Tetanus Clinical Trial
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.
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.
n/a
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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