TetanusNCT01559597
Comparative Study of Two Tetanus Toxoid Vaccination Strategies: Cold Chain Versus Controlled Temperature Chain
A study testing Tetanus toxoid vaccine in people with Tetanus and Tetanus Vaccine, run by Epicentre at 1 site in Chad.
Trial summary
The purpose of this study is to determine the effectiveness, safety and feasibility of a tetanus toxoid (TT) vaccination strategy relying on the maintenance of vaccines in a controlled temperature chain (CTC). Read more about this study
- Who is it for?
- Ages 14 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tetanus, Tetanus Vaccine
- What is being tested?
- Tetanus toxoid vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,129 participants
- Where
- 1 siteChad
- Study dates
- Nov 2012to Mar 2013
- Phase
- Interventional
- 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 14 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women aged between 14 to 49 years of age
- Living in the district of Moïssala, Chad
- Have no proof of previous vaccination or previous vaccination is not greater than 1 dose of vaccine
- Previous dose received more than 1 month before
- Consented to be included in the study
Who cannot join
- Allergic reaction to previous tetanus vaccination
- Severe febrile illness
- Have received a tetanus vaccine within the previous month
- Refuses vaccination or does not consent
- Nomadic population travelling before the end of the study
- Pregnant women due to deliver within 2 weeks
Trial locations and contacts
1 site in 1 country.
Chad1 site
Moïssala health district
Moïssala
About this study
Official title: Etude Comparative de Deux stratégies de Vaccination antitétanique en Situation réelle: Vaccin conservé en chaîne de Froid Versus en chaîne de température contrôlée.
The purpose of this study is to determine the effectiveness, safety and feasibility of a tetanus toxoid (TT) vaccination strategy relying on the maintenance of vaccines in a controlled temperature chain (CTC). The CTC is defined as the storage and transport of vaccines within a temperature range appropriate to the heat stability profile of TT vaccine. In this study vaccines are transported and stored in the cold chain up to district level. From district to beneficiary level vaccines are exposed to ambient temperatures during a limited period of time.
In an initial phase, the stability of 3 lots of TT vaccine kept in CTC is determined. For this, the potency, safety, pH and adsorption of vaccines maintained in CTC will be tested in the laboratory and compared to vaccines that have been maintained in cold chain. If all parameters (i.e. potency, safety, pH and adsorption) are above WHO specifications the strategy in CTC will be used.
Read more
Only if the laboratory results are adequate, villages will be assigned to one of the vaccination strategies. All women between 14 to 49 years of age in the selected villages who fulfill the inclusion criteria will be invited to participate.
In order to determine the baseline anti-tetanus protection, TT vaccination history will be collected from all participants using a standardized questionnaire. Women who have already received at least 2 doses of TT vaccine will be excluded from the study. Moreover, blood will be collected from all participants to later verify in laboratory the baseline protection.
A first dose of TT vaccine will be given according to the assigned strategy (CTC or cold chain). Four weeks after the 1st vaccination, a second TT vaccine will be given using the same strategy employed for the first dose. Finally, four weeks after the second dose, a blood sample will be collected from all participants who received two doses of vaccine. The serological responses will be compared in the group that received two doses of TT vaccine maintained in cold chain ant the group that received two doses of vaccine maintained in CTC.
- Conditions
- Tetanus, Tetanus Vaccine
- Being tested
- Tetanus toxoid vaccine
- Keywords
- controlled temperature chain, outside the cold chain, vaccination, prevention of mother to child transmission
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanus toxoid vaccineBiological
Two doses of tetanus toxoid vaccine separated at least 4 weeks. One arm receives the vaccine kept in cold chain and the other arm receives the vaccine kept in CTC
| Study group | Role | What they receive |
|---|---|---|
| Cold chain | Active comparator | Group vaccinated with tetanus toxoid vaccine kept in cold chain Receives: Biological: Tetanus toxoid vaccine |
| CTC | Experimental | Group vaccinated with tetanus toxoid vaccine kept in controlled temperature chain Receives: Biological: Tetanus toxoid vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protective level of anti-tetanus antibodies
The proportion of women who achieve a protective level of anti-tetanus antibodies after 2 doses of vaccine kept in CTC is not lower to the proportion of women who achieve a protective level of anti-tetanus antibodies after 2 doses of vaccine kept in cold chain.
Measured: 4 weeks after second dose of vaccine
Secondary outcomes (3)
Vaccine stability
Verify the stability of the vaccine (potency, safety, pH and adsorption) after exposure to ambient temperatures
Measured: 30 days after exposure to ambient temperatures
Antibody levels
Evaluate the percentage increase in antibody levels in women who have received 2 doses of vaccine maintained in CTC and in women who have received 2 doses of vaccine maintained in cold chain
Measured: 4 weeks after second dose of vaccine
Adverse events
Compare the adverse events in the group vaccinated with the vaccine kept in CTC and the group vaccinated with the vaccine kept in cold chain.
Measured: 30 min and 7 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2013
- Study completionMar 2013
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aitana Juan Giner, MSc, Principal investigator, Epicentre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559597
- Sponsor's protocol ID
- Epicentre/CTC-TT/2012
- Status last verified
- Feb 2013
- First submitted
- 19 Mar 2012
- Last updated
- 3 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude Comparative de Deux stratégies de Vaccination antitétanique en Situation réelle: Vaccin conservé en chaîne de Froid Versus en chaîne de température contrôlée.
- ClinicalTrials.gov ID
- NCT01559597
- Acronym / sponsor ID
- Epicentre/CTC-TT/2012
- Conditions
- Tetanus, Tetanus Vaccine
- Keywords
- controlled temperature chain, outside the cold chain, vaccination, prevention of mother to child transmission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,129 participants (actual)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 21 Mar 2012 (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 effectiveness, safety and feasibility of a tetanus toxoid (TT) vaccination strategy relying on the maintenance of vaccines in a controlled temperature chain (CTC). The CTC is defined as the storage and transport of vaccines within a temperature range appropriate to the heat stability profile of TT vaccine. In this study vaccines are transported and stored in the cold chain up to district level. From district to beneficiary level vaccines are exposed to ambient temperatures during a limited period of time.
In an initial phase, the stability of 3 lots of TT vaccine kept in CTC is determined. For this, the potency, safety, pH and adsorption of vaccines maintained in CTC will be tested in the laboratory and compared to vaccines that have been maintained in cold chain. If all parameters (i.e. potency, safety, pH and adsorption) are above WHO specifications the strategy in CTC will be used.
Only if the laboratory results are adequate, villages will be assigned to one of the vaccination strategies. All women between 14 to 49 years of age in the selected villages who fulfill the inclusion criteria will be invited to participate.
In order to determine the baseline anti-tetanus protection, TT vaccination history will be collected from all participants using a standardized questionnaire. Women who have already received at least 2 doses of TT vaccine will be excluded from the study. Moreover, blood will be collected from all participants to later verify in laboratory the baseline protection.
A first dose of TT vaccine will be given according to the assigned strategy (CTC or cold chain). Four weeks after the 1st vaccination, a second TT vaccine will be given using the same strategy employed for the first dose. Finally, four weeks after the second dose, a blood sample will be collected from all participants who received two doses of vaccine. The serological responses will be compared in the group that received two doses of TT vaccine maintained in cold chain ant the group that received two doses of vaccine maintained in CTC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold chain | Active comparator | Biological: Tetanus toxoid vaccineGroup vaccinated with tetanus toxoid vaccine kept in cold chain |
| CTC | Experimental | Biological: Tetanus toxoid vaccineGroup vaccinated with tetanus toxoid vaccine kept in controlled temperature chain |
Who may qualify
- Ages
- 14 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Women aged between 14 to 49 years of age
- Living in the district of Moïssala, Chad
- Have no proof of previous vaccination or previous vaccination is not greater than 1 dose of vaccine
- Previous dose received more than 1 month before
- Consented to be included in the study
Key exclusion criteria (6 listed)
- Allergic reaction to previous tetanus vaccination
- Severe febrile illness
- Have received a tetanus vaccine within the previous month
- Refuses vaccination or does not consent
- Nomadic population travelling before the end of the study
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 toxoid vaccineTwo doses of tetanus toxoid vaccine separated at least 4 weeks. One arm receives the vaccine kept in cold chain and the other arm receives the vaccine kept in CTC | Biological | CTC, Cold chain |
Primary outcome
Protective level of anti-tetanus antibodies
Time frame: 4 weeks after second dose of vaccine
The proportion of women who achieve a protective level of anti-tetanus antibodies after 2 doses of vaccine kept in CTC is not lower to the proportion of women who achieve a protective level of anti-tetanus antibodies after 2 doses of vaccine kept in cold chain.
3 secondary outcomes
Vaccine stability
Time frame: 30 days after exposure to ambient temperatures
Antibody levels
Time frame: 4 weeks after second dose of vaccine
Adverse events
Time frame: 30 min and 7 days after vaccination
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 3 May 2013.
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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.
Aitana Juan Giner, MSc principal investigator
Epicentre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetanus toxoid vaccine in people with Tetanus and Tetanus Vaccine, run by Epicentre at 1 site in Chad.
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 6 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 3 May 2013. 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 Chad. 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.
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?
Protective level of anti-tetanus antibodies (time frame: 4 weeks after second dose of vaccine). 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 3 May 2013; AzTrials last refreshed its copy on 7 Nov 2026.