Last updated: 11/03/2018 13:39:30

Long-term follow-up study of children previously primed with GSK pneumococcal vaccine (GSK1024850A) and of unprimed children

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GSK study ID
112801
See study documents
Clinicaltrials.gov ID
NCT00950833
See results summary
EudraCT ID
2008-008104-41
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: Vaccination course in children primed and boosted with pneumococcal vaccine GSK 1024850A and in age-matched unprimed children
Trial description: The objective of this study is to evaluate the immune memory through the administration of an additional dose of GSK Biologicals’ pneumococcal conjugate vaccine GSK1024850A, the antibody persistence and long-term effect on nasopharyngeal carriage of S. pneumoniae and H. influenzae in subjects primed and boosted with GSK Biologicals’ pneumococcal conjugate vaccine GSK1024850A in previous primary and booster studies. For subjects that did not receive the investigational vaccine during the primary and booster study, the objective is to evaluate immunogenicity, safety and reactogenicity of a 2-dose catch-up vaccination with GSK Biologicals’ pneumococcal conjugate vaccine GSK1024850A.
This protocol posting deals with objectives & outcome measures of the extension phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00370318). The objectives & outcome measures of the booster phase are presented in a separate protocol posting (NCT00496015).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Antibody concentrations against vaccine pneumococcal serotypes

Timeframe: At 7-10 days after the first vaccine dose

Secondary outcomes:

Antibody concentrations against vaccine pneumococcal serotypes

Timeframe: Prior to the first study vaccine dose (At Day 0)

Opsonophagocytic activity (OPA) titers against vaccine pneumococcal serotypes

Timeframe: Prior to (Day 0) and 7-10 days after the first vaccine dose

Antibody concentrations against vaccine pneumococcal cross-reactive serotypes 6A and 19A

Timeframe: Prior to (Day 0) and 7-10 days after the first vaccine dose

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

Timeframe: Prior to (Day 0) and 7-10 days after the first vaccine dose

Antibody concentrations against protein D (anti-PD)

Timeframe: Prior to (Day 0) and 7-10 days after the first vaccine dose

Memory B-cell detection for vaccine polysaccharides (PS)

Timeframe: Prior to (Day 0) and 7-10 days after the first vaccine dose

Antibody concentrations against vaccine pneumococcal serotypes

Timeframe: At Month 12, one month after the second vaccine dose

Opsonophagocytic activity (OPA) titers against vaccine pneumococcal serotypes

Timeframe: At Month 12, one month after the second vaccine dose

Antibody concentrations against vaccine pneumococcal cross-reactive serotypes 6A and 19A

Timeframe: At Month 12, one month after the second vaccine dose

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

Timeframe: At Month 12, one month after the second vaccine dose

Antibody concentrations against protein D (anti-PD)

Timeframe: At Month 12, one month after the second vaccine dose

Rabbit complement-mediated serum bactericidal activity titers against Neisseria meningitidis serogroups (rSBA-Men)

Timeframe: At 25-36 months post-vaccination in previous 107137 (NCT00496015) study

Number of subjects with any and grade 3 solicited local symptoms

Timeframe: During the 4-day (Days 0-3) post-vaccination period

Number of subjects with any and grade 3 solicited local symptoms

Timeframe: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses

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

Timeframe: During the 4-day (Days 0-3) post-vaccination period

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

Timeframe: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses

Number of subjects with any unsolicited adverse events (AEs)

Timeframe: Within 31 days (Days 0-30) after each vaccination

Number of subjects with serious adverse events (SAEs)

Timeframe: During the entire study period (from Day 0 up to Month 10 or Month 12)

Number of nasopharyngeal swabs with Streptococcus pneumoniae (vaccine serotypes)

Timeframe: At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age

Number of nasopharyngeal swabs with S.pneumoniae (cross-reactive serotypes)

Timeframe: At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age

Number of nasopharyngeal swabs with S.pneumoniae (non-vaccine and non-cross-reactive serotypes)

Timeframe: At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age

Number of nasopharyngeal swabs with Haemophilus influenzae

Timeframe: At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age

Number of subjects with new acquisition of S. pneumoniae (vaccine serotypes) in nasopharyngeal swabs

Timeframe: At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age

Number of subjects with new acquisition of S. pneumoniae (cross-reactive serotypes) in nasopharyngeal swabs

Timeframe: At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age

Number of subjects with new acquisition of S. pneumoniae (non-vaccine and non-cross-reactive serotypes) in nasopharyngeal swabs

Timeframe: At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age

Number of subjects with new acquisition of H. influenzae in nasopharyngeal swabs

Timeframe: At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age

Interventions:
Biological/vaccine: Pneumococcal vaccine GSK1024850A
Enrollment:
466
Observational study model:
Not applicable
Primary completion date:
2010-16-09
Time perspective:
Not applicable
Clinical publications:
Prymula R et al. (2013) Immunological memory and nasopharyngeal carriage in 4-year-old children previously primed and boosted with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) with or without concomitant prophylactic paracetamol. Vaccine. 31(16):2080-2088. doi: 10.1016/j.
Prymula R et al. Immune memory 2-3 years after vaccination with pneumococcal non-typeable Heamophilus influenzae protein-D conjugate vaccine (PHiD-CV), with or without prophylactic paracetamol. Abstract presented at the 30th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Thessaloniki, Greece, 8-12 May 2012.
Prymula R et al. Long-term effect of 10-valent pneumococcal non-typeable Haemophilus Influenzae protein D conjugate vaccine (PHiD-CV) on nasopharyngeal bacterial carriage in Czech children. Abstract presented at the 8th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD), Iguaçu Falls, Brazil, 11-15 March, 2012.
Silfverdal SA et al. Immunogenicity and reactogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus Influenzae protein D conjugate vaccine (PHiD-CV) during the fourth year of life. Abstract presented at the 8th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD), Iguaçu Falls, Brazil, 11-15 March, 2012.
Prymula R et al. (2013) Immunological memory and nasopharyngeal carriage in 4-year-old children previously primed and boosted with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) with or without concomitant prophylactic paracetamol. Vaccine. 31(16):2080-2088.
Medical condition
Infections, Streptococcal
Product
GSK1024850A
Collaborators
Not applicable
Study date(s)
August 2009 to October 2010
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
31 - 44 months
Accepts healthy volunteers
Yes
  • Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including, 31 and 34 months of age at the time of the enrolment.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding enrolment, or planned use during the entire study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the entire study period.
Inclusion and exclusion criteria
Inclusion criteria:

    Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.

    • A male or female between, and including, 31 and 34 months of age at the time of the enrolment.
    • Subjects who previously participated in study NCT00496015
    • For the subjects in the primed AP-AP and NAP-pre groups: subjects who received a booster dose of the pneumococcal conjugate vaccine prior to the study amendment 3.
    • For the subjects in the unprimed group: subjects who received a dose of the meningococcal vaccine GSK134612.
    • Written informed consent obtained from the parent or guardian 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 vaccine within 30 days preceding enrolment, or planned use during the entire study period.

    • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the entire study period.
    • 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.
    • 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).
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
    • History of seizures or progressive neurological disease.
    • Acute disease at the time of enrolment, defined as the presence of a mild, moderate or severe illness with or without fever.
    • Administration or planned use of immunoglobulins and/ or any blood products during the entire study period.
    • A family history of congenital or hereditary immunodeficiency.
    • Major congenital defects or serious chronic illness.
    • Subjects of which both parents have a history of atopia (polinosis, asthma, atopic eczema).
    • Administration of any pneumococcal vaccine since the end of study NCT00496015.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Nachod, Czech Republic, 547 01
Status
Study Complete
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Location
GSK Investigational Site
Ostrava, Czech Republic, 70800
Status
Study Complete
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Location
GSK Investigational Site
Praha 6, Czech Republic, 160 00
Status
Study Complete
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Location
GSK Investigational Site
Pardubice, Czech Republic, 532 03
Status
Study Complete
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Location
GSK Investigational Site
Jindrichuv Hradec, Czech Republic, 377 01
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01
Status
Study Complete
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Location
GSK Investigational Site
Brno, Czech Republic, 628 00
Status
Study Complete
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Location
GSK Investigational Site
Praha 5, Czech Republic, 150 00
Status
Study Complete
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Location
GSK Investigational Site
Znojmo, Czech Republic, 669 00
Status
Study Complete
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Location
GSK Investigational Site
Praha 9, Czech Republic, 190 00
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
2010-16-09
Actual study completion date
2010-27-10

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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