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Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants

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ClinicalTrials.gov Identifier: NCT00348881
Recruitment Status : Completed
First Posted : July 6, 2006
Results First Posted : October 22, 2013
Last Update Posted : October 22, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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Brief Summary:
This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP~T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks of age.

Condition or disease Intervention/treatment Phase
Diphtheria Tetanus Pertussis Hepatitis B Influenza Biological: DTaP-HB-PRP~T combined vaccine Biological: Tritanrix-HepB/Hib™ vaccine Biological: Oral poliomyelitis vaccine (OPV) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Large Scale Safety and Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix HepB/Hib™, Both Given Concomitantly With OPV at 6, 10, and 14 Weeks of Age in Healthy Filipino Infants
Study Start Date : June 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : June 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1: DTaP-Hep B-PRP-T + OPV vaccine
Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
 Biological: DTaP-HB-PRP~T combined vaccine
0.5 mL, Intramuscular

Biological: Oral poliomyelitis vaccine (OPV)
Oral co-administered with study vaccine.
Active Comparator: Group 2: Tritanrix-HepB/Hib™ + OPV vaccine
Participants received 3 doses of the Tritanrix-HepB/Hib™ concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
 Biological: Tritanrix-HepB/Hib™ vaccine
0.5 mL, Intramuscular

Biological: Oral poliomyelitis vaccine (OPV)
Oral co-administered with study vaccine.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV [ Time Frame: 1 month post third vaccination ]

    Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria.

    Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at 30 days after the third vaccination.


  2. Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV. [ Time Frame: Day 0 to Day 7 post-vaccination ]
    Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.


Secondary Outcome Measures :
  1. Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV [ Time Frame: 1 month post third vaccination ]
    Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies; enzyme immunoassay (EIA) for anti-Tetanus; serum neutralization (SN) for anti-Diphtheria; and enzyme-linked immunosorbent assay (ELISA) for anti-Pertusiss (PT) and anti-Filamentous Hemagglutinin (FHA) titers at Day 150, 1 month after the third vaccination.

  2. Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV [ Time Frame: Day 0 to Day 7 after vaccination ]

    Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability.

    Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal temperature ≥ 39.6ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable.



Eligibility Criteria
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Ages Eligible for Study:   42 Days to 50 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

At Screening:

  • 0 to 3 day old infants
  • Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
  • Apgar score ≥ 7 at three minutes after birth
  • Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)

At Inclusion:

  • Six weeks of age
  • Received a dose of Hepatitis B (HB) in the first three days of life
  • Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

At Screening:

  • Illness at a stage that could interfere with trial conduct or completion
  • Any vaccination before HB vaccination (except bacille Calmette-Guérin [BCG] given at birth)
  • Vaccination planned in the 4 to 6 weeks following the first trial vaccination (except BCG if not given at birth)
  • Acute illness on the day of screening.

At Screening and at Inclusion:

  • Blood or blood-derived products received since birth
  • Planned participation in another clinical trial during the present trial period
  • Mother known as seropositive to Human immunodeficiency virus (HIV) or Hepatitis C, or as carrying the HB surface antigen (HBsAg)
  • Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
  • Known hypersensitivity to any component of any vaccine to be used in the trial (including neomycin and polymixin B)

At Inclusion:

  • Non-trial vaccine administered since birth, except Bacille Calmette-Guérin (BCG)
  • Participation in another clinical trial before the first trial vaccination
  • 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 the trial vaccine or a vaccine containing the same substances
  • Chronic illness at a stage that could interfere with trial conduct or completion
  • Vaccination other than with the study vaccines planned in the 12 weeks following inclusion
  • Documented history of pertussis, tetanus, diphtheria, polio, H. influenza type b, or HB infection (confirmed clinically, serologically, or microbiologically)
  • History of seizures
  • Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.
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): NCT00348881


Locations
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Philippines
Alabang, Muntinlupa City, Philippines
Putatan,, Muntinlupa City, Philippines
Tunasan,, Muntinlupa City, Philippines
Filinvest
Corporate City, Philippines
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.
More Information
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Additional Information:

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00348881    
Other Study ID Numbers: AL201
First Posted: July 6, 2006    Key Record Dates
Results First Posted: October 22, 2013
Last Update Posted: October 22, 2013
Last Verified: August 2013
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Diphtheria
Tetanus
Pertussis
Hepatitis B Hansenula (HB)
Haemophilus influenzae type b
Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hepadnaviridae Infections
 DNA Virus Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Infection
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs