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

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ClinicalTrials.gov Identifier: NCT02477995
Recruitment Status : Completed
First Posted : June 23, 2015
Last Update Posted : June 23, 2015
Sponsor:
Information provided by (Responsible Party):
Jiangsu Province Centers for Disease Control and Prevention

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 Since 2000, the basic immunization DTwP vaccine has been replaced by adsorption tetanus-diphtheria-acellular pertussis vaccine in American.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

Condition or disease Intervention/treatment Phase
Pertussis Biological: DTaP Vaccine A Biological: DTaP Vaccine B Phase 3

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 Since 2000, the basic immunization DTwP vaccine has been replaced by adsorption tetanus-diphtheria-acellular pertussis vaccine (DTaP) vaccine in American.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  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Study Start Date : December 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : July 2014


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.



Primary Outcome Measures :
  1. 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.


  2. 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.


Secondary Outcome Measures :
  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. [ 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.

  2. Proportion of subjects reporting unsolicited injection-site and systemic reactions. [ Time Frame: Day 28 post-each dose ]
  3. Proportion of subjects with serious adverse events(SAE) occurring throughout the trial. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Day 28 post-dose 3 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 5 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477995


Locations
China, Jiangsu
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
Investigators
Principal Investigator: Yuemei Hu, Bachelor Jiangsu Provincial Center for Diseases Control and Prevention

Responsible Party: Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02477995     History of Changes
Other Study ID Numbers: 1110103
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: July 2011

Keywords provided by Jiangsu Province Centers for Disease Control and Prevention:
Immunogenicity
Safety
DTaP Vaccine

Additional relevant MeSH terms:
Whooping Cough
Diphtheria
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs