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

Phase 1TerminatedNCT00836498

Merck Sharp & Dohme LLC66 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Rotavirus

Interventions

Eligibility

Sex: ALLMin age: 65 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3

Secondary Outcomes

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

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

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

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

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

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.

Time frame: 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.

Time frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3