NCT02213432

Brief Summary

The purpose of this study is to determine the timing of influenza vaccination to induce higher antibody response in adult patients with non-hematologic malignancies receiving scheduled cytotoxic chemotherapy.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2014

Completed
21 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

5 months

First QC Date

August 7, 2014

Last Update Submit

February 22, 2016

Conditions

Cancer

Keywords

influenza vaccinecancer

Outcome Measures

Primary Outcomes (1)

  • Seroprotection rate

    The percentage of vaccine recipients with a serum haemagglutination inhibition(HI) titre ≥40 post vaccination (21-28 days)

    21-28 days after vaccination

Secondary Outcomes (4)

  • Seroconversion factor

    21-28 days after vaccination

  • Seroconversion rate

    21-28 days after vaccination

  • Geometric mean titre of HI

    21-28 days after vaccination

  • Vaccine-related adverse events

    within 28 days

Study Arms (2)

Day 1 vaccination

EXPERIMENTAL

Different timing of influenza vaccination: Day 1 Day 1 vaccination group: patients will be vaccinated against influenza at the day (Day 1) when chemotherapy starts.

Biological: Different timing of influenza vaccination

Day 11 vaccination

ACTIVE COMPARATOR

Different timing of influenza vaccination: Day 11 Day 11 vaccination group: patients will be vaccinated against influenza at the 11th days after chemotherapy starts

Biological: Different timing of influenza vaccination

Interventions

Different timing of influenza vaccinationBIOLOGICAL

The timing of Influenza vaccination for cancer patients receiving chemotherapy will be differently assigned to day 1 or day 11.

Day 1 vaccinationDay 11 vaccination

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who receive the scheduled cytotoxic chemotherapy every 3 weeks because of solid cancer.
  • Specific definition of each term is like following:
  • The solid cancer includes various kinds of cancer except hematologic and lymphoid malignancies.
  • Cytotoxic chemotherapy includes adjuvant, neoadjuvant or palliative purpose of chemotherapy with the planned duration at least over 3 cycles every 3 weeks.
  • Targeted therapy drugs like as monoclonal antibody, tyrosine kinase inhibitor or oral chemotherapy drugs like as Xeloda are excluded.
  • Patients who did not receive the influenza vaccination yet in the current year.
  • Older than 19 years
  • Eastern Cooperative Oncology Group (ECOG) performance status is 0, 1, or 2
  • Cell blood count meets following criteria:
  • Neutrophile count ≥ 1.5 x 10\^9/L
  • Platelet count ≥ 100 x 10\^9/L
  • Hemoglobin ≥ 8 g/dL
  • Patients who can understand and agreed with the informed consents.

You may not qualify if:

  • Patients who have any contraindication for influenza vaccination.
  • Patients who are supposed to receive the last chemotherapy at the enrollment
  • Patients who receive simultaneous radiation therapy with cytotoxic chemotherapy
  • Patients who receive any immunosuppressant (excluding steroid for anti-emetic effect)
  • Patients with HIV and low CD 4+ T cell count (\< 500/uL)
  • Patients with autoimmune disease who are anticipated to have a problem with immunogenicity for vaccine
  • Patients who have transplanted organ and receive immunosuppressants
  • Patients who are supposed to get prophylactic G-CSF after chemotherapy
  • Patients who are suspected to have active infectious disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

NeoplasmsInfluenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Wan Beom Park, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 7, 2014

First Posted

August 11, 2014

Study Start

September 1, 2014

Primary Completion

February 1, 2015

Study Completion

August 1, 2015

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations

KR(1)