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

NCT ID: NCT01119703

Last Updated: 2015-12-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

174 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Vaccine Response Impaired

Keywords

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Vaccine Hyporesponse

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Arm 1: Healthy, elderly participants

Healthy participants 65 years old and older.

Tetanus & Diphtheria booster vaccine (Td)

Intervention Type BIOLOGICAL

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

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

Intervention Type 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)

Intervention Type BIOLOGICAL

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

Arm 2: Healthy, young, participants

Healthy participants 25 to 40 years old.

Tetanus & Diphtheria booster vaccine (Td)

Intervention Type BIOLOGICAL

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

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

Intervention Type 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)

Intervention Type BIOLOGICAL

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

Interventions

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Tetanus & Diphtheria booster vaccine (Td)

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

Intervention Type 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)

Intervention Type 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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francois St-Maurice, MD

Role: PRINCIPAL_INVESTIGATOR

Anapharm

Denis Audet, MD

Role: PRINCIPAL_INVESTIGATOR

Anapharm

Countries

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Canada United States

Other Identifiers

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MK-0000-131

Identifier Type: OTHER

Identifier Source: secondary_id

0000-131

Identifier Type: -

Identifier Source: org_study_id