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

NCT00343889 | Completed Phase 3 Results DMC

• 1 other identifier: AL203
• Study Type: interventional
• Target: 379
• Locations: 1 country
• Sites: 2

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.

Conditions

Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Infections

Keywords

Diphtheria; Tetanus; Pertussis; Hepatitis B Hansenula (HB); Haemophilus influenzae type b; Haemophilus Influenzae

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  1 month post third vaccination

Secondary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Group 1: DTaP-Hep B-PRP-T + Oral Polio Vaccine (OPV) vaccine

EXPERIMENTAL

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; Biological: Oral Polio Vaccine

Group 2: Tritanrix-HepB/Hib™ + OPV vaccine

ACTIVE COMPARATOR

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; Biological: Oral Polio Vaccine

Interventions

DTaP-HB-PRP~T vaccine + OPV BIOLOGICAL

0.5 mL, Intramuscular

Group 1: DTaP-Hep B-PRP-T + Oral Polio Vaccine (OPV) vaccine

Tritanrix-HepB/Hib™ + OPV vaccine BIOLOGICAL

0.5 mL, Intramuscular

Group 2: Tritanrix-HepB/Hib™ + OPV vaccine

Oral Polio Vaccine BIOLOGICAL

Oral co-administered with study vaccine

Group 1: DTaP-Hep B-PRP-T + Oral Polio Vaccine (OPV) vaccine; Group 2: Tritanrix-HepB/Hib™ + OPV vaccine

Eligibility Criteria

• Age: 42 Days - 50 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (2)

Unknown Facility

Manila, Philippines

Location

Unknown Facility

Quezon City, Philippines

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Haemophilus Infections

Interventions

diphtheria-tetanus-acellular pertussis-Hib-hepatitis B vaccine; Poliovirus Vaccine, Oral

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Pasteurellaceae Infections

Intervention Hierarchy (Ancestors)

Poliovirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2006
• First Posted: June 23, 2006
• Study Start: August 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: April 1, 2008
• Last Updated: December 10, 2013
• Results First Posted: December 10, 2013

Record last verified: 2013-11

Locations

PH (2)