Last updated: 11/03/2018 13:49:16

Booster and catch-up vaccination with vaccine GSK1024850A

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GSK study ID
112909
See study documents
Clinicaltrials.gov ID
NCT01030822
See results summary
EudraCT ID
2011-002140-27
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: Booster vaccination with pneumococcal vaccine GSK1024850A in primed children and catch-up vaccination in unprimed children
Trial description: The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of pneumococcal vaccine GSK1024850A administered either at 9-18 months or 15-18 months of age in children primed in primary study NCT00814710.
This study also aims to assess the persistence of antibodies induced following primary vaccination with pneumococcal vaccine GSK1024850A in primary study NCT00814710 prior to booster vaccination and following vaccination in the present study at approximately 24 months of age.
The study is also designed to evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A when administered as a catch-up vaccination (2+1) in the second year of life in children unprimed with vaccine GSK1024850A in study NCT00814710.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Concentrations of antibodies against vaccine pneumococcal serotypes

Timeframe: Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for Synflorix 1 Group and at Month 9 for Synflorix 2 Group (24 months of age)

Secondary outcomes:

Concentrations of antibodies against vaccine pneumococcal serotypes

Timeframe: Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)

Concentrations of antibodies against vaccine pneumococcal serotypes (Persistence)

Timeframe: Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB+Hiberix Group

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

Timeframe: Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB + Hiberix Group

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

Timeframe: Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for the Synflorix 1 Group and at Month 9 for Synflorix 2 Group (24 months of age)

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

Timeframe: Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)

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

Timeframe: Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB + Hiberix Group

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

Timeframe: Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for the Synflorix 1 Group and at Month 9 for the Synflorix 2 Group (24 months of age)

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

Timeframe: Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)

Opsonophagocytic activity (OPA) titers against cross-reactive pneumococcal serotypes 6A and 19A (Persistence)

Timeframe: Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB + Hiberix Group

Opsonophagocytic activity (OPA) titers against cross-reactive pneumococcal serotypes 6A and 19A

Timeframe: Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for the Synflorix 1 Group and at Month 9 for the Synflorix 2 Group (24 months of age)

Opsonophagocytic activity (OPA) titers against cross-reactive pneumococcal serotypes 6A and 19A

Timeframe: Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)

Concentrations of antibodies against protein D (Anti-PD) (Persistence)

Timeframe: Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB + Hiberix Group

Concentrations of antibodies against protein D (Anti-PD)

Timeframe: Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for the Synflorix 1 Group and at Month 9 for the Synflorix 2 Group (24 months of age)

Concentrations of antibodies against protein D (Anti-PD)

Timeframe: Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)

Number of subjects with any and grade 3 solicited local symptoms

Timeframe: Within the 4-day follow-up period (Days 0-3) after the booster dose for the Synflorix 1 and Synflorix 2 Groups and across doses for the Tritanrix-HepB + Hiberix Group

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

Timeframe: Within the 4-day follow-up period (Days 0-3) after the booster dose for the Synflorix 1 and Synflorix 2 Groups and across doses for the Tritanrix-HepB + Hiberix Group

Number of subjects with unsolicited adverse events (AEs)

Timeframe: Within 31-day follow-up period (Days 0-30) after vaccination

Number of subjects with serious adverse events (SAEs)

Timeframe: After the first vaccination up to study end (from Month 0 to Month 15)

Interventions:
  • Biological/vaccine: Pneumococcal vaccine GSK1024850A
    • Enrollment:
    282
    Primary completion date:
    2011-19-08
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Lalwani S. et al. Impact of age on booster responses to 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in children in India. Abstract presented at the 6th Asian Congress of Pediatric Infectious Diseases (ACPID), Colombo, Sri Lanka, 28 Nov - 01 Dec 2012.
    Lalwani S et al. (2014) Randomized, open-label study of the impact of age on booster responses to the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in children in India. Clin Vaccine Immunol. 21(9):1292-1300.
    Medical condition
    Infections, Streptococcal
    Product
    GSK1024850A
    Collaborators
    Not applicable
    Study date(s)
    April 2010 to August 2011
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    9 - 18 months
    Accepts healthy volunteers
    Yes
    • Male or female subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
    • Written, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
    • Use of any investigational or non-registered product within 30 days preceding the vaccination, or planned use during the study period.
    • 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.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Male or female subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.

      • Written, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(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. For primed subjects:
      • Completion of the full vaccination course in study NCT00814710.
      • 9-18 months of age at the time of randomization.
      • Group A: 9-18 months of age at the time of booster vaccination.
      • Group B: 15-18 months of age at the time of booster vaccination. For unprimed subjects (Group C):
      • Enrolled in study NCT00814710.
      • 12-18 months of age at the time of first vaccination.
    Exclusion criteria:

      Use of any investigational or non-registered product within 30 days preceding the vaccination, or planned use during the study period.

      • 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.
      • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
      • Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
      • Administration of any pneumococcal vaccine since the end of study NCT00814710.
      • 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 vaccine.
      • Major congenital defects or serious chronic illness.
      • History of any neurologic disorders or seizures.
      • Acute disease at the time of enrolment.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Pune, India
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ludhiana, India, 141 008
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Vellore,, India, 632 004
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kolkata, India, 700073
    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
    2011-19-08
    Actual study completion date
    2011-19-08

    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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