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Safety and Immune Response of Different Pediatric Combination Vaccines.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00255047
First Posted: November 17, 2005
Last Update Posted: February 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
  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
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

Resource links provided by NLM:


Further study details as provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

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 ]
    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 ]
  • 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:
  • 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.


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00255047     History of Changes
Other Study ID Numbers: M5A10
First Submitted: November 15, 2005
First Posted: November 17, 2005
Results First Submitted: September 14, 2010
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
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections