Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Patients ≥65 Years

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular or Subcutaneous Route in Participants Aged 65 Years and Older in Japan

ClinicalTrials.gov ID

NCT03233217

Acronym / sponsor ID

QHD00008

Conditions

Influenza

Keywords

Influenza

Phase

Phase 1/2

Study type

Interventional

Recruitment status

Completed

Enrolment

175 participants (actual)

Lead sponsor

Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)

Collaborators

Sanofi

Study start

15 Sep 2017 (actual)

Primary completion

28 Nov 2017 (actual)

Study completion

28 Nov 2017 (actual)

First posted

28 Jul 2017 (actual)

Results

Posted 17 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Prevention

Allocation

Randomised

Intervention model

Sequential

Masking

Double blind (participant, investigator)

Number of arms

5

Model description

Safety and tolerability was initially assessed in the first 10 participants in a smaller cohort (Cohort 1). Participants were randomized 1:1 into 2 groups in Cohort 1: QIV-HD by IM route (n=5) and QIV-HD by SC route (n=5). After review of the local and systemic adverse events, the remaining 165 participants were enrolled (Cohort 2). Participants were randomized 1:1:1 into 3 groups in Cohort 2: QIV-HD by IM route (n=55), QIV-HD by SC route (n=55), and QIV-SD by SC route (n=55).

Who may qualify

Ages

65 years and older

Sex

All

Healthy volunteers

Accepted

Age groups

Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants With Immediate Unsolicited Adverse Events (AE) After Vaccination

   Time frame: Within 30 minutes after vaccination

   An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.

2. Number of Participants With Solicited Injection Site and Systemic Reactions

   Time frame: Within 7 days after vaccination

   A solicited reaction was an adverse reaction observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions: pain, erythema, swelling, induration, and bruising. Solicited systemic reactions: fever, headache, malaise, myalgia, and shivering.

3. Number of Participants With Unsolicited Adverse Events After Vaccination

   Time frame: Within 28 days after vaccination

   An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.

4. Number of Participant With Serious Adverse Events (SAEs) After Vaccination

   Time frame: Up to 6 months after vaccination

   An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Background: PubMed 31634025Sanchez L, Matsuoka O, Inoue S, Inoue T, Meng Y, Nakama T, Kato K, Pandey A, Chang LJ. Immunogenicity and safety of high-dose quadrivalent influenza vaccine in Japanese adults >/=65 years of age: a randomized controlled clinical trial. Hum Vaccin Immunother. 2020 Apr 2;16(4):858-866. doi: 10.1080/21645515.2019.1677437. Epub 2019 Nov 19.
• Related infoLink provided by the sponsor.
• Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

2 sites in 1 country: see every site and its status.