Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™

Tetanus Clinical Trial

Official title:

Safety and Immunogenicity of DAPTACEL® (CP10/5/5/3DT Aventis Pasteur 5-component Pertussis Vaccine in Combination With Tetanus and Diphtheria Toxoids Adsorbed) Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™ (HCP20/20/5/3DT-mIPV//PRP-T)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00802867
• Other study ID #: P3T10
• Status: Completed
• Phase: Phase 4
• First received: December 4, 2008
• Last updated: April 12, 2016
• Start date: February 2004
• Est. completion date: September 2005

Study information

• Verified date: April 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Objectives:

• To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.

• To present immunogenicity before and after a single dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.

Description:

This study is designed to assess the safety and immunogenicity of DAPTACEL® vaccine administered at 4 to 6 years of age according to the US standard of care. The study population consists of PENTACEL™-primed subjects from Aventis Pasteur's pivotal studies 494-01 and 494-03. These children will receive DAPTACEL® vaccine as a 5th dose immunization between 4 to 6 years of age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 989
• Est. completion date: September 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 6 Years

Eligibility

Inclusion Criteria :

• Aged = 4 years and 6 years.

• Signed and dated Investigational Review Board-approved informed consent from a parent or legally authorized representative.

• 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 4th dose in Study 494-01 or Study 494-03, consisting of four previous administrations of PENTACEL™.

Exclusion Criteria :

• Received a 5th dose of DTaP-containing vaccine scheduled at 4 to 6 years of age.

• Serious underlying chronic disease, including, but not limited to:

• Diabetes mellitus; malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or hematologic disorder; or

• Unstable or evolving neurologic disorders that may predispose the subject to seizures or neurologic deterioration.

• Known or suspected primary or acquired disease of the immune system.

• Administration of immune globulin or other blood products within the last 3 months, or injected or oral corticosteroids or other immunomodulatory therapy within 6 weeks of the study vaccine. 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 the last 4 weeks.

• Receipt of any other vaccine within the past 30 days, or planning to receive another vaccine within 30 days before the Visit 2 blood draw, with the exclusion of M-M-R®II and IPV.

• 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.

Temporary contraindications:

• A subject who meets either of the following criteria at the time of planned vaccination will have enrollment deferred until complete resolution of symptoms:

Oral temperature = 100.4°F (= 38.0ºC) (Note: A tympanic thermometer should not be used).

• Any moderate or severe acute illness with or without fever.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Infection
• Haemophilus Infections
• Pertussis
• Polio
• Tetanus
• Whooping Cough

Intervention

Biological:
• Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose.	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	No
Other	Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose	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	No
Other	Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose	Seroprotection is defined as a titer of = 0.01 IU/mL for both Diphtheria and Tetanus before the fifth dose booster vaccination	Day 28 to 48 Post-dose 5	No
Other	Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose		Pre-dose 5 and Day 28 to 48 Post-dose 5	No
Primary	Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel®	Solicited local reactions: Redness, swelling, tenderness at injection site, change in limb circumference, and limb function.; Systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash.	0 to 3 days post-dose 5 vaccination	Yes

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