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AzTrials

Hepatitis BPhase 3NCT00315055

Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule

A Phase 3 study testing DTaP-IPV-HB-PRP~T vaccine, DTaP-IPV//PRP~T combined and Hepatitis B vaccine in people with Hepatitis B and Polio, run by Sanofi Pasteur, a Sanofi Company at 1 site in Turkey (Türkiye).

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

To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP~T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series. Immunogenicity To assess pre- and post-primary series To assess pre- and post-booster series. Read more about this study

Who is it for?
Ages 50 to 71 daysHealthy volunteers can take part
Conditions the study is for
Hepatitis B, Polio, Diphtheria
What is being tested?
DTaP-IPV-HB-PRP~T vaccine, DTaP-IPV//PRP~T combined and Hepatitis B vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
310 participants
Where
1 siteTurkey (Türkiye)
Study dates
Jul 2006to Feb 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 to 71 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Two-month old infants of either gender on the day of inclusion
  • Born at full term of pregnancy (>=37 weeks) with a birth weight >=2.5 kg
  • Informed consent form signed by the parent(s) or other legal representative(s) and an institution official other than an investigator
  • 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 first trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • 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 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 since birth
Show all 14Show fewer
  • Any vaccination (except BCG) in the 4 weeks preceding the first trial vaccination
  • Vaccination planned in the 4 weeks following trial vaccination
  • History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
  • Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity
  • Previous vaccination against pertussis, tetanus, diphtheria, polio or Hib, and HB infection(s)
  • Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
  • History of seizures
  • Febrile (axillary temperature 37.4°C [rectal equivalent temperature >=38.0°C]) or acute illness on the day of inclusion.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Study site

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2, 3, and 4 Months Primary Schedule in Healthy Turkish Infants

To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP~T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series.

Immunogenicity

  • To assess pre- and post-primary series
  • To assess pre- and post-booster series.
Being tested
DTaP-IPV-HB-PRP~T vaccine, DTaP-IPV//PRP~T combined, Hepatitis B vaccine
Keywords
Hepatitis B, Polio, Diphtheria, Pertussis, H influenzae type b
Medical subject headings
Hepatitis B, Poliomyelitis, Diphtheria, Whooping Cough, Haemophilus Infections

What participants receive

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

  • DTaP-IPV-HB-PRP~T vaccineBiological

    0.5 mL, Intramuscular (IM)

  • DTaP-IPV//PRP~T combinedBiological

    Also called PENTAXIM™

    0.5 mL, IM

  • Hepatitis B vaccineBiological

    Also called ENGERIX B®

    0.5 mL, IM

Study groups in NCT00315055
Study groupRoleWhat they receive
Group 1: DTaP-IPV-Hep B-PRP-TExperimentalParticipants will receive 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T); One dose each at 2, 3, and 4 months of age.
Receives: Biological: DTaP-IPV-HB-PRP~T vaccine
Group 2: PENTAXIM™ and ENGERIX B® PEDIATRICActive comparatorParticipants will receive 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines. One dose each at 2, 3, and 4 months of age.
Receives: Biological: DTaP-IPV//PRP~T combined; Biological: Hepatitis B vaccine

What is being measured

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

  1. Percentage of Participants With Anti HBs Seroprotection After the 3 Dose Primary Vaccination Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® Vaccines

    Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Seroprotection was defined as a titer ≥ 10 mIU/mL.

    Measured: Day 90 post first dose

Secondary outcomes (5)

  1. Percentage of Participants With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B®

    Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to Polyribosyl ribitol phosphate and tetanus were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet. Seroprotection was defined as: titers ≥ 100 mIU/mL for HBs; ≥ 0.01 and ≥ 0.1 IU/mL for anti-Tetanus and anti-diphtheria, and ≥ 0.15 µg/mL and ≥ 1.0 µg/mL for anti-PRP.

    Measured: Day 90 post first dose

  2. Percentage of Participants With Seroprotection Against Poliovirus Antigens After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®

    Antibodies to poliovirus types 1, 2, and 3 were measured by microneutralization on Vero cell culture. Seroprotection was defined as titers ≥8 1/dil.

    Measured: Day 90 post first dose

  3. Percentage of Participants With Anti-Pertussis Seroconversion After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®

    Antibodies to pertussis toxoid (PT) and filamentous hemagglutinin (FHA) were measured by means of enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4-fold increase in titer between baseline (Day 0 pre-vaccination and Day 30 post-dose 3 (Day 90).

    Measured: Day 0 (pre-vaccination) and Day 30 post-dose 3

  4. Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®

    Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to PRP, tetanus, pertussis toxoid (PT), and filamentous hemagglutinin (FHA) were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet.

    Measured: Day 90 (30 Days post-dose 3)

  5. Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®

    Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability

    Measured: Day 0 to Day 7 post any dose

Timeline

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

  1. First posted17 Apr 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionJul 2007
  4. Study completionFeb 2008

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
NCT00315055
Sponsor's protocol ID
A3L10
Status last verified
Sep 2014
First submitted
13 Apr 2006
Last updated
12 Sep 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DTaP-IPV-HB-PRP~T vaccine, DTaP-IPV//PRP~T combined and Hepatitis B vaccine in people with Hepatitis B and Polio, run by Sanofi Pasteur, a Sanofi Company at 1 site in Turkey (Türkiye).

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 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). 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?

Yes. Results are posted in the registry (first posted 4 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 HBs Seroprotection After the 3 Dose Primary Vaccination Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® Vaccines (time frame: Day 90 post first dose). 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 NCT00315055.

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 12 Sep 2014; AzTrials last refreshed its copy on 8 Nov 2026.

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