Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00343889
First received: June 21, 2006
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to support the registration of the pentavalent DTaP-HB-PRP~T vaccine in countries that follow the World Health Organization-Expanded Program of Immunization (WHO-EPI) schedule.

The primary objective is:

  • To demonstrate that the pentavalent DTaP-HB-PRP~T combined vaccine does not induce a lower immune response than Tritanrix-HepB/Hib™ in terms of the seroprotection rate to hepatitis B (HB) one month after a 3-dose primary series at 6, 10, and 14 weeks of age.

The secondary objectives are:

  • To describe in each group the immunogenicity parameters one month after the 3-dose primary series at 6, 10, and 14 weeks of age; and
  • To evaluate the overall safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix-HepB/Hib™, Both Given Concomitantly With the Oral Polio Vaccine at 6, 10, and 14 Weeks of Age in Healthy Infants in the Philippines

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV [ Time Frame: 1 month post third vaccination ] [ Designated as safety issue: No ]

    Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies.

    Seroprotection was defined as titers ≥ 10 mIU/mL at 30 days after the third vaccination.



Secondary Outcome Measures:
  • Number of Participants With Anti-Hepatitis B Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV [ Time Frame: 1 month post third vaccination ] [ Designated as safety issue: No ]

    Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies.

    Anti-Hepatitis B Responses was defined as titers ≥ 100 mIU/mL at 30 days after the third vaccination.


  • 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 ] [ Designated as safety issue: No ]
    Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 1 month after the third vaccination (Day 150).

  • Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV [ Time Frame: 1 month post third vaccination ] [ Designated as safety issue: No ]

    Immunogenicity was assessed by means of radioimmunoassay (RIA) for Diphtheria and Tetanus antibodies.

    Anti-Diphtheria and anti-tetanus Responses were assayed at ≥ 0.01 IU/mL and at ≥ 0.1 IU/mL at 30 days after the third vaccination.


  • Number of Participants With Seroconversion for Anti-Pertussis and Anti-Filamentous Hemagglutinin 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 ] [ Designated as safety issue: No ]

    Anti-Pertussis toxoid and Anti-Filamentous Hemagglutinin antibodies were assessed by means of enzyme immunoassay (EIA).

    Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.


  • Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each 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 after each 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 defined as: Tenderness - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - 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.



Enrollment: 379
Study Start Date: August 2006
Study Completion Date: April 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: DTaP-Hep B-PRP-T + Oral Polio Vaccine (OPV) vaccine
Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
Biological: DTaP-HB-PRP~T vaccine + OPV
0.5 mL, Intramuscular
Biological: Oral Polio Vaccine
Oral co-administered with study vaccine
Active Comparator: Group 2: Tritanrix-HepB/Hib™ + OPV vaccine
Participants received 3 doses of Tritanrix-Hep B/Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10, and 14 weeks of age.
Biological: Tritanrix-HepB/Hib™ + OPV vaccine
0.5 mL, Intramuscular
Biological: Oral Polio Vaccine
Oral co-administered with study vaccine

  Eligibility

Ages Eligible for Study:   42 Days to 50 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Six week old infants (42 to 50 days old) on the day of inclusion; of either gender.
  • Mother tested as seronegative for hepatitis B surface antigen (HBsAg) between 28 weeks of pregnancy and up to 4 days after delivery
  • Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
  • Informed consent form signed by one parent or other legal representative if appropriate (independent witness is 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 first trial 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.
  • Chronic illness at a stage that could interfere with the conduct or completion of the trial
  • Blood or blood-derived products received since birth
  • HB vaccination since birth
  • Any vaccination in the four weeks preceding the first trial vaccination
  • Any planned vaccination (except trial vaccines and bacillus Calmette-Guerin (BCG) during the trial
  • Documented history of pertussis, tetanus (T), diphtheria (D), polio, or Haemophilus influenzae type b (Hib) infection(s) (confirmed either clinically, serologically, or microbiologically)
  • Known personal or maternal history of HIV, HBsAg or hepatitis C seropositivity
  • Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination
  • History of seizures
  • Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343889

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: NCT00343889     History of Changes
Other Study ID Numbers: AL203
Study First Received: June 21, 2006
Results First Received: September 9, 2013
Last Updated: November 11, 2013
Health Authority: Philippines: Department of Health

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

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

ClinicalTrials.gov processed this record on September 16, 2014