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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00255047
Other study ID # M5A10
Secondary ID
Status Completed
Phase Phase 3
First received November 15, 2005
Last updated January 21, 2014
Start date November 2005
Est. completion date February 2009

Study information

Verified date January 2014
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.


Recruitment information / eligibility

Status Completed
Enrollment 2167
Est. completion date February 2009
Est. primary completion date July 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 42 Days to 89 Days
Eligibility Inclusion Criteria:

- Aged = 42 days and = 89 days on the day of inclusion

- Born at full term of pregnancy (= 36 weeks)

- Informed consent form signed by the parent(s) or other legally authorized representative(s) before the 1st study related procedure

- Vaccination with a hepatitis B vaccine at least 30 days before inclusion

- Able to attend all scheduled visits and to comply with all trial procedures(i.e., access to a phone)

- Provide blood sample prior to Dose 1

- Parent or legal representative willing to take rectal temperatures after each vaccination.

Exclusion Criteria:

- Participation in another clinical trial in the 4 weeks preceding the (first)trial vaccination

- Planned participation in another clinical trial during the present trial period

- Personal or immediate family history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy

- Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s)

- Chronic illness that could interfere with trial conduct or completion

- Received blood or blood-derived products since birth

- Any vaccination in the 2 weeks preceding the first trial vaccination or planned in the 4 weeks after any trial vaccination. Flu vaccine could be administered only 2 weeks after any trial vaccination

- Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis- (DTwP) based combination vaccines, Haemophilus influenzae type b (Hib)-conjugate, poliovirus, or pneumococcal conjugate vaccines

- Coagulation disorder contraindicating intramuscular (IM) vaccination

- Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion)

- Developmental delay or neurological disorder

- Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
DAPTACEL®. (DTaP), IPOL®., and ActHIB®.
0.5 mL, Intramuscular
Pentacel®: DTaP-IPV/Hib combined
0.5 mL, Intramuscular
DTaP-IPV and ActHIB®
0.5 mL, Intramuscular
Pentacel®: DTaP-IPV/Hib combined
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 Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 Solicited injection site reactions: Tenderness, Redness, and Swelling. Solicited systemic reactions: Fever (body temperature), Vomiting, Abnormal crying, Lethargy, Appetite decreased, Irritability, and Rash. 7 days post-vaccination 3 No
Primary Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. Vaccine response was calculated as a pre-dose 1 titer = Lower Limit of Quantitation (LLOQ) and post-dose 3 titer > LLOQ; or a pre-dose 1 titer > LLOQ and post-dose 3 titer = pre-dose 1 titer. 30 Days post-dose 3 vaccination No
Primary Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) 30 Days post-dose 3 vaccination No
Primary Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. 30 Days post-dose 3 vaccination. No
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