Phase 3
Completed N=1,881
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
Source: ClinicalTrials.gov NCT02207413 ↗Enrolled (actual)
1,881
Serious AEs
1.1%
Results posted
Jun 2016
Primary outcomePrimary: Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). — 41; 32; 1; 0 Subjects
◆ Published Evidence
Emerging
9citations · ~1 / year
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.
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]).
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). |
41; 32; 1; 0; 1; 1 | — |
| PRIMARY Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. |
32; 20; 0; 0; 28; 20 | — |
| PRIMARY Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. |
2.0; 2.0; 1.5; 1.0; 1.0; 1.5 | — |
| PRIMARY Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects Aged 18-49 Years Reporting the Occurrence of Medically Attended Events (MAEs). |
9; 8; 3; 1; 0; 0 | — |
| PRIMARY Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). |
243; 253; 14; 20; 118; 119 | — |
| PRIMARY Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. |
14; 7; 0; 1; 10; 4 | — |
| PRIMARY Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. |
94; 99; 8; 13; 65; 70 | — |
| PRIMARY Duration of Solicited Local AEs in Subjects Aged 3-17 Years. |
2.0; 2.0; 1.0; 2.0; 2.0; 2.0 | — |
| PRIMARY Duration of Solicited General AEs in Subjects Aged 3-4 Years. |
1.0; 1.0; 1.0; 2.0; 2.0; 1.0 | — |
| PRIMARY Duration of Solicited General AEs in Subjects Aged 5-17 Years. |
2.0; 2.0; 1.0; 1.5; 1.0; 1.0 | — |
| PRIMARY Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. |
2; 6; 0; 0; 0; 3 | — |
| PRIMARY Number of Subjects Aged 3-17 Years Reporting the Occurrence of All Medically Attended Events (MAEs) . |
59; 52; 7; 6; 2; 0 | — |
| PRIMARY Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
14; 14; 3; 2; 2; 1 | — |
| PRIMARY Number of Subjects Aged 3-17 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). |
83; 86; 12; 8; 10; 7 | — |
| PRIMARY Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC Across Doses. |
76; 70; 72; 69 | — |
| PRIMARY Number of Subjects Aged 18-49 Years, Reporting Any and Related Serious Adverse Events (SAEs) |
1; 1; 0; 0 | — |
| PRIMARY Number of Subjects Aged 3-17 Years, Reporting Any and Related Serious Adverse Events (SAEs) |
1; 0; 0; 0 | — |
| PRIMARY 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. |
698.0; 694.1; 158.2; 171.4; 479.0; 527.6 | — |
| PRIMARY 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. |
97.5; 105.5; 45.2; 59.9; 100.8; 105.4 | — |
| SECONDARY 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 |
48.3; 53.6; 655.7; 632.2; 16.7; 16.0 | — |
| SECONDARY Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. |
42; 42; 30; 29; 27; 36 | — |
| SECONDARY Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. |
35; 35; 56; 57; 15; 14 | — |
| SECONDARY Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years. |
13.6; 11.5; 4.8; 4.6; 4.4; 6.0 | — |
| SECONDARY Number of Subjects Aged 5-17 Years Reporting Myalgia Across Doses. |
71; 88 | — |
| SECONDARY Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains |
80.2; 87.7; 698.0; 694.1; 38.9; 41.9 | — |
| SECONDARY Number of Seroconverted Subjects Aged 3-17 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. |
274; 269; 192; 183; 273; 268 | — |
| SECONDARY Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. |
308; 314; 393; 395; 245; 252 | — |
| SECONDARY Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 3-17 Years. |
8.7; 7.9; 4.1; 4.1; 8.2; 7.4 | — |
| SECONDARY Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains |
11.1; 11.2; 97.5; 105.5; 7.5; 8.4 | — |
| SECONDARY Number of Seroconverted Subjects Aged 6-35 Months for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. |
287; 275; 217; 236; 318; 321 | — |
| SECONDARY Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. |
84; 83; 303; 289; 55; 67 | — |
| SECONDARY Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 6-35 Months. |
8.8; 9.5; 6.0; 7.1; 12.2; 13.3 | — |
| SECONDARY Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC After Dose 1 and After Dose 2. |
42; 44; 39; 42; 41; 40 | — |
| SECONDARY Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). |
69; 77; 1; 2; 88; 86 | — |
| SECONDARY Number of Subjects Aged 6 Months to <5 Years, Reporting Fever ≥38ºC (100.4°F) and >39.0°C (102.2ºF) Across Doses. |
29; 31; 28; 31; 4; 1 | — |
| SECONDARY Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. |
87; 77; 3; 7; 54; 50 | — |
| SECONDARY Duration of Solicited Local AEs in Subjects Aged 6-35 Months. |
1.0; 1.0; 2.0; 2.0; 2.0; 2.0 | — |
| SECONDARY Duration of Solicited General AEs in Subjects Aged 6-35 Months. |
2.0; 2.0; 2.0; 2.0; 2.0; 2.0 | — |
| SECONDARY Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. |
2; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Aged 6-35 Months Reporting the Occurrence of All Medically Attended Events (MAEs) |
235; 252; 35; 29; 2; 0 | — |
| SECONDARY Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). |
243; 262; 33; 31; 6; 3 | — |
| SECONDARY Number of Subjects Aged 6-35 Months, Reporting Any and Related Serious Adverse Events (SAEs) |
7; 11; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
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.
- 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 during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion Criteria
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
Data sourced from ClinicalTrials.gov (NCT02207413) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.