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

NCT00534833 | Completed Phase 3 Results DMC

• 1 other identifier: AL205
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Influenzae Type b

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  28 Days post-vaccination

• 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

  Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 28 days after the Booster vaccination

  Day 28 post-vaccination

Secondary Outcomes (1)

• 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

  Day 0 up to Day 7 post-vaccination

Study Arms (2)

Group 1

EXPERIMENTAL

DTaP-Hep B-PRP-T + OPV vaccine group

Biological: DTaP-HB-PRP~T vaccine; Biological: Oral Polio Vaccine

Group 2

ACTIVE COMPARATOR

Tritanrix-HepB/Hib™ + OPV vaccine group

Biological: Tritanrix-HepB/Hib™; Biological: Oral Polio Vaccine

Interventions

DTaP-HB-PRP~T vaccine BIOLOGICAL

0.5 mL, Intramuscular

Group 1

Tritanrix-HepB/Hib™ BIOLOGICAL

0.5 mL, Intramuscular

Group 2

Oral Polio Vaccine BIOLOGICAL

0.5 mL, Oral

Group 1; Group 2

Eligibility Criteria

• Age: 15 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

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: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2007
• First Posted: September 26, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: March 1, 2009
• Last Updated: November 21, 2013
• Results First Posted: November 21, 2013

Record last verified: 2013-09

Locations

PH (2)