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

Study Overview
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Brief Summary
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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.

Official Title
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V260-027 Safety and Immunogenicity of RotaTeq™ in Elderly Subjects

Conditions
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Rotavirus

Intervention / Treatment
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* Biological: Comparator: RotaTeq
* Biological: Comparator: Placebo
* Biological: Comparator: RotaTeq + Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part I, RotaTeq<br>3 doses of RotaTeq | Biological: Comparator: RotaTeq<br>* 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.<br>|
| Placebo Comparator: Part I, placebo<br>3 doses of placebo | Biological: Comparator: Placebo<br>* 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.<br>|
| Experimental: Part II, RotaTeq<br>3 doses of RotaTeq | Biological: Comparator: RotaTeq<br>* 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.<br>|
| Experimental: Part II, RotaTeq and placebo<br>1 dose of RotaTeq and 2 doses of placebo | Biological: Comparator: RotaTeq + Placebo<br>* 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<br>|
| Placebo Comparator: Part II, placebo<br>3 doses of placebo | Biological: Comparator: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part I: Number of Participants With Nonserious and Serious Adverse Experiences (AEs) | 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) | 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) | 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 | 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 | 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) | 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 |  | 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 |  | 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 |  | 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 |  | 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] |  | 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 | 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 | 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 |