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:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00534833
First received: September 24, 2007
Last updated: September 19, 2013
Last verified: September 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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

Ages Eligible for Study:   15 Months to 18 Months
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00534833     History of Changes
Other Study ID Numbers: AL205
Study First Received: September 24, 2007
Results First Received: September 19, 2013
Last Updated: September 19, 2013
Health Authority: Philippines: Department of Health

Keywords provided by Sanofi:
Diphtheria
Tetanus
Pertussis
Hepatitis B Hansenula (HB)
Haemophilus influenzae type b

Additional relevant MeSH terms:
Diphtheria
Hepatitis
Hepatitis B
Actinomycetales Infections
Bacterial Infections
Corynebacterium Infections
Digestive System Diseases
DNA Virus Infections
Gram-Positive Bacterial Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014