A study to compare the safety and efficacy of Abbott's Quadrivalent Influenza Vaccine versus a non-influenza vaccine in children aged 6-35 Months

• Register: EUCTR
• Last refreshed on: 29 April 2020
• Main ID: EUCTR2016-004904-74-DK
• Date of registration: 04/05/2017
• Prospective Registration: Yes
• Primary sponsor: Abbott Biologicals B.V.
• Public title: A study to compare the safety and efficacy of Abbott's Quadrivalent Influenza Vaccine versus a non-influenza vaccine in children aged 6-35 Months
• Scientific title: A Phase III, Observer-Blind, Randomized, Non-influenza Vaccine Comparator-Controlled, Parallel-Group, Multi-Country Study in Children Aged 6-35 Months to Assess the Safety and Efficacy of Abbott’s Candidate Quadrivalent Influenza Vaccine.
• Date of first enrolment: 06/06/2017
• Target sample size: 2000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004904-74
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: yes; Other trial design description: Observer-blind; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Bulgaria, Croatia, Czech Republic, Denmark, Estonia, France, Hungary, Italy, Lithuania, Romania, Slovakia, Slovenia, Spain, Sweden, Ukraine

Contacts

• Name: Global Clinical Director Vaccines
• Affiliation: Abbott Healthcare Products B.V.

• Name: Global Clinical Director Vaccines
• Affiliation: Abbott Healthcare Products B.V.

Key inclusion & exclusion criteria

Inclusion criteria:
1.Male or female subjects between, and including, 6 and 35 months* of age at Day 1 and in stable health as judged by medical history, physical examination and clinical judgment of the Investigator. Subjects may have underlying chronic disorders as long as their symptoms/signs are controlled and yearly (seasonal) influenza vaccination is not recommended as a result of the underlying condition. If at the time of enrolment the subject has been on medication for a pre-existing condition, the dose must have been stable for at least three months.
2.Subjects who are 6-24 months of age at Day 1 should have been born at full term of pregnancy (= 37 weeks gestation) and with a birth weight of = 2.5 kg.
3.Written informed consent obtained from the parent(s)/LAR(s) of the subject.
4.Subject and parent or other legally acceptable representative are able and willing to attend all scheduled visits and to comply with all trial procedures.
* The age range for enrollment may be restricted at a country/region/site level if none of the non-influenza control vaccines can be used in one or more age groups.

Are the trial subjects under 18? yes
Number of subjects for this age range: 2000
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1.Child in care
2.History of allergy to egg, chicken proteins, or other vaccine components.
3.History of serious adverse reaction to any vaccine.
4.History of Guillain-Barré syndrome.
5.Chronic administration (defined as more than 14 days) of immunosuppressants or other immune modifying medication within three months prior to the first vaccine dose or planned use thereof during the study. Topical use of corticosteroids (e.g., cream, ocular drops, inhalation and intranasal sprays), within the dosage noted on the product label, is allowed.
6.Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
7.Use of cytotoxic drugs, anticancer chemotherapy or radiation therapy.
8.Any confirmed or suspected immunosuppressive or immunodeficient condition (including human immunodeficiency virus [HIV]), based on medical history and physical examination.
9.Being a solid organ or bone marrow/stem cell transplant recipient.
10.Ongoing aspirin therapy (to avoid cases of Reye’s syndrome).
11.Receipt of an influenza vaccine ever before or having been diagnosed with influenza (confirmed by laboratory or rapid influenza diagnostic tests) ever before.
12.Receipt of any vaccine (including routine childhood vaccines) within 28 days prior to study vaccination or planned vaccination within 28 days following each study vaccination.
13.Planned administration of any influenza vaccine (other than the study vaccination) during the entire study period.
14.Children with underlying illness who are at risk of complications of influenza and children for whom yearly (seasonal) influenza vaccination is recommended in their respective country.
15.Having fever and/or an acute disease or infection on the day of first study vaccination. Fever is defined as a body temperature = 38.0oC measured rectally (preferred method) or anxillary = 37.5 oC (if rectal method is not possible, e.g. because of medical reason).
16.Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine including (but not limited to) bleeding disorder, immunodeficiency, seizure disorder, acute or progressive hepatic, renal, neurological or neuromuscular disease.
17.Participation in the study prevents the receipt of scheduled routine childhood vaccinations or leads to deviations from recommended vaccination schedule which would have a medical impact.

Addtional exlcusion criteria described in the Protocol section 5.2 would apply for non-influenza vaccines


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Prophylaxis of Influenza
MedDRA version: 20.0 Level: HLT Classification code 10022005 Term: Influenza viral infections System Organ Class: 100000004862

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

Product Name: QIV (Quadrivalent Influenza Vaccine)
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Influenza vaccine (surface antigen, inactivated)
Current Sponsor code: QIV (Quadrivalent Influenza Vaccine)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 15-

Trade Name: Menjugate
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Meningococcal group C conjugate vaccine
Other descriptive name: Meningococcal group C conjugate vaccine
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 10-

Trade Name: Varivax, Provarivax
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: • Varicella vaccine
Other descriptive name: VARICELLA VIRUS OKA/MERCK STRAIN, (LIVE, ATTENUATED) PRODUCED IN HUMAN DIPLOID (MRC-5) CELLS
Concentration unit: PFU plaque forming unit
Concentration type: equal
Concentration number: 1350-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Between 28 days following the second vaccine administration and the end of the influenza surveillance period.

Primary end point(s): Primary efficacy endpoint: First occurrence of reverse transcription RT-PCR confirmed influenza A and/or B illness of any severity due to any circulating seasonal influenza strain

Main Objective: To demonstrate in children 6-35 months of age the absolute efficacy of QIV in the prevention of symptomatic influenza infection due to any circulating seasonal influenza strain compared to a non-influenza vaccine.

Secondary Objective: -Demonstrate the absolute efficacy of QIV in the prevention of symptomatic influenza infection of antigenically-matching influenza strains compared to a non-influenza vaccine
-Describe the immunogenicity of each of the strains in QIV with respect to HI in all subjects and VN and NI antibody titers in randomized population subsets.
-Describe CMI for a subset of subjects at selected sites
-Describe Year 2 baseline and post-vaccination immunogenicity for each of the strains in QIV with respect to HI in all subjects and NI and VN in random population subsets of subjects exposed to QIV in Year 1 and who will receive revaccination
-Evaluate the occurrence of all-cause mortality, hospitalization, ILIs, all-cause pneumonia and otitis media in the QIV group compared with the non-influenza vaccine control groups
-Explore potential immunological correlates of protection based on determined HI antibody titers and RT-PCR outcomes
-Evaluate healthcare utilization and health economic outcomes

Secondary Outcome(s)

Secondary end point(s): The secondary efficacy endpoints concern:
1.First occurrence of cell culture-confirmed influenza A and/or B illness of any severity due to antigenically-matching influenza strains occurring between 28 days following the second vaccine administration and the end of the influenza surveillance period.
2.All-cause mortality, hospitalization, ILIs, all-cause pneumonia and otitis media.
3.Post-vaccination geometric mean HI (all subjects), VN and NI antibody (random population subsets) titers and change from baseline against the four vaccine strains.
4.Seroconversion rates and geometric mean fold increases for HI (all subjects), VN and NI (randomized sample) for the four vaccine strains.
5.Post-vaccination CMI values and change from baseline for a subset of subjects at selected sites.

Timepoint(s) of evaluation of this end point: 1.Between 28 days following the second vaccine administration and the end of the influenza surveillance period.
Others: As soon as these occur

Secondary ID(s)

INFQ3003

2016-004904-74-SK

Source(s) of Monetary Support

Abbott Biologicals B.V.

Ethics review

Status: Approved
Approval date: 18/05/2017
Contact: