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Trial record 1 of 1 for:    A3L21
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Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™

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ClinicalTrials.gov Identifier: NCT00654901
Recruitment Status : Completed
First Posted : April 9, 2008
Results First Posted : June 26, 2013
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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Brief Summary:

This is a follow-up of Study A3L11 (NCT00404651).

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.


Condition or disease Intervention/treatment Phase
Diphtheria Tetanus Pertussis Hepatitis B Poliomyelitis Haemophilus Influenzae Type B Infection Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 1) Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 2) Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 3) Biological: Infanrix Hexa™ Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 881 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity Study of the Antibody Persistence and Booster Effect of the DTaP-IPV-Hep B-PRP~T Combined Vaccine at 15 to 18 Months of Age Following a Primary Series of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Administered at 2, 4, and 6 Months of Age in Healthy Mexican Infants
Study Start Date : March 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : July 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 1)
0.5 mL, Intramuscular
Experimental: 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.
 Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 2)
0.5 mL, Intramuscular
Experimental: 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.
 Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)
0.5 mL, Intramuscular
Active Comparator: 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.
 Biological: Infanrix Hexa™
0.5 mL, Intramuscular


Outcome Measures
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Primary Outcome Measures :
  1. Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T [ Time Frame: Day 0 (pre-booster) and Day 30 (one month post-booster) ]
    Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by ELISA.

  2. Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine [ Time Frame: Day 0 (pre-booster) and Day 30 (one month post-booster) ]

    Antibody persistence and immunogenicity response:

    Level 1: ≥ 10 mIU/mL for hepatitis B (Hep B), ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP), and ≥ 0.01 IU/mL for diphtheria (D) and tetanus (T). Level 2: ≥ 100 mIU/mL (Hep B), ≥ 1.0 µg/mL (PRP), and ≥ 0.1 IU/mL (D and T) Level 3, ≥ 1.0 IU/mL (D and T). Anti-polio titers were defined as ≥ 8 (1.dil), and pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by a 4 fold increase from Day 0.


  3. Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine [ Time Frame: Days 0 up to 7 after any injection ]

    Solicited Injection Site Reactions: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.

    Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb reduced; Erythema and swelling, ≥ 5cm; Extensive swelling of limb; Pyrexia, ≥ 39.6ºC; Vomiting ≥ 6 episodes/24 hours or requiring parenteral hydration; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ feeds or most feeds; Irritability, inconsolable.



Eligibility Criteria
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Ages Eligible for Study:   15 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Toddlers previously included in Study A3L11 (NCT00404651) who completed the three-dose primary series vaccination of either DTaP-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 (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.
Contacts and Locations
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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): NCT00654901


Locations
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Mexico
Estado de Mexico, Mexico
Insurgentes Cuicuilco, Mexico
Monterrey, Mexico
Puebla, Mexico
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur, a Sanofi Company
More Information
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Additional Information:

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00654901    
Other Study ID Numbers: A3L21
First Posted: April 9, 2008    Key Record Dates
Results First Posted: June 26, 2013
Last Update Posted: May 13, 2016
Last Verified: April 2016
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Diphtheria
Tetanus
Pertussis
Hepatitis B
 Poliomyelitis
Invasive Haemophilus influenzae type b.
Haemophilus Influenzae Type B Infection
Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Haemophilus Infections
Influenza, Human
Hepatitis B
Poliomyelitis
Hepatitis
Infection
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Hepadnaviridae Infections
DNA Virus Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Clostridium Infections
Gram-Positive Bacterial Infections
Nervous System Diseases
Corynebacterium Infections
Actinomycetales Infections
Myelitis