Trials / Completed
CompletedNCT01119703
Vaccine Hyporesponse in Healthy Elderly Participants (MK-0000-131 AM2)
A Phase I, Open-Label Observational Study to Develop a Prospective Predictor of Vaccine Hyporesponse in Healthy Elderly Subjects
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 174 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 25 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tetanus & Diphtheria booster vaccine (Td) | Tetanus \& Diphtheria booster vaccine (Td), single intramuscular dose |
| BIOLOGICAL | TwinrixTM [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine] | TwinrixTM \[Hepatitis A Inactivated \& Hepatitis B (Recombinant) Vaccine\], intramuscular, two doses of standard three dose regimen (opposite arms) |
| BIOLOGICAL | Dukoral® Traveler's Diarrhea Vaccine (WC/rBS) | Dukoral® Traveler's Diarrhea Vaccine, recombinant Cholera toxin B subunit (WC/rBS), standard two oral doses per treatment regimen |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2011-11-01
- Completion
- 2011-11-01
- First posted
- 2010-05-07
- Last updated
- 2015-12-29
- Results posted
- 2012-11-22
Source: ClinicalTrials.gov record NCT01119703. Inclusion in this directory is not an endorsement.