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InfantPhase 3NCT00355654

Study to Compare Booster Vaccination With Pediacel® to Infanrix® Hexa When Both Are Co-Administered With Prevenar®

A Phase 3 study testing DT5aP-IPV-Hib 5-component Pertussis vaccine and DT3aP-HBs-IPV in people with Infant and Healthy, run by Sanofi Pasteur, a Sanofi Company at 84 sites in Germany.

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 the study is to provide data on the safety and immunogenicity of Pediacel® to allow its use as a fourth dose administered to 11-18 months old toddlers at the same time as Prevenar®. Read more about this study

Who is it for?
Ages 11 to 18 monthsHealthy volunteers can take part
Conditions the study is for
Infant, Healthy
What is being tested?
DT5aP-IPV-Hib 5-component Pertussis vaccine and DT3aP-HBs-IPV
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
847 participants
Where
84 sitesGermany
Study dates
Sep 2006to Jul 2008
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 11 to 18 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Toddlers 11-18 months of age (from the 11th month birthday to one day prior to the 19th month birthday) who previously received the primary immunisation series with a hexavalent vaccine (consisting of three doses of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and Haemophilus influenza type b combined vaccine administered within the first 6 months of life)
  • Informed consent form signed by both parents or by the legal guardian
  • Parents or a legal guardian able to read and write the local language
  • Parents or a legal guardian able to attend all scheduled visits and to comply with the study procedures.

Who cannot join

  • Presence of fever (defined as rectal body temperature ≥ 38.0°C) reported within the last 72 hours
  • Moderate or severe acute illness with or without fever
  • Participation in another clinical trial in the 30 days preceding study vaccination
  • Planned participation in another clinical trial during the present study period
  • Immunisation with a pneumococcal vaccine prior to study vaccination or planned during the participation in the study
  • Received more than 3 doses of a hexavalent vaccine prior to study vaccination
Show all 16Show fewer
  • Received any vaccination in the 30 days preceding the trial
  • History of serological/microbiologically-confirmed diagnosis of infection due to pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae
  • Congenital or acquired humoral/cellular immunodeficiency or immunosuppressive therapy such as long-term systemic corticosteroids therapy (≥ 2 mg/kg/day prednisone equivalent for ≥ 14 days in the 30 days prior to study vaccination)
  • Systemic or local hypersensitivity to any of the study vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde)
  • History of a life-threatening reaction (such as encephalopathy, Hypotonic-Hyporesponsive Episode (HHE), rectal body temperature ≥ 40.0°C, convulsions with or without fever) to any vaccine containing the same components as the study vaccines
  • Blood or blood-derived products (immunoglobulins) received during 3 months prior to study vaccination
  • Known HIV seropositivity
  • Known thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
  • History of encephalopathy, seizures or progressive, evolving or unstable neurological condition
  • Clinically significant findings on review of systems that might interfere with study vaccination or which, in the opinion of the Investigator, would interfere with the evaluation of the study vaccine/objectives or pose a health risk to the subject.

Trial locations and contacts

84 sites in 1 country.

84 sites in 1 country

Germany84 sites

  • Study site

    Aalen, 73433

  • Study site

    Aisch, 91413

  • Study site

    Alsfeld, 36304

  • Study site

    Augsburg, 86150

  • Study site

    Bad Oeynhausen, 32549

  • Study site

    Bad Säckingen, 79713

  • Study site

    Berlin, 10115

  • Study site

    Berlin, 10783

  • Study site

    Berlin, 13125

  • Study site

    Berlin, 13403

  • Study site

    Bernau B. Berlin, 16321

  • Study site

    Bielefeld, 33611

  • Study site

    Bönnigheim, 74357

  • Study site

    Bramsche, 49565

  • Study site

    Bretten, 75015

  • Study site

    Cham, 93413

  • Study site

    Cologne, 51145

  • Study site

    Datteln, 45711

  • Study site

    Detmold, 32756

  • Study site

    Eisenberg, 07607

  • Study site

    Erfurt, 99086

  • Study site

    Espelkamp, 32339

  • Study site

    Frankenthal, 67227

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Freiburg im Breisgau, 79111

  • Study site

    Gerolstein, 54568

  • Study site

    Gersthofen, 86368

  • Study site

    Goch, 47574

  • Study site

    Göttingen, 37083

  • Study site

    Gütersloh, 33332

  • Study site

    Hamburg, 22305

  • Study site

    Hamburg, 22415

  • Study site

    Hechtsheim, 55129

  • Study site

    Herbolzheim, 79336

  • Study site

    Herrsching am Ammersee, 82211

  • Study site

    Jena, 07745

  • Study site

    Karlsruhe, 76137

  • Study site

    Karlstadtm, 97753

  • Study site

    Kehl, 77694

  • Study site

    Kempten, 87435

  • Study site

    Königstein/Taunus, 61462

  • Study site

    Korbach, 34497

  • Study site

    Krefeld, 47829

  • Study site

    Landshut, 84032

  • Study site

    Lauf/Pegnitz, 91207

  • Study site

    Lauffen am Neckar, 74348

  • Study site

    Leinfelden-Echte, 70771

  • Study site

    Lindenberg, 88161

  • Study site

    Lingen 49 (Ems), 49808

  • Study site

    Ludwigshafen, 67053

  • Study site

    Ludwigshafen, 67069

  • Study site

    Magdeburg, 39116

  • Study site

    Magdeburg, 39130

  • Study site

    Mainz, 55116

  • Study site

    Mainz, 55118

  • Study site

    Mannheim, 68167

  • Study site

    Marburg, 35039

  • Study site

    Marktoberdorf, 87616

  • Study site

    Marktredwitz, 95615

  • Study site

    Melle, 49324

  • Study site

    Mönchengladbach, 41061

  • Study site

    Mönchengladbach, 41068

  • Study site

    Mönchengladbach, 41236

  • Study site

    München, 80634

  • Study site

    München, 80939

  • Study site

    München, 81241

  • Study site

    München, 81479

  • Study site

    München, 81735

  • Study site

    Nabburg, 92507

  • Study site

    Neumünster, 24534

  • Study site

    Niedernhausen, 65527

  • Study site

    Prüm, 54595

  • Study site

    Schwäbisch Gmünd, 73525

  • Study site

    Schwäbisch Hall, 74523

  • Study site

    Schwieberdingen, 71701

  • Study site

    Solingen, 42699

  • Study site

    Solingen, 42719

  • Study site

    Traunreut, 83301

  • Study site

    Ulm, 89077

  • Study site

    Unterschleissheim, 85716

  • Study site

    Weinheim, 69469

  • Study site

    Wiesbaden, 65205

  • Study site

    Wildeshausen, 27793

  • Study site

    Wolfenbüttel, 38300

Other trials in Germany

About this study

Official title: Safety and Immunogenicity of Booster Vaccination With PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed), Compared to Booster Vaccination With Infanrix® Hexa When Both Vaccines Are Co-Administered With Prevenar® to Toddlers 11-18 Months of Age

The purpose of the study is to provide data on the safety and immunogenicity of Pediacel® to allow its use as a fourth dose administered to 11-18 months old toddlers at the same time as Prevenar®.

Primary Objective:

To evaluate the safety of Pediacel® booster dose co-administered with Prevenar® to toddlers at 11-18 months of age.

Secondary Objectives:

  • To describe the incidence rate of severe fever within four days post-vaccination
  • To describe the antibody responses to all antigens in a subgroup of subjects at baseline and post-vaccination.
Conditions
Infant, Healthy
Being tested
DT5aP-IPV-Hib 5-component Pertussis vaccine, DT3aP-HBs-IPV
Keywords
Diphtheria, Tetanus, Pertussis, Poliomyelitis, Haemophilus influenzae type b, Hepatitis B
Medical subject headings
Diphtheria, Tetanus, Whooping Cough, Poliomyelitis, Haemophilus Infections, Hepatitis B

What participants receive

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

  • DT5aP-IPV-Hib 5-component Pertussis vaccineBiological

    Also called Pediacel™

    0.5 mL, IM

  • DT3aP-HBs-IPVBiological

    Also called Infanrix® hexa

    0.5 mL, IM

Study groups in NCT00355654
Study groupRoleWhat they receive
Group 1ExperimentalParticipants will receive PEDIACEL with Prevenar at Visit 1 and ENGERIX-B Kinder at Visit 2
Receives: Biological: DT5aP-IPV-Hib 5-component Pertussis vaccine
Group 2Active comparatorParticipants will receive Infanrix hexa with Prevenar at Visit 1
Receives: Biological: DT3aP-HBs-IPV

What is being measured

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

  1. To provide information concerning the safety after administration of PEDIACEL® booster dose

    Measured: 0 to 3 Days post-vaccination

Secondary outcomes (1)

  1. To provide information concerning the safety (as fever rate) after administration of PEDIACEL® Vaccine

    Measured: 4 days post-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 Jul 2006 (estimated)
  2. Study startSep 2006
  3. Primary completionSep 2007
  4. Study completionJul 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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
847 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00355654
Sponsor's protocol ID
A5I19
Status last verified
Jan 2015
First submitted
20 Jul 2006
Last updated
7 Jan 2015
Results posted
No
Data monitoring committee
No

Publications

  • Berner R, Boisnard F, Thomas S, Mwawasi G, Reynolds D. Safety and immunogenicity of fully liquid DTaP(5)-IPV-Hib pediatric combination vaccine (Pediacel(R)) compared to DTaP(3)-HBV-IPV/Hib (Infanrix(R) Hexa) when coadministered with heptavalent pneumococcal conjugate vaccine (PCV7) as a booster at 11-18 months of age: a phase III, modified double-blind, randomized, controlled, multicenter study. Vaccine. 2012 Jul 27;30(35):5270-7. doi: 10.1016/j.vaccine.2012.05.064. Epub 2012 Jun 9.

    PubMed 22691430

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DT5aP-IPV-Hib 5-component Pertussis vaccine and DT3aP-HBs-IPV in people with Infant and Healthy, run by Sanofi Pasteur, a Sanofi Company at 84 sites in Germany.

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 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 7 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in Germany. 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?

To provide information concerning the safety after administration of PEDIACEL® booster dose (time frame: 0 to 3 Days post-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 NCT00355654, 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 7 Jan 2015.

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