Last updated: 11/03/2018 12:07:21

Vaccination course in primed children and age-matched unprimed children with pneumococcal vaccine GSK1024850A

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GSK study ID
111736
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Clinicaltrials.gov ID
NCT00792909
See results summary
EudraCT ID
2008-003950-14
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Vaccination course in children primed and boosted with pneumococcal vaccine GSK 1024850A and in age-matched unprimed children
Trial description: The purpose of this study is to assess the immune memory induced by primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life through evaluation of the immune responses following vaccination with a booster dose of pneumococcal conjugate vaccine GSK1024850A in the fourth year of life and to assess immune responses following vaccination with a single dose of pneumococcal conjugate vaccine GSK1024850A in age-matched unprimed children.
The study also aims to assess the antibody persistence in the fourth year of life following primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life.
The study is also designed to evaluate the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following a 2-dose vaccination with pneumococcal conjugate vaccine GSK1024850A in the fourth year of life.
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00307034)
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Antibody Geometric Mean Concentrations (GMCs) against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group

Timeframe: Pre-vaccination (PRE/ Day 0)

Antibody Geometric Mean Concentrations (GMCs) against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group

Timeframe: One week after dose 1 (Day 7)

Antibody Geometric Mean Concentrations (GMCs) against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group

Timeframe: One month after dose 2 (Month 3)

Antibody geometric mean concentrations (GMCs) against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2

Timeframe: 1 month after booster dose (Month 10) – in primary study (105539)

Antibody Geometric Mean Concentrations (GMCs) against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2

Timeframe: Pre-additional dose at Month 34 in the current study (Month 34)

Antibody Geometric Mean Concentrations (GMCs) against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2

Timeframe: One week after vaccination at Month 34+7 days (Mth34+D7)

Secondary outcomes:

Number of subjects with anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ the cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2

Timeframe: 1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+ D7);

Number of subjects with Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ the cut-off in the Unprimed Group;

Timeframe: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);

Number of subjects with anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ the cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2

Timeframe: 1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)

Number of subjects with anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ the cut-off in the Unprimed Group

Timeframe: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);

Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2

Timeframe: 1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)

Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group

Timeframe: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)

Antibody Geometric Mean Concentrations (GMCs) against the vaccine pneumococcal serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2

Timeframe: 1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)

Antibody Geometric Mean Concentrations (GMCs) against the vaccine pneumococcal serotypes 6A and 19A in the Unprimed Group

Timeframe: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)

Number of subjects with anti-pneumococcal serotypes 6A and 19A antibody concentrations ≥ the cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2

Timeframe: 1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)

Number of subjects with anti-pneumococcal serotypes 6A and 19A antibody concentrations ≥ the cut-off in the Unprimed Group

Timeframe: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)

Number of subjects with Anti-pneumococcal serotypes 6A and 19A antibody concentrations ≥ the cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2;

Timeframe: 1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7);

Number of subjects with Anti-pneumococcal serotypes 6A and 19A antibody concentrations ≥ 0.20 μg/mL in the Unprimed group

Timeframe: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)

Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2

Timeframe: 1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)

Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 6A and 19A in the Unprimed Group

Timeframe: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)

Concentrations of antibodies against protein D (ANTI-PD) in the Synflorix™ Group 1 and Synflorix™ Group 2

Timeframe: 1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)

Concentrations of antibodies against protein D (ANTI-PD) in the Unprimed Group

Timeframe: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)

Number of subjects with B-cells detection in the Synflorix™ Group 1 and Synflorix™ Group 2

Timeframe: Pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)

Number of subjects with B-cells detection in the Unprimed Group

Timeframe: Pre-vaccination (PRE/ Day 0) and one week after dose 1 (Day 7)

Number of subjects with any and Grade 3 solicited local symptoms

Timeframe: During the 4-day (Days 0-3) post-vaccination period with the Synflorix™ vaccine, following the additional dose in the Synflorix Group1 and the Synflorix Group2 and across the 2 doses in the Unprimed Group

Number/ percentage of subjects with any, Grade 3 and Related solicited general symptoms

Timeframe: During the 4-day (Days 0-3) post-vaccination period with the Synflorix™ vaccine, following the additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.

Number (%) of subjects with unsolicited adverse events

Timeframe: Within the 31-day (Days 0-30) period post vaccination, with the Synflorix™ vaccine, following the additional dose in the Synflorix group1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group

Number (%) of subjects with serious adverse events

Timeframe: During the 31-day period following vaccination period

Interventions:
  • Biological/vaccine: Pneumococcal conjugate vaccine GSK1024850A
    • Enrollment:
    172
    Primary completion date:
    2009-02-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Silfverdal SA et al. (2011) Anamnestic immune response in 3- to 4-year-old children previously immunized with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine as 2 dose or 3 dose priming and a booster dose in the first year of life. Pediatr Infect Dis J. 30(9):155-163.
    Silfverdal SA et al. Assessment of immunological memory following PHiD-CV immunisation according to 2+1 or 3+1 schedules in the first year of life. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14–18 March 2010.
    Silfverdal SA et al. Immunogenicity/reactogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine (PHiD-CV) during fourth year of life. Abstract presented at the 8th Biennial International Symposium on Pneumococci & Pneumococcal Diseases (ISPPD), Foz de Iguaçu, Brazil, 11-15 March 2012.
    Medical condition
    Infections, Streptococcal
    Product
    GSK1024850A
    Collaborators
    Not applicable
    Study date(s)
    December 2008 to July 2009
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    36 - 46 months
    Accepts healthy volunteers
    Yes
    • Male or female between, and including, +- 36-46 months of age at the time of vaccination.
    • For primed subjects: having completed the full vaccination course with GSK1024850A in the primary study (NCT00307034).
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
    • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to vaccination.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Male or female between, and including, +- 36-46 months of age at the time of vaccination.

      • For primed subjects: having completed the full vaccination course with GSK1024850A in the primary study (NCT00307034).
      • Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
      • Written informed consent obtained from the parent(s)/guardian(s) of the subject.
      • Free of obvious health problems 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 the study vaccines, or planned use during the study period.

      • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to vaccination.
      • For primed subjects: administration of any pneumococcal vaccine since the end of the primary study (NCT00307034).
      • For unprimed subjects: previous vaccination with any pneumococcal vaccine.
      • Administration of immunoglobulins and/or any blood products less than 6 months prior to the vaccination or planned administration during the study period.
      • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
      • History of reactions or allergic disease likely to be exacerbated by any component of the study vaccine.
      • Acute disease at the time of enrolment.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Ruzomberok, Slovakia, 034 01
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dolny Kubin, Slovakia, 026 01
    Status
    Study Complete
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    Location
    GSK Investigational Site
    ÖREBRO, Sweden, SE-701 16
    Status
    Study Complete
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    Location
    GSK Investigational Site
    UMEÅ, Sweden, SE-901 85
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dlha nad Oravou, Slovakia, 027 55
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2009-02-07
    Actual study completion date
    2009-02-07

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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