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

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Brief Title

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

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

Brief 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. 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      has been replaced by adsorption tetanus-diphtheria-acellular pertussis vaccine in American.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.
    

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      2000, the basic immunization DTwP vaccine has been replaced by adsorption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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

Immunogenicity after vaccination

Secondary Outcome

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

Condition

Pertussis

Intervention

DTaP Vaccine A

Study Arms / Comparison Groups

 DTaP Vaccine A
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

1200

Start Date

December 2013

Completion Date

July 2014

Primary Completion Date

May 2014

Eligibility Criteria

        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.
      

Gender

All

Ages

3 Months - 5 Months

Accepts Healthy Volunteers

No

Contacts

Yuemei Hu, Bachelor, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02477995

Organization ID

1110103


Responsible Party

Sponsor

Study Sponsor

Jiangsu Province Centers for Disease Control and Prevention


Study Sponsor

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


Verification Date

July 2011