Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®

NCT00258895 | Completed Phase 3 Results

• 1 other identifier: P3T11
• Study Type: interventional
• Target: 649
• Locations: 1 country
• Sites: 22

Brief Summary

Primary Objectives:

1. 1.To present the safety profile after a 5th dose of DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™.
2. 2.To present the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™.
3. 3.To compare under equivalence criteria the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™.
4. 4.To present the pre-vaccination anti-poliovirus GMTs and seroprotection rates.
5. 5.To present the post-vaccination anti-poliovirus GMTs and seroprotection rates among subjects receiving a 4th dose of IPV concurrently with the 5th dose of DAPTACEL and a 2nd dose of MMR.

Conditions

Diphtheria; Tetanus; Pertussis

Keywords

DAPTACEL®; Pentacel™; Diphtheria; Tetanus; Pertussis; Whooping cough; Acellular Pertussis Vaccine Adsorbed

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination

  0 to 7 days Post-Dose 5

• Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination

  Anti-Pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin) Fold-rise is calculated as post-Dose 5/pre-Dose 5 titer.

  Day 28 to 48 Post-dose 5

• Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination

  Booster response calculation: If pre-Dose 5 titer \< 4x limit of quantitation (LOQ) a 4-fold rise of post-Dose 5/pre-Dose 5. If pre-Dose 5 titer ≥ 4x LOQ a 2-fold rise of post-Dose 5/pre-Dose 5.

  Day 28 to 48 Post-Dose 5

• Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination.

  Day 0 and between Days 28-48 Post-dose 5

• Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination

  Day 0 and between Days 28-48 post-dose 5

Study Arms (2)

DAPTACEL Primed

EXPERIMENTAL

Participants received Daptacel in Study P3T06.

Biological: DAPTACEL®: DTaP

Pentacel Primed

EXPERIMENTAL

Participants received Pentacel in Study P3T06

Biological: DAPTACEL®: DTaP

Interventions

DAPTACEL®: DTaP BIOLOGICAL

0.5 mL, Intramuscular

Also known as: DAPTACEL®

DAPTACEL Primed

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged ≥ 4 and \< 7 years from date of birth at the time of study vaccination
• Signed and dated Investigational Review Board (IRB)-approved informed consent from a parent or legally authorized representative. Signed and dated IRB-approved assent from subject if required by IRB
• Judged to be in good health on the basis of reported medical history and physical examination
• Able and willing to attend the scheduled visits and to comply with the study procedures
• Has documented complete infant series and the 4th dose of DAPTACEL® or Pentacel™ in Study P3T06 (i.e., 4 previous administrations of DAPTACEL® or Pentacel™).

You may not qualify if:

• Received a 5th dose of DTaP-containing vaccine
• a. For subjects in the DAPTACEL® arm: Received a 4th dose of Inactivated Poliovirus Vaccine (IPV) vaccine and/or a 2nd dose of Measles, Mumps, and Rubella (MMR) vaccine scheduled at 4 to 6 years of age.
• b. For subjects in the Pentacel™ arm: Received a 2nd dose of MMR vaccine scheduled at 4 to 6 years of age
• Severe hypersensitivity to any component of the vaccine such as an anaphylactic reaction observed following a previous vaccination
• Serious underlying chronic disease, including, but not limited to:·Diabetes mellitus; malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or hematologic disorder·Unstable or evolving neurologic disorders that may predispose the subject to seizures or neurologic deterioration. These may include progressive neurologic disorders (e.g., infantile spasms, uncontrolled progressive encephalopathy) and encephalopathy within 7 days following previous vaccination
• Known or suspected primary or acquired disease of the immune system
• Administration of immune globulin, other blood products within the last 3 months, injected or oral corticosteroids or other immunomodulator therapy within 6 weeks prior to study vaccination. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than 1 course within the last 2 weeks prior to enrollment
• Had allergy shots started or had changes in regimen or dosing of allergy shots within 4 weeks prior to study vaccination
• Receipt of any other vaccine within 30 days prior to study vaccination, or planning to receive another vaccine within 30 days before the Visit 2 blood draw (if applicable)
• Any other condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine
• Enrolled in another vaccine trial
• Personal history of physician-diagnosed or laboratory-confirmed pertussis disease within the past 30 months
• Known or suspected allergy to any of the vaccines or vaccine components intended for use in this study.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (22)

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Fayetteville, Arkansas, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Fountain Valley, California, United States

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Centennial, Colorado, United States

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Norwich, Connecticut, United States

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Marietta, Georgia, United States

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Bardstown, Kentucky, United States

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Bossier City, Louisiana, United States

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Rochester, New York, United States

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Pembroke, North Carolina, United States

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Sylva, North Carolina, United States

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Norristown, Pennsylvania, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Pittsburgh, Pennsylvania, 15241, United States

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Kingsport, Tennessee, United States

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Fort Worth, Texas, United States

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San Antonio, Texas, United States

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Provo, Utah, United States

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Spokane, Washington, United States

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La Crosse, Wisconsin, United States

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Marshfield, Wisconsin, United States

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Related Links

• Related Info

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough

Interventions

Diphtheria-Tetanus-acellular Pertussis Vaccines

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)

Pertussis Vaccine; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit

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 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2005
• First Posted: November 28, 2005
• Study Start: March 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: April 1, 2007
• Last Updated: April 14, 2016
• Results First Posted: September 28, 2009

Record last verified: 2016-04

Locations

US (22)