Pneumococcal Disease Paediatrics
Conditions
Interventions
Sponsors
GlaxoSmithKline Biologicals SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants will be included in the study if they: • Are male or female, aged between 12 and 15 months old (meaning from their first birthday up to the day before their 16-month birthday). • Are healthy or have stable medical conditions, as determined by the study doctor. • Have received the pneumococcal vaccine and has already completed a two-doses of PCV10 (10-valent pneumococcal conjugate vaccine).
Exclusion criteria
Exclusion criteria: Participants will be excluded from the study if they: • Have a confirmed or suspected condition that weakens their immune system, major birth defects, or uncontrolled nerve or brain disorders. • Have previously had confirmed invasive pneumococcal disease (IPD), which is a serious infection caused by Streptococcus pneumoniae bacteria. • Have received other pneumococcal vaccines apart from their two doses of PCV10.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Occurrence of expected medical problems, called solicited Adverse Events (AEs), that occur at the injection site and throughout the body, within 7 days after vaccination. • Occurrence of unexpected medical problems, called unsolicited AEs, that occur during the first month after vaccination. • Occurrence of Serious AE events (SAEs) and AEs of Special Interest (AESIs) and side effects that are so severe which can cause the participant to stop the treatment during the study period • Occurrence of any significant changes in the participants' blood and basic health measurements on Day 8 as compared to pre-vaccination day. | — |
Countries
South Africa
Contacts
Public ContactItumeleng Siweya
Clinical Operations Director. GMASE Head Clinical Operations South Africa
Outcome results
None listed