Last updated: 10/19/2020 07:00:05

Assessment of antibody persistence in children previously vaccinated with pneumococcal conjugate vaccine

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GSK study ID
111345 (Mth 12)
See study documents
Clinicaltrials.gov ID
NCT00624819
See results summary
EudraCT ID
2007-005392-34
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: Long-term follow-up study to assess antibody persistence in children previously vaccinated with four doses of pneumococcal conjugate vaccine in primary vaccination study (105553) and booster vaccination study (107046)
Trial description: This protocol posting deals with objectives & outcome measures of the extension phase up to 48-50 months post booster vaccination, to assess long-term antibody persistence in children at around 30, 42 and 66 months of age, who received previously 4 doses of pneumococcal conjugate vaccine. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00307554). This Protocol posting has been updated in order to comply with the FDA AA (Sep 2007).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of subjects with anti-vaccine pneumococcal serotypes antibody concentrations greater than or equal to (≥) the cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 sub-study)]

Timeframe: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Number of subjects with anti-vaccine pneumococcal serotypes antibody concentrations ≥ the cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 sub-study)]

Timeframe: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)

Number of subjects with anti-vaccine pneumococcal serotypes antibody concentrations ≥ the cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 sub-study)]

Timeframe: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)

Secondary outcomes:

Antibody concentrations against pneumococcal serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 sub-study)]

Timeframe: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Antibody concentrations against pneumococcal serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 sub-study)]

Timeframe: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)

Antibody concentrations against pneumococcal serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 sub-study)]

Timeframe: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PDDIT- 007)

Antibody concentrations against pneumococcal serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 sub-study)]

Timeframe: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]),at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)

Opsonophagocytic activity (OPA) titers against pneumococcal serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 sub-study)]

Timeframe: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Opsonophagocytic activity (OPA) titers against pneumococcal serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 sub-study)]

Timeframe: At Year 2 (Y2) (post booster vaccination administrated in study 10PN-PD-DIT-007)

Opsonophagocytic activity (OPA) titers against pneumococcal serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 sub-study)]

Timeframe: At Year 4 (Y4) (post booster vaccination administrated in study 10PN-PD-DIT-007)

Opsonophagocytic activity (OPA) titers against pneumococcal serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 sub-study)]

Timeframe: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]),at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)

Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 1 (111345 sub-study)]

Timeframe: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A and - 19A) – Follow-Up Period: Persistence analysis in Year 2 (111346 sub-study)

Timeframe: At Year 2 (Y2) (post booster vaccination administrated in study 10PN-PDDIT- 007)

Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 4 (111347 sub-study)]

Timeframe: At Year 4 (Y4) (post booster vaccination administrated in study 10PN-PD-DIT- 007)

Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 sub-study)]

Timeframe: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]),at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)

Opsonophagocytic activity (OPA) titers against crossreactive pneumococcal serotypes 6A and 19 A [Follow-up Period: Persistence analysis in Year 1 (111345 sub-study)]

Timeframe: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Opsonophagocytic activity (OPA) titers against crossreactive pneumococcal serotypes 6A and 19 A [Follow-up Period: Persistence analysis in Year 2 (111346 sub-study)]

Timeframe: At Year 2 (Y2) (post booster vaccination administrated in study 10PN-PD-DIT-007)

Opsonophagocytic activity (OPA) titers against crossreactive pneumococcal serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 4 (111347 sub-study)]

Timeframe: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)

Opsonophagocytic activity (OPA) titers against pneumococcal serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 sub-study)]

Timeframe: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]),at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)

Antibody concentrations to protein D (Anti-PD) - Follow-up Period: Persistence analysis in Year 1 (111345 sub-study)

Timeframe: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Antibody concentrations to protein D (Anti-PD) – Follow-up Period: Persistence analysis in Year 2 (111346 sub-study)

Timeframe: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT- 007)

Antibody concentrations to protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 4 (111347 sub-study)]

Timeframe: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT- 007)

Antibody concentrations to protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 sub-study)]

Timeframe: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]),at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)

Number of subjects reported with solicited local symptoms

Timeframe: Within 4 days (Days 0-3) period(s) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study

Number of subjects reported with solicited general symptoms

Timeframe: Within 4 days (Days 0-3) period(s) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study

Number of subjects with unsolicited adverse events (AEs)

Timeframe: Within 31 days (Day 0-30) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study

Number of subjects with serious adverse events (SAEs) related to study procedures [Follow-up Period: Year 1 (111345 sub-study)]

Timeframe: During Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007) i.e. for each primed subject: from the time the subject was enrolled in the 111345 study until he/she completed the same study (approximatively 12 months)

Number of subjects with serious adverse events (SAEs) related to study procedures [(Follow-up Period: Year 2 (111346 sub-study) until Year 4 (111347 sub-study)]

Timeframe: From Year (Y) 2 to Y4 FU visit (post booster vaccination administered in 10PN-PD-DIT-007) i.e. for each subject(S): when S was enrolled in 111346 study until S completed the same study visit or the 111347 study visit (range of 1 to 3 years for each S))

Number of subjects with serious adverse events (SAEs) [Follow-up Period: Vaccination Period in Year 4 (111347 sub-study)]

Timeframe: For primed groups: from Months 48-49 (additional vaccination period); for unprimed group: from Day 0 up to Month 3 (catch-up vaccination period)

Number of seropositive subjects for opsonophagocytic activity against pneumococcal serotypes [Follow-up Period: Persistence analysis in Year 1 (111345 sub-study)]

Timeframe: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Number of seropositive subjects for opsonophagocytic activity against pneumococcal serotypes [Follow-up Period: persistence analysis in Year 2 (111346 sub-study)]

Timeframe: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)

Number of seropositive subjects for opsonophagocytic activity against pneumococcal serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 sub-study)]

Timeframe: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)

Number of seropositive subjects for opsophagocytic activity against pneumococcal serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 sub-study)]

Timeframe: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]),at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)

Number of seropositive subjects for anti-pneumococcal cross-reactive serotypes 6A and 19A [Follow-up Period: persistence analysis in Year 1 (111345 sub-study)]

Timeframe: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Number of seropositive subjects for anti-pneumococcal cross-reactive serotypes 6A and 19A [Follow-up Period: Persistence analysis in Year 2 (111346 sub-study)]

Timeframe: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)

Number of seropositive subjects for anti-pneumococcal cross-reactive serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 sub-study)]

Timeframe: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)

Number of seropositive subjects for anti-pneumococcal cross-reactive serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 sub-study)]

Timeframe: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]),at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)

Number of seropositive subjects for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A [Follow-up Period: Persistence analysis in Year 1 (111345 sub-study)]

Timeframe: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Number of seropositive subjects for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 sub-study)]

Timeframe: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)

Number of seropositive subjects for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 sub-study)]

Timeframe: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)

Number of seropositive subjects for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 sub-study)]

Timeframe: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]),at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)

Number of seropositive subjects for anti-protein D (Anti-PD) [Follow-up Period: Persistence analysis in Year 1 (111345 sub-study)]

Timeframe: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Number of seropositive subjects for anti protein D (Anti-PD) [Follow-up Period: Persistence analysis in Year 2 (111345 sub-study)]

Timeframe: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)

Number of seropositive subjects for anti-protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 4 (111347 sub-study)]

Timeframe: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)

Number of seropositive subjects for anti-protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 sub-study)]

Timeframe: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]),at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)

Number of seropositive subjects for anti-vaccine pneumococcal serotypes antibodies [Follow-up Period: Immunogenicity analysis in Year 4 (111347 sub-study)]

Timeframe: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]),at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)

Interventions:
  • Biological/vaccine: GSK1024805A
  • Biological/vaccine: Prevenar
  • Biological/vaccine: Infanrix hexa
  • Biological/vaccine: Havrix
  • Biological/vaccine: Varilrix
    • Enrollment:
    524
    Primary completion date:
    2008-02-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Streptococcal
    Product
    GSK1024850A
    Collaborators
    Not applicable
    Study date(s)
    March 2008 to June 2008
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    28 - 32 months
    Accepts healthy volunteers
    Yes
    • Male or female between, and including, 28-30 months of age at the time of first blood sampling.
    • Subjects who previously participated in the 105553 and 107046 studies and who received a full four dose regimen of pneumococcal conjugate vaccine during the primary and booster studies.
    • Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the blood sampling
    • Administration of any additional pneumococcal vaccine since end of 107046 study.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Male or female between, and including, 28-30 months of age at the time of first blood sampling.
    • Subjects who previously participated in the 105553 and 107046 studies and who received a full four dose regimen of pneumococcal conjugate vaccine during the primary and booster studies.
    • Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
    • Written informed consent, covering visits 1, 2 and 3, 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:
    • Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the blood sampling
    • Administration of any additional pneumococcal vaccine since end of 107046 study.
    • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the blood sampling.
    • Administration of immunoglobulins and/or any blood products less than 6 months prior to blood sampling.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition since the end of the 107046 study, based on medical history and physical examination.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bydgoszcz, Poland, 85-021
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Debica, Poland, 39-200
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Krakow, Poland, 31-503
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Olesnica, Poland, 56-400
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Poznan, Poland, 61-709
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Siemianowice Slaskie, Poland, 41-103
    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
    2008-02-06
    Actual study completion date
    2008-02-06

    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.

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