Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants

NCT00514709 | Completed Phase 3 Results DMC

• 1 other identifier: AL204
• Study Type: interventional
• Target: 1,843
• Locations: 1 country
• Sites: 7

Brief Summary

DTaP-HB-PRP\~T combined vaccine is being developed in order to comply with expanding programs for immunization in infancy, while offering the benefit of a reduced number of injections, and potentially of an increased acceptance. Primary Objectives:

• To describe the antibody persistence at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP\~T or Tritanrix-Hep B/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hepatitis B (Hep B) vaccine given at birth.
• To describe the effect of a booster dose of DTaP-HB-PRP\~T on immunogenicity at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP\~T or Tritanrix HepB/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hep B vaccine given at birth. Secondary Objective:
• To describe the safety profile of the booster dose of the DTaP-HB-PRP\~T vaccine when administered concomitantly with Oral Polio Vaccine (OPV).

Conditions

Diphtheria; Tetanus; Pertussis; Hepatitis B; Influenza

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)

  Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) 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; Pertussis Toxoid and Filamentous Hemagglutinin (FHA) 4-fold increase and booster response.

  Day 0 (pre-vaccination) and Day 28 post-booster vaccination

Secondary Outcomes (2)

• Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)

  Day 0 (pre-vaccination) and Day 28 post-vaccination

• Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)

  Day 0 up to Day 7 after vaccination

Study Arms (2)

Group 1

EXPERIMENTAL

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

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

Group 2

EXPERIMENTAL

Tritanrix-HepB/Hib™ + OPV vaccine group

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

Interventions

DTaP-HB PRP~T Combined Vaccine BIOLOGICAL

0.5 mL, Intramuscular (IM)

Group 1

DTaP-HB-PRP~T vaccine BIOLOGICAL

0.5 mL, IM

Group 2

Oral Polio Vaccine BIOLOGICAL

Oral co-administered with study vaccine.

Group 1; Group 2

Eligibility Criteria

• Age: 12 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participated in the AL201 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, and received hepatitis B vaccine at birth
• 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 IM vaccination
• Serious adverse event related to any vaccination in the AL201 study.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (7)

Unknown Facility

City of Muntinlupa, Alabang Junction Alabang, Philippines

Location

Unknown Facility

City of Muntinlupa, Alabang, Philippines

Location

Unknown Facility

City of Muntinlupa, Bayanan Annex, Philippines

Location

Unknown Facility

City of Muntinlupa, Cupang, Philippines

Location

Unknown Facility

City of Muntinlupa, Filinvest, Philippines

Location

Unknown Facility

City of Muntinlupa, Putatan, Philippines

Location

Unknown Facility

City of Muntinlupa, Tunasan, Philippines

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Influenza, Human; 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; Orthomyxoviridae Infections; RNA Virus Infections; 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: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2007
• First Posted: August 10, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: April 1, 2009
• Last Updated: August 2, 2016
• Results First Posted: November 14, 2013

Record last verified: 2016-07

Locations

PH (7)