Humoral and cellular immune response against tetanus and diphtheria following booster vaccinatio

• Conditions: This study will analyze cellular and humoral immune responses after booster vaccination. Healthy adults are vaccinated against tetanus, diphtheria, pertussis and polio on a regular basis. This study will include individuals which are vaccinated according to the official Austrian recommendations.; MedDRA version: 9.1Level: LLTClassification code 10039244Term: Routine vaccination; MedDRA version: 9.1Level: LLTClassification code 10054183Term: Tetanus immunization; MedDRA version: 9.1Level: LLTClassification code 10054180Term: Diphtheria immunization

• Registration Number: EUCTR2009-011742-26-AT
• Lead Sponsor: Institute for Biomedical Aging Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Signed informed consent form
Group 1:
Healthy adults aged 25-40 years
Last vaccination against tetanus and diphtheria 10 years ago
Group 2:
Healthy adults older than 60 years
Last vaccination against tetanus and diphtheria 5 years ago
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

acute illness (e.g. flu-like illness)
chronic inflammatory disease (e.g. inflammatory bowl disease, multiple sclerosis)
chronic hepatitis (HBV, HCV) or HIV
transplant recipients
persons who have recieved chemotherapy in the past
persons under or immediatly after immunosuppressive therapy
pregnant women
participation in another clinical trial during the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To analyze whether the immune response against tetanus and diphtheria is different in young adults vaccinated 10 years after the last vaccination compared to elderly individuals vaccinated 5 years after the last vaccination.;Secondary Objective: To identify predictive markers for the success of the booster vaccination.;Primary end point(s): Quantification of the immune response following booster vaccination 28 days after vaccination