Safety and Immune Response of Different Pediatric Combination Vaccines.

• ClinicalTrials.gov Identifier: NCT00255047
• Recruitment Status: Completed
• First Posted: November 17, 2005
• Results First Posted: November 10, 2010
• Last Update Posted: February 14, 2014
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description

Brief 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®.

Condition or disease	Intervention/treatment	Phase
Diphtheria; Polio; Pertussis	Biological: DAPTACEL®. (DTaP), IPOL®., and ActHIB®.; Biological: Pentacel®: DTaP-IPV/Hib combined; Biological: DTaP-IPV and ActHIB®	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2167 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: November 2005
• Actual Primary Completion Date: July 2008
• Actual Study Completion Date: February 2009

Arms and Interventions

Arm	Intervention/treatment
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®

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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.
2. Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) [ Time Frame: 30 Days post-dose 3 vaccination ]
3. 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. ]

Other Outcome Measures:

1. Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 [ Time Frame: 7 days 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.

Eligibility Criteria

• Ages Eligible for Study: 42 Days to 89 Days (Child)
• Sexes Eligible for Study: All
• 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

Locations

United States, Alabama

Tuscaloosa, Alabama, United States, 35401

United States, Arkansas

Fayetteville, Arkansas, United States, 72703

Jonesboro, Arkansas, United States, 72401

Little Rock, Arkansas, United States, 72205

United States, California

Fountain Valley, California, United States

Oakland, California, United States, 94609

Oakland, California, United States, 94613

Oakland, California, United States, 94618

Paramount, California, United States, 90723

United States, Connecticut

Norwich, Connecticut, United States, 06360

United States, Florida

Palm Beach Gardens, Florida, United States, 33410

United States, Georgia

Marietta, Georgia, United States, 30062

United States, Kentucky

Bardstown, Kentucky, United States, 40004

United States, Louisiana

Bossier City, Louisiana, United States, 71111

United States, Maryland

Baltimore, Maryland, United States, 21201

United States, Massachusetts

Woburn, Massachusetts, United States, 01801

United States, Nebraska

Omaha, Nebraska, United States, 68131

United States, New York

Ithaca, New York, United States

Liverpool, New York, United States, 13088

United States, Ohio

Huber Heights, Ohio, United States, 45424

Youngstown, Ohio, United States, 44514

United States, Pennsylvania

Norristown, Pennsylvania, United States, 19401

Pittsburgh, Pennsylvania, United States, 15227

Pittsburgh, Pennsylvania, United States, 15241

United States, Tennessee

Kingsport, Tennessee, United States, 37660

United States, Texas

Amarillo, Texas, United States, 79124

Ft. Worth, Texas, United States, 76107

San Antonio, Texas, United States, 78205

San Antonio, Texas, United States, 78229

United States, Utah

Provo, Utah, United States, 84604

South Jordan, Utah, United States, 84095

St George, Utah, United States, 84790

United States, Washington

Spokane, Washington, United States, 99216

Vancouver, Washington, United States, 98664

United States, West Virginia

Huntington, West Virginia, United States, 25701

United States, Wisconsin

Marshfield, Wisconsin, United States

Sponsors and Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators

• Study Director: Medical Director; Sanofi Pasteur Inc

More Information

Additional Information:

Related Info 

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chatterjee A, O'Keefe C, Varman M, Klein NP, Luber S, Tomovici A, Noriega F. Comparative immunogenicity and safety of different multivalent component pertussis vaccine formulations and a 5-component acellular pertussis vaccine in infants and toddlers: a randomized, controlled, open-label, multicenter study. Vaccine. 2012 May 14;30(23):3360-8. doi: 10.1016/j.vaccine.2012.03.057. Epub 2012 Apr 1.

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT00255047
• Other Study ID Numbers: M5A10
• First Posted: November 17, 2005
• Results First Posted: November 10, 2010
• Last Update Posted: February 14, 2014
• Last Verified: January 2014

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Pertussis; Whooping cough; Filamentous Haemagglutinin; Fimbriae Types 2 and 3; Pertactin; Diphtheria; Tetanus; Poliovirus Types 1, 2, and 3.

Additional relevant MeSH terms:

Whooping Cough; Diphtheria; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections