An interventional study of Tetanus toxoid vaccine in Tetanus and Tetanus Vaccine, sponsored by Epicentre. Completed at 1 site in Chad. Open to female participants aged 14 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-03.
Sponsored by Epicentre · Not applicable, Interventional, and Prevention
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.
198 studies on the registry are indexed under Tetanus; 21 are open to participants now.
This study's enrollment of 2,129 is above the median of 400 across 172 interventional studies indexed under Tetanus.
Browse Tetanus studies →Epicentre is the lead sponsor of 47 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Group vaccinated with tetanus toxoid vaccine kept in cold chain
Biological: Tetanus toxoid vaccine
Group vaccinated with tetanus toxoid vaccine kept in controlled temperature chain
Biological: Tetanus toxoid vaccine
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
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.
Time frame: 4 weeks after second dose of vaccine
Vaccine stability
Verify the stability of the vaccine (potency, safety, pH and adsorption) after exposure to ambient temperatures
Time frame: 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
Time frame: 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.
Time frame: 30 min and 7 days after vaccination
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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