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

Rotavirus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00836498
• Other study ID #: V260-027
• Secondary ID: 2007_537
• Status: Terminated
• Phase: Phase 1
• First received: February 3, 2009
• Last updated: April 10, 2015
• Start date: January 2009
• Est. completion date: January 2010

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Rotavirus

Intervention

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.
• 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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Lawrence J, He S, Martin J, Schödel 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	No
Primary	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	Yes
Primary	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	Yes
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site