Vaccine Hyporesponse in Healthy Elderly Participants (MK-0000-131 AM2)

Merck Sharp & Dohme (MSD)

Status

Completed

Conditions

Vaccine Response Impaired

Treatments

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

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

Biological: Tetanus & Diphtheria booster vaccine (Td)

Study type

Observational

Funder types

Industry

Identifiers

NCT01119703

0000-131

MK-0000-131 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

174 patients

Sex

All

Ages

25+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female aged 25 to 40 years old or 65 years of age or older at the prestudy (screening) visit
Has no fever on day of screening
Lacks Hepatitis B surface antigen seroreactivity
If female 25 to 40 years of age, is not pregnant nor breastfeeding, and agrees to use effective contraception

Exclusion criteria

Has a prior history of Hepatitis B Virus infection
Has BMI (Body Mass Index) >35
If female 25 to 40 years of age, is pregnant, or expecting to conceive, donate eggs or breastfeed
Has received immune globulin and/or blood products within 3 months prior to first dose received
Has a history of immunosuppression resulting from disease (e.g., malignancy; human immunodeficiency virus [HIV] infection), or is currently taking corticosteroids or other immunosuppressive/cytotoxic therapy (cancer chemotherapy or organ transplantation)
Has an active neoplastic disease
Has had any infection including upper respiratory viral syndrome in the 6 weeks prior to planned collection of baseline laboratory samples
Has received a live virus vaccine or an inactivated vaccine or is scheduled to receive a live virus vaccine or an inactivated vaccine in the period from 6 weeks prior to receipt of the first vaccine through the completion of all study visits