ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03439657
Recruitment Status : Active, not recruiting
First Posted : February 20, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to assess immunogenicity and safety of GSK Biologicals' HZ vaccine when its first dose is co-administered with a pneumococcal polysaccharide conjugate vaccine (Prevenar13) in adults aged ≥50 YOA, as compared to the control group where the two HZ/su doses are administered subsequent to Prevenar13.

Condition or disease Intervention/treatment Phase
Herpes Zoster Biological: HZ/su vaccine GSK1437173A Biological: Prevenar13 Phase 3

Detailed Description:
Following the initial approval of the GlaxoSmithKline (GSK) Biologicals' HZ/su vaccine, the protocol was amended to indicate that the trademark is Shingrix. In addition, the term "candidate" vaccine has been replaced by "study" vaccine throughout the protocol.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 912 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older
Actual Study Start Date : April 12, 2018
Estimated Primary Completion Date : February 26, 2019
Estimated Study Completion Date : January 20, 2020


Arm Intervention/treatment
Experimental: Co-Ad Group
Subjects at least 50 years of age at the time of the first vaccination, who will receive the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines will be administered intramuscularly, GSK1437173A will be administered in the deltoid muscle of the non-dominant arm, while Prevenar13 will be administered in the deltoid muscle of the dominant arm.
Biological: HZ/su vaccine GSK1437173A
2 doses of 0.5 mL of the vaccine in a 0,2 Months schedule. Administered by intramuscular injection into the deltoid muscle of the non-dominant arm.

Biological: Prevenar13
1 dose of 0.5 mL of the vaccine. Administered by intramuscular injection into the deltoid muscle of the dominant arm.
Other Name: PCV13

Active Comparator: Control Group
Subjects at least 50 years of age at the time of the first vaccination, who will receive one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines will be administered intramuscularly, GSK1437173A will be administered in the deltoid muscle of the non-dominant arm, while Prevenar13 will be administered in the deltoid muscle of the dominant arm.
Biological: HZ/su vaccine GSK1437173A
2 doses of 0.5 mL of the vaccine in a 0,2 Months schedule. Administered by intramuscular injection into the deltoid muscle of the non-dominant arm.

Biological: Prevenar13
1 dose of 0.5 mL of the vaccine. Administered by intramuscular injection into the deltoid muscle of the dominant arm.
Other Name: PCV13




Primary Outcome Measures :
  1. Number of subjects with a vaccine response [ Time Frame: One month post-dose 2 (i.e. at Visit Month 3) ]
    Vaccine response rate for anti-gE humoral immunogenicity, as determined by ELISA, in subjects from the Co-Ad Group

  2. Anti-gE antibody concentrations [ Time Frame: One month post-dose 2 (i.e. at Month 3 Visit for the Co-Ad and Month 5 Visit for the Control group). ]
    Anti-gE antibody concentrations as determined by ELISA

  3. Anti-pneumococcal antibody titers [ Time Frame: At one month post-dose 1 (i.e. Month 1) ]
    Anti-pneumococcal antibody titers for the 13 following serotypes as determined by Multiplex Opsonophagocytosis Assay (MOPA) :1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F


Secondary Outcome Measures :
  1. Number of subjects with any and Grade 3 solicited local symptoms [ Time Frame: Within 7 days (Days 1 - 7) after each vaccination ]
    Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.

  2. Number of days with each solicited local symptom [ Time Frame: Within 7 days (Days 1 - 7) after each vaccination ]
    Assessed solicited local symptoms are pain, redness and swelling.

  3. Number of subjects with any, Grade 3 and related solicited general symptoms [ Time Frame: Within 7 days (Days 1 to 7) after each vaccination ]
    Assessed solicited general symptoms are fatigue, fever [defined as axillary temperature ≥ 38.0°C / 100.4°F], gastrointestinal symptoms, headache, myalgia and shivering Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

  4. Number of days with solicited general symptom [ Time Frame: Within 7 days (Days 1 - 7) after each vaccination ]
    Assessed solicited general symptoms are fatigue, fever [defined as axillary temperature ≥ 38.0°C / 100.4°F], gastrointestinal symptoms, headache, myalgia and shivering

  5. Number of subjects with any, Grade 3 and related unsolicited AEs [ Time Frame: Within 30 days (Days 1 to 30) after each vaccination ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

  6. Number of subjects with any and related SAEs [ Time Frame: From first vaccination at Day 1 up to 30 days post last vaccination ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.

  7. Number of subjects with any and related SAEs [ Time Frame: Starting after 30 days post last vaccination up to study end. ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.

  8. Number of subjects with any and related pIMDs [ Time Frame: From first vaccination at Day 1 up to 30 days post last vaccination. ]
    Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology

  9. Number of subjects with any and related pIMDs [ Time Frame: Starting after 30 days post last vaccination up to study end. ]
    Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject prior to performance of any study specific procedure.
  • A male or female, aged ≥50 YOA at the time of the first vaccination with the study vaccine(s).
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • 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:

  • Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day -30 to Day 1), or planned use during the study period.
  • Any medical condition that in the judgment of the investigator would make intramuscular (IM) injection unsafe.
  • Use or anticipated use of immunosuppressants or other immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of corticosteroids (>14 consecutive days of prednisone at a dose of ≥20 mg/day [or equivalent]), long-acting immune modifying agents or immunosuppressive/cytotoxic therapy. Inhaled, topical and intra-articular corticosteroids are allowed.
  • Administration or planned administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration. This includes any type of vaccine such as (but not limited to) live, inactivated and subunit vaccines.
  • 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 vaccine/product.
  • Previous and/or planned administration of an HZ or VZV vaccine other than the study vaccine during the study period.
  • History of HZ.
  • History of documented pneumococcal infection within 5 previous years.
  • Prior receipt of any pneumococcal vaccine or planned use during the study period, other than the study vaccines.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
  • Acute disease and/or fever at the time of enrollment.

    • Fever is defined as temperature ≥ 38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity.
    • Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
  • Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions before 2 months after the last dose of study vaccine.
  • Any person with cerebrospinal fluid (CSF) leaks, cochlear implants, chronic renal failure, nephrotic syndrome and functional or anatomic asplenia.
  • Any medical condition that in the judgment of the investigator would prevent the subject from participating in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439657


Locations
United States, Massachusetts
GSK Investigational Site
Marlborough, Massachusetts, United States, 01752
United States, North Carolina
GSK Investigational Site
Salisbury, North Carolina, United States, 28144
United States, South Carolina
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Canada, Nova Scotia
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L
Canada, Quebec
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1L 0H
Estonia
GSK Investigational Site
Rakvere, Estonia, 44316
GSK Investigational Site
Tallinn, Estonia, 10117
GSK Investigational Site
Tartu, Estonia, 50106
Germany
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45355
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03439657     History of Changes
Other Study ID Numbers: 204487
2017-001220-22 ( EudraCT Number )
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
HZ
Safety
Immunogenicity
Shingles
Adults
Prevenar 13

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs