search
Back to results

Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants.

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PENTAXIM™: DTacP IPV//PRP~T combined vaccine
TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria focused on measuring Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type B, Poliomyelitis, PENTAXIM™, TETRAXIM™

Eligibility Criteria

56 Days - 70 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 2 months (56 to 70 days) inclusive on the day of inclusion
  • Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
  • Informed consent form signed by the parent(s) or other legal representative
  • 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 inclusion
  • Planned participation in another clinical trial during the present trial period
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as long term systemic corticosteroids 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
  • Blood or blood derived products received in the past or current or planned administration during the trial (including immunoglobulins).
  • Any vaccination in the 3 weeks preceding the first trial vaccination.
  • History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically).
  • Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus (HIV) infection
  • Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection with the trial vaccine or another vaccine.
  • Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
  • History of/current major neurological diseases or seizures.
  • Febrile illness (axillary temperature ≥ 38ºC) or acute illness on the day of inclusion.
  • Known family history of congenital or genetic immuno-deficiency.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Group A

Study Group B

Arm Description

Participants will receive a single dose of DTacP-IPV//PRP T combined vaccine (PENTAXIM™) at age 2, 4 and 6 months.

Participants will receive a dose of DTacP IPV combined vaccine (TETRAXIM™) and PRP-T vaccine (ActHIB™) at 2, 4, and 6 months of age.

Outcomes

Primary Outcome Measures

Non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3, Polyribosyl Ribitol Phosphate conjugated to Tetanus protein) of PENTAXIM™ Vaccine to the Tetraxim™ and PRP~T conjugate (Act-HIB™) vaccines.

Secondary Outcome Measures

Information regarding the safety (in terms of solicited injection site and systemic reactions) of PENTAXIM™ vaccine.

Full Information

First Posted
October 1, 2010
Last Updated
April 13, 2012
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT01214889
Brief Title
Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants.
Official Title
Immunogenicity and Safety of the Sanofi Pasteur's DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Versus Sanofi Pasteur's DTacP-IPV Combined Vaccine (TETRAXIM™) Given Simultaneously at Separate Sites With PRP~T Conjugate Vaccine (ACTHIB™) as a Three-dose Primary Vaccination at 2, 4 and 6 Months of Age in South Korean Infants
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to assess the immunogenicity and safety of PENTAXIM™ combined vaccine versus TETRAXIM™ vaccine to support registration of PENTAXIM™ in South Korea. Primary Objective: To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3, Polyribosyl Ribitol Phosphate [PRP]) and vaccine response rates to acellular Pertussis antigens of sanofi pasteur's PENTAXIM™ vaccine versus sanofi pasteur's TETRAXIM™ and Act (Haemophilus influenzae type b) HIB™ vaccines, one month after the three-dose primary vaccination.
Detailed Description
All participants will receive three primary doses of their assigned study the vaccine, on Days 0, 60, and 120. They will be assessed for immunogenicity on Day 0 before vaccination and Day 150 post-vaccination. Safety will be assessed for all participants throughout the study, up to Day 157.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis, Poliomyelitis, Haemophilus Influenzae Type B
Keywords
Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type B, Poliomyelitis, PENTAXIM™, TETRAXIM™

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Study Group A
Arm Type
Experimental
Arm Description
Participants will receive a single dose of DTacP-IPV//PRP T combined vaccine (PENTAXIM™) at age 2, 4 and 6 months.
Arm Title
Study Group B
Arm Type
Active Comparator
Arm Description
Participants will receive a dose of DTacP IPV combined vaccine (TETRAXIM™) and PRP-T vaccine (ActHIB™) at 2, 4, and 6 months of age.
Intervention Type
Biological
Intervention Name(s)
PENTAXIM™: DTacP IPV//PRP~T combined vaccine
Other Intervention Name(s)
PENTAXIM™
Intervention Description
0.5 mL, intramuscular
Intervention Type
Biological
Intervention Name(s)
TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine
Other Intervention Name(s)
TETRAXIM™, ActHIB™
Intervention Description
0.5 mL of each vaccine; intramuscular
Primary Outcome Measure Information:
Title
Non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3, Polyribosyl Ribitol Phosphate conjugated to Tetanus protein) of PENTAXIM™ Vaccine to the Tetraxim™ and PRP~T conjugate (Act-HIB™) vaccines.
Time Frame
1 month post-dose 3 vaccination
Secondary Outcome Measure Information:
Title
Information regarding the safety (in terms of solicited injection site and systemic reactions) of PENTAXIM™ vaccine.
Time Frame
Day 0 up to Day 157

10. Eligibility

Sex
All
Minimum Age & Unit of Time
56 Days
Maximum Age & Unit of Time
70 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 2 months (56 to 70 days) inclusive on the day of inclusion Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg Informed consent form signed by the parent(s) or other legal representative 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 inclusion Planned participation in another clinical trial during the present trial period Congenital or acquired immunodeficiency, immunosuppressive therapy such as long term systemic corticosteroids 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 Blood or blood derived products received in the past or current or planned administration during the trial (including immunoglobulins). Any vaccination in the 3 weeks preceding the first trial vaccination. History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically). Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus (HIV) infection Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection with the trial vaccine or another vaccine. Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination History of/current major neurological diseases or seizures. Febrile illness (axillary temperature ≥ 38ºC) or acute illness on the day of inclusion. Known family history of congenital or genetic immuno-deficiency.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur SA
Official's Role
Study Director
Facility Information:
City
Daejeon
ZIP/Postal Code
301723
Country
Korea, Republic of
City
Gyeionggi do
ZIP/Postal Code
411706
Country
Korea, Republic of
City
Gyeonggi-do
ZIP/Postal Code
420767
Country
Korea, Republic of
City
Gyeonggi-do
ZIP/Postal Code
420818
Country
Korea, Republic of
City
Incheon
ZIP/Postal Code
400700
Country
Korea, Republic of
City
Incheon
ZIP/Postal Code
403720
Country
Korea, Republic of
City
Incheon
ZIP/Postal Code
405760
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
110744
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
130702
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
132703
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
133792
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135710
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
137701
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
158710
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27510380
Citation
Kang JH, Lee HJ, Kim KH, Oh SH, Cha SH, Lee J, Kim NH, Eun BW, Kim CH, Hong YJ, Kim HH, Lee KY, Kim YJ, Cho EY, Kim HS, Guitton F, Ortiz E. The Immunogenicity and Safety of a Combined DTaP-IPV//Hib Vaccine Compared with Individual DTaP-IPV and Hib (PRP~T) Vaccines: a Randomized Clinical Trial in South Korean Infants. J Korean Med Sci. 2016 Sep;31(9):1383-91. doi: 10.3346/jkms.2016.31.9.1383.
Results Reference
derived
Links:
URL
http://www.sanofipasteur.com
Description
Related Info

Learn more about this trial

Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants.

We'll reach out to this number within 24 hrs