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AzTrials

DiphtheriaPhase 3NCT01214889

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

A Phase 3 study testing PENTAXIM™: DTacP IPV//PRP~T combined vaccine and TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine in people with Diphtheria and Tetanus, run by Sanofi at 14 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 56 to 70 daysHealthy volunteers can take part
Conditions the study is for
Diphtheria, Tetanus, Pertussis
What is being tested?
PENTAXIM™: DTacP IPV//PRP~T combined vaccine and TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
370 participants
Where
14 sitesSouth Korea
Study dates
Sep 2010to Dec 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 56 to 70 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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).
Show all 14Show fewer
  • 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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

South Korea14 sites

  • Study site

    Daejeon, 301723

  • Study site

    Gyeionggi Do, 411706

  • Study site

    Gyeonggi-do, 420767

  • Study site

    Gyeonggi-do, 420818

  • Study site

    Incheon, 400700

  • Study site

    Incheon, 403720

  • Study site

    Incheon, 405760

  • Study site

    Seoul, 110744

  • Study site

    Seoul, 130702

  • Study site

    Seoul, 132703

  • Study site

    Seoul, 133792

  • Study site

    Seoul, 135710

  • Study site

    Seoul, 137701

  • Study site

    Seoul, 158710

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
PENTAXIM™: DTacP IPV//PRP~T combined vaccine, TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine
Keywords
Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type B, Poliomyelitis, PENTAXIM™, TETRAXIM™
Medical subject headings
Diphtheria, Tetanus, Whooping Cough, Poliomyelitis, Haemophilus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PENTAXIM™: DTacP IPV//PRP~T combined vaccineBiological

    Also called PENTAXIM™

    0.5 mL, intramuscular

  • TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccineBiological

    Also called TETRAXIM™, ActHIB™

    0.5 mL of each vaccine; intramuscular

Study groups in NCT01214889
Study groupRoleWhat they receive
Study Group AExperimentalParticipants will receive a single dose of DTacP-IPV//PRP T combined vaccine (PENTAXIM™) at age 2, 4 and 6 months.
Receives: Biological: PENTAXIM™: DTacP IPV//PRP~T combined vaccine
Study Group BActive comparatorParticipants will receive a dose of DTacP IPV combined vaccine (TETRAXIM™) and PRP-T vaccine (ActHIB™) at 2, 4, and 6 months of age.
Receives: Biological: TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 month post-dose 3 vaccination

Secondary outcomes (1)

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

    Measured: Day 0 up to Day 157

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionNov 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
370 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01214889
Sponsor's protocol ID
E2I49
Other IDs
U1111-1115-6381
Status last verified
Apr 2012
First submitted
1 Oct 2010
Last updated
17 Apr 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27510380

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PENTAXIM™: DTacP IPV//PRP~T combined vaccine and TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine in people with Diphtheria and Tetanus, run by Sanofi at 14 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01214889, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2012.

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