Simplified basic immunisation after transplantation of stem cells

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005077-36-SE

Enrollment

Registered

2015-01-29

Start date

2015-05-08

Completion date

Unknown

Last updated

2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing stem cell transplantation loose their protection from basic vaccinations done during childhood and need to be immunised again to be protected from diphteria, tetanus, polio and haemophilus influenza. Improved protection against pertussis will also be studied.

Interventions

Trade Name: Infanrix-Polio+Hib Primarily Infanrix-Polio+HIb will be used, if this is not available or the local recommendations are changed Pentavac (Sanofi Pasteur MSD) will be used. To our knowledg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients who have undergone allogeneic or autologous stem cell transplantation • Male or female > 18 years old • Patients who have given written consent to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: • Pregnancy confirmed / suspected by the patient upon request. • Allergy or hypersensitivity to any of the vaccine constituents. • Ongoing acute illness (temperature >38 degrees celsius). • Other immunosuppressive disease or ongoing immunosuppressive therapy for other disease than GVH. • Recurrence of malignancy. • Treatment with rituximab in the last 6 months. • Alcohol abuse. • Mental retardation • If the investigator for any other reason determines that the patient is not suitable to be included.

Design outcomes

Primary

Measure	Time frame
Main Objective: Does immunisation with combination vaccine DTPPH give the same levels of protecting antibodies 1 and 6 months after the third dose, as immunistion with individual vaccines after stem cell transplantation? ;Secondary Objective: Are achieved levels of antibodies higher, leading to an assumed longer protection against Bordetella pertussis after immunisation with Infanrix-Polio-Hib after stem cell transplantation 1 and 6 months after the third dose?;Primary end point(s): Quantitative IgG antibody level for tetanus and diphtheria, 1 and 6 months after the third dose. At a later stage the study might possibly be extended to include analysis of IgG antibodies against Polio and HIB. ;Timepoint(s) of evaluation of this end point: 1 and 6 months after the third dose.	—

Measure

Time frame

Main Objective: Does immunisation with combination vaccine DTPPH give the same levels of protecting antibodies 1 and 6 months after the third dose, as immunistion with individual vaccines after stem cell transplantation? ;Secondary Objective: Are achieved levels of antibodies higher, leading to an assumed longer protection against Bordetella pertussis after immunisation with Infanrix-Polio-Hib after stem cell transplantation 1 and 6 months after the third dose?;Primary end point(s): Quantitative IgG antibody level for tetanus and diphtheria, 1 and 6 months after the third dose. At a later stage the study might possibly be extended to include analysis of IgG antibodies against Polio and HIB. ;Timepoint(s) of evaluation of this end point: 1 and 6 months after the third dose.

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Secondary

Measure	Time frame
Secondary end point(s): Quantitative IgG antibodies against pertussis 1 and 6 months after the third dose.;Timepoint(s) of evaluation of this end point: 1 and 6 months after the third dose.	—

Countries

Sweden

Contacts

Public ContactAnja Rosdahl, Infektionskliniken

Örebro Läns Landsting

anja.rosdahl@orebroll.se+46 1960 211 57

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026