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

June 22, 2015 updated by: Jiangsu Province Centers for Disease Control and Prevention

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 Since 2000, the basic immunization DTwP vaccine has been replaced by adsorption tetanus-diphtheria-acellular pertussis vaccine in American.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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Since 2000, the basic immunization DTwP vaccine has been replaced by adsorption tetanus-diphtheria-acellular pertussis vaccine (DTaP) vaccine in American.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 .

Study Type

Interventional

Enrollment (Actual)

1200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Provincial Center for Diseases Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 11 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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
  • 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

Exclusion criteria for the second and third dose:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DTaP Vaccine A
Adsorption 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.
Biological: DTaP Vaccine A
Adsorption tetanus-diphtheria-acellular pertussis (DTaP) Vaccine A(Bejing minhai Biological Co., LTD) of 0.5ml, three doses, 28 days interval
Active Comparator: DTaP Vaccine B
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.
Biological: DTaP Vaccine B
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity after vaccination
Time Frame: Day 28 post-dose 3

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.
Day 28 post-dose 3
Proportion of subjects reporting solicited injection-site reactions, solicited systemic reactions.
Time Frame: Day 7 post-each dose
Proportion of subjects reporting solicited injection-site reactions, solicited systemic reactions on day 7 post-each dose.
Day 7 post-each dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The seropositivity rates of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibodies in serum on day 28 post-dose3.
Time Frame: Day 28 post-dose 3
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.
Day 28 post-dose 3
Proportion of subjects reporting unsolicited injection-site and systemic reactions.
Time Frame: Day 28 post-each dose
Day 28 post-each dose
Proportion of subjects with serious adverse events(SAE) occurring throughout the trial.
Time Frame: Day 0 up to 90 post-vaccination
Day 0 up to 90 post-vaccination
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.
Time Frame: Day 28 post-dose 3
Day 28 post-dose 3
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.
Time Frame: Day 28 post-dose 3
Day 28 post-dose 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Yuemei Hu, Bachelor, Jiangsu Provincial Center for Diseases Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

June 9, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (Estimate)

June 23, 2015

Study Record Updates

Last Update Posted (Estimate)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1110103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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