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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Epicentre
ClinicalTrials.gov Identifier:
NCT01559597
First received: March 19, 2012
Last updated: May 1, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Tetanus
Tetanus Vaccine
Biological: Tetanus toxoid vaccine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Epicentre:

Primary Outcome Measures:
  • Protective level of anti-tetanus antibodies [ Time Frame: 4 weeks after second dose of vaccine ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Vaccine stability [ Time Frame: 30 days after exposure to ambient temperatures ] [ Designated as safety issue: No ]
    Verify the stability of the vaccine (potency, safety, pH and adsorption) after exposure to ambient temperatures

  • Antibody levels [ Time Frame: 4 weeks after second dose of vaccine ] [ Designated as safety issue: No ]
    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

  • Adverse events [ Time Frame: 30 min and 7 days after vaccination ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 2129
Study Start Date: November 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cold chain
Group vaccinated with tetanus toxoid vaccine kept in cold 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
Experimental: CTC
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

  Eligibility

Ages Eligible for Study:   14 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559597

Locations
Chad
Moïssala health district
Moïssala, Chad
Sponsors and Collaborators
Epicentre
Investigators
Principal Investigator: Aitana Juan Giner, MSc Epicentre
  More Information

No publications provided

Responsible Party: Epicentre
ClinicalTrials.gov Identifier: NCT01559597     History of Changes
Other Study ID Numbers: Epicentre/CTC-TT/2012
Study First Received: March 19, 2012
Last Updated: May 1, 2013
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by Epicentre:
controlled temperature chain
outside the cold chain
vaccination
prevention of mother to child transmission

Additional relevant MeSH terms:
Tetanus
Tetany
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014