Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00907777
• Date of registration: 21/05/2009
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™
• Scientific title: Vaccination With the Pneumococcal Vaccine GSK 1024850A or Prevenar™ at Approximately 4 Years of Age in Children Primed With 3 Doses of GSK 1024850A Vaccine or Prevenar™ and Boosted With 23-valent Pneumococcal Plain Polysaccharide Vaccine
• Date of first enrolment: June 23, 2009
• Target sample size: 52
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00907777
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Germany

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female between, and including, 46-50 months of age at the time of vaccination.

- Subjects for whom the investigator believes that their parents/guardians can and will
comply with the requirements of the protocol.

- Subjects who previously participated in study NCT00333450 in centres with more than 2
subjects and received a booster dose of Pneumovax 23™.

- Written informed consent obtained from both parents/guardians of the subject.

- Healthy subjects as established by medical history and clinical examination before
entering into the study.

Exclusion Criteria:

- Use of any investigational or non-registered product other than the study vaccine(s)
within 30 days preceding the vaccination, or planned use during the study period.

- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months prior to the vaccination.

- Planned administration/ administration of a vaccine not foreseen by the study protocol
during the period starting one month before study vaccination and during the entire
study period.

- Administration of any pneumococcal vaccine since the end of study NCT00333450.

- Administration of immunoglobulins and/or any blood products less than 3 months prior
to the vaccination or planned use during the study period.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical

- History of any neurologic disorders or seizures

- Anaphylactic reaction following previous administration of the vaccine or history of
reactions or allergic disease likely to be exacerbated by any component of the
vaccine.

- History of hypotonic-hyporesponsive episode after any previous vaccination.

- Major congenital defects or serious chronic illness.

- History of invasive pneumococcal diseases.

- Acute disease at the time of vaccination

- Rectal temperature >= 38.0°C or oral/axillary/tympanic temperature >= 37.5°C. A
temperature greater than or equal to these cut-offs warrants deferral of the
vaccination pending recovery of the subject.



Age minimum: 46 Months
Age maximum: 50 Months
Gender: All

Health Condition(s) or Problem(s) studied

Infections, Streptococcal

Streptococcus Pneumoniae

Intervention(s)

Biological: Pneumococcal conjugate vaccine GSK 1024850A

Biological: Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)

Primary Outcome(s)

Vaccine Pneumococcal Serotype Antibody Concentrations [Time Frame: Before (PRE) and one month after (POST) the additional dose]

Secondary Outcome(s)

Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes [Time Frame: Before (PRE) and one month after (POST) the additional dose]

Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes [Time Frame: Before (PRE) and one month after (POST) the additional dose]

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms [Time Frame: During the 8-day (Days 0-7) post-additional dose]

Number of Subjects With Unsolicited Adverse Events (AEs) [Time Frame: Within 31 days (Day 0-30) post-additional vaccination]

Number of Subjects With Serious Adverse Events (SAEs) [Time Frame: Throughout the entire study period (approximately 1 month per subject)]

Cross-reactive Pneumococcal Serotype Antibody Concentrations [Time Frame: Before (PRE) and one month after (POST) the additional dose]

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [Time Frame: During the 8-day (Days 0-7) post-additional dose]

Anti-protein D Antibody Concentrations [Time Frame: Before (PRE) and one month after (POST) the additional dose]

Secondary ID(s)

2008-007605-37

112807

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/01/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00907777