Allogeneic Haematopoietic Stem Cell TransplantationPhase 3NCT00169728
Vaccination of Children Following Allogeneic Stem Cell Transplantation
A Phase 3 study testing DTaP-IPV-HBV/Hib combination vaccine, Infanrix hexa and heptavalent pneumococcal conjugate vaccine, Prevenar in people with Allogeneic Haematopoietic Stem Cell Transplantation, run by Heinrich-Heine University, Duesseldorf at 11 sites in Germany.
Trial summary
The purpose of this study is to determine the immunogenicity and tolerability of the DTaP-IPV-HBV/Hib combination vaccine Infanrix hexa and the heptavalent pneumococcal conjugate vaccine Prevenar in pediatric recipients of allogeneic haematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Allogeneic Haematopoietic Stem Cell Transplantation
- What is being tested?
- DTaP-IPV-HBV/Hib combination vaccine, Infanrix hexa and heptavalent pneumococcal conjugate vaccine, Prevenar
- Type of treatment
- Vaccines
- How many people
- 53 participants
- Where
- 11 sitesGermany
- Study dates
- Sep 2003to Oct 2006
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric recipient of allogeneic haematopoietic stem cell transplantation
- complete remission of underlying malignant disease (if applicable)
- stable haematopoietic engraftment
- Lansky-/Karnofsky-score >= 60%
Who cannot join
- primary immunodeficiency
- hepatitis B or C, HIV infection
- application of radio-/ chemotherapy following stem cell transplantation
- extended chronic graft-versus-host disease (Karnofsky-scale < 60%)
- coagulopathy
- known allergy/hypersensitivity towards ingredients of study vaccines
- seizure disorder, progressive neurologic disease
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
University Childrens Hospital
Berlin, D-13353
University Children Hospital
Düsseldorf, D-40225
University Children Hospital
Erlangen, D-91054
University Children Hospital
Frankfurt, D-60590
University Childrens Hospital
Freiburg im Breisgau, D-79106
University Childrens Hospital
Giessen, D-35385
University Childrens Hospital
Hamburg, D-20246
University Childrens Hospital
Hanover, D-30625
University Childrens Hospital
Jena, D-07740
University Childrens Hospital
Münster, D-48129
University Childrens Hospital
Tübingen, D-72076
About this study
Official title: Immunogenicity of the DTaP-IPV-HBV/Hib Combination Vaccine Infanrix Hexa and the Heptavalent Pneumococcal Conjugate Vaccine Prevenar in Pediatric Recipients of Allogeneic Haematopoietic Stem Cell Transplantation
The purpose of this study is to determine the immunogenicity and tolerability of the DTaP-IPV-HBV/Hib combination vaccine Infanrix hexa and the heptavalent pneumococcal conjugate vaccine Prevenar in pediatric recipients of allogeneic haematopoietic stem cell transplantation.
- Being tested
- DTaP-IPV-HBV/Hib combination vaccine, Infanrix hexa, heptavalent pneumococcal conjugate vaccine, Prevenar
- Keywords
- allogeneic haematopoietic stem cell transplantation, bone marrow transplantation, children, vaccination, invasive pneumococcal disease, tetanus, diphtheria, poliomyelitis, pertussis, Hepatitis B, Haemophilus influenzae type B infection
- Medical subject headings
- Tetanus, Diphtheria, Poliomyelitis, 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-IPV-HBV/Hib combination vaccine, Infanrix hexaBiological
heptavalent pneumococcal conjugate vaccine, PrevenarBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
serologic response at 1 months following primary three dose vaccination series
Measured: first month
Secondary outcomes (3)
serologic response at 1 months following booster immunization
Measured: first month
tolerability of primary and booster vaccination
Measured: at least monthly
identification of factors influencing immunogenicity and tolerability of study vaccines
Measured: at least monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionJun 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Allogeneic Haematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer, GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Dagmar Dilloo, MD, PhD, Principal investigator, University Hospital Duesseldorf, Department of Pediatric Oncolgy, Hematolgy and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169728
- Sponsor's protocol ID
- IKAST-01
- Status last verified
- Jun 2012
- First submitted
- 13 Sep 2005
- Last updated
- 7 Jun 2012
- Results posted
- No
Publications
Meisel R, Laws HJ, Dilloo D. Vaccination of pediatric recipients of allogeneic hematopoietic stem cell grafts using a hexavalent combination vaccine and a pneumococcal conjugate vaccine - a prospective trial of the PÄD-AG-KBT - Bone Marrow Transplantation 30(S1): S63, 2002 (abstract)
Meisel R, Dilloo D. Pneumococcal vaccination of children after hematopoietic stem cell transplantation: timing is crucial. Clin Infect Dis. 2007 Aug 1;45(3):397-8; author reply 398-9. doi: 10.1086/518981. No abstract available.
PubMed 17599322Hilgendorf I, Freund M, Jilg W, Einsele H, Gea-Banacloche J, Greinix H, Halter J, Lawitschka A, Wolff D, Meisel R. Vaccination of allogeneic haematopoietic stem cell transplant recipients: report from the international consensus conference on clinical practice in chronic GVHD. Vaccine. 2011 Apr 5;29(16):2825-33. doi: 10.1016/j.vaccine.2011.02.018. Epub 2011 Feb 20.
PubMed 21345379Meisel R, Kuypers L, Dirksen U, Schubert R, Gruhn B, Strauss G, Beutel K, Groll AH, Duffner U, Blutters-Sawatzki R, Holter W, Feuchtinger T, Gruttner HP, Schroten H, Zielen S, Ohmann C, Laws HJ, Dilloo D; Impfung von Kindern nach allogener Stammzelltransplantation (IKAST) Study Group. Pneumococcal conjugate vaccine provides early protective antibody responses in children after related and unrelated allogeneic hematopoietic stem cell transplantation. Blood. 2007 Mar 15;109(6):2322-6. doi: 10.1182/blood-2006-06-032284. Epub 2006 Nov 7.
PubMed 17090650
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of the DTaP-IPV-HBV/Hib Combination Vaccine Infanrix Hexa and the Heptavalent Pneumococcal Conjugate Vaccine Prevenar in Pediatric Recipients of Allogeneic Haematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00169728
- Acronym / sponsor ID
- IKAST-01
- Keywords
- allogeneic haematopoietic stem cell transplantation, bone marrow transplantation, children, vaccination, invasive pneumococcal disease, tetanus, diphtheria, poliomyelitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer, GlaxoSmithKline
- Study start
- Sep 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the immunogenicity and tolerability of the DTaP-IPV-HBV/Hib combination vaccine Infanrix hexa and the heptavalent pneumococcal conjugate vaccine Prevenar in pediatric recipients of allogeneic haematopoietic stem cell transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- pediatric recipient of allogeneic haematopoietic stem cell transplantation
- complete remission of underlying malignant disease (if applicable)
- stable haematopoietic engraftment
- Lansky-/Karnofsky-score >= 60%
Key exclusion criteria (7 listed)
- primary immunodeficiency
- hepatitis B or C, HIV infection
- application of radio-/ chemotherapy following stem cell transplantation
- extended chronic graft-versus-host disease (Karnofsky-scale < 60%)
- coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DTaP-IPV-HBV/Hib combination vaccine, Infanrix hexa | Biological | – |
| heptavalent pneumococcal conjugate vaccine, Prevenar | Biological | – |
Primary outcome
serologic response at 1 months following primary three dose vaccination series
Time frame: first month
3 secondary outcomes
serologic response at 1 months following booster immunization
Time frame: first month
tolerability of primary and booster vaccination
Time frame: at least monthly
identification of factors influencing immunogenicity and tolerability of study vaccines
Time frame: at least monthly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
- BackgroundMeisel R, Laws HJ, Dilloo D. Vaccination of pediatric recipients of allogeneic hematopoietic stem cell grafts using a hexavalent combination vaccine and a pneumococcal conjugate vaccine - a prospective trial of the PÄD-AG-KBT - Bone Marrow Transplantation 30(S1): S63, 2002 (abstract)
- Background: PubMed 17599322Meisel R, Dilloo D. Pneumococcal vaccination of children after hematopoietic stem cell transplantation: timing is crucial. Clin Infect Dis. 2007 Aug 1;45(3):397-8; author reply 398-9. doi: 10.1086/518981. No abstract available.
- Background: PubMed 21345379Hilgendorf I, Freund M, Jilg W, Einsele H, Gea-Banacloche J, Greinix H, Halter J, Lawitschka A, Wolff D, Meisel R. Vaccination of allogeneic haematopoietic stem cell transplant recipients: report from the international consensus conference on clinical practice in chronic GVHD. Vaccine. 2011 Apr 5;29(16):2825-33. doi: 10.1016/j.vaccine.2011.02.018. Epub 2011 Feb 20.
- Results publication: PubMed 17090650Meisel R, Kuypers L, Dirksen U, Schubert R, Gruhn B, Strauss G, Beutel K, Groll AH, Duffner U, Blutters-Sawatzki R, Holter W, Feuchtinger T, Gruttner HP, Schroten H, Zielen S, Ohmann C, Laws HJ, Dilloo D; Impfung von Kindern nach allogener Stammzelltransplantation (IKAST) Study Group. Pneumococcal conjugate vaccine provides early protective antibody responses in children after related and unrelated allogeneic hematopoietic stem cell transplantation. Blood. 2007 Mar 15;109(6):2322-6. doi: 10.1182/blood-2006-06-032284. Epub 2006 Nov 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dagmar Dilloo, MD, PhD principal investigator
University Hospital Duesseldorf, Department of Pediatric Oncolgy, Hematolgy and Immunology
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DTaP-IPV-HBV/Hib combination vaccine, Infanrix hexa and heptavalent pneumococcal conjugate vaccine, Prevenar in people with Allogeneic Haematopoietic Stem Cell Transplantation, run by Heinrich-Heine University, Duesseldorf at 11 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 7 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 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
serologic response at 1 months following primary three dose vaccination series (time frame: first month). 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 NCT00169728, which also lists 4 linked publications.
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 Jun 2012.