Safety and Immune Response of Different Pediatric Combination Vaccines.

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


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

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
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Please refer to this study by its identifier: NCT00255047

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Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Study Director: Medical Director Sanofi Pasteur Inc
  More Information

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company ) 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:
Whooping cough
Filamentous Haemagglutinin
Fimbriae Types 2 and 3;
Poliovirus Types 1, 2, and 3.

Additional relevant MeSH terms:
Whooping Cough
Actinomycetales Infections
Bacterial Infections
Bordetella Infections
Corynebacterium Infections
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections processed this record on November 24, 2015