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Co-administration of Meningococcal Vaccine GSK134612 and Pneumococcal Vaccine GSK1024850A vs Individual Administration

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ClinicalTrials.gov Identifier: NCT00758264
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : May 9, 2018
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to demonstrate, in 12-23 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 and pneumococcal vaccine GSK1024850A when co-administered, compared to each vaccine administered individually.

Condition or disease Intervention/treatment Phase
Infections, Meningococcal Biological: Meningococcal vaccine GSK134612 Biological: Pneumococcal vaccine GSK1024850A Phase 3

Detailed Description:

Multi-center study with 3 parallel groups. One group will receive 2 vaccines injections at the same visit (pneumococcal+ meningococcal), one group will receive a pneumococcal vaccine followed one month later by a meningococcal vaccine, and the last group will receive the meningococcal vaccine followed one month later by the pneumococcal vaccine.

All subjects will have one blood sample taken before vaccination and one blood sample taken one month after each vaccination (i.e. the first group will have 2 blood samples taken, and the other two groups will have 3 blood sample taken)


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 363 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When Co-administered With GSK Biologicals' Pneumococcal Vaccine GSK1024850A in Healthy 12-23-month-old Children Previously Primed With GSK1024850A
Study Start Date : October 30, 2008
Actual Primary Completion Date : June 2, 2009
Actual Study Completion Date : November 2, 2009


Arm Intervention/treatment
Experimental: Group A
Meningococcal vaccine GSK134612 co-administered with pneumococcal vaccine GSK1024850A.
Biological: Meningococcal vaccine GSK134612
Single dose intramuscular injection.

Biological: Pneumococcal vaccine GSK1024850A
Single dose intramuscular injection.

Active Comparator: Group B
Pneumococcal vaccine GSK1024850A followed one month later by meningococcal vaccine GSK134612.
Biological: Meningococcal vaccine GSK134612
Single dose intramuscular injection.

Biological: Pneumococcal vaccine GSK1024850A
Single dose intramuscular injection.

Active Comparator: Group C
Meningococcal vaccine GSK134612 followed one month later by pneumococcal vaccine GSK1024850A.
Biological: Meningococcal vaccine GSK134612
Single dose intramuscular injection.

Biological: Pneumococcal vaccine GSK1024850A
Single dose intramuscular injection.




Primary Outcome Measures :
  1. Anti-pneumococcal Antibody Concentrations [ Time Frame: At Month 1 ]
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). Anti-pneumococcal serotypes assessed were Anti-1, Anti-4, Anti-5, Anti-6B, Anti-7F, Anti-9V, Anti-14, Anti-18C, Anti-19F and Anti-23F via the 22F-inhibition Enzyme Linked Immunosorbent Assay (ELISA).

  2. Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value [ Time Frame: At Month 1 ]
    The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.

  3. rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers [ Time Frame: At Month 1 ]
    Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.


Secondary Outcome Measures :
  1. Anti-pneumococcal Antibody Concentrations [ Time Frame: Before vaccination (PRE) and at one month post dose 2 (Month 2) ]
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) via 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

  2. Cross-reactive Anti-pneumococcal Antibody Concentrations [ Time Frame: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2) ]
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in µg/mL. The pneumococcal serotypes assessed were 6A and 19A (anti-6A and anti-19A) via the 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

  3. Opsonophagocytic Titers Against Pneumococcal Serotypes [ Time Frame: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2) ]
    Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPSONO-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

  4. Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes [ Time Frame: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2) ]
    Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 6A and 19A (OPSONO-6A and OPSONO-19A). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

  5. Anti-protein D (Anti-PD) Antibody Concentrations [ Time Frame: Before vaccination (PRE), at one month post dose 1(Month 1) and at one month post dose 2 (Month 2) ]
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

  6. rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers [ Time Frame: Before vaccination (PRE) and at one month post dose 2 (Month 2) ]
    Antibody titers are presented as geometric mean titers (GMTs) and measured in titers. GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

  7. Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations [ Time Frame: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2) ]
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

  8. Anti-tetanus (Anti-T) Antibody Concentrations [ Time Frame: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2) ]
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

  9. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: Within the 4-day (Days 0-3) post-vaccination period after each dose ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

  10. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: Within the 4-day (Days 0-3) post-vaccination period after each dose ]
    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as rectally temperature equal to or above (≥) 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activities. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever higher than (>) 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

  11. Number of Subjects With Any Unsolicited Adverse Events (AEs) [ Time Frame: Within the 31-day (Day 0-30) post-vaccination period after each dose ]
    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.

  12. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: Throughout the entire study duration (Day 0-Month 7) ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  13. Number of Subjects Reporting Rash [ Time Frame: Throughout the entire study duration (Day 0-Month 7) ]
    Rash-like symptoms assessed were hives, idiopathic thrombocytopenic purpura, petechiae.

  14. Number of Subjects With New Onset Chronic Illnesses (NOCIs) [ Time Frame: Throughout the entire study duration (Day 0-Month 7) ]
    NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

  15. Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits [ Time Frame: Throughout the entire study duration (Day 0-Month 7) ]
    Among AEs prompting emergency room visits were: infections, injuries, skin diseases, gastrointestinal symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 12 and 23 months of age at the time of the first booster vaccination, who previously participated in study 109661 conducted in Mexico or in study 109861 conducted in Taiwan and who received 3 doses of the GSK1024850A vaccine.
  • Written informed consent obtained from the parent or guardian 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 (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine(s), or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine(s) and 30 days after the last dose of vaccine(s).
  • 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 product or device).
  • Previous vaccination with a meningococcal vaccine.
  • Previous administration of a fourth dose of a pneumococcal vaccine
  • Previous vaccination with tetanus toxoid within the last month (including also tetanus toxoid given as part of Hib-TT conjugate vaccine).
  • History of meningococcal or pneumococcal invasive disease.
  • History of reactions or allergic disease likely to be exacerbated by any component of the vaccines.
  • Hypersensitivity reaction due to previous vaccination with GSK1024850A vaccine.
  • History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
  • A family history of congenital or hereditary immunodeficiency, unless the child has previously been documented, through laboratory testing, to have normal immune function.
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

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): NCT00758264


Locations
Mexico
GSK Investigational Site
Mexico city, Mexico, 14000
GSK Investigational Site
Mexico, Mexico, 14000
Taiwan
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Taipei, Taiwan, 105
GSK Investigational Site
Taoyuan Hsien, Taiwan
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 111393
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 111393
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 111393
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 111393
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 111393
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 111393
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 111393
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00758264     History of Changes
Other Study ID Numbers: 111393
First Posted: September 25, 2008    Key Record Dates
Results First Posted: May 9, 2018
Last Update Posted: May 9, 2018
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Safety
Routine infancy vaccination
Meningococcal vaccine
Immunogenicity
Pneumococcal vaccine

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs