Study of the Tdap Combined Vaccine (ADACEL™) as a Booster Dose in Healthy Adults and Children in China

NCT01933776 | Completed Phase 1 Results

• 2 other identifiers: Td527U1111-1127-7738
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess the safety profile of ADACEL vaccine in a small number of participants in China. Primary objective:

• To describe the safety in terms of occurrence of serious adverse reactions and grade 3 adverse reactions after administration of Sanofi Pasteur's Tdap vaccine (ADACEL) given as a single dose in 20 adults and 20 children. Secondary objective:
• To describe the full reactogenicity profile after administration of sanofi pasteur's Tdap vaccine (ADACEL) given as a single dose in 20 adults and 20 children.

Conditions

Diphtheria; Tetanus; Pertussis

Keywords

Diphtheria; Tetanus; Pertussis; ADACEL®; Tdap vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine

  Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling \>30 mm; Fever (temperature) \>39˚C; Headache, Malaise, and Myalgia, significant, prevents daily activity.

  Day 0 up to Day 28 post-vaccination

Secondary Outcomes (1)

• Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine

  Day 0 up to Day 7 post-vaccination

Study Arms (2)

Group 1: Adults

EXPERIMENTAL

Participants 18 through 64 years of age will receive a single booster dose of Tdap vaccine (ADACEL).

Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap

Group 2: Children

EXPERIMENTAL

Participants 4 through 8 years of age will receive a single booster dose of Tdap vaccine (ADACEL)

Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap

Interventions

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap BIOLOGICAL

0.5 mL, Intramuscular (IM)

Also known as: ADACEL™

Group 1: Adults

Eligibility Criteria

• Age: 4 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Informed consent form signed by the subject (Group 1) or by the parent(s) or legal representative (Group 2)
• Subject (Group 1 and 2) and parent/legal representative (Group 2 only) able to attend all scheduled visits and to comply with all trial procedures
• Group 1 only: For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) from at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination
• Group 2 only: Written documentation of complete primary series and fourth dose of Diphtheria, Tetanus, Pertussis (DTP) vaccine as per China National Immunization Recommendations

You may not qualify if:

• Group 1 only: For a woman of child-bearing potential, known pregnancy or positive serum or urine pregnancy test
• Group 1 only: Currently breast-feeding a child
• Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
• Planned participation in another clinical trial during the present trial period
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine or to a vaccine containing any of the same substances
• Chronic illness that, in the opinion of the Investigator, is at a stage that could interfere with trial conduct or completion
• Group 1 only: Current alcohol abuse or drug addiction that may interfere with the ability to comply with trial procedures
• Receipt or planned receipt of any vaccine in the 4 weeks preceding or following trial vaccination, except for influenza vaccination, which may be received at least two weeks before the study vaccine
• Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
• History of diphtheria, tetanus, or pertussis infection (confirmed either clinically, serologically or microbiologically)
• Previous fifth vaccination against pertussis disease and/or previous sixth vaccination against diphtheria and tetanus disease with either the trial vaccine or another vaccine (except Tetanus-prone wound management in Group 1)
• Subject at high risk for diphtheria, tetanus, or pertussis infection during the trial, including persons who have exposure (e.g., member of a household with another infected member, travelers to or residents of areas where one of this disease is hyperendemic or epidemic, or microbiologists routinely working with one of these pathogens,)
• Group 1 only: Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• History of contra-indication to vaccination with pertussis containing vaccine, including:

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Unknown Facility

Jiangsu, Jiangsu, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough

Interventions

Tetanus Toxoid; adacel

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: September 2, 2013
• Study Start: August 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: January 1, 2014
• Last Updated: March 7, 2016
• Results First Posted: April 21, 2014

Record last verified: 2016-02

Locations

CN (1)