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DiphtheriaPhase 1PCTDTcPNCT04099303

Phase I Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed .

A Phase 1 study testing Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, Diphtheria and Tetanus Combined Vaccine, Adsorbed and Diphtheria-tetanus-acellular pertussis vaccine in people with Diphtheria and Tetanus, run by CanSino Biologics Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. 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?
Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, Diphtheria and Tetanus Combined Vaccine, Adsorbed and Diphtheria-tetanus-acellular pertussis vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteChina
Study dates
28 Apr 2020to 25 Nov 2021
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

  • Healthy subjects aged 2months、3months、18-24months and 4-6 years old;
  • Willing to provide proof of identity;
  • Able to understand and sign the informed consent by guardians or trustees;
  • Able and willing comply with the requirements of the protocol by guardians or trustees;
  • Subjects of 2 months age have not been vaccinated with diphtheria, IPV, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine;
  • Subjects of 3 months have not been inoculated with vaccines containing diphtheria, Hib, 13-valent pneumococcal polysaccharide conjugate vaccine and Meningococcal Group AC Bivalent Meningococcal Conjugate Vaccine;volunteers of 3 months (C3 group) have not been inoculated with vaccines containing IPV;
  • Subjects aged 18-24 months who had completed the immunization program of 3 doses of DTaP and had without the fourth DTaP vaccine ;
  • Subjects aged 4-6 years who have completed the immunization program of 4 doses of DTaP or similar vaccines containing DTP component, but who have not received DT vaccine;

Who cannot join

  • Premature birth in infant under 1 year of age (delivery before the 37th week of pregnancy)or low birth weight (birth weight< 2300g for girls,<2500g for boys);
  • History of abnormal labor process or asphyxia rescue ;
  • Subjects who has a medical history of diphtheria, pertussis or tetanus;
  • In the past 30 days, individuals who have had contact with individuals with confirmed pertussis, diphtheria and tetanus diseases in their families;
  • Allergic person;
  • Any prior administration of blood products in last 3 month;
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  • Any prior administration of other research medicines in last 1 month;
  • Plans to participate in or is participating in any other drug clinical study;
  • Any prior administration of attenuated live vaccine in last 14 days;
  • Any prior administration of subunit or inactivated vaccines in last 7 days;
  • Had fever before vaccination, Subjects with temperature >37.0°C on axillary setting;
  • According to the investigator's judgment, the subjects have any other factors that make them unfit to participate in the clinical trial

Trial locations and contacts

1 site in 1 country.

China1 site

  • Changge Center for Disease Control and Prevention

    Xuchang, Henan, 461500

Other trials in China

About this study

Official title: A Randomized,Blind, Positive-controlled Phase I Clinical Trial to Preliminary Evaluate the Safety of DTcP Vaccine in Healthy Children Aged Between 2 Months and 6 Years

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.

Read the detailed description

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.

Being tested
Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, Diphtheria and Tetanus Combined Vaccine, Adsorbed, Diphtheria-tetanus-acellular pertussis vaccine, Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
Keywords
Infection, DTcP, Whooping Cough, Vaccine, Diphtheria, Tetanus, Pertussis
Medical subject headings
Diphtheria, Tetanus, Whooping Cough, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, AdsorbedBiological

    0.5 mL, Intramuscular Other Name: DTcP

  • Diphtheria and Tetanus Combined Vaccine, AdsorbedBiological

    2mL, Intramuscular Other Name: DT

  • Diphtheria-tetanus-acellular pertussis vaccineBiological

    0.5 mL, Intramuscular Other Name: DTaP

  • Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccineBiological

    0.5 mL, Intramuscular Other Name: PENTAXIM

Study groups in NCT04099303
Study groupRoleWhat they receive
Vaccine 1AExperimentalSubjects received one dose of DTaP aged 4 to 6 years.
Receives: Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Vaccine 1BActive comparatorSubjects received one dose of DT aged 4 to 6 years.
Receives: Biological: Diphtheria and Tetanus Combined Vaccine, Adsorbed
Vaccine 2AExperimentalSubjects received one dose of DTcP aged 18 to 24 months.
Receives: Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Vaccine 2BActive comparatorSubjects received one dose of DTaP aged 18 to 24 months.
Receives: Biological: Diphtheria-tetanus-acellular pertussis vaccine
Vaccine 3AExperimentalSubjects received three doses of DTcP at 3,4,5 months of age.
Receives: Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Vaccine 3BActive comparatorSubjects received three doses of DTaP at 3,4,5 months of age.
Receives: Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed; Biological: Diphtheria-tetanus-acellular pertussis vaccine
Vaccine 3CActive comparatorSubjects received three doses of DTaP-IPV-Hib at 3,4,5 months of age.
Receives: Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
Vaccine 4AExperimentalSubjects received three doses of DTcP at 2,3,4 months of age.
Receives: Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Vaccine 4BActive comparatorSubjects received three doses of DTaP-IPV-Hib at 2,3,4 months of age.
Receives: Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
Vaccine 4CExperimentalSubjects received three doses of DTcP at 2,4,6 months of age.
Receives: Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety items of adverse reactions

    Occurrence of adverse reactions

    Measured: within 30 minutes post-vaccination

  2. Safety items of adverse reactions

    Occurrence of adverse reactions

    Measured: within 7 days post-vaccination

  3. Safety items of SAE: Occurrence of SAE

    Occurrence of SAE

    Measured: within 360 days post-vaccination

  4. Safety itmes of laboratory measures: Occurrence of abnormal changes of laboratory measures

    Occurrence of abnormal changes of laboratory measures

    Measured: the fourth day post-vaccination

  5. Safety items of adverse reactions

    Occurrence of adverse reactions

    Measured: within 8-30 days post-vaccination

  6. Safety items of adverse reactions

    Occurrence of adverse reactions

    Measured: within 30 days post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2019
  2. Study start28 Apr 2020
  3. Primary completion27 Oct 2021
  4. Study completion25 Nov 2021

Resources

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04099303
Sponsor's protocol ID
CS-CTP-DTcP-Ⅰ
Acronym
PCTDTcP
Status last verified
Oct 2022
First submitted
18 Sep 2019
Last updated
31 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: In order to maintain the rights of the subject, do not open the IPD

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, Diphtheria and Tetanus Combined Vaccine, Adsorbed and Diphtheria-tetanus-acellular pertussis vaccine in people with Diphtheria and Tetanus, run by CanSino Biologics Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 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: finished, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety items of adverse reactions (time frame: within 30 minutes post-vaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04099303.

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 31 Oct 2022.

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