Overview

This trial is active, not recruiting.

Condition influenza
Treatments aqiv-aqiv, aqiv-qiv, qiv-aqiv, qiv-qiv
Phase phase 3
Sponsor Seqirus
Start date January 2016
End date September 2016
Trial size 1601 participants
Trial identifier NCT02583256, V118_05E3

Summary

Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously vaccinated in Trial V118_05. Subjects will receive either the Same or Alternate Type of Vaccine.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Subjects previously vaccinated with aQIV followed one year later by aQiV
aqiv-aqiv
aQIV in V118_05 and aQIV in V118_05E3
(Experimental)
Subjects previously vaccinated with aQIV followed one year later by QIV
aqiv-qiv
aQIV in V118_05 and QIV in V118_05E3
(Experimental)
Subjects previously vaccinated with QIV followed one year later by aQIV
qiv-aqiv
QIV in V118_05 and aQIV in V118_05E3
(Experimental)
Subjects previously vaccinated with QIV followed one year later by QIV
qiv-qiv
QIV in V118_05 and QIV in V118_05E3

Primary Outcomes

Measure
Geometric Mean Titer (GMT)
time frame: Day 22

Secondary Outcomes

Measure
Geometric Mean Titer (GMT)
time frame: Day 22 and Day 181
Seroconversion
time frame: Day 22 and Day 181
Percentage of subjects with Serious Adverse Events (SAE)
time frame: Day 1 - Day 366
Percentage of subjects with Adverse Events (AE) leading to withdrawal
time frame: Day 1 - Day 366
Percentage of subjects with New Onset of Chronic Disease (NOCD)
time frame: Day 1 - Day 366
Percentage of subjects with Adverse Events of Special Interest (AESI)
time frame: Day 1 - Day 366
Percentage of subjects with Medically attended AEs and associated medications
time frame: Day 1 - Day 366
Percentage of subjects with solicited AEs
time frame: Day 1- Day 7 after vaccination
Percentage of subjects with unsolicited AEs
time frame: Day 1- Day 22

Eligibility Criteria

Male or female participants from 18 months up to 85 months old.

Inclusion Criteria: - Male or female subject who has completed their last visit in trial V118_05. - Subject's parent/legal guardian has voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study enter Exclusion Criteria: - Individuals recently vaccinated against influenza - Subjects with contraindications to receive influenza vaccines - Please contact the site for additional eligibility criteria.

Additional Information

Official title Phase III, Randomized, Observer Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Repeated Exposure to Either the Same or Alternate Type of Vaccine, Adjuvanted or Non-adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV or QIV), Administered to Subjects Previously Vaccinated in Trial V118_05 (NCT01964989)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Seqirus.