Comparative Study of Two Tetanus Toxoid Vaccination Strategies: Cold Chain Versus Controlled Temperature Chain

Brief Title

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.

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.
    



Study Type

Interventional


Primary Outcome

Protective level of anti-tetanus antibodies

Secondary Outcome

 Vaccine stability

Condition

Tetanus

Intervention

Tetanus toxoid vaccine

Study Arms / Comparison Groups

 Cold chain
Description:  Group vaccinated with tetanus toxoid vaccine kept in cold chain

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

2129

Start Date

November 2012

Completion Date

March 2013

Primary Completion Date

March 2013

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
      

Gender

Female

Ages

14 Years - 49 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Aitana Juan Giner, MSc, , 

Location Countries

Chad

Location Countries

Chad

Administrative Informations


NCT ID

NCT01559597

Organization ID

Epicentre/CTC-TT/2012


Responsible Party

Sponsor

Study Sponsor

Epicentre


Study Sponsor

Aitana Juan Giner, MSc, Principal Investigator, Epicentre


Verification Date

February 2013