Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01090453
First received: March 18, 2010
Last updated: July 24, 2014
Last verified: June 2014
  Purpose

This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 months of age.


Condition Intervention Phase
Tetanus
Hepatitis B
Haemophilus Influenzae Type b
Poliomyelitis
Acellular Pertussis
Diphtheria
Neisseria Meningitidis
Biological: GSK2202083A vaccine
Biological: Prevenar 13®
Biological: Infanrix hexa™
Biological: Menjugate®
Biological: Rotarix™
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 4 and 12 Months of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-offs. [ Time Frame: At Month 3, Month 10 and Month 11. ] [ Designated as safety issue: No ]
    The anti-PRP antibody concentrations cut-off was ≥ 0.15 and ≥ 1.0 micrograms per milliliter (µg/mL). The results for Month 3 ≥ 0.15 µg/mL were the primary efficacy variables.

  • Number of Subjects With Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) Antibodies Above the Cut-offs. [ Time Frame: At Month 3, Month 10 and Month 11. ] [ Designated as safety issue: No ]
    The rSBA-MenC cut-offs were ≥ 1:8 and ≥ 1:128. The results for Month 3 ≥ 1:8 were the primary efficacy variables.


Secondary Outcome Measures:
  • Concentrations for Anti-PRP. [ Time Frame: At Month 3, Month 10 and Month 11. ] [ Designated as safety issue: No ]
    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off values were ≥ 0.15 µg/mL and ≥ 1.0 µg/mL.

  • Titers for rSBA-MenC. [ Time Frame: At Month 3, Month 10 and Month 11. ] [ Designated as safety issue: No ]
    Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off values were ≥ 1:8 and ≥ 1:128.

  • Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off. [ Time Frame: At Month 3, Month 10 and Month 11. ] [ Designated as safety issue: No ]
    The anti-D and anti-T antibody cut-off was ≥ 0.1 international units per milliliter (IU/mL).

  • Concentrations for Anti-T and Anti-D. [ Time Frame: At Month 3, Month 10 and Month 11. ] [ Designated as safety issue: No ]
    Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 0.1 IU/mL.

  • Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL) [ Time Frame: At Month 3, Month 10 and Month 11. ] [ Designated as safety issue: No ]
    A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.

  • Concentrations for Anti-HBs. [ Time Frame: At Month 3, Month 10 and Month 11. ] [ Designated as safety issue: No ]
    A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.

  • Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. [ Time Frame: At Month 3, Month 10 and Month 11. ] [ Designated as safety issue: No ]
    The anti-polio 1, 2 and 3 antibody concentrations cut-off value was ≥ 1:8.

  • Titers for Anti-polio 1, 2 and 3. [ Time Frame: At Month 3, Month 10 and Month 11. ] [ Designated as safety issue: No ]
    Titers were expressed as geometric mean titers (GMTs). The reference cut-off value was ≥ 1:8.

  • Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. [ Time Frame: At Month 3, Month 10 and Month 11. ] [ Designated as safety issue: No ]
    The reference cut-off for anti-PT, anti-FHA and anti-PRN antibody concentrations was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).

  • Concentrations for Anti-PT, Anti-FHA and Anti-PRN. [ Time Frame: At Month 3, Month 10 and Month 11. ] [ Designated as safety issue: No ]
    Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 5 EL.U/mL.

  • Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN. [ Time Frame: At Month 11. ] [ Designated as safety issue: No ]
    Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL at Month 11; for initially seropositive subjects: antibody concentration at Month 11 ≥ 2 fold the pre-vaccination antibody concentration

  • Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. [ Time Frame: At Month 3 and Month 11 ] [ Designated as safety issue: No ]
    The anti-PNE antibody concentrations reference cut-offs were ≥ 0.2 and ≥ 0.05 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

  • Concentrations for Anti-PNE Serotypes. [ Time Frame: At Month 3 and Month 11 ] [ Designated as safety issue: No ]
    Concentrations were expressed as geometric mean concentreations (GMCs). The reference cut-off value was ≥ 0.2 µg/mL.

  • Anti-PRP and rSBA-MenC Fold Increase Distribution. [ Time Frame: At Month 11. ] [ Designated as safety issue: No ]
    The fold increase distribution cut-offs were: ≥2, ≥4, ≥6, ≥8 and ≥10.

  • Number of Subjects Reporting Any Solicited Local Symptoms. [ Time Frame: During the 8-day (Days 0-7) post-vaccination period ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.

  • Number of Subjects Reporting Any Solicited General Symptoms. [ Time Frame: During the 8-day (Days 0-7) post-vaccination period ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.

  • Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). [ Time Frame: Within the 31-day (Days 0-30) follow up period after vaccination ] [ Designated as safety issue: No ]
    An unsolicited AE is any AE (i.e. any 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) 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 = occurrence of an AE regardless of intensity grade or relationship to study vaccination.

  • Number of Subjects Reporting Any Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (Month 0 to Month 11) ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.


Enrollment: 480
Study Start Date: May 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK2202083A Group
Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Biological: GSK2202083A vaccine
3 doses given at 2, 4 and 12 months of age
Biological: Prevenar 13®
3 co-administered doses
Biological: Rotarix™
Oral, two doses
Active Comparator: Infanrix hexa Group
Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Biological: Prevenar 13®
3 co-administered doses
Biological: Infanrix hexa™
3 doses given at 2, 4 and 12 months of age
Biological: Menjugate®
3 co-administered doses
Biological: Rotarix™
Oral, two doses

  Eligibility

Ages Eligible for Study:   8 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
  • A male or female infant between, and including, 8 and 12 weeks at the time of the first vaccination.
  • Born after a gestation period of 36 to 42 weeks inclusive.
  • Written informed consent obtained from the parent(s), Legally Acceptable Representative(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
  • Child in care.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to randomisation, or planned administration from randomisation to the end of the study with the exception of inactivated influenza vaccines. The administration of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, pneumococcal, rotavirus and/or MenC vaccines is not allowed at any time during the study period but other vaccines are allowed during the period from one day after study Visit 3 to 31 days before study Visit 4.
  • 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.
  • Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal, rotavirus and/or MenC vaccination or disease, including Hepatitis B virus vaccination at birth.
  • History of seizures or progressive neurological disease.
  • Subjects with history of intussusception or uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or serious chronic illness.

The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:

  • Current febrile illness or other moderate to severe illness within 24 hours of study vaccine administration.
  • Current gastrointestinal infection.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090453

Locations
Canada, British Columbia
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 4H4
Canada, Manitoba
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
GSK Investigational Site
Hamilton, Ontario, Canada, L8L 5G8
France
GSK Investigational Site
Aix en Provence, France, 13100
GSK Investigational Site
Dax, France, 40100
GSK Investigational Site
Draguignan, France, 83300
GSK Investigational Site
Essey les Nancy, France, 54270
GSK Investigational Site
Floirac, France, 33270
GSK Investigational Site
Le Havre, France, 76600
GSK Investigational Site
Lingolsheim, France, 67380
GSK Investigational Site
Nice, France, 06300
GSK Investigational Site
Trélazé, France, 49800
Germany
GSK Investigational Site
Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
GSK Investigational Site
Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
GSK Investigational Site
Tuttlingen, Baden-Wuerttemberg, Germany, 78532
GSK Investigational Site
Berchtesgaden, Bayern, Germany, 83471
GSK Investigational Site
Bindlach, Bayern, Germany, 95463
GSK Investigational Site
Muenchen, Bayern, Germany, 81735
GSK Investigational Site
Noerdlingen, Bayern, Germany, 86720
GSK Investigational Site
Eschwege, Hessen, Germany, 37269
GSK Investigational Site
Wolfenbuettel, Niedersachsen, Germany, 38302
GSK Investigational Site
Detmold, Nordrhein-Westfalen, Germany, 32756
GSK Investigational Site
Heiligenhaus, Nordrhein-Westfalen, Germany, 42579
GSK Investigational Site
Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
GSK Investigational Site
Loehne, Nordrhein-Westfalen, Germany, 32584
GSK Investigational Site
Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
GSK Investigational Site
Solingen, Nordrhein-Westfalen, Germany, 42719
GSK Investigational Site
Willich, Nordrhein-Westfalen, Germany, 47877
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
GSK Investigational Site
Worms, Rheinland-Pfalz, Germany, 67547
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01090453     History of Changes
Other Study ID Numbers: 113615
Study First Received: March 18, 2010
Results First Received: June 19, 2014
Last Updated: July 24, 2014
Health Authority: Canada: Biologics and Genetic Therapies Directorate (BGTD)
France: Agence Française de Sécurité Sanitaire des Produits de Santé
Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Hepatitis B
Poliomyelitis
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
Myelitis
Nervous System Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014