Clinical trial NCT00836498: A Study of the Safety and Immune Response to RotaTeq™ Vaccine in the Elderly (V260-027)
Official title: V260-027 Safety and Immunogenicity of RotaTeq™ in Elderly Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Rotavirus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-02-04
Enrollment: 66
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Part I: Number of Participants With Nonserious and Serious Adverse Experiences (AEs)
timeFrame: Up to 42 days following any dose of RotaTeq™ or placebo
measure: Part I: Number of Participants With Serious Adverse Experiences (SAEs)
timeFrame: Up to 180 days following the third dose of RotaTeq™ or placebo
measure: Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA)
timeFrame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
measure: Part II: Number of Participants With Nonserious Adverse Experiences
timeFrame: Up to 42 days following any dose of RotaTeq™ and/or placebo
measure: Part II: Number of Participants With Serious Adverse Experiences
timeFrame: Up to 180 days following the third dose of RotaTeq™ and/or placebo
measure: Part II: Geometric Mean Titer (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA)
timeFrame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3
Secondary outcomes:
measure: Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1
timeFrame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
measure: Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2
timeFrame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
measure: Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3
timeFrame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
measure: Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4
timeFrame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
measure: Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8]
timeFrame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
measure: Part II: Geometric Mean Titers (GMTs) of Serum Neutralizing Antibody (SNA) Responses to G1, G2, G3, G4, and P1A
timeFrame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3
measure: 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
timeFrame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Lawrence J, He S, Martin J, Schodel F, Ciarlet M, Murray AV. Safety and immunogenicity of pentavalent rotavirus vaccine in a randomized, double-blind, placebo-controlled study in healthy elderly subjects. Hum Vaccin Immunother. 2014;10(8):2247-54. doi: 10.4161/hv.29107.