Safety and Immune Response of Different Pediatric Combination Vaccines.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00255047
First received: November 15, 2005
Last updated: January 21, 2014
Last verified: January 2014
  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 3

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:


Further study details as provided by Sanofi:

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 Pertussis 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 ]

Other Outcome Measures:
  • Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 [ Time Frame: 7 days post-vaccination 3 ] [ Designated as safety issue: No ]
    Solicited injection site reactions: Tenderness, Redness, and Swelling. Solicited systemic reactions: Fever (body temperature), Vomiting, Abnormal crying, Lethargy, Appetite decreased, Irritability, and Rash.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 36 Study Locations
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc
  More Information

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
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: January 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
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 July 24, 2014