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Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status
Completed
Phase
Phase 3
Locations
Philippines
Study Type
Interventional
Intervention
DTaP-HB-PRP~T combined vaccine
Tritanrix-HepB/Hib™ vaccine
Oral poliomyelitis vaccine (OPV)
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

42 Days - 50 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: At Screening: 0 to 3 day old infants Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg Apgar score ≥ 7 at three minutes after birth Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate) At Inclusion: Six weeks of age Received a dose of Hepatitis B (HB) in the first three days of life Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: At Screening: Illness at a stage that could interfere with trial conduct or completion Any vaccination before HB vaccination (except bacille Calmette-Guérin [BCG] given at birth) Vaccination planned in the 4 to 6 weeks following the first trial vaccination (except BCG if not given at birth) Acute illness on the day of screening. At Screening and at Inclusion: Blood or blood-derived products received since birth Planned participation in another clinical trial during the present trial period Mother known as seropositive to Human immunodeficiency virus (HIV) or Hepatitis C, or as carrying the HB surface antigen (HBsAg) Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination Known hypersensitivity to any component of any vaccine to be used in the trial (including neomycin and polymixin B) At Inclusion: Non-trial vaccine administered since birth, except Bacille Calmette-Guérin (BCG) Participation in another clinical trial before the first trial vaccination Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances Chronic illness at a stage that could interfere with trial conduct or completion Vaccination other than with the study vaccines planned in the 12 weeks following inclusion Documented history of pertussis, tetanus, diphtheria, polio, H. influenza type b, or HB infection (confirmed clinically, serologically, or microbiologically) History of seizures Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.

Sites / Locations

  • Filinvest

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1: DTaP-Hep B-PRP-T + OPV vaccine

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

Arm Description

Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.

Participants received 3 doses of the Tritanrix-HepB/Hib™ concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.

Outcomes

Primary Outcome Measures

Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Seroprotection 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. Seroprotection was 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 30 days after the third vaccination.
Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV.
Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.

Secondary Outcome Measures

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
Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies; enzyme immunoassay (EIA) for anti-Tetanus; serum neutralization (SN) for anti-Diphtheria; and enzyme-linked immunosorbent assay (ELISA) for anti-Pertusiss (PT) and anti-Filamentous Hemagglutinin (FHA) titers at Day 150, 1 month after the third vaccination.
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability. Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal 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.

Full Information

First Posted
July 5, 2006
Last Updated
August 15, 2013
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00348881
Brief Title
Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants
Official Title
Large Scale Safety and Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix HepB/Hib™, Both Given Concomitantly With OPV at 6, 10, and 14 Weeks of Age in Healthy Filipino Infants
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
June 2008 (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
This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP~T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks of age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis, Hepatitis B, Influenza
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: DTaP-Hep B-PRP-T + OPV vaccine
Arm Type
Experimental
Arm Description
Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
Arm Title
Group 2: Tritanrix-HepB/Hib™ + OPV vaccine
Arm Type
Active Comparator
Arm Description
Participants received 3 doses of the Tritanrix-HepB/Hib™ concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
Intervention Type
Biological
Intervention Name(s)
DTaP-HB-PRP~T combined vaccine
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Tritanrix-HepB/Hib™ vaccine
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Oral poliomyelitis vaccine (OPV)
Intervention Description
Oral co-administered with study vaccine.
Primary Outcome Measure Information:
Title
Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Description
Seroprotection 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. Seroprotection was 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 30 days after the third vaccination.
Time Frame
1 month post third vaccination
Title
Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV.
Description
Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.
Time Frame
Day 0 to Day 7 post-vaccination
Secondary Outcome Measure Information:
Title
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
Description
Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies; enzyme immunoassay (EIA) for anti-Tetanus; serum neutralization (SN) for anti-Diphtheria; and enzyme-linked immunosorbent assay (ELISA) for anti-Pertusiss (PT) and anti-Filamentous Hemagglutinin (FHA) titers at Day 150, 1 month after the third vaccination.
Time Frame
1 month post third vaccination
Title
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Description
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability. Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal 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.
Time Frame
Day 0 to Day 7 after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
50 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: At Screening: 0 to 3 day old infants Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg Apgar score ≥ 7 at three minutes after birth Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate) At Inclusion: Six weeks of age Received a dose of Hepatitis B (HB) in the first three days of life Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: At Screening: Illness at a stage that could interfere with trial conduct or completion Any vaccination before HB vaccination (except bacille Calmette-Guérin [BCG] given at birth) Vaccination planned in the 4 to 6 weeks following the first trial vaccination (except BCG if not given at birth) Acute illness on the day of screening. At Screening and at Inclusion: Blood or blood-derived products received since birth Planned participation in another clinical trial during the present trial period Mother known as seropositive to Human immunodeficiency virus (HIV) or Hepatitis C, or as carrying the HB surface antigen (HBsAg) Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination Known hypersensitivity to any component of any vaccine to be used in the trial (including neomycin and polymixin B) At Inclusion: Non-trial vaccine administered since birth, except Bacille Calmette-Guérin (BCG) Participation in another clinical trial before the first trial vaccination Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances Chronic illness at a stage that could interfere with trial conduct or completion Vaccination other than with the study vaccines planned in the 12 weeks following inclusion Documented history of pertussis, tetanus, diphtheria, polio, H. influenza type b, or HB infection (confirmed clinically, serologically, or microbiologically) History of seizures Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.
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
Alabang
State/Province
Muntinlupa City
Country
Philippines
City
Putatan,
State/Province
Muntinlupa City
Country
Philippines
City
Tunasan,
State/Province
Muntinlupa City
Country
Philippines
Facility Name
Filinvest
City
Corporate City
Country
Philippines

12. IPD Sharing Statement

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

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Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants

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