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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Diphtheria

Pertussis

Tetanus

Treatments

Biological: DAPTACEL®: DTaP

Study type

Interventional

Funder types

Industry

Identifiers

NCT00258895

P3T11

Details and patient eligibility

About

Primary Objectives:

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™.
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™.

Observational Objectives:

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™.
To present the pre-vaccination anti-poliovirus GMTs and seroprotection rates.
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.

Enrollment

649 patients

Sex

All

Ages

4 to 6 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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™).

Exclusion criteria

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.