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Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00534833
First Posted: September 26, 2007
Last Update Posted: November 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
  Purpose

The present trial is a follow-up of AL203 study (NCT00343889).

Primary Objectives:

To describe the antibody persistence at 15 to 18 months of age and the booster effect of a dose of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ (given concomitantly with Oral Polio Vaccine [OPV]).

Secondary Objective:

To describe the safety profile of a booster dose of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ when administered concomitantly with OPV in each vaccine group.


Condition Intervention Phase
Diphtheria Tetanus Pertussis Hepatitis B Haemophilus Influenzae Type b Biological: DTaP-HB-PRP~T vaccine Biological: Tritanrix-HepB/Hib™ Biological: Oral Polio Vaccine Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity Study of the Antibody Persistence and Booster Effect of DTaP-Hep B-PRP-T Combined Vaccine or Tritanrix HepB/Hib™ at 15 to 18 Months of Age Following a Primary Series at 6, 10 and 14 Weeks of Age in Healthy Filipino Infants

Resource links provided by NLM:


Further study details as provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Primary Outcome Measures:
  • Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV [ Time Frame: 28 Days post-vaccination ]

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

    Booster responses 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 Day 28 after the third vaccination; Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) 4-fold increase, and individual titers ratio.


  • Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV [ Time Frame: Day 28 post-vaccination ]
    Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 28 days after the Booster vaccination


Secondary Outcome Measures:
  • Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV [ Time Frame: Day 0 up to Day 7 post-vaccination ]

    Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.

    Grade 3 reactions are defined as: Tenderness - cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.5ºC; 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.



Enrollment: 362
Study Start Date: September 2007
Study Completion Date: March 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
DTaP-Hep B-PRP-T + OPV vaccine group
Biological: DTaP-HB-PRP~T vaccine
0.5 mL, Intramuscular
Biological: Oral Polio Vaccine
0.5 mL, Oral
Active Comparator: Group 2
Tritanrix-HepB/Hib™ + OPV vaccine group
Biological: Tritanrix-HepB/Hib™
0.5 mL, Intramuscular
Biological: Oral Polio Vaccine
0.5 mL, Oral

Detailed Description:
Study participants will receive a booster vaccination of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ either concomitantly with Oral Polio Vaccine (OPV) following the completion of a three dose primary series with DTaP-Hep B-PRP-T combined vaccine or Tritanrix HepB/Hib™, both given concomitantly with OPV. Participants will receive a booster dose of the vaccine they had received in the primary series, and a concomitant dose of OPV Study AL203 (NCT00343889).
  Eligibility

Information from the National Library of Medicine

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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:

  • Toddler aged 15 to 18 months of age on the day of inclusion (range: 456 days to 578 days of age inclusive)
  • Participated in the AL203 study and completed the three-dose primary series with either DTaP-HB-PRP~T or Tritanrix-HepB/Hib™, and OPV, at 6, 10 and 14 weeks of age
  • Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)
  • 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 trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the preceding 3 months
  • Known 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 trial vaccination
  • Vaccination planned in the 4 weeks following the trial vaccination
  • Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion
  • History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B or poliomyelitis infection(s) (confirmed either clinically, serologically, or microbiologically)
  • Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B, or poliovirus 3 types antigen since the end of the primary series
  • Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination
  • Serious adverse event related to any vaccination in the AL203 study.
  Contacts and Locations
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): NCT00534833


Locations
Philippines
Manila, Philippines
Quezon City, Philippines
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00534833     History of Changes
Other Study ID Numbers: AL205
First Submitted: September 24, 2007
First Posted: September 26, 2007
Results First Submitted: September 19, 2013
Results First Posted: November 21, 2013
Last Update Posted: November 21, 2013
Last Verified: September 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:
Hepatitis
Hepatitis B
Whooping Cough
Tetanus
Diphtheria
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Vaccines
Antibodies
Immunologic Factors
Physiological Effects of Drugs