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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2011-19-08
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
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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
Completed
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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