Clinical Trials List
Protocol NumberV118_05
2014-09-01 - 2018-09-04
Phase III
Terminated2
Study ended1
ICD-10Z23
Encounter for immunization
ICD-9V04.8
Need for prophylactic vaccination and inoculation against influenza
A Phase III, Stratified, Randomized, Observer Blind, Controlled, Multicenter Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to NonAdjuvanted Comparator Influenza Vaccine in Children ≥6 to < 72 Months of Age.
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Sponsor
Novartis Pharma Services AG / Novartis Vaccines
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/19
Investigators and Locations
Co-Principal Investigator
- Chi-Long Chen Division of Pediatrics
- 郭貞孍 Division of Pediatrics
- 謝育嘉 Division of Pediatrics
- Yhu-Chering Huang Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chun-yi Lu Division of Pediatrics
- 吳仲琳 Division of Pediatrics
- Luan-Yin Chang Division of Pediatrics
- 馬瑄吟 Division of Pediatrics
- 黃文嬋 Division of Pediatrics
- 林谷龍 Division of Pediatrics
- 賴貞吟 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Hung-Chih Lin Division of Pediatrics
- Hsiao-chuan Lin Division of Pediatrics
- An-Chyi Chen Division of Pediatrics
The Actual Total Number of Participants Enrolled
11 Study ended
Condition/Disease
Vaccines to prevent influenza
Objectives
The primary and secondary relative efficacy objectives will be measured in all subjectsin relation to cases occurring at >21 days and ≤180 days after the last vaccination oruntil the end of the influenza season (see Definitions), whichever is longer. In all cases,efficacy will be determined on influenza cases caused by any of the influenza strainsrelated to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e.A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIVand QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and throughthe end of the trial) (see Definitions). Data from all seasons will be combined.
Test Drug
aQIV
Active Ingredient
hemagglutinin (HA) of each of the 2 influenza type A
strains and each of the 2 influenza type B strains
strains and each of the 2 influenza type B strains
Dosage Form
Suspension for Injection in PFS
Dosage
30mcg or 60mcg
Endpoints
The endpoint of relative vaccine efficacy (rVE) is defined as rVE=1-HR = 1- λaQIV(t)/
λComp(t) , where HR is the hazard ratio and λ(t) the hazardrates of each vaccine group. λ
(t) = f(t)/S(t), where f(t) is the rate of first-occurrence RT-PCR-confirmed influenza
events per unit time t and S(t) is the survival function, i.e. function of time without
influenza events. In the first season influenza cases of any of the influenza strains
related to the two A subtypes and the B lineage common to aQIV and non-adjuvanted
TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata) will be used for calculation. In the second
and possible subsequent seasons the cases related to the A subtypes and the B lineages
common to both aQIV and non adjuvanted QIV will be used (i.e. A/H1N1, A/H3N2 and
both B lineages).
Primary efficacy endpoint:
The primary endpoint is on RT-PCR-confirmed influenza cases occurring at >21 days
and ≤ 180 days after the last vaccination or until the end of the influenza season,
whichever is longer.
λComp(t) , where HR is the hazard ratio and λ(t) the hazardrates of each vaccine group. λ
(t) = f(t)/S(t), where f(t) is the rate of first-occurrence RT-PCR-confirmed influenza
events per unit time t and S(t) is the survival function, i.e. function of time without
influenza events. In the first season influenza cases of any of the influenza strains
related to the two A subtypes and the B lineage common to aQIV and non-adjuvanted
TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata) will be used for calculation. In the second
and possible subsequent seasons the cases related to the A subtypes and the B lineages
common to both aQIV and non adjuvanted QIV will be used (i.e. A/H1N1, A/H3N2 and
both B lineages).
Primary efficacy endpoint:
The primary endpoint is on RT-PCR-confirmed influenza cases occurring at >21 days
and ≤ 180 days after the last vaccination or until the end of the influenza season,
whichever is longer.
Inclution Criteria
1. Children, males and females, healthy or at high risk of complications from influenza,
between ≥6 months to <72 months of age (see Appendix B)
2. Documented consent provided by the subject’s parent(s)/legal guardian(s) according
to local regulatory requirements after the nature of the study has been explained to
them.
3. Subjects and/or subject’s parent(s)/legal guardian(s) able to comply with all study
procedures, and available for all clinic visits and telephone, email and/or text message
(SMS) contacts scheduled in the study.
4. Subject’s parent(s)/legal guardian(s) willing to allow for serum samples to be stored
beyond the study period, for potential additional future testing to better characterize
the immune response.
between ≥6 months to <72 months of age (see Appendix B)
2. Documented consent provided by the subject’s parent(s)/legal guardian(s) according
to local regulatory requirements after the nature of the study has been explained to
them.
3. Subjects and/or subject’s parent(s)/legal guardian(s) able to comply with all study
procedures, and available for all clinic visits and telephone, email and/or text message
(SMS) contacts scheduled in the study.
4. Subject’s parent(s)/legal guardian(s) willing to allow for serum samples to be stored
beyond the study period, for potential additional future testing to better characterize
the immune response.
Exclusion Criteria
1. Children, whose parent(s)/legal guardian(s) are not able to comprehend and to follow
all required study procedures for the whole period of the study.
2. History of Guillain-Barré Syndrome, epilepsy, or history of convulsions (excluding
febrile convulsions).
3. Children with any fatal prognosis of an underlying medical condition (<12 month life
expectancy).
4. Children who have any medical condition meeting the definition of the Adverse Event
of Special Interest defined for the purposes of this trial.
5. Children hospitalized at the time of enrollment.
6. History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any
vaccine component, to eggs (including ovalbumin), and chicken protein, latex.
7. Children of research staff directly involved with the clinical study or who are
otherwise related to research staff or have household members who are research staff.
Research staff are individuals with direct or indirect contact with study subjects, or study site personnel who have access to any study documents containing subject
information. This would include receptionists, persons scheduling appointments or
making screening calls, regulatory specialists, laboratory technicians, etc.
8. Fever [i.e. body temperature measurement ≥ 38°C (≥ 100.4°F)] measured preferably
orally. This is not an absolute exclusion criterion. The subject may be
enrolled/vaccinated once he/she is free of fever (defined as ≥ 38°C (≥ 100.4°F)) for at
least 3 days.
9. Children who have received vaccines within 14 days (for inactivated vaccines) or 28
days (for live vaccines) prior to enrollment into this study. Depending upon the
duration of enrollment, children with this exclusion criterion may be eligible for
enrollment into the study once either 14 days (for inactivated vaccine administration)
or 28 days (for live vaccine administration) have passed.
10. Individuals who have received antipyretic medication within the past 24 hours prior to
vaccination. The subject may return for vaccination after a period of 24 hours has
passed since the administration of an antipyretic.
11. Receipt of another investigational agent within 30 days prior to enrollment or before
completion of safety follow-up period in this or in another study, or unwillingness to
refuse to participate in another clinical study through the duration of this study.
12. Children who have been immunized with any influenza vaccine (licensed or
investigational) or with laboratory confirmed influenza within 6 months prior to
enrollment.
13. Subject’s parent(s)/guardian(s) who are unwilling to be contacted by the phone for the
safety phone calls (see section 3.2.5.6) or phone, email, or text message (SMS) for
active influenza surveillance (see section 3.2.5.7).
14. Individuals who have been diagnosed with any disorders in growth such as failure to
thrive or short stature.
all required study procedures for the whole period of the study.
2. History of Guillain-Barré Syndrome, epilepsy, or history of convulsions (excluding
febrile convulsions).
3. Children with any fatal prognosis of an underlying medical condition (<12 month life
expectancy).
4. Children who have any medical condition meeting the definition of the Adverse Event
of Special Interest defined for the purposes of this trial.
5. Children hospitalized at the time of enrollment.
6. History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any
vaccine component, to eggs (including ovalbumin), and chicken protein, latex.
7. Children of research staff directly involved with the clinical study or who are
otherwise related to research staff or have household members who are research staff.
Research staff are individuals with direct or indirect contact with study subjects, or study site personnel who have access to any study documents containing subject
information. This would include receptionists, persons scheduling appointments or
making screening calls, regulatory specialists, laboratory technicians, etc.
8. Fever [i.e. body temperature measurement ≥ 38°C (≥ 100.4°F)] measured preferably
orally. This is not an absolute exclusion criterion. The subject may be
enrolled/vaccinated once he/she is free of fever (defined as ≥ 38°C (≥ 100.4°F)) for at
least 3 days.
9. Children who have received vaccines within 14 days (for inactivated vaccines) or 28
days (for live vaccines) prior to enrollment into this study. Depending upon the
duration of enrollment, children with this exclusion criterion may be eligible for
enrollment into the study once either 14 days (for inactivated vaccine administration)
or 28 days (for live vaccine administration) have passed.
10. Individuals who have received antipyretic medication within the past 24 hours prior to
vaccination. The subject may return for vaccination after a period of 24 hours has
passed since the administration of an antipyretic.
11. Receipt of another investigational agent within 30 days prior to enrollment or before
completion of safety follow-up period in this or in another study, or unwillingness to
refuse to participate in another clinical study through the duration of this study.
12. Children who have been immunized with any influenza vaccine (licensed or
investigational) or with laboratory confirmed influenza within 6 months prior to
enrollment.
13. Subject’s parent(s)/guardian(s) who are unwilling to be contacted by the phone for the
safety phone calls (see section 3.2.5.6) or phone, email, or text message (SMS) for
active influenza surveillance (see section 3.2.5.7).
14. Individuals who have been diagnosed with any disorders in growth such as failure to
thrive or short stature.
The Estimated Number of Participants
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Taiwan
650 participants
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Global
10616 participants
