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Study of the DTacP-IPV-HepB-PRP-T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™
This study is enrolling participants by invitation only.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00654901
  Purpose

This is a follow-up of Study A3L11. Immunogenicity

  • To describe the antibody persistence following a primary series vaccination of either DTacP IPV HepB PRP T or Infanrix hexa™.
  • To describe the immunogenicity of a booster dose of DTacP-IPV-HepB-PRP-T in a subset of subjects.

Safety

- To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP-T.


Condition Intervention Phase
Diphtheria
Tetanus
Pertussis
Hepatitis B
Poliomyelitis
Haemophilus Influenzae Type B
Biological: DTaP-IPV-HB-PRP~T vaccine
Phase III

MedlinePlus related topics: Diphtheria Flu Hepatitis Hepatitis B Polio and Post-Polio Syndrome Tetanus Whooping Cough
Drug Information available for: Hepatitis B Vaccines Infanrix hexa
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of DTacP-IPV-HepB-PRP-T. [ Time Frame: Day 0 and 1 month post-vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 1199
Study Start Date: March 2008
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Biological: DTaP-IPV-HB-PRP~T vaccine
0.5 mL, IM

  Eligibility

Ages Eligible for Study:   15 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Toddlers previously included in Study A3L11 who completed the three-dose primary series vaccination of either DTacP-IPV-HepB-PRP-T or Infanrix hexa™ at 2, 4 and 6 months of age
  • Toddlers of 15 to 18 months (456 to 578 days) of age, inclusive
  • Informed Consent Form signed by at least one parent or legal representative and two mandatory witnesses
  • Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

  • Participation in another clinical trial in the 4 weeks preceding the booster vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy.
  • Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to a vaccine containing the same substances.
  • Chronic illness at a stage that could interfere with trial conduct or completion.
  • Blood or blood-derived products received in the last 3 months.
  • Any vaccination in the 4 weeks preceding the booster vaccination.
  • Any vaccination planned until the next visit.
  • History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically).
  • Administration of a vaccine against pertussis, tetanus, diphtheria, polio, Hib, and/or hepatitis B infection(s) since the end of participation in Study A3L11.
  • Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination.
  • Known maternal history of HIV, HB (HbsAg) or Hepatitis C seropositivity.
  • Subjects with any related SAE that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L11.
  • History of seizures.
  • Febrile (temperature >=38.0°C) or acute illness on the day of inclusion
  • Known contraindication to further vaccination with a pertussis vaccine, i.e.: Encephalopathy; Temperature >40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series; Inconsolable crying that occurred for >3 hours within 48 hours following vaccine injection during the primary series; Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series; Seizures with or without fever within 3 days following vaccine injection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654901

Locations
Mexico
Monterrey, Mexico
Puebla, Mexico
Estado de Mexico, Mexico
Insurgentes Cuicuilco, Mexico
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Clinical Trials sanofi pasteur
  More Information

Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Sanofi Pasteur, Inc ( Medical Monitor )
Study ID Numbers: A3L21, A3L21
Study First Received: April 3, 2008
Last Updated: April 3, 2008
ClinicalTrials.gov Identifier: NCT00654901  
Health Authority: Mexico: Ministry of Health

Keywords provided by Sanofi-Aventis:
Diphtheria
Tetanus
Pertussis
Hepatitis B
Poliomyelitis
Invasive Haemophilus influenzae type b.

Study placed in the following topic categories:
Bacterial Infections
Liver Diseases
Spinal Cord Diseases
Whooping Cough
Hepatitis, Viral, Human
Orthomyxoviridae Infections
Tetanus
Whooping cough
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Neuromuscular Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Hepatitis B
Motor Neuron Disease
Haemophilus influenzae
Cough
Picornaviridae Infections
Central Nervous System Diseases
Degenerative motor system disease
Diphtheria
Motor neuron disease
Hepatitis
Virus Diseases
Digestive System Diseases
Central Nervous System Infections
Poliomyelitis
Influenza, Human
DNA Virus Infections
Myelitis

Additional relevant MeSH terms:
Bordetella Infections
RNA Virus Infections
Corynebacterium Infections
Nervous System Diseases
Central Nervous System Viral Diseases
Infection
Hepadnaviridae Infections
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009