Comparative study of immune response and safety of booster immunisation with two vaccines against tetanus and diphtheriae (VACDITE and IMOVAX D.T. ADULT) in health adults.

A single blind, randomized comparative and multicentre clinical trial of the immunogenicity and safety of booster immunisation with bivalent vaccine against tetanus and diphtheria VACDITE (BIODRUG) and IMOVAX D.T. ADULT (Sanofi Pasteur SA) in healthy adults. - Immunogenicity and safety of vaccine VACDITE in health adults

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001604-10-SK

Enrollment

200

Registered

2018-07-20

Start date

2018-09-05

Completion date

Unknown

Last updated

2022-04-19

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

Conditions

Verification of immune response after booster immunisation with one dose of vaccine against tetanus and diphtheriae MedDRA version: 20.0 Level: LLT Classification code 10054183 Term: Tetanus immunization System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: PT Classification code 10054129 Term: Diphtheria immunisation System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: VACDITE Pharmaceutical Form: Suspension for injection INN or Proposed INN: tetani et diphtheriae anatoxinum Other descriptive name: DIPHTHERIA AND TETANUS VACCINE (ADSORBED, REDUCED ANTIGE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subject provides written informed consent with the study participation 2. Subjects must have written confirmation on previous immunisation against tetanus and diphtheriae not later than 15.9 years and not early than 9.9 years 3. Men and women aged 24.1- 64.9 years 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 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Subject with acute infectious diseases. 2. Subject allergic to any of the substances of the investigational medicinal product administered in clinical trial (i.e., test and reference vaccine). 3. Subject with Guillain-Barré syndrome or neuropathy, some anaphylactic or other allergic reactions after previous vaccination against tetanus and diphtheriae. 4. Pregnant woman and breastfeeding (anamnestically). 5. Subject with primary or secondary immunodeficiency (e.g. congenital immunodeficiency, HIV infection, organ or bone marrow transplantation, leukaemia, lymphoma, Hodgkin's disease, multiple myeloma, generalised malignancy, drugs or other causes induced immunodeficiency). 6. Subject with progressive or unstable neurological disorder. 7. Subject with severe thrombocytopenia or any coagulation disorder not allowing the intramuscular use. 8. Subject with blood product treatment, including immunoglobulins within the last 90 days prior to study entry. 9. Subject vaccinated less than 30 days inactivated or live vaccine prior to study entry. 10. Subject - pregnant or breast feeding women. Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrolment.* 11. Subject unable to understand consent or follow study protocol. 12. Subject addicted to alcohol or drugs. 13. Subject currently participating in another clinical trial of a medication or in a trial that has taken place in the last 4 weeks. 14. A subject requiring tetanus vaccination after an injury

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective of this trial is to demonstrate non-inferior immunogenicity (represented by seroconversion rate for tetanus and/or diphtheriae) of booster vaccination with the VACDITE vaccine compared to that of the reference vaccine (IMOVAX D.T. ADULT) in healthy adults. ;Secondary Objective: Secondary objective of this trial is to demonstrate non-inferior immunogenicity (represented by modified seroconversion rates for tetanus and/or diphtheriae, GMC of antibodies against tetanus and/or diphtheriae and RA of tetanus and/or diphtheriae) of booster vaccination with the VACDITE vaccine compared to that of the reference vaccine (IMOVAX D.T. ADULT) in healthy adults. Safety objective is to evaluate safety of the VACDITE vaccine on the base of reported adverse events during study follow-up, i.e. 28 days after booster immunisation.;Primary end point(s): The primary measured endpoint is the concentration of tetanus-specific antibodies and/or diphtheriae-specific antibodies before and after booster vaccination. They are used to calculate the seroconversion rate, i.e. the proportion of subjects who will have a minimum limit of measured antibodies after vaccination. Seroconversion rate will be considered in this study as the primary calculated endpoint. The primary endpoint in this trial is the seroconversion rate defined by 4-fold increase of antibody concentration, 4 weeks after booster immunisation, in relation to pre-vaccination antibody concentration. The minimum antibody concentration after immunisation must be 0.4 IU/ml, if pre-vaccination levels are lower than 0.1 IU/mL. The same definition of seroconversion rate is considered for both types of antibodies, i.e. against tetanus and/or diphtheriae. This seroconversion will be further reported as SCR4. ;Timepoint(s) of evaluation of this end point: Before vaccine administration at the same day (V1) and 28 days after vaccine administration (V2).	—

Measure

Time frame

Main Objective: Primary objective of this trial is to demonstrate non-inferior immunogenicity (represented by seroconversion rate for tetanus and/or diphtheriae) of booster vaccination with the VACDITE vaccine compared to that of the reference vaccine (IMOVAX D.T. ADULT) in healthy adults. ;Secondary Objective: Secondary objective of this trial is to demonstrate non-inferior immunogenicity (represented by modified seroconversion rates for tetanus and/or diphtheriae, GMC of antibodies against tetanus and/or diphtheriae and RA of tetanus and/or diphtheriae) of booster vaccination with the VACDITE vaccine compared to that of the reference vaccine (IMOVAX D.T. ADULT) in healthy adults. Safety objective is to evaluate safety of the VACDITE vaccine on the base of reported adverse events during study follow-up, i.e. 28 days after booster immunisation.;Primary end point(s): The primary measured endpoint is the concentration of tetanus-specific antibodies and/or diphtheriae-specific antibodies before and after booster vaccination. They are used to calculate the seroconversion rate, i.e. the proportion of subjects who will have a minimum limit of measured antibodies after vaccination. Seroconversion rate will be considered in this study as the primary calculated endpoint. The primary endpoint in this trial is the seroconversion rate defined by 4-fold increase of antibody concentration, 4 weeks after booster immunisation, in relation to pre-vaccination antibody concentration. The minimum antibody concentration after immunisation must be 0.4 IU/ml, if pre-vaccination levels are lower than 0.1 IU/mL. The same definition of seroconversion rate is considered for both types of antibodies, i.e. against tetanus and/or diphtheriae. This seroconversion will be further reported as SCR4. ;Timepoint(s) of evaluation of this end point: Before vaccine administration at the same day (V1) and 28 days after vaccine administration (V2).

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Secondary

Measure	Time frame
Secondary end point(s): Whereas the selection of subjects is not performed exclusively from subjects who are seronegative (or naive) prior to the booster immunisation the seroconversion rate will be also assessed by modified definitions. The reason is that subjects with relatively high levels of pre-vaccination levels may respond with a lower increase of post-vaccination levels than those with a low pre-vaccination levels of antibodies. Therefore, there will be tested the seroconversion rate obtained from 2-fold increase of antibody concentration in subject with pre-vaccination levels = 1.0 IU/mL. If the pre-vaccination levels are <1.0 IU/mL the seroconversion rate will be achieved under the condition of 4-fold increase with post-vaccination concentration of at least 0.4 IU/mL. This seroconversion rate will be further named as SCR2. A commercial kit used for serological assay has pre-determined measuring range. If the measured antibody concentrations above upper limit of such a range are considered to be less precise then 4-fold increase could be limited by a quarter of this upper limit, i.e. value ULR/4 IU/mL (upper limit of range divided by four). In this case, there will be tested the seroconversion rate obtained from 2-fold increase of antibody concentration in subject with pre-vaccination levels = ULR/4 IU/mL. If pre-vaccination levels are <URL/4 IU/mL the seroconversion rate will be achieved under the condition of 4-fold increase with post-vaccination concentration of at least 0.4 IU/mL. This seroconversion rate will be further named as SCR-URL/4. As an indicator of long-term protection, the proportion of subjects with a post-vaccination antibody level of 1.0 IU/mL or greater will be evaluated as a secondary end-point, i.e. seroconversion rate SCR1. All modified seroconversion rates will be used for both types of antibody against tetanus and diphtheriae. Because both vaccines should not differ in immunogenicity the composite seroconversion rate will be applied	—

Measure

Time frame

Secondary end point(s): Whereas the selection of subjects is not performed exclusively from subjects who are seronegative (or naive) prior to the booster immunisation the seroconversion rate will be also assessed by modified definitions. The reason is that subjects with relatively high levels of pre-vaccination levels may respond with a lower increase of post-vaccination levels than those with a low pre-vaccination levels of antibodies. Therefore, there will be tested the seroconversion rate obtained from 2-fold increase of antibody concentration in subject with pre-vaccination levels = 1.0 IU/mL. If the pre-vaccination levels are <1.0 IU/mL the seroconversion rate will be achieved under the condition of 4-fold increase with post-vaccination concentration of at least 0.4 IU/mL. This seroconversion rate will be further named as SCR2. A commercial kit used for serological assay has pre-determined measuring range. If the measured antibody concentrations above upper limit of such a range are considered to be less precise then 4-fold increase could be limited by a quarter of this upper limit, i.e. value ULR/4 IU/mL (upper limit of range divided by four). In this case, there will be tested the seroconversion rate obtained from 2-fold increase of antibody concentration in subject with pre-vaccination levels = ULR/4 IU/mL. If pre-vaccination levels are <URL/4 IU/mL the seroconversion rate will be achieved under the condition of 4-fold increase with post-vaccination concentration of at least 0.4 IU/mL. This seroconversion rate will be further named as SCR-URL/4. As an indicator of long-term protection, the proportion of subjects with a post-vaccination antibody level of 1.0 IU/mL or greater will be evaluated as a secondary end-point, i.e. seroconversion rate SCR1. All modified seroconversion rates will be used for both types of antibody against tetanus and diphtheriae. Because both vaccines should not differ in immunogenicity the composite seroconversion rate will be applied

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Countries

Slovakia

Contacts

Public ContactClinical Trial Information Desk

BIODRUG s.r.o.

biodrugpost@gmail.com

Outcome results

None listed

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