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

Phase 3

Completed

• Conditions: Pertussis; Diphtheria; Tetanus; Hepatitis B; Haemophilus Infections
• Interventions: Biological: DTaP-HB-PRP~T vaccine + OPV; Biological: Tritanrix-HepB/Hib™ + OPV vaccine; Biological: Oral Polio Vaccine

• Registration Number: NCT00343889
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-21
• Study First Submitted QC: 2006-06-21
• Study First Posted: 2006-06-23
• Study Start: 2006-08
• Primary Completion: 2007-11
• Study Completion: 2008-04
• Results First Submitted: 2013-09-09
• Status Verified: 2013-11
• Results First Submitted QC: 2013-11-11
• Last Update Submitted: 2013-11-11
• Results First Posted: 2013-12-10
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 379

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: DTaP-Hep B-PRP-T + Oral Polio Vaccine (OPV) vaccine	DTaP-HB-PRP~T vaccine + OPV	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.
Group 1: DTaP-Hep B-PRP-T + Oral Polio Vaccine (OPV) vaccine	Oral Polio 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.
Group 2: Tritanrix-HepB/Hib™ + OPV vaccine	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.
Group 2: Tritanrix-HepB/Hib™ + OPV vaccine	Oral Polio Vaccine	Participants received 3 doses of Tritanrix-Hep B/Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10, and 14 weeks of age.

Primary Outcome Measures

Name	Time	Method
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	1 month post third vaccination	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

Name	Time	Method
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	1 month post third vaccination	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	1 month post third vaccination	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	1 month post third vaccination	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	1 month post third vaccination	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	Day 0 up to Day 7 after each vaccination	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.