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®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Comparative Immunogenicity of Different Multivalent Component Pertussis Vaccine Formulations Based on a 5 Component Acellular Pertussis Vaccine in Infants and Toddlers

Resource links provided by NLM:

MedlinePlus related topics: Cough Diphtheria Polio and Post-Polio Syndrome Whooping Cough

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. [ Time Frame: 30 Days post-dose 3 vaccination ] [ Designated as safety issue: No ]
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.
Percentage of Participants With a Four-fold Rise in Pertusis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) [ Time Frame: 30 Days post-dose 3 vaccination ] [ Designated as safety issue: No ]
Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. [ Time Frame: 30 Days post-dose 3 vaccination. ] [ Designated as safety issue: No ]

Enrollment:	2167
Study Start Date:	November 2005
Study Completion Date:	February 2009
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Study Group 1: DAPTACEL®, ActHIB®, and IPOL® Participants will receive 3 doses of DAPTACEL®, ActHIB®, and IPOL® at Months 2, 4, and 6, respectively	Biological: DAPTACEL®. (DTaP), IPOL®., and ActHIB®. 0.5 mL, Intramuscular Other Names: DAPTACEL® IPOL® ActHIB®
Experimental: Study Group 2: Pentacel® Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively	Biological: Pentacel®: DTaP-IPV/Hib combined 0.5 mL, Intramuscular Other Name: Pentacel®
Experimental: Study Group 3: DTaP-IPV and ActHIB® Participants will receive 3 doses of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively	Biological: DTaP-IPV and ActHIB® 0.5 mL, Intramuscular Other Name: ActHIB®
Experimental: Study Group 4: Pentacel® Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively	Biological: Pentacel®: DTaP-IPV/Hib combined 0.5 mL, Intramuscular Other Name: Pentacel®

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 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.

Contacts and Locations

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

Show 36 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Director

Sanofi Pasteur Inc

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Director, Sanofi Pasteur Inc
ClinicalTrials.gov Identifier:	NCT00255047 History of Changes
Other Study ID Numbers:	M5A10
Study First Received:	November 15, 2005
Results First Received:	September 14, 2010
Last Updated:	October 14, 2010
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:

Diphtheria
Whooping Cough
Poliomyelitis
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on February 12, 2012