A Phase 1 interventional study of DTacP (one-dose booster) and DTacP (three-dose primary vaccination) in Diphtheria, Tetanus and Pertussis, sponsored by Institute of Medical Biology, Chinese Academy of Medical Sciences. Recruiting at 3 sites in China. Open to participants aged 2 Months to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-03.
Sponsored by Institute of Medical Biology, Chinese Academy of Medical Sciences · Phase 1, Interventional, and Prevention
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.
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).
267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's planned enrollment of 460 is close to the median of 448 across 241 interventional studies indexed under Diphtheria.
Browse Diphtheria studies →Institute of Medical Biology, Chinese Academy of Medical Sciences is the lead sponsor of 29 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects meeting any of the following exclusion criteria will be not eligible for enrollment.
of the second and third doses of the vaccine:
Subjects meeting any of the following contraindications will be not eligible for the following doses.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine in Children aged 6 years on Day 0
Biological: DTacP (one-dose booster)
Diphtheria-Tetanus Combined Vaccine in Children aged 6 years on Day 0
Biological: DT (one-dose booster)
Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine in toddlers aged 18-24 months on Day 0
Biological: DTacP (one-dose booster)
Diphtheria-Tetanus-acellular Pertussis Vaccine in toddlers aged 18-24 months on Day 0
Biological: DTaP (one-dose booster)
PENTAXIM (DTaP-IPV-Hib) Vaccine in toddlers aged 18-24 months on Day 0
Biological: PENTAXIM (one-dose booster)
Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine in infants aged 3 months on an M3-M4-M5 immunization schedule
Biological: DTacP (three-dose primary vaccination)
Diphtheria-Tetanus-acellular Pertussis Vaccine in infants aged 3 months on an M3-M4-M5 immunization schedule
Biological: DTaP (three-dose primary vaccination)
PENTAXIM (DTaP-IPV-Hib) Vaccine infants aged 3 months on an M3-M4-M5 immunization schedule
Biological: PENTAXIM (three-dose primary vaccination)
Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine in infants aged 2 months on an M2-M3-M4 immunization schedule
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
Biological: DTacP (three-dose primary vaccination)
PENTAXIM (DTaP-IPV-Hib) Vaccine infants aged 2 months on an M2-M3-M4 immunization schedule
Biological: PENTAXIM (three-dose primary vaccination)
Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine of 0.5mL on Day 0
Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine of 0.5mL on the M3-M4-M5, M2-M3-M4, or M2-M4-M6 immunization schedule
Diphtheria-Tetanus Combined Vaccine of 0.5mL on Day 0
Diphtheria-Tetanus-acellular Pertussis Vaccine of 0.5mL on Day 0
Diphtheria, Tetanus, acellular Pertussis, inactivated Polio, conjugate Haemophilus influenzae type b Combined Vaccine of 0.5mL on Day 0
Diphtheria-Tetanus-acellular Pertussis Vaccine of 0.5mL on an M3-M4-M5immunization schedule
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
Safety index-incidence of adverse events
Incidence of adverse events after the first dose vaccination (Applicable for Infants)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Day 0 to 30 after the booster dose
Safety index-incidence of adverse events
Occurrence of adverse events after vaccination
Time frame: From the beginning of the vaccination up to 30 days after the last vaccination completed
Safety index-incidence of serious adverse events
Occurrence of serious adverse events after vaccination
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against TT
Antibody assay will be performed using the ELISA method
Time frame: Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against PT
Antibody assay will be performed using the ELISA method
Time frame: Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against FHA
Antibody assay will be performed using the ELISA method
Time frame: Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against PRN
Antibody assay will be performed using the ELISA method
Time frame: Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against DT
Antibody assay will be performed using the ELISA method
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 30 after vaccination
Immunogenicity index-seropositive rates of neutralizing antibody against DT
Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seropositive will be defined as the antibody titer ≥ 1:4.
Time frame: Day 30 after vaccination
Immunogenicity index-seropositive rates of neutralizing antibody against PT
Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seropositive will be defined as the antibody titer ≥ 1:4.
Time frame: Day 30 after vaccination
Immunogenicity index-seropositive rates of neutralizing antibody against FHA
Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seropositive will be defined as the antibody titer ≥ 1:4.
Time frame: Day 30 after vaccination
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody against DT
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Time frame: Day 30 after vaccination
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody against PT
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Time frame: Day 30 after vaccination
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody against FHA
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Time frame: Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of neutralizing antibody against DT
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Time frame: Between baseline and Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of neutralizing antibody against PT
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Time frame: Between baseline and Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of neutralizing antibody against FHA
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Time frame: Between baseline and Day 30 after vaccination
Immunogenicity index-seroconversion or ≥4-fold increase rates of neutralizing antibody against DT
Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seroconversion will be defined as a change from seronegative (Antibody Concentration\<0.1 IU/ml) to seropositive (≥ 1:4), or a ≥4-fold increase from baseline.
Time frame: Between baseline and Day 30 after vaccination
Immunogenicity index-seroconversion or ≥4-fold increase rates of neutralizing antibody against PT
Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seroconversion will be defined as a change from seronegative (Antibody Concentration\<0.1 IU/ml) to seropositive (≥ 1:4), or a ≥4-fold increase from baseline.
Time frame: Between baseline and Day 30 after vaccination
Immunogenicity index-seroconversion or ≥4-fold increase rates of neutralizing antibody against FHA
Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seroconversion will be defined as a change from seronegative (Antibody Concentration\<0.1 IU/ml) to seropositive (≥ 1:4), or a ≥4-fold increase from baseline.
Time frame: 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. (Applicable for Infants)
Time frame: 12 months after primary vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against TT
Antibody assay will be performed using the ELISA method. (Applicable for Infants)
Time frame: 12 months after primary vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against PT
Antibody assay will be performed using the ELISA method. (Applicable for Infants)
Time frame: 12 months after primary vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against FHA
Antibody assay will be performed using the ELISA method. (Applicable for Infants)
Time frame: 12 months after primary vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against PRN
Antibody assay will be performed using the ELISA method. (Applicable for Infants)
Time frame: 12 months after primary 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. (Applicable for Infants)
Time frame: 12 months after primary 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. (Applicable for Infants)
Time frame: 12 months after primary 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. (Applicable for Infants)
Time frame: 12 months after primary 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. (Applicable for Infants)
Time frame: 12 months after primary 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. (Applicable for Infants)
Time frame: 12 months after primary vaccination
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody against Type I Poliovirus
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Time frame: Day 30 after vaccination
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody against Type II Poliovirus
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Time frame: Day 30 after vaccination
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody against Type III Poliovirus
Neutralizing antibody assay will be performed using the neutralization and ELISA method.
Time frame: Day 30 after vaccination
Immunogenicity index-seropositive rate of neutralizing antibody against Type I Poliovirus
Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seropositive will be defined as the antibody titer ≥ 1:8.
Time frame: Day 30 after vaccination
Immunogenicity index-seropositive rate of neutralizing antibody against Type II Poliovirus
Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seropositive will be defined as the antibody titer ≥ 1:8.
Time frame: Day 30 after vaccination
Immunogenicity index-seropositive rate of neutralizing antibody against Type III Poliovirus
Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seropositive will be defined as the antibody titer ≥ 1:8.
Time frame: Day 30 after vaccination
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody against Type I Poliovirus
Neutralizing antibody assay will be performed using the neutralization and ELISA method. (Applicable for Infants)
Time frame: 12 months after the primary vaccination
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody against Type II Poliovirus
Neutralizing antibody assay will be performed using the neutralization and ELISA method. (Applicable for Infants)
Time frame: 12 months after the primary vaccination
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody against Type III Poliovirus
Neutralizing antibody assay will be performed using the neutralization and ELISA method. (Applicable for Infants)
Time frame: 12 months after the primary vaccination
Immunogenicity index-seropositive rate of neutralizing antibody against Type I Poliovirus
Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seropositive will be defined as the antibody titer ≥ 1:8. (Applicable for Infants)
Time frame: 12 months after the primary vaccination
Immunogenicity index-seropositive rate of neutralizing antibody against Type II Poliovirus
Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seropositive will be defined as the antibody titer ≥ 1:8. (Applicable for Infants)
Time frame: 12 months after the primary vaccination
Immunogenicity index-seropositive rate of neutralizing antibody against Type III Poliovirus
Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seropositive will be defined as the antibody titer ≥ 1:8. (Applicable for Infants)
Time frame: 12 months after the primary vaccination
Started Dec 2023 (actual). Primary completion is estimated for Dec 2024, 11 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Pentavac
Institute of Medical Biology, Chinese Academy of Medical Sciences