Last updated: 11/03/2018 14:25:21

Immunization of children previously primed with GSK pneumococcal vaccine GSK1024850A and of unprimed children in Mali

Request patient level data
GSK study ID
113166
See study documents
Clinicaltrials.gov ID
NCT00985465
See results summary
EudraCT ID
2011-003711-39
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: Safety, reactogenicity and immunogenicity study of GSK Biologicals’ pneumococcal vaccine GSK1024850A, given either as a booster dose or as a 2-dose catch-up immunization in healthy Malian children
Trial description: The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK Biologicals’ pneumococcal conjugate vaccine GSK1024850A when administered either as a booster dose or as a two dose catch-up vaccination in the second year of life to the Malian subjects previously enrolled in the primary vaccination study NCT00678301.
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 = NCT00678301).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of subjects with Grade 3 adverse events (solicited and unsolicited)

Timeframe: Within 31 days (Day 0-Day 30) after booster vaccination

Secondary outcomes:

Number of subjects with any and Grade 3 solicited local symptoms

Timeframe: Within 4 days (Day 0-Day 3) after the booster dose

Number of subjects with any, Grade 3 and related solicited general symptoms

Timeframe: Within 4 days (Day 0-Day 3) after the booster dose

Number of subjects with any and Grade 3 solicited local symptoms

Timeframe: Within 4 days (Day 0-Day 3) after each vaccine dose

Number of subjects with any, Grade 3 and related solicited general symptoms

Timeframe: Within 4 days (Day 0-Day 3) after each vaccine dose

Number of subjects with any unsolicited adverse events (AEs)

Timeframe: Within 31 days (Day 0-Day 30) after each vaccine dose

Number of subjects with serious adverse events (SAEs)

Timeframe: From the first vaccination up to one month (31 days) after the last vaccination for each subject

Concentrations of antibodies against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F

Timeframe: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group

Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F

Timeframe: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group

Concentrations of antibodies against cross-reactive pneumococcal serotypes 6A and 19A

Timeframe: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group

Opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A

Timeframe: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group

Concentrations of antibodies against protein D (PD)

Timeframe: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group

Interventions:
  • Biological/vaccine: Pneumococcal vaccine GSK1024850A
    • Enrollment:
    218
    Primary completion date:
    2010-26-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Dicko A et al. (2013) Safety, reactogenicity and immunogenicity of a booster dose of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children. Hum Vaccin Immunother. 4;9(2).
    Dicko A et al. Safety and immunogenicity of booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children. Abstract presented at the 7th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Melbourne, Australia, 16–19 November 2011 (Abstract 532).
    Dicko et al. Safety/reactogenicity and immunogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine (PHiD-CV) in Malian children. Abstract presented at the 8th International Symposium on Pneumococci & Pneumococcal Diseases (ISPPD), Iguaçu Falls, Brazil, 11-15 March 2012 (Abstract 085).
    Dicko A et al. (2015) Safety, reactogenicity and immunogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children in the second year of life: Results from an open study. Hum Vaccin Immunother. 11(9):2207-2214.
    Medical condition
    Infections, Streptococcal
    Product
    GSK1024850A
    Collaborators
    Not applicable
    Study date(s)
    November 2009 to July 2010
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    15 - 21 months
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
    • A male or female, between and including 15-21 months of age at the time of visit 1.
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s)/product(s) within 30 days preceding the first dose of vaccine, or planned use during the study period.
    • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.

      • A male or female, between and including 15-21 months of age at the time of visit 1.
      • For the Pn-Pn group, subjects who completed the full vaccination course in study NCT00678301. For the Zil-Pn group, subjects who were previously enrolled in the control group of study NCT00678301.
      • Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
      • 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 vaccine(s)/product(s) within 30 days preceding the first dose of vaccine, or planned use during the study period.

      • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
      • Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after. Locally recommended vaccines for example Oral Polio Vaccine or influenza vaccine are always allowed, even if concomitantly administered with the study vaccines, but should be documented in the CRF.
      • 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).
      • Administration of any pneumococcal vaccine since the end of study NCT00678301.
      • Any confirmed or suspected immunosuppressive or immunodeficient condition, since the end of study NCT00678301, based on medical history and physical examination.
      • Major congenital defects or serious chronic illness.
      • History of any progressive neurological disorders or seizures.
      • Acute disease and/or fever at the time of enrolment.
      • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
      • Administration of immunoglobulins and/or any blood products less than 3 months prior to visit 1 or planned use during the study.
      • Child in care.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bamako, Mali
    Status
    Study Complete
    Contact us

    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
    2010-26-06
    Actual study completion date
    2010-26-07

    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

    Participate in clinical trial
    Additional information
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Click here
    Access to clinical trial data by researchers
    Visit website