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Efficacy Study With QIVc in Pediatric Subjects

Primary Purpose

Influenza, Human

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
QIVc
Comparator
Sponsored by
Seqirus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza, Human focused on measuring Influenza Vaccine

Eligibility Criteria

6 Months - 47 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

In order to participate in this study, all subjects must meet all of the inclusion criteria described.

  • Individuals of 6 through 47 months of age on the day of informed consent.
  • Individuals whose parent(s)/Legally Acceptable Representative (LAR) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
  • Individuals who can comply with study procedures including follow-up.
  • Individuals in generally good health as per the Investigator's medical judgement.

Prior to receipt of second study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects do not meet the criteria of the original inclusion criteria listed above, they should not receive additional vaccinations.

Exclusion Criteria:

  • Acute (severe) febrile illness. Enrollment could be considered if the fever is absent for 72 hours.
  • History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study.
  • Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. These may include known bleeding disorders, or treatment with anticoagulants in the 3 weeks preceding vaccination.
  • A known history of Guillain-Barré Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.
  • Abnormal function of the immune system resulting from a clinical condition
  • Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.
  • Prior vaccination to prevent Neisseria meningitides serogroup C disease or prior infection caused by this organism.

Additional eligibility criteria may be discussed by contacting the site.

Sites / Locations

  • International Centre for Diarrhoeal Disease Research, Bangladesh
  • 10008-Medical Center Viva Feniks
  • 10007-MHAT Dr. Stamen Iliev AD
  • 10003-UMHAT Dr. Georgi Stranski EAD
  • 10002-UMHAT Sveti Georgi EAD
  • 10006-UMHAT-Plovdiv AD
  • 10004-SHATPPD Dr Dimitar Gramatikov Ruse EOOD
  • 10009-Medical Center Unimed Eood
  • 20303-MUDr. Stefan Hrunka, Prakticky lekar pro deti a dorost
  • 20301-MUDr. Daniel Drazan, Prakticky lekar pro deti a dorost
  • 20304-MUDr. David Zeman s.r.o.
  • 20302-MUDr. Daniela Pniakova s.r.o.
  • 20305-MUDr. Iva Madejova, Prakticky lekar pro deti a dorost
  • 23305-Vee Family Doctor's Centre
  • 23301-Innomedica OÜ
  • 23304-Merelahe Family Doctors Center
  • 23307-Tallinn Children's Hospital
  • 23303-Al Mare Perearstikeskus OU
  • 23302-Clinical Research Centre
  • 34001-Demedica
  • 34003-Clínica Médica y Dental CLIMEDENTY
  • 34002-Inversiones en Investigación Médica (INVERIME)
  • 42802-OLVI Medical Centre
  • 45804-Clinical Research Centre (CRC), Hospital Tuanku Fauziah
  • 45803-Sarawak General Hospital
  • 45802-Hospital Sibu
  • 45805-Klinik Kesihatan Putrajaya Presint 9
  • 45801-University Malaya Medical Centre
  • 55403-Christchurch Clinical Studies Trust
  • 55401-Wellington Hospital
  • 58602-Shifa International Hospital
  • 58604-The Aga Khan
  • 58605-Avicenna Hospital
  • 58607-Central Park Teaching Hospital
  • 58601-Al Shifa Research Centre
  • 60808-University of the Philippines Manila Development Foundation Inc
  • 60810-UERM Memorial Medical Center
  • 60817-Health Index Multispecialty Clinic
  • 60801-Chong Hua Hospital
  • 60812-De La Salle Medical and Health Sciences Institute
  • 60816-De La Salle Medical and Health Sciences Institute
  • 60806-Mary Chiles General Hospital
  • 60814-Philippine General Hospital
  • 60815-Philippine General Hospital
  • 60818-Philippine General Hospital
  • 60811-UERM Memorial Medical Center
  • 60813-Philippine Children's Medical Center
  • 61605-Osrodek Badan Klinicznych IN-VIVO sp. z o.o.
  • 61603-Jerzy Brzostek Prywatny Gabinet Lekarski
  • 61607-Gdanskie Centrum Zdrowia Sp. z o.o.
  • 61604-Hanna Czajka, Indywidualna Specjalistyczna Praktyka Lekarska
  • 61608-Gabinet Lekarski Bartosz Korczowski
  • 61602-Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice
  • 61601-ETG Network- Skierniewice,Clinmed Research
  • 61609-Szpital im. Swietej Jadwigi Slaskiej w Trzebnicy
  • 64201-SC Sana Monitoring SRL.
  • 64202-Spitalul Municipal Caracal
  • 64205-Sc Med Fam Apolo srl
  • 64206-S.C Centrul Clinic Mediquest S.R.L
  • 71006-Madibeng Centre for Research
  • 71004-Tread Research
  • 71007-Allergy & Immunology Unit
  • 71002-Synergy Biomed Research Institute
  • 71009-Perinatal HIV Research Unit, Tshepong Hospital
  • 71001-Be Part Yoluntu Centre
  • 71008-Clinical Trial Systems
  • 71003-Soweto Clinical Trials Centre
  • 71005-Limpopo Clinical Research Initiative
  • 76405-Phramongkutklao Hospital
  • 76401-Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
  • 76404-Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University
  • 80404-Reg Mun NPE Chernivtsi RCCH Infectious Dept for Infants SHEI of UBSMU
  • 80405-CI Dnipro Children's City CH #5 of Dnipro City Council
  • 80401-Vinnytsia RCCH Policlinic Dept Vinnytsia M.I.Pyrogov NMU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Seqirus QIVc

Comparator

Arm Description

Cell-derived Quadrivalent Influenza Vaccine

Non-influenza Comparator (NesiVac-C)

Outcomes

Primary Outcome Measures

Efficacy Endpoint: First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match
First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined influenza-like illness (ILI) symptoms
Efficacy Endpoint: First occurrence of culture confirmed influenza, due to influenza Type A and/or B virus antigenically matched by ferret antigenicity testing to the strains selected for the seasonal influenza vaccine
First occurrence of culture confirmed influenza, due to influenza Type A and/or B virus antigenically matched by ferret antigenicity testing to the strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms

Secondary Outcome Measures

Efficacy Endpoint: First occurrence of culture confirmed influenza caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal influenza vaccine
First occurrence of culture confirmed influenza caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal vaccine occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
Efficacy Endpoint: First occurrence of culture confirmed influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine
First occurrence of culture confirmed influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
Efficacy Endpoint: First occurrence of RT-PCR confirmed moderate-to-severe influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine
First occurrence of RT-PCR confirmed moderate-to-severe influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season
Immunogenicity Endpoint: a) Prevaccination and postvaccination Geometric Mean Titer (GMT)
The measures for immunogenicity are determined by a haemagglutination inhibition [HI] and/or a microneutralization [MN] assay prior to first vaccination and 28 days after last vaccination for all four influenza strains
Immunogenicity Endpoint: Seroconversion rates (SCR)
The measures for immunogenicity are determined by a HI and/or a MN assay prior to first vaccination and 28 days after last vaccination for all four influenza strains SCR is defined as the percentage of subjects with either a prevaccination HI (or MN) titer < 1:10 and a postvaccination HI (or MN) titer ≥ 1:40, or a prevaccination HI (or MN) titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination HI (or MN) titer
Immunogenicity endpoint: Geometric Mean Ratio (GMR)
The measures for immunogenicity are determined by a haemagglutination inhibition [HI] and/or a micro neutralization [MN] assay prior to first vaccination and 28 days after last vaccination for all four influenza strains GMR is the geometric mean of the fold increase of post-vaccination HI (or MN) titer over the pre-vaccination HI (or MN) titer
Safety Endpoint: Percentage of subjects with solicited local and systemic adverse events (AE)
Percentage of subjects with solicited local and systemic AEs will be assessed for 7 days following each vaccination in the QIVc group and in the comparator group
Safety Endpoint: Percentage of subjects with unsolicited AEs
Percentage of subjects with any unsolicited AEs will be assessed in the QIVc group and in the comparator group until 28 days after each vaccination
Safety Endpoint: Percentage of subjects with SAEs, NOCDs, AEs leading to withdrawal from the study or vaccination
Percentage of subjects with serious AEs (SAE), new onset of chronic disease (NOCD), AEs leading to withdrawal from the study or vaccination, and all medications associated with these events will be reported in the QIVc group and in the comparator group
Safety Endpoint: Percentage of subjects with medically-attended AEs
Percentage of subjects with medically-attended AEs within 30 days after ILI onset will be reported in the QIVc group and in the comparator group

Full Information

First Posted
April 22, 2019
Last Updated
October 1, 2023
Sponsor
Seqirus
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1. Study Identification

Unique Protocol Identification Number
NCT03932682
Brief Title
Efficacy Study With QIVc in Pediatric Subjects
Official Title
A Phase 3, Randomized, Observer-blind, Multicenter Study to Evaluate the Efficacy, Immunogenicity and Safety of Seqirus' Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) Compared to a Non-Influenza Vaccine When Administrated in Healthy Subjects Aged 6 Months Through 47 Months
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 13, 2019 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seqirus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus a non-influenza vaccine in subjects 6 months though 47 months of age. The purpose of this study is to evaluate efficacy of QIVc in the prevention of Reverse transcription polymerase chain reaction (RT-PCR) confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human
Keywords
Influenza Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The trial is designed as an observer-blind study. During the treatment period of the study designated and trained unblinded personnel will be responsible for administering the study vaccines to the subjects.
Allocation
Randomized
Enrollment
3830 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Seqirus QIVc
Arm Type
Experimental
Arm Description
Cell-derived Quadrivalent Influenza Vaccine
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
Non-influenza Comparator (NesiVac-C)
Intervention Type
Biological
Intervention Name(s)
QIVc
Other Intervention Name(s)
Flucelvax Quadrivalent
Intervention Description
QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
Intervention Type
Biological
Intervention Name(s)
Comparator
Intervention Description
Meningococcal Group C Polysaccharide Conjugate Vaccine (MenC vaccine, Neisvac-C)
Primary Outcome Measure Information:
Title
Efficacy Endpoint: First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match
Description
First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined influenza-like illness (ILI) symptoms
Time Frame
Day 14 to Day 180
Title
Efficacy Endpoint: First occurrence of culture confirmed influenza, due to influenza Type A and/or B virus antigenically matched by ferret antigenicity testing to the strains selected for the seasonal influenza vaccine
Description
First occurrence of culture confirmed influenza, due to influenza Type A and/or B virus antigenically matched by ferret antigenicity testing to the strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
Time Frame
Day 14 to Day 180
Secondary Outcome Measure Information:
Title
Efficacy Endpoint: First occurrence of culture confirmed influenza caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal influenza vaccine
Description
First occurrence of culture confirmed influenza caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal vaccine occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
Time Frame
Day 14 to Day 180
Title
Efficacy Endpoint: First occurrence of culture confirmed influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine
Description
First occurrence of culture confirmed influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
Time Frame
Day 14 to Day 180
Title
Efficacy Endpoint: First occurrence of RT-PCR confirmed moderate-to-severe influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine
Description
First occurrence of RT-PCR confirmed moderate-to-severe influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season
Time Frame
Day 14 to Day 180
Title
Immunogenicity Endpoint: a) Prevaccination and postvaccination Geometric Mean Titer (GMT)
Description
The measures for immunogenicity are determined by a haemagglutination inhibition [HI] and/or a microneutralization [MN] assay prior to first vaccination and 28 days after last vaccination for all four influenza strains
Time Frame
Day 1 and 28 days after last vaccination
Title
Immunogenicity Endpoint: Seroconversion rates (SCR)
Description
The measures for immunogenicity are determined by a HI and/or a MN assay prior to first vaccination and 28 days after last vaccination for all four influenza strains SCR is defined as the percentage of subjects with either a prevaccination HI (or MN) titer < 1:10 and a postvaccination HI (or MN) titer ≥ 1:40, or a prevaccination HI (or MN) titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination HI (or MN) titer
Time Frame
Day 1 and 28 days after last vaccination
Title
Immunogenicity endpoint: Geometric Mean Ratio (GMR)
Description
The measures for immunogenicity are determined by a haemagglutination inhibition [HI] and/or a micro neutralization [MN] assay prior to first vaccination and 28 days after last vaccination for all four influenza strains GMR is the geometric mean of the fold increase of post-vaccination HI (or MN) titer over the pre-vaccination HI (or MN) titer
Time Frame
Day 1 and 28 days after last vaccination
Title
Safety Endpoint: Percentage of subjects with solicited local and systemic adverse events (AE)
Description
Percentage of subjects with solicited local and systemic AEs will be assessed for 7 days following each vaccination in the QIVc group and in the comparator group
Time Frame
7 days following each vaccination
Title
Safety Endpoint: Percentage of subjects with unsolicited AEs
Description
Percentage of subjects with any unsolicited AEs will be assessed in the QIVc group and in the comparator group until 28 days after each vaccination
Time Frame
28 days following each vaccination
Title
Safety Endpoint: Percentage of subjects with SAEs, NOCDs, AEs leading to withdrawal from the study or vaccination
Description
Percentage of subjects with serious AEs (SAE), new onset of chronic disease (NOCD), AEs leading to withdrawal from the study or vaccination, and all medications associated with these events will be reported in the QIVc group and in the comparator group
Time Frame
Day 1 to Day 180
Title
Safety Endpoint: Percentage of subjects with medically-attended AEs
Description
Percentage of subjects with medically-attended AEs within 30 days after ILI onset will be reported in the QIVc group and in the comparator group
Time Frame
30 days following ILI onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
47 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: In order to participate in this study, all subjects must meet all of the inclusion criteria described. Individuals of 6 through 47 months of age on the day of informed consent. Individuals whose parent(s)/Legally Acceptable Representative (LAR) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. Individuals who can comply with study procedures including follow-up. Individuals in generally good health as per the Investigator's medical judgement. Prior to receipt of second study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects do not meet the criteria of the original inclusion criteria listed above, they should not receive additional vaccinations. Exclusion Criteria: Acute (severe) febrile illness. Enrollment could be considered if the fever is absent for 72 hours. History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. These may include known bleeding disorders, or treatment with anticoagulants in the 3 weeks preceding vaccination. A known history of Guillain-Barré Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis. Abnormal function of the immune system resulting from a clinical condition Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent. Prior vaccination to prevent Neisseria meningitides serogroup C disease or prior infection caused by this organism. Additional eligibility criteria may be discussed by contacting the site.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Program Director
Organizational Affiliation
Seqirus
Official's Role
Study Director
Facility Information:
Facility Name
International Centre for Diarrhoeal Disease Research, Bangladesh
City
Dhaka
Country
Bangladesh
Facility Name
10008-Medical Center Viva Feniks
City
Dobrich
Country
Bulgaria
Facility Name
10007-MHAT Dr. Stamen Iliev AD
City
Montana
Country
Bulgaria
Facility Name
10003-UMHAT Dr. Georgi Stranski EAD
City
Pleven
Country
Bulgaria
Facility Name
10002-UMHAT Sveti Georgi EAD
City
Plovdiv
Country
Bulgaria
Facility Name
10006-UMHAT-Plovdiv AD
City
Plovdiv
Country
Bulgaria
Facility Name
10004-SHATPPD Dr Dimitar Gramatikov Ruse EOOD
City
Ruse
Country
Bulgaria
Facility Name
10009-Medical Center Unimed Eood
City
Sevlievo
Country
Bulgaria
Facility Name
20303-MUDr. Stefan Hrunka, Prakticky lekar pro deti a dorost
City
Chlumec Nad Cidlinou
ZIP/Postal Code
503 51
Country
Czechia
Facility Name
20301-MUDr. Daniel Drazan, Prakticky lekar pro deti a dorost
City
Jindřichův Hradec
ZIP/Postal Code
377 01
Country
Czechia
Facility Name
20304-MUDr. David Zeman s.r.o.
City
Ostrava-poruba
ZIP/Postal Code
708 00
Country
Czechia
Facility Name
20302-MUDr. Daniela Pniakova s.r.o.
City
Ostrava
ZIP/Postal Code
700 30
Country
Czechia
Facility Name
20305-MUDr. Iva Madejova, Prakticky lekar pro deti a dorost
City
Pardubice
ZIP/Postal Code
530 09
Country
Czechia
Facility Name
23305-Vee Family Doctor's Centre
City
Paide
ZIP/Postal Code
72713
Country
Estonia
Facility Name
23301-Innomedica OÜ
City
Tallinn
ZIP/Postal Code
10117
Country
Estonia
Facility Name
23304-Merelahe Family Doctors Center
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
23307-Tallinn Children's Hospital
City
Tallinn
Country
Estonia
Facility Name
23303-Al Mare Perearstikeskus OU
City
Tallin
ZIP/Postal Code
10617
Country
Estonia
Facility Name
23302-Clinical Research Centre
City
Tartu
ZIP/Postal Code
10117
Country
Estonia
Facility Name
34001-Demedica
City
San Pedro Sula
ZIP/Postal Code
21104
Country
Honduras
Facility Name
34003-Clínica Médica y Dental CLIMEDENTY
City
Tegucigalpa
ZIP/Postal Code
11101
Country
Honduras
Facility Name
34002-Inversiones en Investigación Médica (INVERIME)
City
Tegucigalpa
ZIP/Postal Code
2449
Country
Honduras
Facility Name
42802-OLVI Medical Centre
City
Daugavpils
ZIP/Postal Code
LV 1004
Country
Latvia
Facility Name
45804-Clinical Research Centre (CRC), Hospital Tuanku Fauziah
City
Kangar
State/Province
Perlis
ZIP/Postal Code
01000
Country
Malaysia
Facility Name
45803-Sarawak General Hospital
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
45802-Hospital Sibu
City
Sibu
State/Province
Sarawak
ZIP/Postal Code
96000
Country
Malaysia
Facility Name
45805-Klinik Kesihatan Putrajaya Presint 9
City
Putrajaya
State/Province
Wilyah Persekutuan Putrajaya
ZIP/Postal Code
62250
Country
Malaysia
Facility Name
45801-University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
55403-Christchurch Clinical Studies Trust
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
55401-Wellington Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
58602-Shifa International Hospital
City
Islamabad
Country
Pakistan
Facility Name
58604-The Aga Khan
City
Karachi
Country
Pakistan
Facility Name
58605-Avicenna Hospital
City
Lahore
Country
Pakistan
Facility Name
58607-Central Park Teaching Hospital
City
Lahore
Country
Pakistan
Facility Name
58601-Al Shifa Research Centre
City
Rawalpindi
Country
Pakistan
Facility Name
60808-University of the Philippines Manila Development Foundation Inc
City
Ermita
State/Province
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
60810-UERM Memorial Medical Center
City
Quezon City
State/Province
Quezon
Country
Philippines
Facility Name
60817-Health Index Multispecialty Clinic
City
Bacoor
Country
Philippines
Facility Name
60801-Chong Hua Hospital
City
Cebu City
Country
Philippines
Facility Name
60812-De La Salle Medical and Health Sciences Institute
City
Dasmariñas
Country
Philippines
Facility Name
60816-De La Salle Medical and Health Sciences Institute
City
Dasmariñas
Country
Philippines
Facility Name
60806-Mary Chiles General Hospital
City
Manila
ZIP/Postal Code
1008
Country
Philippines
Facility Name
60814-Philippine General Hospital
City
Manila
Country
Philippines
Facility Name
60815-Philippine General Hospital
City
Manila
Country
Philippines
Facility Name
60818-Philippine General Hospital
City
Manila
Country
Philippines
Facility Name
60811-UERM Memorial Medical Center
City
Quezon City
Country
Philippines
Facility Name
60813-Philippine Children's Medical Center
City
Quezon City
Country
Philippines
Facility Name
61605-Osrodek Badan Klinicznych IN-VIVO sp. z o.o.
City
Bydgoszcz
ZIP/Postal Code
85-090
Country
Poland
Facility Name
61603-Jerzy Brzostek Prywatny Gabinet Lekarski
City
Dębica
ZIP/Postal Code
39-200
Country
Poland
Facility Name
61607-Gdanskie Centrum Zdrowia Sp. z o.o.
City
Gdańsk
ZIP/Postal Code
80-542
Country
Poland
Facility Name
61604-Hanna Czajka, Indywidualna Specjalistyczna Praktyka Lekarska
City
Kraków
ZIP/Postal Code
31-302
Country
Poland
Facility Name
61608-Gabinet Lekarski Bartosz Korczowski
City
Rzeszów
ZIP/Postal Code
35-302
Country
Poland
Facility Name
61602-Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice
City
Siemianowice Śląskie
ZIP/Postal Code
41-103
Country
Poland
Facility Name
61601-ETG Network- Skierniewice,Clinmed Research
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
Facility Name
61609-Szpital im. Swietej Jadwigi Slaskiej w Trzebnicy
City
Trzebnica
ZIP/Postal Code
55-100
Country
Poland
Facility Name
64201-SC Sana Monitoring SRL.
City
Bucuresti
ZIP/Postal Code
011025
Country
Romania
Facility Name
64202-Spitalul Municipal Caracal
City
Caracal
ZIP/Postal Code
235200
Country
Romania
Facility Name
64205-Sc Med Fam Apolo srl
City
Călăraşi
ZIP/Postal Code
910160
Country
Romania
Facility Name
64206-S.C Centrul Clinic Mediquest S.R.L
City
Sângeorgiu De Mureş
ZIP/Postal Code
547530
Country
Romania
Facility Name
71006-Madibeng Centre for Research
City
Brits
Country
South Africa
Facility Name
71004-Tread Research
City
Cape Town
Country
South Africa
Facility Name
71007-Allergy & Immunology Unit
City
Cape Town
Country
South Africa
Facility Name
71002-Synergy Biomed Research Institute
City
East London
Country
South Africa
Facility Name
71009-Perinatal HIV Research Unit, Tshepong Hospital
City
Klerksdorp
Country
South Africa
Facility Name
71001-Be Part Yoluntu Centre
City
Paarl
Country
South Africa
Facility Name
71008-Clinical Trial Systems
City
Pretoria
Country
South Africa
Facility Name
71003-Soweto Clinical Trials Centre
City
Soweto
Country
South Africa
Facility Name
71005-Limpopo Clinical Research Initiative
City
Thabazimbi
Country
South Africa
Facility Name
76405-Phramongkutklao Hospital
City
Ratchathewi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
76401-Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
76404-Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
80404-Reg Mun NPE Chernivtsi RCCH Infectious Dept for Infants SHEI of UBSMU
City
Chernivtsi
ZIP/Postal Code
58023
Country
Ukraine
Facility Name
80405-CI Dnipro Children's City CH #5 of Dnipro City Council
City
Dnipro
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
80401-Vinnytsia RCCH Policlinic Dept Vinnytsia M.I.Pyrogov NMU
City
Vinnytsia
ZIP/Postal Code
21000
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy Study With QIVc in Pediatric Subjects

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