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DiphtheriaPhase 3NCT02094833

DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants

A Phase 3 study testing DTaP-IPV-Hep B-PRP~T combined vaccine and DTaP-IPV//PRP~T and Hepatitis B vaccine in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 16 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

The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep B-PRP~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6 months of age compared to Sanofi Pasteur's DTaP-IPV//PRP~T combined vaccine (Pentaxim™) given at 2, 4, and 6 months of age and Hep B… Read more about this study

Who is it for?
Ages 1 month to 6 monthsHealthy volunteers can take part
Conditions the study is for
Diphtheria, Tetanus, Pertussis
What is being tested?
DTaP-IPV-Hep B-PRP~T combined vaccine and DTaP-IPV//PRP~T and Hepatitis B vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
310 participants
Where
16 sitesSouth Korea
Study dates
Mar 2014to Nov 2016
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 1 month to 6 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Aged 30 to 40 days on the day of the first study visit
  • Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
  • Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative
  • Participant and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
  • Born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is available)
  • Have received one documented dose of Hep B vaccine at birth according to the national recommendations.

Who cannot join

  • Participation in the 4 weeks preceding the trial inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
  • Receipt of any vaccine in the 4 weeks preceding any trial vaccination (except Bacille Calmette Guerin (BCG) vaccine) or planned receipt of any vaccine in the 8 days following any trial vaccination
  • Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (except the dose of Hep B vaccine given at birth) diseases or Haemophilus influenzae type b infection with either the trial vaccine or another vaccine
  • Past or current receipt of immune globulins, blood or blood-derived products or planned administration during the trial
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
  • Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity
Show all 15Show fewer
  • History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infection, confirmed either clinically, serologically, or microbiologically
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
  • Known thrombocytopenia, as reported by the parent/legally acceptable representative
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
  • In an emergency setting, or hospitalized involuntarily
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
  • Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
  • History of seizures.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

South Korea16 sites

  • Study site

    Daejeon, 301 724

  • Study site

    Gyeonggi-do, 425 707

  • Study site

    Gyeonggi-do

  • Study site

    Gyeongsangnam Do, 641 560

  • Study site

    Gyeongsangnam Do

  • Study site

    Jeollabuk Do, 570 711

  • Study site

    Jeonbuk, 561 712

  • Study site

    Kangwon Do, 220 701

  • Study site

    Kyunggi Do, 420 717

  • Study site

    Seoul, 120 752

  • Study site

    Seoul, 130 87

  • Study site

    Seoul, 137 701

  • Study site

    Seoul, 139 709

  • Study site

    Seoul, 158 710

  • Study site

    Seoul

  • Study site

    Suwon Gyeonggi Do, 442 723

Other trials in South Korea

About this study

Official title: Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP~T Combined Vaccine at 2, 4, and 6 Months of Age Versus Sanofi Pasteur's DTaP IPV//PRP~T Combined Vaccine at 2, 4, and 6 Months of Age + Hep B Vaccine at 1 and 6 Months of Age, in South Korean Infants Primed With Hep B at Birth

The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep B-PRP~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6 months of age compared to Sanofi Pasteur's DTaP-IPV//PRP~T combined vaccine (Pentaxim™) given at 2, 4, and 6 months of age and Hep B vaccine (Euvax B®) given at 1 and 6 months of age in South Korean infants that received a birth dose of Hep B and born to mothers documented to be serum anti-HBs Ag negative.

Primary Objective

Read more
  • To demonstrate the non-inferiority in terms of seroprotection (Diphtheria, Tetanus, poliovirus types 1, 2, and 3, PRP-T, Hep B) and vaccine response for pertussis antigens (pertussis toxoid [PT] and filamentous haemagglutinin [FHA]) of Group A versus Group B, one month after the third dose of combined vaccines.

Secondary Objectives:

  • To further study the immunogenicity of the two vaccination schemes, before the first dose and one month after the last dose of vaccines.
  • To study the safety after each and any dose of vaccines administered in the two vaccination schemes
Read the detailed description

Study participants who received a first dose of recombinant Hep B vaccine at birth will receive either DTaP-IPV-Hep B-PRP~T combined vaccine at 2, 4, and 6 months of age + 3 doses of Hep B vaccine or Hep B vaccine (Euvax B®) at 1 and 6 months of age and DTaP IPV//PRP~T combined vaccine (Pentaxim™) at 2, 4, and 6 months of age, according to the official vaccination schedule for Hep B, DTaP, poliovirus, and Hib vaccinations in South Korea.

Being tested
DTaP-IPV-Hep B-PRP~T combined vaccine, DTaP-IPV//PRP~T and Hepatitis B vaccine
Keywords
Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b infection, Hepatitis B, DTaP-IPV-Hep - PRP-T vaccine
Medical subject headings
Diphtheria, Tetanus, Whooping Cough, Haemophilus Infections, Poliomyelitis, Hepatitis B

What participants receive

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

  • DTaP-IPV-Hep B-PRP~T combined vaccineBiological

    0.5 mL, Intramuscular

  • DTaP-IPV//PRP~T and Hepatitis B vaccineBiological

    Also called Pentaxim™, Euvax B®

    0.5 mL, Intramuscular

Study groups in NCT02094833
Study groupRoleWhat they receive
Group AExperimentalParticipants will receive 3 injections of the study vaccine (DTaP-IPV-Hep B-PRP~T combined vaccine) at 2, 4, and 6 months of age
Receives: Biological: DTaP-IPV-Hep B-PRP~T combined vaccine
Group BActive comparatorParticipants will receive 2 injections of monovalent Hep B vaccine (Euvax B®) at age 1 and 6 months and 3 injections of DTaP IPV//PRP~T vaccine (Pentaxim™) at age 2, 4, and 6 months
Receives: Biological: DTaP-IPV//PRP~T and Hepatitis B vaccine

What is being measured

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

  1. Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 International Units (IU)/mL

    Anti-Diphtheria antibodies will be measured by a toxin neutralization test

    Measured: 1 month post third vaccination

  2. Number of participants with anti-Tetanus antibody concentrations ≥ 0.1 International unit (IU)/mL

    Anti-Tetanus antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).

    Measured: 1 month post third vaccination

  3. Number of participants with ≥ 4 fold increase in anti-PT and anti-FHA antibody concentrations (EU/mL) from 1 month pre-dose 1 to 1 month post-dose 3

    Anti-PT and anti-FHA antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).

    Measured: I month post dose 3

Secondary outcomes (5)

  1. Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 IU/mL and ≥ 0.1 IU/mL International Units (IU)/mL

    Anti-Diphtheria antibodies will be measured by a toxin neutralization test

    Measured: Day 0 Pre-vaccination

  2. Number of participants with anti-Hepatitis B antibody concentrations ≥ 10 mIU/mL international unit (IU)/mL

    Anti-Hepatitis B antibodies will be measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System using chemiluminescence detection technology

    Measured: Day 0 Pre-vaccination

  3. Number of participants with anti Diphtheria antibody concentrations ≥ 0.1 IU/mL International Units (IU)/mL

    Anti-Diphtheria antibodies will be measured by a toxin neutralization test

    Measured: 1 month post third vaccination

  4. Number of participants reporting solicited injection site and solicited systemic reactions, unsolicited adverse events, and serious adverse events following vaccination with either DTaP-IPV-Hep B-PRP~T combined vaccine or Pentaxim™ and Euvax B® vaccine

    Solicited injection site reactions Tenderness, Erythema, and Swelling. Solicited systemic reactions Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite loss, and Irritability.

    Measured: Day 0 and up to Day 180 post-vaccination

  5. Number of participants with response to vaccine Pertussis toxoid (PT) and Filamentous Haemagglutinin (FHA) antigens

    Vaccine response defined as: Post-dose 3 anti-PT and anti-FHA antibody concentrations in ELISA units (EU)/mL ≥ 4 x Lower Limit of Quantitation (LLOQ) if pre-vaccination concentration is < 4 x LLOQ or ≥ pre-vaccination concentration if pre-vaccination concentrations ≥ 4 x LLOQ

    Measured: 1 month post third vaccination

Timeline

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

  1. First posted24 Mar 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionApr 2016
  4. Study completionNov 2016

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
310 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02094833
Sponsor's protocol ID
A3L31
Other IDs
U1111-1127-6896
Status last verified
Apr 2017
First submitted
20 Mar 2014
Last updated
26 Apr 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DTaP-IPV-Hep B-PRP~T combined vaccine and DTaP-IPV//PRP~T and Hepatitis B vaccine in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 16 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 6 inclusion and 15 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 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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?

Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 International Units (IU)/mL (time frame: 1 month post third vaccination). The study lists 3 primary outcomes in all. 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 NCT02094833.

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 26 Apr 2017.

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