Vaccine Response ImpairedNCT01119703

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

An observational study of Vaccine Response Impaired, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 25 years and olderHealthy volunteers can take part
Conditions the study is for: Vaccine Response Impaired
What is being tested?: Tetanus & Diphtheria booster vaccine (Td), TwinrixTM [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine] and Dukoral® Traveler's Diarrhea Vaccine (WC/rBS)
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion
How many people: 174 participants
Where: No sites listed yet
Study dates: Jul 2010to Nov 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Adults 25 to 40 years old or 65 years and older

Who may be able to join

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

Who cannot join

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

About this study

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

Conditions: Vaccine Response Impaired
Being tested: Tetanus & Diphtheria booster vaccine (Td), TwinrixTM [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine], Dukoral® Traveler's Diarrhea Vaccine (WC/rBS)
Keywords: Vaccine Hyporesponse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01119703
Study group	Role	What they receive
Arm 1: Healthy, elderly participants		Healthy participants 65 years old and older. Receives: Biological: Tetanus & Diphtheria booster vaccine (Td); Biological: TwinrixTM [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine]; Biological: Dukoral® Traveler's Diarrhea Vaccine (WC/rBS)
Arm 2: Healthy, young, participants		Healthy participants 25 to 40 years old. Receives: Biological: Tetanus & Diphtheria booster vaccine (Td); Biological: TwinrixTM [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine]; Biological: Dukoral® Traveler's Diarrhea Vaccine (WC/rBS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.
Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to HBV sAg were then measured 1 month after final vaccination, based on enzyme linked immunosorbent assay (ELISA), and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by messenger RNA (mRNA) profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln).
Measured: Baseline and 1 month after final vaccination
Antibody Titer Responses to Tetanus Booster Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.
Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to tetanus were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln).
Measured: Baseline and 1 month after final vaccination
Antibody Titer Responses to Reduced Diphtheria Toxin Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.
Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to diphtheria were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln).
Measured: Baseline and 1 month after final vaccination
Antibody Titer Responses to Oral Cholera Vaccine (WC/rBS), Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.
Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to cholera were then measured 3 weeks after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln).
Measured: Baseline and 3 weeks after final vaccination
Post-vaccination Antibody Titer Responses to Different Vaccines in Healthy, Elderly, Participants.
Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to each of these four antigens were then measured 1 month after each final vaccination (3 weeks for cholera toxin), based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln).
Measured: 3 weeks or 1 month after each final vaccination

Secondary outcomes (4)

Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.
Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to HBV sAg were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected at 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln).
Measured: Day 7 and 1 month after final vaccination
Antibody Titer Responses to Tetanus Booster Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.
Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to tetanus were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log(ln).
Measured: Day 7 and 1 month after each final vaccination
Antibody Titer Responses to Reduced Diphtheria Toxin Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.
Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to diphtheria were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log(ln).
Measured: Day 7 and 1 month after final vaccination
Antibody Titer Responses to Oral Cholera Vaccine (WC/rBS), Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.
Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to cholera were then measured 3 weeks after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log(ln).
Measured: Day 7 and 3 weeks after final vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Nov 2011

First posted7 May 2010 (estimated)
Study startJul 2010
Primary completionNov 2011
Study completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Vaccine Response ImpairedStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 174 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01119703
Sponsor's protocol ID: 0000-131
Other IDs: MK-0000-131
Status last verified: Nov 2015
First submitted: 5 May 2010
Last updated: 29 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Vaccine Response Impaired trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open-Label Observational Study to Develop a Prospective Predictor of Vaccine Hyporesponse in Healthy Elderly Subjects
ClinicalTrials.gov ID: NCT01119703
Acronym / sponsor ID: 0000-131
Conditions: Vaccine Response Impaired
Keywords: Vaccine Hyporesponse
Study type: Observational
Recruitment status: Completed
Enrolment: 174 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 7 May 2010 (estimated)
Results: Posted 22 Nov 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Arm 1: Healthy, elderly participants	–	Biological: Tetanus & Diphtheria booster vaccine (Td), Biological: TwinrixTM [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine], Biological: Dukoral® Traveler's Diarrhea Vaccine (WC/rBS)Healthy participants 65 years old and older.
Arm 2: Healthy, young, participants	–	Biological: Tetanus & Diphtheria booster vaccine (Td), Biological: TwinrixTM [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine], Biological: Dukoral® Traveler's Diarrhea Vaccine (WC/rBS)Healthy participants 25 to 40 years old.

Who may qualify

Ages: 25 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Adults 25 to 40 years old or 65 years and older

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tetanus & Diphtheria booster vaccine (Td)Tetanus \& Diphtheria booster vaccine (Td), single intramuscular dose	Biological	Arm 1: Healthy, elderly participants, Arm 2: Healthy, young, participants
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	Arm 1: Healthy, elderly participants, Arm 2: Healthy, young, participants
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	Biological	Arm 1: Healthy, elderly participants, Arm 2: Healthy, young, participants

Primary outcome

Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.
Time frame: Baseline and 1 month after final vaccination
Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to HBV sAg were then measured 1 month after final vaccination, based on enzyme linked immunosorbent assay (ELISA), and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by messenger RNA (mRNA) profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln).
Antibody Titer Responses to Tetanus Booster Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.
Time frame: Baseline and 1 month after final vaccination
Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to tetanus were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln).
Antibody Titer Responses to Reduced Diphtheria Toxin Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.
Time frame: Baseline and 1 month after final vaccination
Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to diphtheria were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln).
Antibody Titer Responses to Oral Cholera Vaccine (WC/rBS), Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.
Time frame: Baseline and 3 weeks after final vaccination
Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to cholera were then measured 3 weeks after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln).
Post-vaccination Antibody Titer Responses to Different Vaccines in Healthy, Elderly, Participants.
Time frame: 3 weeks or 1 month after each final vaccination
Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to each of these four antigens were then measured 1 month after each final vaccination (3 weeks for cholera toxin), based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln).

4 secondary outcomes

Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.
Time frame: Day 7 and 1 month after final vaccination
Antibody Titer Responses to Tetanus Booster Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.
Time frame: Day 7 and 1 month after each final vaccination
Antibody Titer Responses to Reduced Diphtheria Toxin Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.
Time frame: Day 7 and 1 month after final vaccination
Antibody Titer Responses to Oral Cholera Vaccine (WC/rBS), Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.
Time frame: Day 7 and 3 weeks after final vaccination

Results and safety

Results posted to the registry on 22 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Younger Participants	30	30
Elderly Participants	144	143

Primary outcome: Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.

Time frame: Baseline and 1 month after final vaccination. Mean (Standard Deviation). Unit: ln International Units

Measure	Elderly Participants n = 143
Predicted Titer	2.27 (1.24)
Measured Titer	2.12 (1.91)

Elderly Participants: Coefficient of Determination %: -9.1 (95% CI -13.8 to -0.7)

Population analysed: Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.

Primary outcome: Antibody Titer Responses to Tetanus Booster Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.

Time frame: Baseline and 1 month after final vaccination. Mean (Standard Deviation). Unit: ln International Units

Measure	Elderly Participants n = 143
Predicted Titer	1.40 (1.24)
Measured Titer	1.32 (1.84)

Elderly Participants: Coefficient of Determination %: 17.6 (95% CI 10.6 to 20.9)

Primary outcome: Antibody Titer Responses to Reduced Diphtheria Toxin Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.

Time frame: Baseline and 1 month after final vaccination. Mean (Standard Deviation). Unit: ln International Units

Measure	Elderly Participants n = 143
Predicted Titer	-0.43 (1.25)
Measured Titer	-0.46 (1.77)

Elderly Participants: Coefficient of Determination %: 27.8 (95% CI 19.6 to 32.4)

Primary outcome: Antibody Titer Responses to Oral Cholera Vaccine (WC/rBS), Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.

Time frame: Baseline and 3 weeks after final vaccination. Mean (Standard Deviation). Unit: ln International Units

Measure	Elderly Participants n = 143
Predicted Titer	5.24 (0.99)
Measured Titer	5.20 (1.55)

Elderly Participants: Coefficient of Determination %: 3.3 (95% CI -2.8 to 8.5)

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 174 (0%)	14 of 174 (8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Francois St-Maurice, MD principal investigator

Anapharm

Denis Audet, MD principal investigator

Anapharm

Questions about this trial

What is this clinical trial studying?

An observational study of Vaccine Response Impaired, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants. (time frame: Baseline and 1 month after final vaccination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01119703.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2015.