Clinical trial NCT01559597: Comparative Study of Two Tetanus Toxoid Vaccination Strategies: Cold Chain Versus Controlled Temperature Chain
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tetanus
Tetanus Vaccine
Keywords: controlled temperature chain
outside the cold chain
vaccination
prevention of mother to child transmission
Lead sponsor: Epicentre
Sponsor class: OTHER
First posted: 2012-03-21
Enrollment: 2129
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Protective level of anti-tetanus antibodies
timeFrame: 4 weeks after second dose of vaccine
Secondary outcomes:
measure: Vaccine stability
timeFrame: 30 days after exposure to ambient temperatures
measure: Antibody levels
timeFrame: 4 weeks after second dose of vaccine
measure: Adverse events
timeFrame: 30 min and 7 days after vaccination
Other outcomes:
Locations:
city: Moïssala
country: Chad
facility: Moïssala health district
Study officials:
affiliation: Epicentre
name: Aitana Juan Giner, MSc
role: PRINCIPAL_INVESTIGATOR
References: