Submitted by: Quintiles 2018-12-19 00:00:00 Last Updated by: Jeverly Ann S. Principe 2018-12-20 15:18:42 Export to PDF

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

PHRR181220-001995

INFQ3003

2018-CT0461

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

This is a Phase III randomized, observer-blind, multicenter study in children aged 6-35 months to demonstrate 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.

Regime Classification Priority
2017 - 2022 Research to enhance and extend healthy lives Maternal, newborn and child health
Start Date Duration in Months Target Completion Date Actual Completion Date
2019-03-15 10 2020-01-15 0000-00-00

Ongoing

Institution Classification Region LTO #
Abbott Biologicals B.V. Private Business Netherlands N/A
Institution Classification Region LTO #
IQVIA RDS Philippines, Inc. Private Business NCR LTO-3000003797863
Institution Amount Region
Abbott Biologicals B.V. N/A Netherlands
Name E-Mail Phone Number Postal Address
Elena Lam QMNL.HealthRegistryMailbox@quintiles.com +6328783111 Unit 7A, 7th Floor Rockwell Building, Hidalgo Drive, Rockwell Center, Makati City 1210 Philippines
Name E-Mail Phone Number Postal Address
Serge van de Witte serge.vandewitt@abbott.com +31294477184 Abbott Healthcare products B.V. C.J. van Houtenlaan 36 1381 CP Weesp The Netherlands
Name Expertise Affiliation
Salvacion R. Gatchalian, MD Pediatrics Manila Doctors Hospital
Delia Caparas-Yu, MD Pediatrics De La Salle Health Sciences Institute
Josefina B. Cadorna-Carlos, MD Pediatrics University of the East Ramon Magsaysay Memorial Medical Center
May N. Montellano, MD Pediatrics Far Eastern University - Nicanor Reyes Memorial Foundation Hospital
Project Location Institutional Ethics Review Board
Manila Doctors Hospital Manila Doctors Hospital Institutional Review Board
De La Salle Health Sciences Institute De La Salle Health Sciences Institute Independent Ethics Committee
University of the East Ramon Magsaysay Memorial Medical Center N/A
Far Eastern University - Nicanor Reyes Memorial Foundation Hospital Far Eastern University - Nicanor Reyes Memorial Foundation Hospital Ethics Review Committee

Influenza (Flu) is a contagious illness of the lungs and airways caused by the influenza viruses. It can cause mild to severe illness and at times can lead to death.
The best way to prevent and control this illness is by getting a flu vaccination (flu shot) each year in the autumn.

The primary objective is 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.

The secondary objective includes following:                   

(1) To demonstrate in children 6-35 months of age the absolute efficacy of QIV in the prevention of symptomatic influenza infection of antigenically-matching influenza strains compared to a non-influenza vaccine.                                                                        

(2) To describe the immunogenicity of each of the strains in QIV with respect to HI in all subjects and virus neutralization (VN) and neuraminidase inhibition (NI) antibody titers in randomized population subsets.                                                                     

 (3) To 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.                                                                             

(4) To explore potential immunological correlates of protection based on determined HI antibody titers and reverse transcription polymerase chain reaction (RT-PCR) outcomes.                                                             

                                                                                                                          

Safety Objective                                                                                   

To evaluate the safety and reactogenicity of each of the study vaccines in children 6-35 months of age.      

Pending

  • Bulgaria
  • Czech Republic
  • Denmark
  • Estonia
  • Hungary
  • Italy
  • Lithuania
  • Malaysia
  • Philippines
  • Romania
  • Slovakia
  • Spain
  • Thailand
  • Vietnam

Clinical Trial

2018-CT0461

2018-11-21

None

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 enrollment 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.                                                                                   

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 axillary ≥ 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. 

Interventional

Quadrivalent influenza vaccine (QIV) (referred throughout the document as the study vaccine)

QIV

The test product will be the Candidate Quadrivalent Influenza Vaccine (QIV; subunit, inactivated) and will consist of 15 μg of hemagglutinin of each of the 4 viral strains recommended by the WHO for the strains recommended by the WHO for the strains recommended for the southern hemisphere season 2019.

The vaccine is kept in a type I glass syringe barrel without needle. The needle will be provided in conjunct with the syringe and the type is a stainless steel needle, length 25 mm and diameter 0.5 mm.                                                                                                  

Non-influenza vaccines                                                                

The reference products will be any of the non-influenza control vaccines listed below. For each subject enrolled in the non-influenza control group only one reference product can be used. Eligible participants are to be randomly assigned to vaccination with QIV or a non-influenza (child) vaccine in a 1:1 ratio, respectively. Depending on their age, the non-influenza, control vaccines used for the sites in the Philippines are :                                                                                                               

 For infants 6-11 months of age:                                            

 

Pneumococcal conjugated vaccine

Prevenar 13, Pfizer: suspension for injection (0.5 mL) that contains parts from 13 different types of the bacterium Streptococcus pneumoniae (S. pneumoniae). Conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate.               

For toddlers 12-35 months of age:                                                  

 

Varicella vaccine

Varivax /Provarivax, Sanofi Pasteur MSD: powder and solvent for suspension for injection (0.5 mL) contains Varicella virus (Oka/Merck strain, live, attenuated; ≥1350 Plaque-forming units), produced in human diploid cells (MRC-5); this vaccine may
contain a trace amount of neomycin.

Randomized

Not Applicable

Unspecified

Parallel

The purpose of this study is to demonstrate in children 6-35 months of age the absolute efficacy of QIV compared to a non-influenza vaccine in the prevention of laboratory confirmed symptomatic influenza infection due to any circulating seasonal influenza strain.

Phase III

465

Unspecified

Recruitment has not started.

15 Mar 2019

Utilization Utilization Info
No records found.

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