Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™
NCT ID: NCT00654901
Last Updated: 2016-05-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
881 participants
INTERVENTIONAL
2008-03-31
2009-07-31
Brief Summary
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Immunogenicity
* To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP\~T or Infanrix hexa™.
* To describe the immunogenicity of a booster dose of DTaP-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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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DTaP-IPV-Hep B-PRP~T Batch 1
Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 (NCT00404651); and will receive a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
DTaP-IPV-Hep B-PRP~T vaccine (Batch 1)
0.5 mL, Intramuscular
DTaP-IPV-Hep B-PRP~T Batch 2
Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 (NCT00404651) and will receive a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
DTaP-IPV-Hep B-PRP~T vaccine (Batch 2)
0.5 mL, Intramuscular
DTaP-IPV-Hep B-PRP~T Batch 3
Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 (NCT00404651) and will receive a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)
0.5 mL, Intramuscular
Infanrix Hexa™
Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), (Infanrix Hexa™) plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 (NCT00404651) and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
Infanrix Hexa™
0.5 mL, Intramuscular
Interventions
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DTaP-IPV-Hep B-PRP~T vaccine (Batch 1)
0.5 mL, Intramuscular
DTaP-IPV-Hep B-PRP~T vaccine (Batch 2)
0.5 mL, Intramuscular
DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)
0.5 mL, Intramuscular
Infanrix Hexa™
0.5 mL, Intramuscular
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 (HB) 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 human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbsAg) or Hepatitis C seropositivity.
* Subjects with any related serious adverse event 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.
15 Months
18 Months
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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Estado de México, , Mexico
Insurgentes Cuicuilco, , Mexico
Monterrey, , Mexico
Puebla City, , Mexico
Countries
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Related Links
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Related Info
Other Identifiers
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A3L21
Identifier Type: -
Identifier Source: org_study_id
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