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临床试验/NCT00624819
NCT00624819已完成3 期

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)

GlaxoSmithKline7 个研究点 分布在 1 个国家目标入组 524 人开始时间: 2008年3月3日最近更新:
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适应症

试验速览

阶段
3 期
状态
已完成
入组人数
524
试验地点
7
主要终点
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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).

详细描述

This study consists in a serological follow-up study to evaluate persistence 12, 24 and 48 months after the booster vaccination study (107046). No study vaccines will be administered within this study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
28 Months 至 32 Months（Child）
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

结局指标

主要结局

Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]

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

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using 0.05 μg/mL as seropositivity cut off.

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)]

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

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using 0.05 microgram per milliliter (µg/mL) as seropositivity cut off.

Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)]

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

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme -linked immunosorbent assay (ELISA), using 0.05 μg/mL as seropositivity cut off.

次要结局

  • Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)](At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007))
  • Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)](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 2 (111346 Sub-study)(At Year 2 (Y2) (post booster vaccination administrated in study 10PN-PDDIT- 007))
  • Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)](At Year 4 (Y4) (post booster vaccination administered in study 10PN-PDDIT- 007))
  • Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)](At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007))
  • Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)](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)](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)](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)](At Year 4 (Y4) (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)(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 1 (111345 Sub-study)](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 4 (111347 Sub-study)](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: Persistence Analysis in Year 1 (111345 Sub-study)](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 1 (111345 Sub-study)](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 1 (111345 Sub-study)](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)](At Year 2 (Y2) (post booster vaccination administrated 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)](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)(At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007))
  • Number of Subjects With Serious Adverse Events (SAEs) [Follow-up Period: Vaccination Period in Year 4 (111347 Sub-study)](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 Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)](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 4 (111347 Sub-study)](At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007))
  • Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)](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)](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)](At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007))
  • Number of Subjects With Unsolicited Adverse Events (AEs)(Within 31 days (Day 0-30) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study)
  • 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)](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)](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)](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 4 (111347 Sub-study)](At Year 4 (Y4) (post booster vaccination administrated 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)](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: Immunogenicity Analysis in Year 4 (111347 Sub-study)](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: Immunogenicity Analysis in Year 4 (111347 Sub-study)](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 2 (111345 Sub-study)](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)](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)](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(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(Within 4 days (Days 0-3) period(s) 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)](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)](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 Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)](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 1 (111345 Sub-study)](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)](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)](At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (7)

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