A 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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12-15
SponsorGlaxoSmithKline

About this trial

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.

Eligibility criteria

Qualifiers

Participants' parent(s)/Legally acceptable representative [LAR(s)] who, in the opinion of the investigator, can and will comply with all protocol requirements.

Written or witnessed/thumb printed informed consent obtained from the participants' parent(s)/LAR(s) prior any study-specific procedure is performed.

A male or female between, and including, 12 to15 Months of age at the time of the study intervention administration.

Healthy participants or medically stable patients as established by medical history and clinical examination before entering the study.

Disqualifiers

History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).

Hypersensitivity to latex.

History of microbiologically proven Invasive pneumococcal Disease (IPD).

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

Trial design

Treatments tested in this trial

  • Pn-MAPS30plus
  • PCV20

Treatment groups

45 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators