Pn-MAPS30plus
BiologicalPn-MAPS30plus vaccine will be administered intramuscularly.
NCT Number: NCT07406334
The main purpose of this study is to assess the safety and reactogenicity of a single dose of the new pneumococcal vaccine (called Pn-MAPS30plus) in toddlers who have previously completed a two-dose primary vaccination series with PCV used in local immunization program. PCV20 will be used as a comparator for this study.
Interested in participating?
Request Info12 month–15 month
All sexes
Interventional
Phase 1
GSK Investigational Site, Soweto, Johannesburg, Gauteng, South Africa
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pn-MAPS30plus vaccine will be administered intramuscularly.
PCV20 vaccine will be administered intramuscularly.
Time frame: Day 1 to Day 7
The AEs considered are tenderness, redness, and swelling at the administration site.
Time frame: Day 1 to Day 7
The AEs considered are fever, irritability, loss of appetite and somnolence (sleepiness/drowsiness).
Time frame: Day 1 to Day 30
An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Time frame: Day 1 up to trial end (Month 6)
Time frame: On Day 8 compared to Day 1 (pre-vaccination)
Contact information is provided by the study sponsor or research team.
EU GSK Clinical Trials Call Center
CONTACT
US GSK Clinical Trials Call Center
CONTACT
GlaxoSmithKline
Industry
A Phase 1, Observer-Blind, Randomized, Active Controlled Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 To 15 Months of Age Receiving a Single Booster Dose
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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