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

NCT02477995 | Completed Phase 3 DMC

• 1 other identifier: 1110103
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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 Since 2000, the basic immunization DTwP vaccine has been replaced by adsorption tetanus-diphtheria-acellular pertussis vaccine in American.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

Conditions

Pertussis

Keywords

Immunogenicity; Safety; DTaP Vaccine

Outcome Measures

Primary Outcomes (2)

• Immunogenicity after vaccination

  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.

  Proportion of subjects reporting solicited injection-site reactions, solicited systemic reactions on day 7 post-each dose.

  Day 7 post-each dose

Secondary Outcomes (5)

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

  Day 28 post-dose 3

• Proportion of subjects reporting unsolicited injection-site and systemic reactions.

  Day 28 post-each dose

• Proportion of subjects with serious adverse events(SAE) occurring throughout the trial.

  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.

  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.

  Day 28 post-dose 3

Study Arms (2)

DTaP Vaccine A

EXPERIMENTAL

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

DTaP Vaccine B

ACTIVE COMPARATOR

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

Interventions

DTaP Vaccine A BIOLOGICAL

Adsorption tetanus-diphtheria-acellular pertussis (DTaP) Vaccine A(Bejing minhai Biological Co., LTD) of 0.5ml, three doses, 28 days interval

DTaP Vaccine A

DTaP Vaccine B BIOLOGICAL

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.

DTaP Vaccine B

Eligibility Criteria

• Age: 3 Months - 5 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead

Study Sites (1)

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Whooping Cough

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Yuemei Hu, Bachelor

  Jiangsu Provincial Center for Diseases Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 23, 2015
• Study Start: December 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: July 1, 2014
• Last Updated: June 23, 2015

Record last verified: 2011-07

Locations

CN (1)