A Study of the Safety and Immune Response to RotaTeq™ Vaccine in the Elderly (V260-027)
April 10, 2015 updated by: Merck Sharp & Dohme LLC
V260-027 Safety and Immunogenicity of RotaTeq™ in Elderly Subjects
This is a Phase I clinical trial including 2 parts to evaluate the safety and immune response to RotaTeq™ /placebo in subjects of 65 to 80 years of age. In Part I, approximately 60 subjects in US will be randomly assigned to 1 of 2 treatment groups receiving 3 doses of RotaTeq™ or placebo. In Part II, approximately 200 subjects internationally will be randomly assigned to 1 of 3 treatment groups. Part II will start after Part I data analysis is reviewed and approved by the FDA/CBER, the Safety Evaluation Committee (SEC) and other regulatory agencies. Duration for the entire study will be approximately 4 years.
Note: As the result of a business decision by the Sponsor, the study did not proceed with Part II. Therefore, this report includes the results for Part I only.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 80 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Is 65 to 80 years of age with controlled chronic illness
- agrees to participate in the study by giving written informed consent and cognitively competent as assessed by Mini-Mental State Examination
- for Part I: subject is living independently outside any long-term care facilities; for Part II: subject is expected to be a resident in a long term care facility (LTCF) including nursing homes with the exception of hospice care
- can be adequately followed for safety via visit or phone
- subject's routine safety lab results are within specified ranges
- has negative test results for HIV, Hepatitis B, and Hepatitis C
Exclusion Criteria:
- abdominal cancer/surgery within the past 6 months
- known or suspected immune diseases, e.g. diabetes
- any chronic or relapsing infections
- a fever at the time of immunization
- active vomiting or diarrhea at the time of immunization
- chronic diarrhea, irritable bowel syndrome, or inflammatory disease of intestinal or colon in the past 12 months
- subjects' spouses/cohabitants are not healthy or are immunocompromised; roommates in LTCFs are not healthy and/or do not agree to participate in the study
- cannot be adequately followed for safety via visit or phone
- any other clinically significant conditions that, in the investigators' opinion, would interfere with subject's participation in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Part I, RotaTeq
3 doses of RotaTeq
|
Three 2.0 mL oral doses of RotaTeq.
Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
|
Placebo Comparator: Part I, placebo
3 doses of placebo
|
Three 2.0 mL oral doses of RotaTeq.
Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
|
Experimental: Part II, RotaTeq
3 doses of RotaTeq
|
Three 2.0 mL oral doses of RotaTeq.
Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
|
Experimental: Part II, RotaTeq and placebo
1 dose of RotaTeq and 2 doses of placebo
|
One 2.0 mL oral dose of RotaTeq and two 2.0 mL oral doses of placebo over an approximately 3-5 month treatment period
|
|
Placebo Comparator: Part II, placebo
3 doses of placebo
|
Three 2.0 mL oral doses of RotaTeq.
Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Part I: Number of Participants With Nonserious and Serious Adverse Experiences (AEs)
Time Frame: Up to 42 days following any dose of RotaTeq™ or placebo
|
All randomized participants were contacted via telephone or in-center visit on Days 7, 14, 28, and 42 after each dose.
Participants received a Vaccination Report Card (VRC) at each vaccination visit as well as instructions for recording AEs.
Participants were also instructed to record potential acute gastroenteritis episodes (AGEs) that occurred within 42 days after any dose on the report card.
|
Up to 42 days following any dose of RotaTeq™ or placebo
|
|
Part I: Number of Participants With Serious Adverse Experiences (SAEs)
Time Frame: Up to 180 days following the third dose of RotaTeq™ or placebo
|
All randomized participants were contacted via telephone or in-center visit on Days 7, 14, 28, and 42 after each dose. Participants received a Vaccination Report Card (VRC) at each vaccination visit as well as instructions for recording AEs. Participants were also instructed to record potential acute gastroenteritis episodes (AGEs) that occurred within 42 days after any dose on the report card. SAEs were followed by passive surveillance (in which either participants self reported or information was collected at participants' last visit) for 180 days following the final dose. |
Up to 180 days following the third dose of RotaTeq™ or placebo
|
|
Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA)
Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
|
GMTs of serum anti-rotavirus IgA responses after 1, 2, or 3 doses of RotaTeq™ or placebo.
|
Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
|
|
Part II: Number of Participants With Nonserious Adverse Experiences
Time Frame: Up to 42 days following any dose of RotaTeq™ and/or placebo
|
Part II was not conducted due to study termination; this report summarizes study results from Part I only.
|
Up to 42 days following any dose of RotaTeq™ and/or placebo
|
|
Part II: Number of Participants With Serious Adverse Experiences
Time Frame: Up to 180 days following the third dose of RotaTeq™ and/or placebo
|
Part II was not conducted due to study termination; this report summarizes study results from Part I only.
|
Up to 180 days following the third dose of RotaTeq™ and/or placebo
|
|
Part II: Geometric Mean Titer (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA)
Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3
|
Part II was not conducted due to study termination; this report summarizes study results from Part I only.
|
Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1
Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
|
Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
|
|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2
Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
|
Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
|
|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3
Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
|
Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
|
|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4
Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
|
Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
|
|
|
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8]
Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
|
Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
|
|
|
Part II: Geometric Mean Titers (GMTs) of Serum Neutralizing Antibody (SNA) Responses to G1, G2, G3, G4, and P1A
Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3
|
Part II was not conducted due to study termination; this report summarizes study results from Part I only.
|
Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3
|
|
Part II: Percentage of Participants With a >=3-fold Rise From Baseline of Serum Anti-rotavirus IgA and SNA Responses to Rotavirus Serotypes G1, G2, G3, G4 and P1A
Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3
|
Part II was not conducted due to study termination; this report summarizes study results from Part I only.
|
Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
February 3, 2009
First Submitted That Met QC Criteria
February 3, 2009
First Posted (Estimate)
February 4, 2009
Study Record Updates
Last Update Posted (Estimate)
May 1, 2015
Last Update Submitted That Met QC Criteria
April 10, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- V260-027
- 2007_537
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.