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PertussisPhase 3NCT02477995

Study of Adsorption Tetanus-diphtheria-acellular Pertussis (DTaP) Vaccine in Healthy 3 to 5 Months Infants

A Phase 3 study testing DTaP Vaccine A and DTaP Vaccine B in people with Pertussis, run by Jiangsu Province Centers for Disease Control and Prevention 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 adsorption diphtheria-tetanus-whole-cell pertussis (DTwP), it greatly reduced incidence of the three kinds of diseases. But the thallus of pertussis in the vaccine may cause more side reactions after vaccination. Read more about this study

Who is it for?
Ages 3 to 5 months
Conditions the study is for
Pertussis
What is being tested?
DTaP Vaccine A and DTaP Vaccine B
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
1 siteChina
Study dates
Dec 2013to Jul 2014
Phase
Phase 3
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 3 to 5 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Healthy infants aged 3-5months old as established by medical history and clinical examination
  • The subjects' guardians are able to understand and sign the informed consent
  • Subjects who can and will comply with the requirements of the protocol
  • Subjects with temperature ≤37.0°C on axillary setting

Who cannot join

  • Subjects who was premature birth
  • Subjects who has a medical history of diphtheria, pertussis or tetanus.
  • Had been vaccined for DTwP or DTaP
  • Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
  • Severe malnutrition or dysgenopathy
  • Family history of seizures or progressive neurological disease
Show all 27Show fewer
  • Family history of congenital or hereditary immunodeficiency
  • Thyroid disease
  • Coagulation disorder diagnosed by a doctor(such as the lack of clotting factors, clotting hemorrhagic disease, platelet abnormalities) or significant bruising
  • No spleen, functional asplenia, and any situation caused by no spleen or splenectomy
  • Any acute infections in last 7 days
  • Any prior administration of immunodepressant or corticosteroids
  • Any prior administration of blood products in last 3 month
  • Any prior administration of other research medicines in last 1 month
  • Any prior administration of attenuated live vaccine in last 15 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
  • Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
  • If subjects who have one condition of 1 to 4 as followed, prohibiting to continue the vaccination, and they will be continue observed in the opinion of the investigator. If Subjects who had one condition of 5 to 6 as followed, must be determined whether to continue by the investigator. If Subjects who had one condition of 7 to 8 as followed, they can had a delayed vaccination during time frame of the program. All participants with adverse events as followed, must be settled in follow-up to the end of events.
  • Any serious adverse events caused by vaccination.
  • Hypersensitivity after vaccination.
  • Anaphylaxis after vaccination
  • Any confirmed or suspected autoimmune diseases or immune deficiency disorders, including human immunodeficiency virus (HIV) infection
  • Have acute or new chronic disease during vaccination
  • Other reactions that in the opinion of the investigator ( include: severely serious symptom of pain, swelling, Limitation of motion, continuous high fever, headache and other Systemic or local reactions )
  • Have acute disease during vaccination (Acute disease refers to with or without fever of moderate or severe disease)
  • Subjects with temperature >37.0°C on axillary settin.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jiangsu Provincial Center for Diseases Control and Prevention

    Nanjing, Jiangsu, 210009

Other trials in China

About this study

Official title: Study of Adsorption Tetanus-diphtheria-acellular Pertussis (DTaP) Vaccine in Healthy Infants 3 to 5 Months of Age: A Randomized, Blinded, Single-center, Positive Controlled Clinical Trial

Pertussis, diphtheria and tetanus are seriously infectious diseases in children. Since using of the adsorption diphtheria-tetanus-whole-cell pertussis (DTwP), it greatly reduced incidence of the three kinds of diseases. But the thallus of pertussis in the vaccine may cause more side reactions after vaccination. Since 2000, the basic immunization DTwP vaccine has been replaced by adsorption tetanus-diphtheria-acellular pertussis vaccine in American. In 1995, DTaP was successfully developed in China, and have been used in EPI at present. Because of effective immunity and little side reaction, DTaP has been widely recognized and accepted by the parents.

Read the detailed description

Pertussis, diphtheria and tetanus are seriously infectious diseases for children. The world health organization (WHO) included the adsorption diphtheria-tetanus-whole-cell pertussis (DTwP) into the expanded program on immunization (EPI), as a basic immunization. Since using the DTwP, it greatly reduced incidence of the three kinds of diseases. Thousands of children have been saved since its application. Although the DTwP was productively in against pertussis, diphtheria and tetanus, thallus of pertussis in the vaccine could cause more side reactions after vaccination. Many individuals did not want to be vaccinated. However, there was two large epidemics of pertussis during the period of 1977-1979 and 1981-1983. Since 2000, the basic immunization DTwP vaccine has been replaced by adsorption tetanus-diphtheria-acellular pertussis vaccine (DTaP) vaccine in American. In 1995, DTaP was successful developed in the investigators' country, and is used in EPI at present. Because of effective immunity and causing little side reaction, DTaP has been widely recognized and accepted by the parents. This clinical trial is planning to evaluate the immunogenicity and safety of DTaP in 3-5 months infants .

Conditions
Pertussis
Being tested
DTaP Vaccine A, DTaP Vaccine B
Keywords
Immunogenicity, Safety, DTaP Vaccine
Medical subject headings
Whooping Cough

What participants receive

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

  • DTaP Vaccine ABiological

    Adsorption tetanus-diphtheria-acellular pertussis (DTaP) Vaccine A(Bejing minhai Biological Co., LTD) of 0.5ml, three doses, 28 days interval

  • DTaP Vaccine BBiological

    Adsorption tetanus-diphtheria-acellular pertussis (DTaP) Vaccine B(Changchun changsheng Biological Co., LTD ) of 0.5ml in 600 infants aged 3-5months on day 0, 28, 56.

Study groups in NCT02477995
Study groupRoleWhat they receive
DTaP Vaccine AExperimentalAdsorption tetanus-diphtheria-acellular pertussis (DTaP) Vaccine A(Bejing minhai Biological Co., LTD) of 0.5ml in 600 infants aged 3-5months on day 0, 28, 56.
Receives: Biological: DTaP Vaccine A
DTaP Vaccine BActive comparatorAdsorption tetanus-diphtheria-acellular pertussis (DTaP) Vaccine B (Changchun changsheng Biological Co., LTD ) of 0.5ml in 600 infants aged 3-5months on day 0, 28, 56.
Receives: Biological: DTaP Vaccine B

What is being measured

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

  1. Immunogenicity after vaccination

    The seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody on day 28 post-dose 3.

    seroconversion is defined as post-third dose anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody concentrations ≥ protective antibody concentration, if pre-vaccination concentration is < protective antibody concentration or ≥ 4 x protective antibody concentration if pre- vaccination concentrations ≥ protective antibody concentration.

    Measured: Day 28 post-dose 3

  2. Proportion of subjects reporting solicited injection-site reactions, solicited systemic reactions.

    Proportion of subjects reporting solicited injection-site reactions, solicited systemic reactions on day 7 post-each dose.

    Measured: Day 7 post-each dose

Secondary outcomes (5)

  1. The seropositivity rates of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibodies in serum on day 28 post-dose3.

    The seropositive rates of anti-pertussis tox oid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibodies in serum on day 28 post-dose3. Seropositivity is defined as post-third dose anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody concentrations ≥ protective antibody concentration.

    Measured: Day 28 post-dose 3

  2. Proportion of subjects reporting unsolicited injection-site and systemic reactions.

    Measured: Day 28 post-each dose

  3. Proportion of subjects with serious adverse events(SAE) occurring throughout the trial.

    Measured: Day 0 up to 90 post-vaccination

  4. Geometric mean concentration(GMC)of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibodies in serum on day 28 post-dose3.

    Measured: Day 28 post-dose 3

  5. Geometric mean fold increase（GMFI）of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibodies in serum on day 28 post-dose3.

    Measured: Day 28 post-dose 3

Timeline

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

  1. First posted23 Jun 2015 (estimated)
  2. Study startDec 2013
  3. Primary completionMay 2014
  4. Study completionJul 2014

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02477995
Sponsor's protocol ID
1110103
Status last verified
Jul 2011
First submitted
9 Jun 2015
Last updated
23 Jun 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DTaP Vaccine A and DTaP Vaccine B in people with Pertussis, run by Jiangsu Province Centers for Disease Control and Prevention 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 4 inclusion and 27 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 23 Jun 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Immunogenicity after vaccination (time frame: Day 28 post-dose 3). The study lists 2 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 NCT02477995.

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 23 Jun 2015.

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