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DiphtheriaPhase 3NCT00343889

Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine

A Phase 3 study testing DTaP-HB-PRP~T vaccine + OPV, Tritanrix-HepB/Hib™ + OPV vaccine and Oral Polio Vaccine in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 2 sites in Philippines.

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 purpose of this study is to support the registration of the pentavalent DTaP-HB-PRP~T vaccine in countries that follow the World Health Organization-Expanded Program of Immunization (WHO-EPI) schedule. Read more about this study

Who is it for?
Ages 42 to 50 daysHealthy volunteers can take part
Conditions the study is for
Diphtheria, Tetanus, Pertussis
What is being tested?
DTaP-HB-PRP~T vaccine + OPV, Tritanrix-HepB/Hib™ + OPV vaccine and Oral Polio Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
379 participants
Where
2 sitesPhilippines
Study dates
Aug 2006to Apr 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 42 to 50 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Six week old infants (42 to 50 days old) on the day of inclusion; of either gender.
  • Mother tested as seronegative for hepatitis B surface antigen (HBsAg) between 28 weeks of pregnancy and up to 4 days after delivery
  • Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
  • Informed consent form signed by one parent or other legal representative if appropriate (independent witness is mandatory if parent is illiterate)
  • 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.
  • Chronic illness at a stage that could interfere with the conduct or completion of the trial
  • Blood or blood-derived products received since birth
  • HB vaccination since birth
Show all 13Show fewer
  • Any vaccination in the four weeks preceding the first trial vaccination
  • Any planned vaccination (except trial vaccines and bacillus Calmette-Guerin (BCG) during the trial
  • Documented history of pertussis, tetanus (T), diphtheria (D), polio, or Haemophilus influenzae type b (Hib) infection(s) (confirmed either clinically, serologically, or microbiologically)
  • Known personal or maternal history of HIV, HBsAg or hepatitis C seropositivity
  • Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination
  • History of seizures
  • Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.

Trial locations and contacts

2 sites in 1 country.

Philippines2 sites

  • Study site

    Manila

  • Study site

    Quezon City

Other trials in Philippines

About this study

Official title: Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix-HepB/Hib™, Both Given Concomitantly With the Oral Polio Vaccine at 6, 10, and 14 Weeks of Age in Healthy Infants in the Philippines

The purpose of this study is to support the registration of the pentavalent DTaP-HB-PRP~T vaccine in countries that follow the World Health Organization-Expanded Program of Immunization (WHO-EPI) schedule.

The primary objective is:

Read more
  • To demonstrate that the pentavalent DTaP-HB-PRP~T combined vaccine does not induce a lower immune response than Tritanrix-HepB/Hib™ in terms of the seroprotection rate to hepatitis B (HB) one month after a 3-dose primary series at 6, 10, and 14 weeks of age.

The secondary objectives are:

  • To describe in each group the immunogenicity parameters one month after the 3-dose primary series at 6, 10, and 14 weeks of age; and
  • To evaluate the overall safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.
Being tested
DTaP-HB-PRP~T vaccine + OPV, Tritanrix-HepB/Hib™ + OPV vaccine, Oral Polio Vaccine
Keywords
Diphtheria, Tetanus, Pertussis, Hepatitis B Hansenula (HB), Haemophilus influenzae type b, Haemophilus Influenzae
Medical subject headings
Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Haemophilus Infections

What participants receive

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

  • DTaP-HB-PRP~T vaccine + OPVBiological

    0.5 mL, Intramuscular

  • Tritanrix-HepB/Hib™ + OPV vaccineBiological

    0.5 mL, Intramuscular

  • Oral Polio VaccineBiological

    Oral co-administered with study vaccine

Study groups in NCT00343889
Study groupRoleWhat they receive
Group 1: DTaP-Hep B-PRP-T + Oral Polio Vaccine (OPV) vaccineExperimentalParticipants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
Receives: Biological: DTaP-HB-PRP~T vaccine + OPV; Biological: Oral Polio Vaccine
Group 2: Tritanrix-HepB/Hib™ + OPV vaccineActive comparatorParticipants received 3 doses of Tritanrix-Hep B/Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10, and 14 weeks of age.
Receives: Biological: Tritanrix-HepB/Hib™ + OPV vaccine; Biological: Oral Polio Vaccine

What is being measured

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

  1. Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV

    Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies.

    Seroprotection was defined as titers ≥ 10 mIU/mL at 30 days after the third vaccination.

    Measured: 1 month post third vaccination

Secondary outcomes (5)

  1. Number of Participants With Anti-Hepatitis B Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV

    Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies.

    Anti-Hepatitis B Responses was defined as titers ≥ 100 mIU/mL at 30 days after the third vaccination.

    Measured: 1 month post third vaccination

  2. Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV

    Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 1 month after the third vaccination (Day 150).

    Measured: 1 month post third vaccination

  3. Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV

    Immunogenicity was assessed by means of radioimmunoassay (RIA) for Diphtheria and Tetanus antibodies.

    Anti-Diphtheria and anti-tetanus Responses were assayed at ≥ 0.01 IU/mL and at ≥ 0.1 IU/mL at 30 days after the third vaccination.

    Measured: 1 month post third vaccination

  4. Number of Participants With Seroconversion for Anti-Pertussis and Anti-Filamentous Hemagglutinin Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV

    Anti-Pertussis toxoid and Anti-Filamentous Hemagglutinin antibodies were assessed by means of enzyme immunoassay (EIA).

    Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.

    Measured: 1 month post third vaccination

  5. Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV

    Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.

    Grade 3 reactions defined as: Tenderness - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.6ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable.

    Measured: Day 0 up to Day 7 after 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 posted23 Jun 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionNov 2007
  4. Study completionApr 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
Single blind
Who is masked
Outcomes assessor
Enrolment
379 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00343889
Sponsor's protocol ID
AL203
Status last verified
Nov 2013
First submitted
21 Jun 2006
Last updated
10 Dec 2013
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DTaP-HB-PRP~T vaccine + OPV, Tritanrix-HepB/Hib™ + OPV vaccine and Oral Polio Vaccine in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 2 sites in Philippines.

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 5 inclusion and 13 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 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Philippines. 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 10 Dec 2013). 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?

Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV (time frame: 1 month post third 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 NCT00343889.

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 10 Dec 2013.

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