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Tetanus clinical trials

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NCT ID: NCT02673255 Completed - Healthy Clinical Trials

Safety and Efficacy of Two Tetanus-Diphtheria Vaccines for a Donor Hyper Immunization Program

Start date: August 22, 2016
Phase: Phase 1
Study type: Interventional

Many plasma donation centers have Tetanus immunization programs that are implemented in order to collect plasma with high levels of tetanus antibodies. The immunization program requires participants to receive multiple tetanus vaccinations over a period of time with the goal of hyper-immunizing them to tetanus. Their antibody-rich plasma is then used to manufacture a tetanus immunoglobulin product which helps with the prophylaxis and treatment of tetanus disease. The Tetanus vaccine previously used for these programs is no longer being manufactured. Therefore, we must evaluate the safety and efficacy of a different vaccine when used for this purpose. The only other FDA approved Tetanus vaccines currently available for adults in the US are combination vaccines that also immunize against Diphtheria and/or Pertussis. In this study, the investigators will evaluate two vaccines that are combinations of Tetanus and Diphtheria (Td). Investigators will not evaluate any vaccines containing Pertussis antigen. The vaccines to be evaluated are manufactured by MassBiologics and Sanofi Pasteur (Tenivac). The package insert for these vaccines indicates they should be administered to previously vaccinated people once every 10 years. However, this study will evaluate whether they are safe and effective for dosing every 90 days. The investigators hypothesize that at least 25% of study subjects will have a positive response to at least one of the five planned doses. Each vaccine will be evaluated separately.

NCT ID: NCT02587520 Completed - Tetanus Clinical Trials

Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects

Start date: October 22, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This was a dose and formulation ranging study to assess the safety and immunogenicity of SP0173 in healthy adolescents, adults, and older adults in the United States (US). Primary Objective - To describe the safety profile of each SP0173 investigational formulation. Observational Objective: - To describe the immunogenicity of each SP0173 investigational formulation.

NCT ID: NCT02569879 Completed - Tetanus Clinical Trials

Impact of Boostrix™ Maternal Vaccination on Morbidity and Mortality of Pertussis Disease in Infants ≤6 Weeks of Age, in Bogota, Colombia.

Start date: October 1, 2015
Phase:
Study type: Observational

This study is being conducted to assess impact of maternal immunisation against pertussis in infants ≤12 months of age before and after introduction of pertussis maternal immunisation in Bogota, Colombia from January 2005-December 2014.

NCT ID: NCT02538211 Completed - Tetanus Clinical Trials

The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses

Rota-biome
Start date: September 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate if the intestinal microbiota influences rotavirus vaccine immune responses in healthy adult volunteers.

NCT ID: NCT02458183 Completed - Tetanus Clinical Trials

Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS

Venus
Start date: February 2, 2015
Phase: Phase 3
Study type: Interventional

The objective of this study is to assess the immunogenicity and safety of the DTaP-IPV combination vaccine compared with those of separate DTaP and IPV vaccines administered to healthy infants at 2, 4, and 6 months of age.

NCT ID: NCT02447978 Completed - Tetanus Clinical Trials

Duration of Protection: GSK DTaP Vaccines

Start date: February 2015
Phase: N/A
Study type: Observational

The purpose of this study is to assess duration of protection for GSK DTaP vaccines in preventing pertussis.

NCT ID: NCT02428491 Completed - Hepatitis B Clinical Trials

Immunogenicity and Safety of Sanofi Pasteur's Combined Vaccine Given as a Three-Dose Primary Series at 2, 3,4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or Within 1 Week After Birth

Start date: April 20, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to describe the immunogenicity and safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T fully liquid combined hexavalent vaccine (Hexaxim®) administered at 2, 3, and 4 months of age and at 16 to 17 months of age in infants and toddlers who received a dose of Hep B vaccine at birth or within 1 week after birth. Primary Objective: - To describe the safety profile after each and all doses of Sanofi-Pasteur's DTaP-IPV-Hep B-PRP-T combined vaccine in Vietnamese infants and toddlers. Secondary Objective: - To demonstrate the non-inferiority of the immune response to all antigens induced by the study vaccine in Vietnamese infants one month after the third dose in a 3-dose primary series with the immune response to all antigens induced by the same study vaccine outside Vietnam. - To evaluate the immunogenicity of the study vaccine one month after the 3-dose primary series. - To describe the persistence of all antibodies before receipt of the booster vaccination. - To evaluate the immunogenicity of the study vaccine one month after the booster.

NCT ID: NCT02422264 Completed - Tetanus Clinical Trials

Immunogenicity and Safety Study of Infanrix Hexa in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery

Start date: January 22, 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' Infanrix hexa, given in the primary vaccination schedule to infants born to pregnant women who participated in study 116945 [DTPA (BOOSTRIX)-047]. This study will help us evaluate if the presence of transplacentally transferred maternal antibodies interfere with the immune response to primary vaccination with Infanrix hexa and a co-administered pneumococcal conjugate vaccine given as a part of this study in infants.

NCT ID: NCT02274285 Completed - Tetanus Clinical Trials

DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants

Start date: October 2014
Phase: Phase 3
Study type: Interventional

Primary objective: - To demonstrate the non-inferiority in terms of seroprotection rates (Hib antigen (PRP), Diphtheria, Tetanus, and Pertussis antigens (PT and FHA), and polio types 1, 2 and 3 antigens) of investigational arm (Group A: DTaP-IPV/Hib) versus control arm (Group B: DTaP-IPV and Hib vaccines administered at separate sites), one month after the primary vaccination (all antigens). Secondary objectives: - To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4) in the two study groups (Group A and Group B). - To describe the safety after each dose of each vaccine in the two study groups (Group A and Group B). - To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4 (Group C)

NCT ID: NCT02139228 Completed - Clinical trials for Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b

Persistency Study After Hib-CRM (Cross-Reacting Material)197 or Hib-TT (Tetanus Toxoid) Vaccines in Chinese Children

Start date: November 2014
Phase: Phase 3
Study type: Interventional

Evaluate the persistency of immune response against Haemophilus influenzae type b by assessing anti-PRP antibody levels in children vaccinated with either Hib-CRM197 or Hib-TT booster vaccine approximately 4 years before.