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TetanusPhase 3NCT02274285

DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants

A Phase 3 study testing DTaP-IPV/Hib Combined vaccine and DTaP-IPV vaccine and Hib vaccine in people with Tetanus and Diphtheria, run by Sanofi Pasteur, a Sanofi Company at 12 sites in Japan.

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

Primary objective: To demonstrate the non-inferiority in terms of seroprotection rates (Hib antigen (PRP), Diphtheria, Tetanus, and Pertussis antigens (PT and FHA), and polio types 1, 2 and 3 antigens) of investigational arm (Group A: DTaP-IPV/Hib) versus control arm (Group B: DTaP-IPV and Hib vaccines administered at… Read more about this study

Who is it for?
Ages 2 to 68 monthsHealthy volunteers can take part
Conditions the study is for
Tetanus, Diphtheria, Pertussis
What is being tested?
DTaP-IPV/Hib Combined vaccine and DTaP-IPV vaccine and Hib vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
424 participants
Where
12 sitesJapan
Study dates
Oct 2014to 28 May 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 2 to 68 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Aged 2 months to 68 months inclusive (recommended 3 to 8 months for Groups A and B; 2 months for Group C) on the day of inclusion
  • 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

  • Fever ≥ 37.5°C (axillary temperature) on the day of inclusion
  • Any serious disease whether acute or chronic
  • Past or current medical history of Guillain-Barre syndrome, acute thrombocytopenic purpura or encephalopathy
  • History of diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b infections
  • History of a life threatening reaction to a vaccine containing the same substances of the study vaccine
  • History of anaphylaxis to any of the study vaccine components
Show all 16Show fewer
  • Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis or Haemophilus influenzae type b infections with a trial vaccine or another vaccine
  • Congenital or current acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
  • Participation in another clinical trial preceding the trial inclusion
  • Planned participation in another clinical trial during the present trial period
  • Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins)
  • Any vaccination with live vaccines within the past 27 days preceding the first trial vaccination
  • Any vaccination with inactivated vaccines within the past 6 days preceding the first trial vaccination
  • Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection
  • Subject ineligible according to the Investigator's clinical judgment
  • Identified as employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family member (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Japan12 sites

  • Study site

    Aichi

  • Study site

    Chiba

  • Study site

    Fukui

  • Study site

    Fukuoka

  • Study site

    Gunma

  • Study site

    Hokkaido

  • Study site

    Miyagi

  • Study site

    Nagano

  • Study site

    Osaka

  • Study site

    Shizuoka

  • Study site

    Tokyo

  • Study site

    Yamanashi

Other trials in Japan

About this study

Official title: Immunogenicity and Safety of the DTaP-IPV/Hib Vaccine SP0204) Given as Three-dose Primary and One-dose Booster Vaccinations Versus Co-administration of DTaP-IPV Vaccine (DD-687) and Hib Vaccine (DF-098) in Infants in Japan

Primary objective:

  • To demonstrate the non-inferiority in terms of seroprotection rates (Hib antigen (PRP), Diphtheria, Tetanus, and Pertussis antigens (PT and FHA), and polio types 1, 2 and 3 antigens) of investigational arm (Group A: DTaP-IPV/Hib) versus control arm (Group B: DTaP-IPV and Hib vaccines administered at separate sites), one month after the primary vaccination (all antigens).
Read more

Secondary objectives:

  • To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4) in the two study groups (Group A and Group B).
  • To describe the safety after each dose of each vaccine in the two study groups (Group A and Group B).
  • To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4 (Group C)
Read the detailed description

Participants will be enrolled in two steps (Cohort 1 and Cohort 2). Step one will enroll Cohort 1 made of 40 participants randomized in two groups with a 1:1 ratio.

After review of the local and systemic adverse events occurring during the 7 Days following the first dose administered in these subjects, 2nd vaccination of Cohort 1 participants will resume and enrollment of the participants of Cohort number 2 will start. Step two will enroll Cohort 2 made of subjects randomized in two groups with a 1:1 ratio.

A sub-study Group C will be enrolled and will receive the vaccine by intramuscular route.

Being tested
DTaP-IPV/Hib Combined vaccine, DTaP-IPV vaccine and Hib vaccine
Keywords
Tetanus, Diphtheria, Pertussis, Poliomyelitis, Bacterial meningitis, DTaP-IPV/Hib Combination vaccine
Medical subject headings
Tetanus, Diphtheria, Whooping Cough, Poliomyelitis, Meningitis, Bacterial

What participants receive

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

  • DTaP-IPV/Hib Combined vaccineBiological

    Also called SP0204

    0.5 mL, Subcutaneously. 3 times, each given 3 to 8 weeks apart

  • DTaP-IPV vaccine and Hib vaccineBiological

    Also called DD 687; DF 098

    0.5 mL each, Subcutaneously, 3 times, each given 3 to 8 weeks apart

  • DTaP-IPV/Hib Combined vaccineBiological

    Also called SP0204

    0.5 mL, Intramuscularly. 3 times, each given 4 to 8 weeks apart

Study groups in NCT02274285
Study groupRoleWhat they receive
Group A (SP0204)ExperimentalParticipants will receive DTaP-IPV/Hib vaccine administered subcutaneously
Receives: Biological: DTaP-IPV/Hib Combined vaccine
Group B (control)Active comparatorParticipants will be given a co-administration of DTaP-IPV vaccine and Hib vaccine subcutaneously
Receives: Biological: DTaP-IPV vaccine and Hib vaccine
Group CExperimentalParticipants will receive DTaP-IPV/Hib vaccine administered intramuscularly
Receives: Biological: DTaP-IPV/Hib Combined vaccine

What is being measured

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

  1. Percentage of participants with anti-Diphtheria level ≥ 0.1 IU/mL post-dose 3

    Anti-Diphtheria antibody titers will be assayed by neutralization test on Vero cells culture in comparison to the WHO equine antitoxin standard (seroneutralization)

    Measured: 21 Days post-dose 3

Secondary outcomes (3)

  1. Percentage of participants with Seroprotection to vaccine antigens following vaccination

    Seroprotection is defined as: percentage of participants with anti-Diphtheria and anti Tetanus antibody levels ≥0.01, ≥0.1 and ≥1.0 IU/mL

    Measured: Day 0 (pre-vaccination ) and 21 Days post-dose 3

  2. Geometric Mean Titer (GMT) of antibodies to vaccine antigens following vaccination

    Anti-Diphtheria antibody titers will be assayed by neutralization test on Vero cells culture in comparison to the WHO equine antitoxin standard (seroneutralization)

    Measured: 21 Days post-dose 3

  3. Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events post vaccination with DTaP IPV/Hib vaccine.

    Solicited injection site reactions: Tenderness, Erythema, Swelling and Induration; Solicited Systemic Reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost and Irritability.

    Measured: Day 0 (post-vaccination) up to 21 days post each 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 Oct 2014 (estimated)
  2. Study startOct 2014
  3. Primary completion28 May 2016
  4. Study completion28 May 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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
424 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02274285
Sponsor's protocol ID
J2I02 (EFC13640)
Other IDs
U1111-1143-9112
Status last verified
Apr 2022
First submitted
22 Oct 2014
Last updated
25 Apr 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Nakayama T, Vidor E, Tsuzuki D, Nishina S, Sasaki T, Ishii Y, Mizukami H, Tsuge H. Immunogenicity and safety of a DTaP-IPV/Hib pentavalent vaccine given as primary and booster vaccinations in healthy infants and toddlers in Japan. J Infect Chemother. 2020 Jul;26(7):651-659. doi: 10.1016/j.jiac.2019.11.012. Epub 2020 Apr 16.

    PubMed 32307307

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DTaP-IPV/Hib Combined vaccine and DTaP-IPV vaccine and Hib vaccine in people with Tetanus and Diphtheria, run by Sanofi Pasteur, a Sanofi Company at 12 sites in Japan.

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 3 inclusion and 16 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 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Japan. 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?

Percentage of participants with anti-Diphtheria level ≥ 0.1 IU/mL post-dose 3 (time frame: 21 Days post-dose 3). 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 NCT02274285, 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 25 Apr 2022.

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