Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00792909
• Date of registration: 17/11/2008
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A
• Scientific title: Vaccination Course in Children Primed and Boosted With Pneumococcal Vaccine GSK 1024850A and in Age-matched Unprimed Children
• Date of first enrolment: December 2, 2008
• Target sample size: 172
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00792909
• 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

Slovakia, Sweden

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female between, and including, +- 36-46 months of age at the time of
vaccination.

- For primed subjects: having completed the full vaccination course with GSK1024850A in
the primary study (NCT00307034).

- Subjects for whom the investigator believes that their parent(s)/guardian(s) can and
will comply with the requirements of the protocol.

- Written informed consent obtained from the parent(s)/guardian(s) 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 vaccines within 30 days preceding the first dose of the study vaccines, or
planned use during the study period.

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within 6 months prior to vaccination.

- For primed subjects: administration of any pneumococcal vaccine since the end of the
primary study (NCT00307034).

- For unprimed subjects: previous vaccination with any pneumococcal vaccine.

- Administration of immunoglobulins and/or any blood products less than 6 months prior
to the vaccination or planned administration during the study period.

- 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 study vaccine.

- Acute disease at the time of enrolment.



Age minimum: 36 Months
Age maximum: 46 Months
Gender: All

Health Condition(s) or Problem(s) studied

Infections, Streptococcal

Intervention(s)

Biological: Pneumococcal conjugate vaccine GSK1024850A

Primary Outcome(s)

Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2 [Time Frame: One week after vaccination at Month 34+7 days (Mth34+D7)]

Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group [Time Frame: One month after dose 2 (Month 3)]

Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group [Time Frame: One week after dose 1 (Day 7)]

Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2 [Time Frame: 1 month after booster dose (Month 10) - in primary study (105539)]

Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2 [Time Frame: Pre-additional dose at Month 34 in the current study (Month 34)]

Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group [Time Frame: Pre-vaccination (PRE/ Day 0)]

Secondary Outcome(s)

Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations = the Cut-off in the Unprimed Group; [Time Frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);]

Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations = the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2 [Time Frame: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)]

Concentrations of Antibodies Against Protein D (ANTI-PD) in the Synflorix™ Group 1 and Synflorix™ Group 2 [Time Frame: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)]

Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2 [Time Frame: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)]

Concentrations of Antibodies Against Protein D (ANTI-PD) in the Unprimed Group [Time Frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)]

Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations = the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2 [Time Frame: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+ D7);]

Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations = the Cut-off in the Unprimed Group [Time Frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)]

Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations = 0.20 µg/mL in the Unprimed Group [Time Frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)]

Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations = the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2; [Time Frame: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7);]

Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group [Time Frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)]

Number (%) of Subjects With Unsolicited Adverse Events [Time Frame: Within the 31-day (Days 0-30) period post vaccination, with the Synflorix™ vaccine, following the additional dose in the Synflorix group1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group]

Number/ Percentage of Subjects With Any, Grade 3 and Related Solicited General Symptoms [Time Frame: During the 4-day (Days 0-3) post-vaccination period with the Synflorix™ vaccine, following the additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.]

Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group [Time Frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)]

Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations = the Cut-off in the Unprimed Group [Time Frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);]

Number (%) of Subjects With Serious Adverse Events [Time Frame: During the 31-day period following vaccination period]

Number of Subjects With B-cells Detection in the Synflorix™ Group 1 and Synflorix™ Group 2 [Time Frame: Pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)]

Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2 [Time Frame: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)]

Number of Subjects With Any and Grade 3 Solicited Local Symptoms [Time Frame: During the 4-day (Days 0-3) post-vaccination period with the Synflorix™ vaccine, following the additional dose in the Synflorix Group1 and the Synflorix Group2 and across the 2 doses in the Unprimed Group]

Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2 [Time Frame: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)]

Number of Subjects With B-cells Detection in the Unprimed Group [Time Frame: Pre-vaccination (PRE/ Day 0) and one week after dose 1 (Day 7)]

Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations = the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2 [Time Frame: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)]

Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group [Time Frame: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)]

Secondary ID(s)

111736

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/12/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00792909