Safety and Immune Response of Different Pediatric Combination Vaccines. - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00255047

Purpose

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®, IPOL®, and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.

Condition	Intervention	Phase
Diphtheria Polio Pertussis	Biological: DAPTACEL (DTaP) Biological: DTaP-IPV/Hib combined Biological: DTaP-IPV and ActHIB	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Diphtheria Whooping Cough

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

To provide information concerning the immunogenicity of Pentacel [ Time Frame: Post-dose 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To provide information concerning the safety of pentacel [ Time Frame: 180 days after the last vaccination. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	2160
Study Start Date:	November 2005
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Received DAPTACEL, ActHIB, IPOL Months 2, 4, and 6	Biological: DAPTACEL (DTaP) 0.5 mL, Intramuscular
2: Experimental Received Pentacel at Months 2, 4, and 6	Biological: DTaP-IPV/Hib combined 0.5 mL, Intramuscular
3: Experimental Received DTaP-IPV, ActHIB at Months 2, 4, 6 and 15	Biological: DTaP-IPV and ActHIB 0.5 mL, Intramuscular
4: Experimental Received Pentacel at Months 2, 4, 6, and 15	Biological: DTaP-IPV/Hib combined 0.5 mL, Intramuscular

Eligibility

Ages Eligible for Study:	42 Days to 89 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255047

Show 29 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Clinical Trials

sanofi pasteur

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanofi Pasteur Inc ( Medical Director )
Study ID Numbers:	M5A10
Study First Received:	November 15, 2005
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00255047 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Pertussis
Whooping cough
Filamentous Haemagglutinin
Fimbriae Types 2 and 3;

Pertactin
Diphtheria
Tetanus
Poliovirus Types 1, 2, and 3.

Additional relevant MeSH terms:

Bacterial Infections
Bordetella Infections
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Corynebacterium Infections

Whooping Cough
Diphtheria
Infection
Actinomycetales Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on November 27, 2009