A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK2321138A) Manufactured Using a New Process in Adults and Children

NCT02207413 | Completed Phase 3 Results

• 1 other identifier: 201251
• Study Type: interventional
• Target: 1,886
• Locations: 7 countries
• Sites: 53

Brief Summary

The purpose of this trial is to demonstrate the acceptable safety profile and the immunological non-inferiority of the FLU D-QIV vaccine manufactured with this investigational process (FLU D-QIV Investigational Process \[IP\]) compared to FLU D-QIV manufactured with the current licensed process (FLU D-QIV Licensed Process \[LP\]).

Conditions

Influenza

Keywords

Quadrivalent influenza vaccine; Safety; Children; Adults; Immunogenicity

Outcome Measures

Primary Outcomes (20)

• Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs).

  Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 100 millimeters (mm) i.e. \>100mm.

  During the 7-day (Days 0-6) post-vaccination period

• Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms.

  Solicited general symptoms assessed were fatigue,gastrointestinal symptoms, headache, Joint Pain, myalgia, shivering and fever. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activities. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (\< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature ≥39.0°C.

  During the 7-day (Days 0-6) post-vaccination period

• Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years.

  Duration was defined as number of days with any grade of local and general symptoms.

  During the 7-day (Days 0-6) post-vaccination period

• Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms.

  Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any was defined as any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 ORS was defined as ORS symptoms that prevented normal activities. Related ORS was defined as ORS symptom(s) assessed by the investigator as causally related to the vaccination.

  During the 3-day (Days 0-2) post-vaccination period

• Number of Subjects Aged 18-49 Years Reporting the Occurrence of Medically Attended Events (MAEs).

  MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was defined as MAE that prevented normal activities. Related was defined as MAE assessed by the investigator to be causally related to the study vaccination.

  During the entire study period (approximately 21 days following vaccination)

• Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs).

  Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. \>50mm.

  During the 7-day (Days 0-6) post-vaccination period

• Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms.

  Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (\< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (\>) 39.0°C.

  During the 7-day (Days 0-6) post-vaccination period

• Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms.

  Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain, myalgia, shivering and fever (Fever = temperature above 38.0 degrees Celsius (°C)). Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature \< 38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever = temperature above 39.0°C.

  During the 7-day (Days 0-6) post-vaccination period

• Duration of Solicited Local AEs in Subjects Aged 3-17 Years.

  Duration was defined as number of days with any grade of local symptoms.

  During the 7-day (Days 0-6) post-vaccination period

• Duration of Solicited General AEs in Subjects Aged 3-4 Years.

  Duration was defined as number of days with any grade of general symptoms.

  During the 7-day (Days 0-6) post-vaccination period

• Duration of Solicited General AEs in Subjects Aged 5-17 Years.

  Duration was defined as number of days with any grade of general symptoms.

  During the 7-day (Days 0-6) post-vaccination period

• Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms.

  Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any = occurrence of any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 = ORS symptoms that prevented normal activities. Related = ORS symptom assessed by the investigator as causally related to the vaccination.

  During the 3-day (Days 0-2) post-vaccination period

• Number of Subjects Aged 3-17 Years Reporting the Occurrence of All Medically Attended Events (MAEs) .

  MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was a MAE that prevented normal activities. Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination.

  During the entire study period (approximately 28 days (primed subjects) and 56 days (unprimed subjects) following vaccination

• Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

  An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

  During the 21-day (Days 0-20) follow-up period after vaccination

• Number of Subjects Aged 3-17 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).

  An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

  During the 28-day (Days 0-27) follow-up period after vaccination

• Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC Across Doses.

  Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature \< 38°C but with missing values (MC) for at least one day during the solicited period.

  During 7 days (Days 0-6) post-vaccination

• Number of Subjects Aged 18-49 Years, Reporting Any and Related Serious Adverse Events (SAEs)

  A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.

  During the entire study period (approximately 21 days)

• Number of Subjects Aged 3-17 Years, Reporting Any and Related Serious Adverse Events (SAEs)

  A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.

  During the entire study period [approximately 28 days (primed subjects) and 56 days (unprimed subjects)]

• Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.

  HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).

  At Day 28 post last vaccination

• Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.

  HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).

  At Day 28 post last vaccination

Secondary Outcomes (23)

• Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains

  At Day 0 and Day 21

• Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.

  At Day 21

• Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.

  At Day 0 and Day 21

• Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years.

  At Day 21

• Number of Subjects Aged 5-17 Years Reporting Myalgia Across Doses.

  During the 7-day (Days 0-6) post-vaccination period

Study Arms (6)

Influsplit Tetra_IP Adult Group

EXPERIMENTAL

Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.

Biological: Influsplit Tetra™ vaccine produced by investigational process (IP)

Influsplit Tetra_LP Adult Group

ACTIVE COMPARATOR

Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.

Biological: Influsplit Tetra™ vaccine produced by licensed process (LP)

Influsplit Tetra_IP 3-17y Group

EXPERIMENTAL

Subjects in the Influsplit Tetra\_IP group aged between 3 years to \<9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).

Biological: Influsplit Tetra™ vaccine produced by investigational process (IP)

Influsplit Tetra_LP 3-17y Group

ACTIVE COMPARATOR

Subjects in the Influsplit Tetra\_LP group aged between 3 years to \<9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).

Biological: Influsplit Tetra™ vaccine produced by licensed process (LP)

Influsplit Tetra_IP 6-35m Group

EXPERIMENTAL

Subjects in the Influsplit Tetra\_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).

Biological: Influsplit Tetra™ vaccine produced by investigational process (IP)

Influsplit Tetra_LP 6-35m Group

ACTIVE COMPARATOR

Subjects in the Influsplit Tetra\_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).

Biological: Influsplit Tetra™ vaccine produced by licensed process (LP)

Interventions

Influsplit Tetra™ vaccine produced by investigational process (IP) BIOLOGICAL

Influsplit Tetra™ vaccine using a new manufacturing process administered intramuscularly (IM) in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.

Also known as: Fluarix Tetra™, Fluarix Quadrivalent® (GSK2321138A)

Influsplit Tetra_IP 3-17y Group; Influsplit Tetra_IP 6-35m Group; Influsplit Tetra_IP Adult Group

Influsplit Tetra™ vaccine produced by licensed process (LP) BIOLOGICAL

Influsplit Tetra™ vaccine using a licensed manufacturing process administered IM in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.

Also known as: Fluarix Tetra™, Fluarix Quadrivalent® (GSK2321138A)

Influsplit Tetra_LP 3-17y Group; Influsplit Tetra_LP 6-35m Group; Influsplit Tetra_LP Adult Group

Eligibility Criteria

• Age: 6 Months - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adults 18-49 years cohort:
• A male or female between, and including, 18 and 49 years of age at the time of vaccination.
• Subjects who the investigator believes that they/their parent(s)/Legally Acceptable Representatives (LAR(s)) can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject/parent(s)/LAR(s) of the subject.
• Written informed assent obtained from the subject if/as required by local regulations.
• Healthy subjects or those with chronic well-controlled disease as established by medical history and clinical examination before entering into the study.
• Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy.
• Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception for 2 months after vaccination.
• Pediatric cohort:
• United States:
• A male or female subject between, and including, the ages of 3 and 17 years in the United States.
• Rest of the World:
• A male or female subject between, and including, the ages of 6 months to 17 years all countries with the exception of the United States.
• All participating countries:
• Subjects who the investigator believes that they/their parent(s)/Legally Acceptable Representatives (LAR(s)) can and will comply with the requirements of the protocol.

You may not qualify if:

• Adults aged 18-49 years cohort:
• Child in care.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical or device).
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.
• Administration of an influenza vaccine during the 6 months preceding entry into the study.
• Administration of a vaccine not foreseen by the study protocol within 30 days before vaccination or planned administration during the study period.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
• Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
• Acute or un-controlled, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
• Any history of Guillain-Barré Syndrome.
• Acute disease and/or fever at the time of enrolment. Fever is defined as temperature ≥ 38.0ºC/100.4ºF.
• Pregnant or lactating female.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (53)

GSK Investigational Site

Wichita, Kansas, 67207, United States

Location

GSK Investigational Site

Rochester, New York, 14609, United States

Location

GSK Investigational Site

Warwick, Rhode Island, 02886, United States

Location

GSK Investigational Site

Nashville, Tennessee, 37203, United States

Location

GSK Investigational Site

Dhaka, 1000, Bangladesh

Location

GSK Investigational Site

Brno, 613 00, Czechia

Location

GSK Investigational Site

Chlumec nad Cidlinou, 50351, Czechia

Location

GSK Investigational Site

Děčín, 405 01, Czechia

Location

GSK Investigational Site

Jindřichův Hradec, 37701, Czechia

Location

GSK Investigational Site

Liberec, Czechia

Location

GSK Investigational Site

Lipník nad Bečvou, 75131, Czechia

Location

GSK Investigational Site

Náchod, 547 01, Czechia

Location

GSK Investigational Site

Odolena Voda, 25070, Czechia

Location

GSK Investigational Site

Ostrava - Poruba, 70800, Czechia

Location

GSK Investigational Site

Pardubice, 532 03, Czechia

Location

GSK Investigational Site

Prague, 1600, Czechia

Location

GSK Investigational Site

Aix-en-Provence, 13100, France

Location

GSK Investigational Site

Dax, 40100, France

Location

GSK Investigational Site

Draguignan, 83300, France

Location

GSK Investigational Site

Essey-lès-Nancy, 54270, France

Location

GSK Investigational Site

Le Havre, 76620, France

Location

GSK Investigational Site

Nantes, 44277, France

Location

GSK Investigational Site

Nice, 06300, France

Location

GSK Investigational Site

Kehl, Baden-Wurttemberg, 77694, Germany

Location

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, 70469, Germany

Location

GSK Investigational Site

Kirchheim, Bavaria, 85551, Germany

Location

GSK Investigational Site

Schönau am Königssee, Bavaria, 83471, Germany

Location

GSK Investigational Site

Würzburg, Bavaria, 97070, Germany

Location

GSK Investigational Site

Detmold, North Rhine-Westphalia, 32756, Germany

Location

GSK Investigational Site

Essen, North Rhine-Westphalia, 45355, Germany

Location

GSK Investigational Site

Essen, North Rhine-Westphalia, 45359, Germany

Location

GSK Investigational Site

Goch, North Rhine-Westphalia, 47574, Germany

Location

GSK Investigational Site

Kleve-Materborn, North Rhine-Westphalia, 47533, Germany

Location

GSK Investigational Site

Löhne, North Rhine-Westphalia, 32584, Germany

Location

GSK Investigational Site

Trier, Rhineland-Palatinate, 54290, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04178, Germany

Location

GSK Investigational Site

Radebeul, Saxony, 01445, Germany

Location

GSK Investigational Site

Wurzen, Saxony, 04808, Germany

Location

GSK Investigational Site

Flensburg, Schleswig-Holstein, 24937, Germany

Location

GSK Investigational Site

Berlin, 13055, Germany

Location

GSK Investigational Site

Neumünster, 24534, Germany

Location

GSK Investigational Site

Bydgoszcz, 85-168, Poland

Location

GSK Investigational Site

Dębica, 39-200, Poland

Location

GSK Investigational Site

Katowice, 40-018, Poland

Location

GSK Investigational Site

Poznan, 62-064, Poland

Location

GSK Investigational Site

Siemianowice Śląskie, 41-103, Poland

Location

GSK Investigational Site

Wroclaw, 54-019, Poland

Location

GSK Investigational Site

Antequera/Málaga, 29200, Spain

Location

GSK Investigational Site

Badalona, 08916, Spain

Location

GSK Investigational Site

Burgos, 09006, Spain

Location

GSK Investigational Site

Madrid, 28050, Spain

Location

GSK Investigational Site

Santiago de Compostela, 15706, Spain

Location

GSK Investigational Site

Seville, 41014, Spain

Location

Related Publications (1)

• Claeys C, Drame M, Garcia-Sicilia J, Zaman K, Carmona A, Tran PM, Miranda M, Martinon-Torres F, Thollot F, Horn M, Schwarz TF, Behre U, Merino JM, Sadowska-Krawczenko I, Szymanski H, Schu P, Neumeier E, Li P, Jain VK, Innis BL. Assessment of an optimized manufacturing process for inactivated quadrivalent influenza vaccine: a phase III, randomized, double-blind, safety and immunogenicity study in children and adults. BMC Infect Dis. 2018 Apr 18;18(1):186. doi: 10.1186/s12879-018-3079-8.

  PMID: 29669531 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: August 4, 2014
• Study Start: August 18, 2014
• Primary Completion: April 18, 2015
• Study Completion: April 18, 2015
• Last Updated: June 6, 2018
• Results First Posted: June 20, 2016

Record last verified: 2018-05

Locations

DE (18); US (4); BA (1); PL (6); FR (7); ES (6); CZ (11)