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RotavirusPhase 1NCT00836498

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

A Phase 1 study testing Comparator: RotaTeq in people with Rotavirus, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 65 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Rotavirus
What is being tested?
Comparator: RotaTeq
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
No sites listed yet
Study dates
Jan 2009to Jan 2010
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

About this study

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

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
Being tested
Comparator: RotaTeq, Comparator: Placebo, Comparator: RotaTeq + Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comparator: RotaTeqBiological

    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: PlaceboBiological

    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 + PlaceboBiological

    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

Study groups in NCT00836498
Study groupRoleWhat they receive
Part I, RotaTeqExperimental3 doses of RotaTeq
Receives: Biological: Comparator: RotaTeq
Part I, placeboPlacebo comparator3 doses of placebo
Receives: Biological: Comparator: Placebo
Part II, RotaTeqExperimental3 doses of RotaTeq
Receives: Biological: Comparator: RotaTeq
Part II, RotaTeq and placeboExperimental1 dose of RotaTeq and 2 doses of placebo
Receives: Biological: Comparator: RotaTeq + Placebo
Part II, placeboPlacebo comparator3 doses of placebo
Receives: Biological: Comparator: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 42 days following any dose of RotaTeq™ or placebo

  2. 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.

    Measured: Up to 180 days following the third dose of RotaTeq™ or placebo

  3. 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.

    Measured: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo

  4. 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.

    Measured: Up to 42 days following any dose of RotaTeq™ and/or placebo

  5. 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.

    Measured: Up to 180 days following the third dose of RotaTeq™ and/or placebo

  6. 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.

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

Secondary outcomes (7)

  1. Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1

    Measured: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo

  2. Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2

    Measured: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo

  3. Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3

    Measured: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo

  4. Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4

    Measured: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo

  5. Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8]

    Measured: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo

  6. 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.

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

  7. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionJan 2010
  4. Study completionJan 2010

Why it stopped: Strategic business decision not to pursue indication due to lack of demonstrable medical need

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00836498
Sponsor's protocol ID
V260-027
Other IDs
2007_537
Status last verified
Apr 2015
First submitted
3 Feb 2009
Last updated
1 May 2015

Publications

  • 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.

    PubMed 25424929

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Comparator: RotaTeq in people with Rotavirus, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00836498, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2015.

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