Back to results

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

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed

Diphtheria and Tetanus Combined Vaccine, Adsorbed

Diphtheria-tetanus-acellular pertussis vaccine

Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine

About this trial

This is an interventional prevention trial for Diphtheria focused on measuring Infection, DTcP, Whooping Cough, Vaccine, Diphtheria, Tetanus, Pertussis

Eligibility Criteria

2 Months - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Changge Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Vaccine 1A

Vaccine 1B

Vaccine 2A

Vaccine 2B

Vaccine 3A

Vaccine 3B

Vaccine 3C

Vaccine 4A

Vaccine 4B

Vaccine 4C

Arm Description

Subjects received one dose of DTaP aged 4 to 6 years.

Subjects received one dose of DT aged 4 to 6 years.

Subjects received one dose of DTcP aged 18 to 24 months.

Subjects received one dose of DTaP aged 18 to 24 months.

Subjects received three doses of DTcP at 3,4,5 months of age.

Subjects received three doses of DTaP at 3,4,5 months of age.

Subjects received three doses of DTaP-IPV-Hib at 3,4,5 months of age.

Subjects received three doses of DTcP at 2,3,4 months of age.

Subjects received three doses of DTaP-IPV-Hib at 2,3,4 months of age.

Subjects received three doses of DTcP at 2,4,6 months of age.

Outcomes

Primary Outcome Measures

Safety items of adverse reactions

Occurrence of adverse reactions

Safety items of adverse reactions

Occurrence of adverse reactions

Safety items of SAE: Occurrence of SAE

Occurrence of SAE

Safety itmes of laboratory measures: Occurrence of abnormal changes of laboratory measures

Occurrence of abnormal changes of laboratory measures

Safety items of adverse reactions

Occurrence of adverse reactions

Safety items of adverse reactions

Occurrence of adverse reactions

Secondary Outcome Measures

Full Information

NCT ID

NCT04099303

First Posted

September 18, 2019

Last Updated

October 28, 2022

Sponsor

CanSino Biologics Inc.

Collaborators

Henan Center for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT04099303

Brief Title

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

Acronym

PCTDTcP

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

April 28, 2020 (Actual)

Primary Completion Date

October 27, 2021 (Actual)

Study Completion Date

November 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CanSino Biologics Inc.

Collaborators

Henan Center for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diphtheria, Tetanus, Pertussis

Keywords

Infection, DTcP, Whooping Cough, Vaccine, Diphtheria, Tetanus, Pertussis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

400 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vaccine 1A

Arm Type

Experimental

Arm Description

Subjects received one dose of DTaP aged 4 to 6 years.

Arm Title

Vaccine 1B

Arm Type

Active Comparator

Arm Description

Subjects received one dose of DT aged 4 to 6 years.

Arm Title

Vaccine 2A

Arm Type

Experimental

Arm Description

Subjects received one dose of DTcP aged 18 to 24 months.

Arm Title

Vaccine 2B

Arm Type

Active Comparator

Arm Description

Subjects received one dose of DTaP aged 18 to 24 months.

Arm Title

Vaccine 3A

Arm Type

Experimental

Arm Description

Subjects received three doses of DTcP at 3,4,5 months of age.

Arm Title

Vaccine 3B

Arm Type

Active Comparator

Arm Description

Subjects received three doses of DTaP at 3,4,5 months of age.

Arm Title

Vaccine 3C

Arm Type

Active Comparator

Arm Description

Subjects received three doses of DTaP-IPV-Hib at 3,4,5 months of age.

Arm Title

Vaccine 4A

Arm Type

Experimental

Arm Description

Subjects received three doses of DTcP at 2,3,4 months of age.

Arm Title

Vaccine 4B

Arm Type

Active Comparator

Arm Description

Subjects received three doses of DTaP-IPV-Hib at 2,3,4 months of age.

Arm Title

Vaccine 4C

Arm Type

Experimental

Arm Description

Subjects received three doses of DTcP at 2,4,6 months of age.

Intervention Type

Biological

Intervention Name(s)

Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed

Intervention Description

0.5 mL, Intramuscular Other Name: DTcP

Intervention Type

Biological

Intervention Name(s)

Diphtheria and Tetanus Combined Vaccine, Adsorbed

Intervention Description

2mL, Intramuscular Other Name: DT

Intervention Type

Biological

Intervention Name(s)

Diphtheria-tetanus-acellular pertussis vaccine

Intervention Description

0.5 mL, Intramuscular Other Name: DTaP

Intervention Type

Biological

Intervention Name(s)

Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine

Intervention Description

0.5 mL, Intramuscular Other Name: PENTAXIM

Primary Outcome Measure Information:

Title

Safety items of adverse reactions

Description

Occurrence of adverse reactions

Time Frame

within 30 minutes post-vaccination

Title

Safety items of adverse reactions

Description

Occurrence of adverse reactions

Time Frame

within 7 days post-vaccination

Title

Safety items of SAE: Occurrence of SAE

Description

Occurrence of SAE

Time Frame

within 360 days post-vaccination

Title

Safety itmes of laboratory measures: Occurrence of abnormal changes of laboratory measures

Description

Occurrence of abnormal changes of laboratory measures

Time Frame

the fourth day post-vaccination

Title

Safety items of adverse reactions

Description

Occurrence of adverse reactions

Time Frame

within 8-30 days post-vaccination

Title

Safety items of adverse reactions

Description

Occurrence of adverse reactions

Time Frame

within 30 days post-vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Months

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wang Yanxia

Organizational Affiliation

Henan Province Center for Disease Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Changge Center for Disease Control and Prevention

City

Xuchang

State/Province

Henan

ZIP/Postal Code

461500

Country

China

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

In order to maintain the rights of the subject, do not open the IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs