A Study of the Safety and Immune Response to RotaTeq™ Vaccine in the Elderly (V260-027)

This study has been terminated.
(Strategic business decision not to pursue indication due to lack of demonstrable medical need)
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00836498
First received: February 3, 2009
Last updated: February 24, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Rotavirus
Biological: Comparator: RotaTeq
Biological: Comparator: Placebo
Biological: Comparator: RotaTeq + Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: V260-027 Safety and Immunogenicity of RotaTeq™ in Elderly Subjects

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Part I: Number of Participants With Serious Adverse Experiences (SAEs) [ Time Frame: Up to 180 days following the third dose of RotaTeq™ or placebo ] [ Designated as safety issue: Yes ]

    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.


  • 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 ] [ Designated as safety issue: No ]
    GMTs of serum anti-rotavirus IgA responses after 1, 2, or 3 doses 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 ] [ Designated as safety issue: Yes ]
    Part II was not conducted due to study termination; this report summarizes study results from Part I only.

  • Part II: Number of Participants With Serious Adverse Experiences [ Time Frame: Up to 180 days following the third dose of RotaTeq™ and/or placebo ] [ Designated as safety issue: Yes ]
    Part II was not conducted due to study termination; this report summarizes study results from Part I only.

  • 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 ] [ Designated as safety issue: No ]
    Part II was not conducted due to study termination; this report summarizes study results from Part I only.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Part II was not conducted due to study termination; this report summarizes study results from Part I only.

  • 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 ] [ Designated as safety issue: No ]
    Part II was not conducted due to study termination; this report summarizes study results from Part I only.


Enrollment: 66
Study Start Date: February 2009
Study Completion Date: April 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part I, RotaTeq
3 doses of RotaTeq
Biological: Comparator: 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
Biological: Comparator: 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
Biological: Comparator: 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
Biological: Comparator: RotaTeq + 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
Biological: Comparator: 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.

  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836498

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00836498     History of Changes
Other Study ID Numbers: V260-027, 2007_537
Study First Received: February 3, 2009
Results First Received: January 12, 2011
Last Updated: February 24, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 18, 2014