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

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status
Completed
Phase
Phase 3
Locations
Philippines
Study Type
Interventional
Intervention
DTaP-HB-PRP~T vaccine
Tritanrix-HepB/Hib™
Oral Polio Vaccine
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria focused on measuring Diphtheria, Tetanus, Pertussis, Hepatitis B Hansenula (HB), Haemophilus influenzae type b

Eligibility Criteria

15 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Toddler aged 15 to 18 months of age on the day of inclusion (range: 456 days to 578 days of age inclusive)
  • 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

Exclusion Criteria:

  • 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
  • Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion
  • 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

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

Tritanrix-HepB/Hib™ + OPV vaccine group

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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
Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 reactions are defined as: Tenderness - cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.5ºC; 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.

Full Information

First Posted
September 24, 2007
Last Updated
September 19, 2013
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00534833
Brief Title
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™
Official Title
Immunogenicity Study of the Antibody Persistence and Booster Effect of DTaP-Hep B-PRP-T Combined Vaccine or Tritanrix HepB/Hib™ at 15 to 18 Months of Age Following a Primary Series at 6, 10 and 14 Weeks of Age in Healthy Filipino Infants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Study participants will receive a booster vaccination of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ either concomitantly with Oral Polio Vaccine (OPV) following the completion of a three dose primary series with DTaP-Hep B-PRP-T combined vaccine or Tritanrix HepB/Hib™, both given concomitantly with OPV. Participants will receive a booster dose of the vaccine they had received in the primary series, and a concomitant dose of OPV Study AL203 (NCT00343889).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus Influenzae Type b
Keywords
Diphtheria, Tetanus, Pertussis, Hepatitis B Hansenula (HB), Haemophilus influenzae type b

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
362 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
DTaP-Hep B-PRP-T + OPV vaccine group
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Tritanrix-HepB/Hib™ + OPV vaccine group
Intervention Type
Biological
Intervention Name(s)
DTaP-HB-PRP~T vaccine
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Tritanrix-HepB/Hib™
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Oral Polio Vaccine
Intervention Description
0.5 mL, Oral
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
28 Days post-vaccination
Title
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
Description
Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 28 days after the Booster vaccination
Time Frame
Day 28 post-vaccination
Secondary Outcome Measure Information:
Title
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
Description
Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 reactions are defined as: Tenderness - cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.5ºC; 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.
Time Frame
Day 0 up to Day 7 post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Toddler aged 15 to 18 months of age on the day of inclusion (range: 456 days to 578 days of age inclusive) 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 Exclusion Criteria: 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 Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Manila
Country
Philippines
City
Quezon City
Country
Philippines

12. IPD Sharing Statement

Links:
URL
http://www.sanofipasteur.com
Description
Related Info

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

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