Thus, the duration of each subject in these two groups will be approximately 12 months. The duration of infants for intervention is 2 or 4 months, and as infants will be followed up to 18 months old, thus, each subject in such group will be approximately 15 or 16 months.
For safety assessment, the observation and evaluation of adverse events from Day 0 to Day 30 after each dose will be conducted by diary/contact cards and investigators' phone calls. Besides, the observation and evaluation of serious adverse events up to 12 months after vaccination will be conducted by active reports by subjects' legal guardians, or investigators' phone calls as well as face-to-face visits. Meanwhile, subjects will be observed at the site for at least 30 minutes after each dose.
For laboratory examination, blood biochemistry, blood routine, and urine routine tests will be performed on Day 0 before vaccination as well as Day 4 after administration in Children and Toddlers groups. If one of these two groups meets the criteria assessed by DSMB that over 20% of subjects in each group experience grade 3 or above laboratory abnormalities related to investigational vaccines on Day 4, then blood biochemistry, blood routine, and urine routine tests will be performed in the Infant Group on Day 0 before first dose, Day 4 after first dose and Day 4 after third dose.
For immunogenicity assessment, antibodies against anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN, as well as neutralizing antibodies against anti-DT, anti-PT, anti-FHA, and anti-type I, type II, and type III poliovirus will be assessed in all subjects before vaccination and 30 days after vaccination. Moreover, antibodies against anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN, as well as neutralizing antibodies against anti-type I, type II, and type III poliovirus will be assessed in infants around 12 months after primary vaccination (aged 18 months).
- Conditions
- Diphtheria, Tetanus, Pertussis
- Being tested
- DTacP (one-dose booster), DTacP (three-dose primary vaccination), DT (one-dose booster), DTaP (one-dose booster), PENTAXIM (one-dose booster)
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTacP (one-dose booster)Biological
Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine of 0.5mL on Day 0
DTacP (three-dose primary vaccination)Biological
Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine of 0.5mL on the M3-M4-M5, M2-M3-M4, or M2-M4-M6 immunization schedule
DT (one-dose booster)Biological
Diphtheria-Tetanus Combined Vaccine of 0.5mL on Day 0
DTaP (one-dose booster)Biological
Diphtheria-Tetanus-acellular Pertussis Vaccine of 0.5mL on Day 0
PENTAXIM (one-dose booster)Biological
Diphtheria, Tetanus, acellular Pertussis, inactivated Polio, conjugate Haemophilus influenzae type b Combined Vaccine of 0.5mL on Day 0
DTaP (three-dose primary vaccination)Biological
Diphtheria-Tetanus-acellular Pertussis Vaccine of 0.5mL on an M3-M4-M5immunization schedule
PENTAXIM (three-dose primary vaccination)Biological
Diphtheria, Tetanus, acellular Pertussis, inactivated Polio, conjugate Haemophilus influenzae type b Combined Vaccine of 0.5mL on the M3-M4-M5 or M2-M3-M4 immunization schedule
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Children aged 6 years, one-dose) | Experimental | Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine in Children aged 6 years on Day 0 Receives: Biological: DTacP (one-dose booster) |
| DT Control (Children aged 6 years, one-dose) | Active comparator | Diphtheria-Tetanus Combined Vaccine in Children aged 6 years on Day 0 Receives: Biological: DT (one-dose booster) |
| Intervention (Toddlers aged 18-24 months, one-dose) | Experimental | Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine in toddlers aged 18-24 months on Day 0 Receives: Biological: DTacP (one-dose booster) |
| DTaP Control (Toddlers aged 18-24 months, one-dose) | Active comparator | Diphtheria-Tetanus-acellular Pertussis Vaccine in toddlers aged 18-24 months on Day 0 Receives: Biological: DTaP (one-dose booster) |
| PENTAXIM Control (Toddlers aged 18-24 months, one-dose) | Active comparator | PENTAXIM (DTaP-IPV-Hib) Vaccine in toddlers aged 18-24 months on Day 0 Receives: Biological: PENTAXIM (one-dose booster) |
| Intervention (Infants aged 3 months, three-dose) | Experimental | Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine in infants aged 3 months on an M3-M4-M5 immunization schedule Receives: Biological: DTacP (three-dose primary vaccination) |
| DTaP Control (Infants aged 3 months, three-dose) | Active comparator | Diphtheria-Tetanus-acellular Pertussis Vaccine in infants aged 3 months on an M3-M4-M5 immunization schedule Receives: Biological: DTaP (three-dose primary vaccination) |
| PENTAXIM Control (Infants aged 3 months, three-dose) | Active comparator | PENTAXIM (DTaP-IPV-Hib) Vaccine infants aged 3 months on an M3-M4-M5 immunization schedule Receives: Biological: PENTAXIM (three-dose primary vaccination) |
| Intervention (Infants aged 2 months, three-dose, 2-3-4) | Experimental | Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine in infants aged 2 months on an M2-M3-M4 immunization schedule Receives: Biological: DTacP (three-dose primary vaccination) |
| Intervention (Infants aged 2 months, three-dose, 2-4-6) | Experimental | Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine in infants aged 2 months on an M2-M4-M6 immunization schedule Receives: Biological: DTacP (three-dose primary vaccination) |
| PENTAXIM Control (Infants aged 2 months, three-dose) | Active comparator | PENTAXIM (DTaP-IPV-Hib) Vaccine infants aged 2 months on an M2-M3-M4 immunization schedule Receives: Biological: PENTAXIM (three-dose primary vaccination) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety index-incidence of adverse events
Incidence of adverse events after the first dose vaccination (Applicable for Infants)
Measured: 0-30 minutes after the first dose vaccination
Safety index-incidence of adverse events
Incidence of adverse events after the second dose vaccination (Applicable for Infants)
Measured: 0-30 minutes after the second dose vaccination
Safety index-incidence of adverse events
Incidence of adverse events after the third dose vaccination (Applicable for Infants)
Measured: 0-30 minutes after the third dose vaccination
Safety index-incidence of adverse events
Incidence of adverse events after the booster dose (Applicable for Toddlers and Children)
Measured: 0-30 minutes after the booster dose
Safety index-incidence of solicited adverse events
Incidence of solicited adverse events after the first dose vaccination (Applicable for Infants)
Measured: Day 0 to 7 after the first dose vaccination
Safety index-incidence of solicited adverse events
Incidence of solicited adverse events after the second dose vaccination (Applicable for Infants)
Measured: Day 0 to 7 after the second dose vaccination
Safety index-incidence of solicited adverse events
Incidence of solicited adverse events after the third dose vaccination (Applicable for Infants)
Measured: Day 0 to 7 after the third dose vaccination
Safety index-incidence of solicited adverse events
Incidence of solicited adverse events after the booster dose (Applicable for Toddlers and Children)
Measured: Day 0 to 7 after the booster dose
Safety index-incidence of unsolicited adverse events
Incidence of unsolicited adverse events after the first dose vaccination (Applicable for Infants)
Measured: Day 0 to 30 after the first dose vaccination
Safety index-incidence of unsolicited adverse events
Incidence of unsolicited adverse events after the second dose vaccination (Applicable for Infants)
Measured: Day 0 to 30 after the second dose vaccination
Safety index-incidence of unsolicited adverse events
Incidence of unsolicited adverse events after the third dose vaccination (Applicable for Infants)
Measured: Day 0 to 30 after the third dose vaccination
Safety index-incidence of unsolicited adverse events
Incidence of unsolicited adverse events after the booster dose (Applicable for Toddlers and Children)
Measured: Day 0 to 30 after the booster dose
Safety index-incidence of adverse events
Occurrence of adverse events after vaccination
Measured: From the beginning of the vaccination up to 30 days after the last vaccination completed
Secondary outcomes (21)
Safety index-incidence of serious adverse events
Occurrence of serious adverse events after vaccination
Measured: From the beginning of the vaccination up to 12 months after the last vaccination completed
Immunogenicity index-seroconversion or ≥4-fold increase rates of antibody against DT
Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (Antibody Concentration<0.1 IU/ml) to seropositive (Antibody Concentration≥0.1 IU/ml), or a ≥4-fold increase from baseline.
Measured: Between baseline and Day 30 after vaccination
Immunogenicity index-seroconversion or ≥4-fold increase rates of antibody against TT
Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (Antibody Concentration<0.1 IU/ml) to seropositive (Antibody Concentration≥0.1 IU/ml), or a ≥4-fold increase from baseline.
Measured: Between baseline and Day 30 after vaccination
Immunogenicity index-seroconversion or ≥4-fold increase rates of antibody against PT
Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (Antibody Concentration<20 IU/ml) to seropositive (Antibody Concentration≥20 IU/ml), or a ≥4-fold increase from baseline.
Measured: Between baseline and Day 30 after vaccination
Immunogenicity index-seroconversion or ≥4-fold increase rates of antibody against FHA
Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (Antibody Concentration<20 IU/ml) to seropositive (Antibody Concentration≥20 IU/ml), or a ≥4-fold increase from baseline.
Measured: Between baseline and Day 30 after vaccination
Immunogenicity index-seroconversion or ≥4-fold increase rates of antibody against PRN
Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (Antibody Concentration<20 IU/ml) to seropositive (Antibody Concentration≥20 IU/ml), or a ≥4-fold increase from baseline.
Measured: Between baseline and Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against DT
Antibody assay will be performed using the ELISA method
Measured: Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against TT
Antibody assay will be performed using the ELISA method
Measured: Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against PT
Antibody assay will be performed using the ELISA method
Measured: Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against FHA
Antibody assay will be performed using the ELISA method
Measured: Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against PRN
Antibody assay will be performed using the ELISA method
Measured: Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against DT
Antibody assay will be performed using the ELISA method
Measured: Between baseline and Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against TT
Antibody assay will be performed using the ELISA method
Measured: Between baseline and Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against PT
Antibody assay will be performed using the ELISA method
Measured: Between baseline and Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against FHA
Antibody assay will be performed using the ELISA method
Measured: Between baseline and Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against PRN
Antibody assay will be performed using the ELISA method
Measured: Between baseline and Day 30 after vaccination
Immunogenicity index-seropositive rates of antibody against DT
Antibody assay will be performed using the ELISA method. Seropositive will be defined as the Antibody Concentration≥0.1 IU/ml.
Measured: Day 30 after vaccination
Immunogenicity index-seropositive rates of antibody against TT
Antibody assay will be performed using the ELISA method. Seropositive will be defined as the Antibody Concentration≥0.1 IU/ml.
Measured: Day 30 after vaccination
Immunogenicity index-seropositive rates of antibody against PT
Antibody assay will be performed using the ELISA method. Seropositive will be defined as the Antibody Concentration≥20 IU/ml.
Measured: Day 30 after vaccination
Immunogenicity index-seropositive rates of antibody against FHA
Antibody assay will be performed using the ELISA method. Seropositive will be defined as the Antibody Concentration≥20 IU/ml.
Measured: Day 30 after vaccination
Immunogenicity index-seropositive rates of antibody against PRN
Antibody assay will be performed using the ELISA method. Seropositive will be defined as the Antibody Concentration≥20 IU/ml.
Measured: Day 30 after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start23 Dec 2023
- Primary completion15 Dec 2024 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiphtheriaStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Three stages (Children, Toddlers, and Infants) will be conducted according to the age-escalating principle. If safety assessed by DSMB meets the criteria, then the enrollment of the next stage could be continued.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan Center for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184542
- Sponsor's protocol ID
- 20200610
- Status last verified
- Jan 2024
- First submitted
- 14 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate Safety and Preliminary Immunogenicity of the Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine in Children Aged 2 Months to 6 Years: A Randomized, Blinded, Active-controlled Phase I Clinical Trial
- ClinicalTrials.gov ID
- NCT06184542
- Acronym / sponsor ID
- 20200610
- Conditions
- Diphtheria, Tetanus, Pertussis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Sichuan Center for Disease Control and Prevention
- Study start
- 23 Dec 2023 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 28 Dec 2023 (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.
This study is a randomized, blinded, active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine (DTacP) in subjects (aged 2 months to 6 years). Primary safety endpoints are the occurrence of solicited adverse events within 30 minutes after each dose, the occurrence of solicited adverse events within 7 days after each dose, the occurrence of unsolicited adverse events within 30 days after each dose, and the occurrence of adverse events 30 days after immunization. The secondary safety endpoint is the occurrence of serious adverse events (SAEs) within 12 months after immunization. Secondary immunogenicity endpoints are the geometric mean concentration (GMC), geometric mean fold increase (GMFI), seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 30 days after immunization. The exploratory endpoints are the GMC, GMFI, seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-PT, and anti-FHA neutralizing antibodies 30 days after immunization in all groups, the GMC and seropositive rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 12 months after primary immunization in the infant group, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 30 days after immunization in all groups, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 12 months after primary immunization in the infant group.
Detailed description
This is a randomized, blinded, active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity in 460 subjects (aged 2 months to 6 years). Then 40 children (aged 6 years), 60 toddlers (aged 18-24 months), and 360 infants (180 subjects aged 3 months and 180 subjects aged 2 months) are eligible for enrollment after assessing thorough medical history and physical examination according to the principle of age escalating from children to infants.
[First Stage] 40 Children (aged 6 years) in the first stage of the study will be randomly assigned to the vaccine cohort and DT cohort in a ratio of 1:1, that is, 20 subjects in such group will be injected with the DTacP vaccine while 20 subjects with the DT vaccine. All children will receive the injection in the deltoid muscle of the upper arm on Day 0. The safety evaluation will be conducted by the Data and Safety Monitoring Board (DSMB) through assessing the preliminary safety data between Day 0 and Day 7 after administration. If results given by DSMB meet the criterion (no more than 25% of participants experienced Grade 3 or above adverse events and/or laboratory abnormalities), the study will continue to the second stage.
[Second Stage] 60 Toddlers (aged 18-24 months) in the second stage of the study will be randomly assigned to the vaccine cohort, DTaP cohort, and Pentaxim cohort in a ratio of 1:1:1, that is, 20 subjects in such group will be injected with the DTacP vaccine, 20 subjects will be injected with the DTaP vaccine, and the 20 subjects will be injected with DTaP-IPV-Hib (Pentaxim). All toddlers will receive the injection in the deltoid muscle of the upper arm on Day 0. The safety evaluation will be conducted by the Data and Safety Monitoring Board (DSMB) through assessing the preliminary safety data between Day 0 and Day 7 after administration. If results given by DSMB meet the criterion (no more than 25% of participants experienced Grade 3 or above adverse events and/or laboratory abnormalities), the study will continue to the third stage.
[Third Stage] (1) 180 Children (aged 3 months) in the third stage of the study will be randomly assigned to the vaccine cohort, DTaP cohort, and Pentaxim cohort in a ratio of 1:1:1, that is, 60 subjects in such group will be injected with the DTacP vaccine, 60 subjects will be injected with the DTaP vaccine, and 60 subjects will be injected with DTaP-IPV-Hib (Pentaxim). The vaccine cohort will be randomly assigned to two sub-cohorts in a ratio of 1:1 according to different injection sites, that is, 30 subjects will receive three injections in the anterolateral midthigh while 30 subjects in the deltoid muscle of the upper arm on an M3-M4-M5 immunization schedule. The DTaP cohort will receive three injections in the deltoid muscle of the upper arm on an M3-M4-M5 immunization schedule. The Pentaxim cohort will receive three injections in the anterolateral midthigh on an M3-M4-M5 immunization schedule. (2) 180 Children (aged 2 months) in the third stage of the study will be randomly assigned to the vaccine cohort, and Pentaxim cohort in a ratio of 2:1, that is, 120 subjects in such group will be injected with the DTacP vaccine, and 60 subjects will be injected with DTaP-IPV-Hib (Pentaxim). The vaccine cohort will be randomly assigned to four sub-cohorts in a ratio of 1:1:1:1 according to different injection sites and immunization schedules, that is, 30 subjects will receive three injections in the anterolateral midthigh on an M2-M3-M4 immunization schedule, 30 subjects will receive three injections in the anterolateral midthigh on an M2-M4-M6 immunization schedule, 30 subjects will receive three injections in the deltoid muscle of the upper arm on an M2-M3-M4 immunization schedule, 30 subjects will receive three injections in the deltoid muscle of the upper arm on an M2-M4-M6 immunization schedule. The Pentaxim cohort will receive three injections in the anterolateral midthigh on an M2-M3-M4 immunization schedule.
The duration of children and toddlers for intervention is 1 day. Thus, the duration of each subject in these two groups will be approximately 12 months. The duration of infants for intervention is 2 or 4 months, and as infants will be followed up to 18 months old, thus, each subject in such group will be approximately 15 or 16 months.
For safety assessment, the observation and evaluation of adverse events from Day 0 to Day 30 after each dose will be conducted by diary/contact cards and investigators' phone calls. Besides, the observation and evaluation of serious adverse events up to 12 months after vaccination will be conducted by active reports by subjects' legal guardians, or investigators' phone calls as well as face-to-face visits. Meanwhile, subjects will be observed at the site for at least 30 minutes after each dose.
For laboratory examination, blood biochemistry, blood routine, and urine routine tests will be performed on Day 0 before vaccination as well as Day 4 after administration in Children and Toddlers groups. If one of these two groups meets the criteria assessed by DSMB that over 20% of subjects in each group experience grade 3 or above laboratory abnormalities related to investigational vaccines on Day 4, then blood biochemistry, blood routine, and urine routine tests will be performed in the Infant Group on Day 0 before first dose, Day 4 after first dose and Day 4 after third dose.
For immunogenicity assessment, antibodies against anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN, as well as neutralizing antibodies against anti-DT, anti-PT, anti-FHA, and anti-type I, type II, and type III poliovirus will be assessed in all subjects before vaccination and 30 days after vaccination. Moreover, antibodies against anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN, as well as neutralizing antibodies against anti-type I, type II, and type III poliovirus will be assessed in infants around 12 months after primary vaccination (aged 18 months).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 11
- Model description
- Three stages (Children, Toddlers, and Infants) will be conducted according to the age-escalating principle. If safety assessed by DSMB meets the criteria, then the enrollment of the next stage could be continued.
| Arm | Type | Receives |
|---|---|---|
| Intervention (Children aged 6 years, one-dose) | Experimental | Biological: DTacP (one-dose booster)Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine in Children aged 6 years on Day 0 |
| DT Control (Children aged 6 years, one-dose) | Active comparator | Biological: DT (one-dose booster)Diphtheria-Tetanus Combined Vaccine in Children aged 6 years on Day 0 |
| Intervention (Toddlers aged 18-24 months, one-dose) | Experimental | Biological: DTacP (one-dose booster)Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine in toddlers aged 18-24 months on Day 0 |
| DTaP Control (Toddlers aged 18-24 months, one-dose) | Active comparator | Biological: DTaP (one-dose booster)Diphtheria-Tetanus-acellular Pertussis Vaccine in toddlers aged 18-24 months on Day 0 |
| PENTAXIM Control (Toddlers aged 18-24 months, one-dose) | Active comparator | Biological: PENTAXIM (one-dose booster)PENTAXIM (DTaP-IPV-Hib) Vaccine in toddlers aged 18-24 months on Day 0 |
| Intervention (Infants aged 3 months, three-dose) | Experimental | Biological: DTacP (three-dose primary vaccination)Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine in infants aged 3 months on an M3-M4-M5 immunization schedule |
| DTaP Control (Infants aged 3 months, three-dose) | Active comparator | Biological: DTaP (three-dose primary vaccination)Diphtheria-Tetanus-acellular Pertussis Vaccine in infants aged 3 months on an M3-M4-M5 immunization schedule |
| PENTAXIM Control (Infants aged 3 months, three-dose) | Active comparator | Biological: PENTAXIM (three-dose primary vaccination)PENTAXIM (DTaP-IPV-Hib) Vaccine infants aged 3 months on an M3-M4-M5 immunization schedule |
| Intervention (Infants aged 2 months, three-dose, 2-3-4) | Experimental | Biological: DTacP (three-dose primary vaccination)Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine in infants aged 2 months on an M2-M3-M4 immunization schedule |
| Intervention (Infants aged 2 months, three-dose, 2-4-6) | Experimental | Biological: DTacP (three-dose primary vaccination)Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine in infants aged 2 months on an M2-M4-M6 immunization schedule |
| PENTAXIM Control (Infants aged 2 months, three-dose) | Active comparator | Biological: PENTAXIM (three-dose primary vaccination)PENTAXIM (DTaP-IPV-Hib) Vaccine infants aged 2 months on an M2-M3-M4 immunization schedule |
Who may qualify
- Ages
- 2 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age Requirement: children aged 6 years, toddlers aged 18-24 months, and infants aged 2-3 months at the time of enrollment
- Previous Vaccination Requirements: (a) Children (aged 6 years) enrolled in the study should have received four doses of the Diphtheria, Tetanus, and Pertussis combined vaccine, and not yet received the Diphtheria, Tetanus combined vaccine; (b) Toddlers (aged 18-24 months) enrolled in the study should have received three doses of Diphtheria, Tetanus, and Pertussis combined vaccine as well as three doses of the Polio vaccine, and not yet received the booster dose of Diphtheria, Tetanus, and Pertussis combined vaccine and the Polio vaccine; (c) Infants (aged 3 months) enrolled in the study should not have received diphtheria-tetanus-pertussis-containing vaccine, polio-containing vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine, Haemophilus influenzae type b conjugate vaccine, or meningococcal group A and C polysaccharide conjugate vaccine; (d) Infants (aged 2 months) enrolled in the study should not received diphtheria-tetanus-pertussis-containing vaccine, polio-containing vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine, or Haemophilus influenzae type b conjugate vaccine.
- Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
- Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.
- Birth Outcome Condition: Toddlers (aged 18-24 months) and Infants (aged 2-3 months) should be born at full term (37-42 weeks of gestation) with birth weight ≥2500g.
Key exclusion criteria (23 listed)
- Subjects meeting any of the following exclusion criteria will be not eligible for enrollment.
- Previous Diagnosis: Subjects diagnosed with pertussis, tetanus, or diphtheria disease.
- Special Conditions for Toddlers (aged 18-24 months) and Infants (aged 2-3 months): Subjects have been with abnormal labor (dystocia, instrumental delivery) or a history of asphyxia, nervous system damage, or clinically confirmed pathological jaundice.
- Allergic History: Subjects have a history of allergies to any component of the vaccine (such as aluminum hydroxide), or previous allergy or suspected allergy to any vaccine, or other serious adverse reactions, such as anaphylactic shock, laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, local anaphylactic necrosis reaction, dyspnea, angioedema, systemic rash and/or urticaria.
- Vaccination History: Subjects received any inactivated vaccines or subunit vaccines within 7 days before vaccination (except COVID-19 vaccines) with the investigational vaccine, or any other live attenuated vaccines or COVID-19 vaccines within 14 days before 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 |
|---|---|---|
| DTacP (one-dose booster)Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine of 0.5mL on Day 0 | Biological | Intervention (Children aged 6 years, one-dose), Intervention (Toddlers aged 18-24 months, one-dose) |
| DTacP (three-dose primary vaccination)Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine of 0.5mL on the M3-M4-M5, M2-M3-M4, or M2-M4-M6 immunization schedule | Biological | Intervention (Infants aged 2 months, three-dose, 2-3-4), Intervention (Infants aged 2 months, three-dose, 2-4-6), Intervention (Infants aged 3 months, three-dose) |
| DT (one-dose booster)Diphtheria-Tetanus Combined Vaccine of 0.5mL on Day 0 | Biological | DT Control (Children aged 6 years, one-dose) |
| DTaP (one-dose booster)Diphtheria-Tetanus-acellular Pertussis Vaccine of 0.5mL on Day 0 | Biological | DTaP Control (Toddlers aged 18-24 months, one-dose) |
| PENTAXIM (one-dose booster)Diphtheria, Tetanus, acellular Pertussis, inactivated Polio, conjugate Haemophilus influenzae type b Combined Vaccine of 0.5mL on Day 0 | Biological | PENTAXIM Control (Toddlers aged 18-24 months, one-dose) |
| DTaP (three-dose primary vaccination)Diphtheria-Tetanus-acellular Pertussis Vaccine of 0.5mL on an M3-M4-M5immunization schedule | Biological | DTaP Control (Infants aged 3 months, three-dose) |
| PENTAXIM (three-dose primary vaccination)Diphtheria, Tetanus, acellular Pertussis, inactivated Polio, conjugate Haemophilus influenzae type b Combined Vaccine of 0.5mL on the M3-M4-M5 or M2-M3-M4 immunization schedule | Biological | PENTAXIM Control (Infants aged 2 months, three-dose), PENTAXIM Control (Infants aged 3 months, three-dose) |
Primary outcome
Safety index-incidence of adverse events
Time frame: 0-30 minutes after the first dose vaccination
Incidence of adverse events after the first dose vaccination (Applicable for Infants)
Safety index-incidence of adverse events
Time frame: 0-30 minutes after the second dose vaccination
Incidence of adverse events after the second dose vaccination (Applicable for Infants)
Safety index-incidence of adverse events
Time frame: 0-30 minutes after the third dose vaccination
Incidence of adverse events after the third dose vaccination (Applicable for Infants)
Safety index-incidence of adverse events
Time frame: 0-30 minutes after the booster dose
Incidence of adverse events after the booster dose (Applicable for Toddlers and Children)
Safety index-incidence of solicited adverse events
Time frame: Day 0 to 7 after the first dose vaccination
Incidence of solicited adverse events after the first dose vaccination (Applicable for Infants)
Safety index-incidence of solicited adverse events
Time frame: Day 0 to 7 after the second dose vaccination
Incidence of solicited adverse events after the second dose vaccination (Applicable for Infants)
Safety index-incidence of solicited adverse events
Time frame: Day 0 to 7 after the third dose vaccination
Incidence of solicited adverse events after the third dose vaccination (Applicable for Infants)
Safety index-incidence of solicited adverse events
Time frame: Day 0 to 7 after the booster dose
Incidence of solicited adverse events after the booster dose (Applicable for Toddlers and Children)
Safety index-incidence of unsolicited adverse events
Time frame: Day 0 to 30 after the first dose vaccination
Incidence of unsolicited adverse events after the first dose vaccination (Applicable for Infants)
Safety index-incidence of unsolicited adverse events
Time frame: Day 0 to 30 after the second dose vaccination
Incidence of unsolicited adverse events after the second dose vaccination (Applicable for Infants)
Safety index-incidence of unsolicited adverse events
Time frame: Day 0 to 30 after the third dose vaccination
Incidence of unsolicited adverse events after the third dose vaccination (Applicable for Infants)
Safety index-incidence of unsolicited adverse events
Time frame: Day 0 to 30 after the booster dose
Incidence of unsolicited adverse events after the booster dose (Applicable for Toddlers and Children)
Safety index-incidence of adverse events
Time frame: From the beginning of the vaccination up to 30 days after the last vaccination completed
Occurrence of adverse events after vaccination
21 secondary outcomes
Safety index-incidence of serious adverse events
Time frame: From the beginning of the vaccination up to 12 months after the last vaccination completed
Immunogenicity index-seroconversion or ≥4-fold increase rates of antibody against DT
Time frame: Between baseline and Day 30 after vaccination
Immunogenicity index-seroconversion or ≥4-fold increase rates of antibody against TT
Time frame: Between baseline and Day 30 after vaccination
Immunogenicity index-seroconversion or ≥4-fold increase rates of antibody against PT
Time frame: Between baseline and Day 30 after vaccination
Immunogenicity index-seroconversion or ≥4-fold increase rates of antibody against FHA
Time frame: Between baseline and Day 30 after vaccination
Immunogenicity index-seroconversion or ≥4-fold increase rates of antibody against PRN
Time frame: Between baseline and Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against DT
Time frame: Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against TT
Time frame: Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against PT
Time frame: Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against FHA
Time frame: Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against PRN
Time frame: Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against DT
Time frame: Between baseline and Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against TT
Time frame: Between baseline and Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against PT
Time frame: Between baseline and Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against FHA
Time frame: Between baseline and Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against PRN
Time frame: Between baseline and Day 30 after vaccination
Immunogenicity index-seropositive rates of antibody against DT
Time frame: Day 30 after vaccination
Immunogenicity index-seropositive rates of antibody against TT
Time frame: Day 30 after vaccination
Immunogenicity index-seropositive rates of antibody against PT
Time frame: Day 30 after vaccination
Immunogenicity index-seropositive rates of antibody against FHA
Time frame: Day 30 after vaccination
Immunogenicity index-seropositive rates of antibody against PRN
Time frame: Day 30 after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DTacP (one-dose booster), DTacP (three-dose primary vaccination) and DT (one-dose booster) in people with Diphtheria and Tetanus, run by Institute of Medical Biology, Chinese Academy of Medical Sciences 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 6 inclusion and 23 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 Jan 2024. 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 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.
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 Jingsi Yang (0871-68334551 ext. +86, yjs@imbcams.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety index-incidence of adverse events (time frame: 0-30 minutes after the first dose vaccination). The study lists 13 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 Jan 2024.