CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 174 enrolled
Drug / intervention
Tetanus & Diphtheria booster vaccine (Td) +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01119703
NCT01119703N/ACompleted
CompareCT.gov

A Phase I, Open-Label Observational Study to Develop a Prospective Predictor of Vaccine Hyporesponse in Healthy Elderly Subjects

Merck Sharp & Dohme LLC·observational·Posted May 7, 2010·Updated Dec 29, 2015

In Brief

An observational study evaluating Tetanus & Diphtheria booster vaccine (Td), TwinrixTM [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine], and 1 other intervention for Vaccine Response Impaired. Completed, enrolled 174 participants.

Detailed Summary

This study evaluated whether it is possible in healthy elderly participants to generate baseline biomarker-based prediction rules (PdR) for vaccine response (post baseline absolute serum antibody titer) using each of the protocol selected vaccines separately; and examined the rank correlation coefficients of pairs of post vaccination antibody titers within the same elderly individuals.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsVaccine Response Impaired
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 7, 2010
Enrollment StartJul 1, 2010
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.2 years ago

Interventions

Tetanus & Diphtheria booster vaccine (Td)biological

Tetanus \& Diphtheria booster vaccine (Td), single intramuscular dose

TwinrixTM [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine]biological

TwinrixTM \[Hepatitis A Inactivated \& Hepatitis B (Recombinant) Vaccine\], intramuscular, two doses of standard three dose regimen (opposite arms)

Dukoral® Traveler's Diarrhea Vaccine (WC/rBS)biological

Dukoral® Traveler's Diarrhea Vaccine, recombinant Cholera toxin B subunit (WC/rBS), standard two oral doses per treatment regimen