TetanusPhase 4NCT00437671
Tetanus Immunization in Subjects With No Immunization History or With Tetanus Antibody Levels Below Protective Levels
A Phase 4 study testing Tetanus Immune Globulin (Human) and Diphtheria-Tetanus Toxoids Adsorbed in people with Tetanus, run by Grifols Therapeutics LLC at 1 site in United States.
Trial summary
The goal of this study is to re-evaluate the tetanus antibody pharmacokinetic profile when Tetanus Immune Globulin (Human)(TIG) and Tetanus vaccine (Tetanus toxoid; TT) are given concurrently with strict control on the anatomical location and timing of administration of TIG and TT. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Tetanus
- What is being tested?
- Tetanus Immune Globulin (Human) and Diphtheria-Tetanus Toxoids Adsorbed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Sep 2007
- Phase
- Phase 4
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 90 years.
- Signed a written informed consent prior to initiation of any study-related procedures.
- No known primary immunization history with TT/dT or >10 years have passed since the last dose of tetanus containing vaccine was received. Subjects with unknown or uncertain previous vaccination histories are considered to have no previous tetanus and toxoid doses. Subjects who have had military service since 1941 will be considered to have had 1 dose of tetanus vaccine.
- Subjects must have documented tetanus antibody levels that are non-protective levels (< 0.15 IU/ml).
- Subjects must be free of any presenting wound or wound infection
Who cannot join
- History or suspicion of significant allergic reaction to intravenous immune globulin, and or blood products
- A history of selective IgA deficiency (serum level <5.0 mg/dL) and known antibodies to IgA
- Congestive heart failure (New York Association stage greater than Class II)
- Conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome)
- Women of child bearing potential who do not practice adequate contraception (i.e. chemical or mechanical methods) and pregnant or lactating females
- Subjects who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
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- TIG therapy within the previous six months
- Investigational drug therapy within the previous three months
- History of Thromboembolism
Trial locations and contacts
1 site in 1 country.
United States1 site
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
About this study
Official title: Pharmacokinetics Of Active And Passive Tetanus Immunization Given Concurrently In Subjects With No Known Primary Immunization History Or In Subjects With Tetanus Antibody Levels Below Protective Levels
The goal of this study is to re-evaluate the tetanus antibody pharmacokinetic profile when Tetanus Immune Globulin (Human)(TIG) and Tetanus vaccine (Tetanus toxoid; TT) are given concurrently with strict control on the anatomical location and timing of administration of TIG and TT. Pharmacokinetic profile of antibody titer including the duration of adequate titer protection provided by TIG and TT given in combination will be assessed using a standardized administration regimen and standardized antibody assay procedure. This study may provide evidence for the recommendations of the World Health Organisation (WHO) whereby dual coverage with both a vaccine and tetanus hyperimmune would ideally provide the best coverage for anyone with the potential of developing tetanus.
Read the detailed description
This is a prospective, open-label, single-center trial including a single group of subjects with no known primary immunization history with TT or >10 years have passed since the last dose of tetanus containing vaccine was received. The study will enroll six subjects who would receive both dT and TIG concurrently on Day 1.
All dosed subjects will be followed for 40 days during which Day 1, 2, 3, 4, 5, 7, 14, 21, 30 and 40 time levels of tetanus antibodies will be measured in order to determine the serum level vs. time curve, Cmax, Tmax, and duration of protective antibody levels.
- Conditions
- Tetanus
- Being tested
- Tetanus Immune Globulin (Human), Diphtheria-Tetanus Toxoids Adsorbed
- Keywords
- trismus, lockjaw
- Medical subject headings
- Tetanus, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanus Immune Globulin (Human)Drug
Also called HyperTET S/D, BayTet, BAY 19-8515, TAL-05-00013
Based on package insert recommendation and recommendations of WHO
Diphtheria-Tetanus Toxoids AdsorbedBiological
Based on package insert recommendations and recommendations of WHO
| Study group | Role | What they receive |
|---|---|---|
| Entered study | Experimental | Not described Receives: Drug: Tetanus Immune Globulin (Human); Biological: Diphtheria-Tetanus Toxoids Adsorbed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody titer serum level at each time point
Measured: 40 days
Cmax
Measured: 40 days
Tmax
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startMar 2007
- Primary completionSep 2007
- Study completionSep 2007
Why it stopped: Study terminated for cGCP non-compliance. Analyses could not be performed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetanusStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grifols Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kumar Alagappan, MD, Principal investigator, Long Island Jewish Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437671
- Sponsor's protocol ID
- 060002
- Status last verified
- Jan 2016
- First submitted
- 20 Feb 2007
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics Of Active And Passive Tetanus Immunization Given Concurrently In Subjects With No Known Primary Immunization History Or In Subjects With Tetanus Antibody Levels Below Protective Levels
- ClinicalTrials.gov ID
- NCT00437671
- Acronym / sponsor ID
- 060002
- Conditions
- Tetanus
- Keywords
- trismus, lockjaw
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated for cGCP non-compliance. Analyses could not be performed.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Grifols Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 21 Feb 2007 (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 goal of this study is to re-evaluate the tetanus antibody pharmacokinetic profile when Tetanus Immune Globulin (Human)(TIG) and Tetanus vaccine (Tetanus toxoid; TT) are given concurrently with strict control on the anatomical location and timing of administration of TIG and TT. Pharmacokinetic profile of antibody titer including the duration of adequate titer protection provided by TIG and TT given in combination will be assessed using a standardized administration regimen and standardized antibody assay procedure. This study may provide evidence for the recommendations of the World Health Organisation (WHO) whereby dual coverage with both a vaccine and tetanus hyperimmune would ideally provide the best coverage for anyone with the potential of developing tetanus.
Detailed description
This is a prospective, open-label, single-center trial including a single group of subjects with no known primary immunization history with TT or >10 years have passed since the last dose of tetanus containing vaccine was received. The study will enroll six subjects who would receive both dT and TIG concurrently on Day 1.
All dosed subjects will be followed for 40 days during which Day 1, 2, 3, 4, 5, 7, 14, 21, 30 and 40 time levels of tetanus antibodies will be measured in order to determine the serum level vs. time curve, Cmax, Tmax, and duration of protective antibody levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Entered study | Experimental | Drug: Tetanus Immune Globulin (Human), Biological: Diphtheria-Tetanus Toxoids Adsorbed |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 90 years.
- Signed a written informed consent prior to initiation of any study-related procedures.
- No known primary immunization history with TT/dT or >10 years have passed since the last dose of tetanus containing vaccine was received. Subjects with unknown or uncertain previous vaccination histories are considered to have no previous tetanus and toxoid doses. Subjects who have had military service since 1941 will be considered to have had 1 dose of tetanus vaccine.
- Subjects must have documented tetanus antibody levels that are non-protective levels (< 0.15 IU/ml).
- Subjects must be free of any presenting wound or wound infection
Key exclusion criteria (9 listed)
- History or suspicion of significant allergic reaction to intravenous immune globulin, and or blood products
- A history of selective IgA deficiency (serum level <5.0 mg/dL) and known antibodies to IgA
- Congestive heart failure (New York Association stage greater than Class II)
- Conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome)
- Women of child bearing potential who do not practice adequate contraception (i.e. chemical or mechanical methods) and pregnant or lactating females
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 |
|---|---|---|
| Tetanus Immune Globulin (Human)Also: HyperTET S/D, BayTet, BAY 19-8515, TAL-05-00013Based on package insert recommendation and recommendations of WHO | Drug | Entered study |
| Diphtheria-Tetanus Toxoids AdsorbedBased on package insert recommendations and recommendations of WHO | Biological | Entered study |
Primary outcome
Antibody titer serum level at each time point
Time frame: 40 days
Cmax
Time frame: 40 days
Tmax
Time frame: 40 days
Results and safety
The study was stopped early (reason given: Study terminated for cGCP non-compliance. Analyses could not be performed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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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.
Kumar Alagappan, MD principal investigator
Long Island Jewish Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tetanus Immune Globulin (Human) and Diphtheria-Tetanus Toxoids Adsorbed in people with Tetanus, run by Grifols Therapeutics LLC at 1 site in United States.
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 9 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: stopped early, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Study terminated for cGCP non-compliance. Analyses could not be performed.). Results are not available in the source record.
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?
Antibody titer serum level at each time point (time frame: 40 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2016.