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Trial record 7 of 13 for:    boostrix | Phase 1

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099303
Recruitment Status : Active, not recruiting
First Posted : September 23, 2019
Last Update Posted : March 11, 2021
Sponsor:
Collaborator:
Henan Center for Disease Control and Prevention
Information provided by (Responsible Party):
CanSino Biologics Inc.

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Diphtheria Tetanus Pertussis Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed Biological: Diphtheria and Tetanus Combined Vaccine, Adsorbed Biological: Diphtheria-tetanus-acellular pertussis vaccine Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : April 28, 2020
Estimated Primary Completion Date : December 20, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vaccine 1A
Subjects received one dose of DTaP aged 4 to 6 years.
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
0.5 mL, Intramuscular Other Name: DTcP

Active Comparator: Vaccine 1B
Subjects received one dose of DT aged 4 to 6 years.
Biological: Diphtheria and Tetanus Combined Vaccine, Adsorbed
2mL, Intramuscular Other Name: DT

Experimental: Vaccine 2A
Subjects received one dose of DTcP aged 18 to 24 months.
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
0.5 mL, Intramuscular Other Name: DTcP

Active Comparator: Vaccine 2B
Subjects received one dose of DTaP aged 18 to 24 months.
Biological: Diphtheria-tetanus-acellular pertussis vaccine
0.5 mL, Intramuscular Other Name: DTaP

Experimental: Vaccine 3A
Subjects received three doses of DTcP at 3,4,5 months of age.
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
0.5 mL, Intramuscular Other Name: DTcP

Active Comparator: Vaccine 3B
Subjects received three doses of DTaP at 3,4,5 months of age.
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
0.5 mL, Intramuscular Other Name: DTcP

Biological: Diphtheria-tetanus-acellular pertussis vaccine
0.5 mL, Intramuscular Other Name: DTaP

Active Comparator: Vaccine 3C
Subjects received three doses of DTaP-IPV-Hib at 3,4,5 months of age.
Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
0.5 mL, Intramuscular Other Name: PENTAXIM

Experimental: Vaccine 4A
Subjects received three doses of DTcP at 2,3,4 months of age.
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
0.5 mL, Intramuscular Other Name: DTcP

Active Comparator: Vaccine 4B
Subjects received three doses of DTaP-IPV-Hib at 2,3,4 months of age.
Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
0.5 mL, Intramuscular Other Name: PENTAXIM

Experimental: Vaccine 4C
Subjects received three doses of DTcP at 2,4,6 months of age.
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
0.5 mL, Intramuscular Other Name: DTcP




Primary Outcome Measures :
  1. Safety items of adverse reactions [ Time Frame: within 30 minutes post-vaccination ]
    Occurrence of adverse reactions

  2. Safety items of adverse reactions [ Time Frame: within 7 days post-vaccination ]
    Occurrence of adverse reactions

  3. Safety items of SAE: Occurrence of SAE [ Time Frame: within 360 days post-vaccination ]
    Occurrence of SAE

  4. Safety itmes of laboratory measures: Occurrence of abnormal changes of laboratory measures [ Time Frame: the fourth day post-vaccination ]
    Occurrence of abnormal changes of laboratory measures

  5. Safety items of adverse reactions [ Time Frame: within 8-30 days post-vaccination ]
    Occurrence of adverse reactions

  6. Safety items of adverse reactions [ Time Frame: within 30 days post-vaccination ]
    Occurrence of adverse reactions



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Ages Eligible for Study:   2 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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;
  • 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

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): NCT04099303


Locations
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China, Henan
Changge Center for Disease Control and Prevention
Xuchang, Henan, China, 461500
Sponsors and Collaborators
CanSino Biologics Inc.
Henan Center for Disease Control and Prevention
Investigators
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Principal Investigator: Wang Yanxia Henan Province Center for Disease Control and Prevention
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Responsible Party: CanSino Biologics Inc.
ClinicalTrials.gov Identifier: NCT04099303    
Other Study ID Numbers: CS-CTP-DTcP-Ⅰ
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: In order to maintain the rights of the subject, do not open the IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CanSino Biologics Inc.:
Infection
DTcP
Whooping Cough
Vaccine
Diphtheria
Tetanus
Pertussis
Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Tetany
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Corynebacterium Infections
Actinomycetales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs