A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose Primary Dosing Series Followed by a Booster Dose at 12 to 15 Months of Age

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age42-90
SponsorGlaxoSmithKline

About this trial

The main purpose of this study is to evaluate safety and reactogenicity of the investigational pneumococcal vaccine (called Pn-MAPS30plus). 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 to performance of any study-specific procedure.

Participant is approximately 2 Months of Age [MOA (42 to 90 days, inclusive)] at time of first study intervention administration.

Healthy participants as established by medical history and clinical examination before entering the trial.

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

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators