Assessment of Antibody Persistence in Children Previously Vaccinated With Pneumococcal Conjugate Vaccine

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00624819
• Date of registration: 15/02/2008
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Assessment of Antibody Persistence in Children Previously Vaccinated With Pneumococcal Conjugate Vaccine
• Scientific 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)
• Date of first enrolment: March 3, 2008
• Target sample size: 524
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00624819
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Poland

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & 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.



Age minimum: 28 Months
Age maximum: 32 Months
Gender: All

Health Condition(s) or Problem(s) studied

Infections, Streptococcal

Streptococcus Pneumoniae Vaccines

Intervention(s)

Biological: Infanrix hexa

Biological: Havrix

Biological: Prevenar

Biological: Varilrix

Biological: GSK1024805A

Primary Outcome(s)

Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations = the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] [Time Frame: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)]

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)] [Time Frame: 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)] [Time Frame: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)]

Secondary Outcome(s)

Number of Seropositive Subjects for Anti Protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 2 (111345 Sub-study)] [Time Frame: 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 2 (111346 Sub-study)] [Time Frame: At Year 2 (Y2) (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 1 (111345 Sub-study)] [Time Frame: 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 1 (111345 Sub-study)] [Time Frame: 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: Immunogenicity Analysis in Year 4 (111347 Sub-study)] [Time Frame: 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 4 (111347 Sub-study)] [Time Frame: At Year 4 (Y4) (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)] [Time Frame: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)]

Number of Subjects Reported With Solicited Local Symptoms [Time Frame: Within 4 days (Days 0-3) period(s) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study]

Antibody Concentrations to Protein D (Anti-PD) - Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study) [Time Frame: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)]

Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] [Time Frame: 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 Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] [Time Frame: 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) [Time Frame: 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)] [Time Frame: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PDDIT- 007)]

Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] [Time Frame: At Year 4 (Y4) (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 4 (111347 Sub-study)] [Time Frame: At Year 4 (Y4) (post booster vaccination administrated in study 10PN-PD-DIT- 007)]

Antibody Concentrations to Protein D (Anti-PD) - Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study) [Time Frame: 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: Immunogenicity Analysis in Year 4 (111347 Sub-study)] [Time Frame: 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)] [Time Frame: 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)] [Time Frame: At Year 2 (Y2) (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)] [Time Frame: At Year 2 (Y2) (post booster vaccination administrated in study 10PN-PD-DIT-007)]

Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] [Time Frame: At Year 2 (Y2) (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)] [Time Frame: 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 4 (111347 Sub-study)] [Time Frame: At Year 4 (Y4) (post booster vaccination administrated in study 10PN-PD-DIT-007)]

Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] [Time Frame: At Year 4 (Y4) (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 4 (111347 Sub-study)] [Time Frame: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)]

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)] [Time Frame: 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))]

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] [Time Frame: 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)] [Time Frame: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)]

Number of Subjects Reported With Solicited General Symptoms [Time Frame: Within 4 days (Days 0-3) period(s) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study]

Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] [Time Frame: 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 With Serious Adverse Events (SAEs) [Follow-up Period: Vaccination Period in Year 4 (111347 Sub-study)] [Time Frame: 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 Subjects With Serious Adverse Events (SAEs) Related to Study Procedures [Follow-up Period: Year 1 (111345 Sub-study)] [Time Frame: 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)]

Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] [Time Frame: 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 4 (111347 Sub-study)] [Time Frame: At Year 4 (Y4) (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)] [Time Frame: 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)] [Time Frame: 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: Immunogenicity Analysis in Year 4 (111347 Sub-study)] [Time Frame: 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 Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] [Time Frame: 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)] [Time Frame: 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 1 (111345 Sub-study)] [Time Frame: At Year 1 (Y1) (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)] [Time Frame: 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 With Unsolicited Adverse Events (AEs) [Time Frame: Within 31 days (Day 0-30) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study]

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] [Time Frame: 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)]

Secondary ID(s)

2007-005392-34

111345 (Mth 12)

111346 (Mth 24)

111347 (Mth 48)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/03/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00624819