A Phase 1 interventional study of Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed and Diphtheria and Tetanus Combined Vaccine, Adsorbed in Diphtheria, Tetanus and Pertussis, sponsored by CanSino Biologics Inc.. Completed at 1 site in China. Open to participants aged 2 Months to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-31.
Sponsored by CanSino Biologics Inc. · Phase 1, Interventional, and Prevention
Pertussis, diphtheria and tetanus are seriously infectious diseases in children. Since using of the vaccine targeted the three components, it greatly reduced incidence of the three kinds of diseases. The Purpose of this study is to preliminary evaluate the safety of DTcP compared to adsorbed diphtheria and tetanus combined vaccine （DT），Diphtheria-tetanus-acellular pertussis vaccine（DTaP） or PENTAXIM（DTaP-IPV-Hib） in participants.
Study participants will receive a single booster dose of DTcP or a single booster dose of local DT in 4 to 6 years old ,a singel booster dose of DTcP or a single booster dose of DTaP in 18 to 24 months, three basic doses of DTcP or three doses of DTaP/ DTaP-IPV-Hib in 2 to 6 months.Safety profile will be assessed in all subjects up to Day 30 post vaccination.
267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's enrollment of 400 is below the median of 448 across 241 interventional studies indexed under Diphtheria.
Browse Diphtheria studies →CanSino Biologics Inc. is the lead sponsor of 41 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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.
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.
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.
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.
Subjects received one dose of DTaP aged 4 to 6 years.
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Subjects received one dose of DT aged 4 to 6 years.
Biological: Diphtheria and Tetanus Combined Vaccine, Adsorbed
Subjects received one dose of DTcP aged 18 to 24 months.
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Subjects received one dose of DTaP aged 18 to 24 months.
Biological: Diphtheria-tetanus-acellular pertussis vaccine
Subjects received three doses of DTcP at 3,4,5 months of age.
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Subjects received three doses of DTaP at 3,4,5 months of age.
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed · Biological: Diphtheria-tetanus-acellular pertussis vaccine
Subjects received three doses of DTaP-IPV-Hib at 3,4,5 months of age.
Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
Subjects received three doses of DTcP at 2,3,4 months of age.
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Subjects received three doses of DTaP-IPV-Hib at 2,3,4 months of age.
Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
Subjects received three doses of DTcP at 2,4,6 months of age.
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
0.5 mL, Intramuscular Other Name: DTcP
2mL, Intramuscular Other Name: DT
0.5 mL, Intramuscular Other Name: DTaP
0.5 mL, Intramuscular Other Name: PENTAXIM
Safety items of adverse reactions
Occurrence of adverse reactions
Time frame: within 30 minutes post-vaccination
Safety items of adverse reactions
Occurrence of adverse reactions
Time frame: within 7 days post-vaccination
Safety items of SAE: Occurrence of SAE
Occurrence of SAE
Time frame: within 360 days post-vaccination
Safety itmes of laboratory measures: Occurrence of abnormal changes of laboratory measures
Occurrence of abnormal changes of laboratory measures
Time frame: the fourth day post-vaccination
Safety items of adverse reactions
Occurrence of adverse reactions
Time frame: within 8-30 days post-vaccination
Safety items of adverse reactions
Occurrence of adverse reactions
Time frame: within 30 days post-vaccination
Plan to share: No — In order to maintain the rights of the subject, do not open the IPD
No publications or documents are linked to this record.
Ran from Apr 2020 to primary completion in Oct 2021, 17 months.
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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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