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

NCT00836498 | Terminated Phase 1 Results

• 2 other identifiers: V260-0272007_537
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rotavirus

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• 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

Study Arms (5)

Part I, RotaTeq

EXPERIMENTAL

3 doses of RotaTeq

Biological: Comparator: RotaTeq

Part I, placebo

PLACEBO COMPARATOR

3 doses of placebo

Biological: Comparator: Placebo

Part II, RotaTeq

EXPERIMENTAL

3 doses of RotaTeq

Biological: Comparator: RotaTeq

Part II, RotaTeq and placebo

EXPERIMENTAL

1 dose of RotaTeq and 2 doses of placebo

Biological: Comparator: RotaTeq + Placebo

Part II, placebo

PLACEBO COMPARATOR

3 doses of placebo

Biological: Comparator: Placebo

Interventions

Comparator: RotaTeq BIOLOGICAL

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.

Part I, RotaTeq; Part II, RotaTeq

Comparator: Placebo BIOLOGICAL

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.

Part I, placebo; Part II, placebo

Comparator: RotaTeq + Placebo BIOLOGICAL

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

Part II, RotaTeq and placebo

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 25424929 RESULT

Results Point of Contact

• Title: Vice President of Late Stage Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 4, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: May 1, 2015
• Results First Posted: February 4, 2011

Record last verified: 2015-04