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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Pn-MAPS30plus

    Biological/Vaccine

    Pn-MAPS30plus vaccine will be administered intramuscularly.

  • PCV20

    Combination product

    PCV20 vaccine will be administered intramuscularly.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Pn-MAPS30plus GroupExperimental treatment 1 intervention
Group B: PCV20 GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with solicited administration site adverse events (AEs)

The AEs considered are tenderness, redness, and swelling.

Time frame
Day 1 to Day 7
2

Number of participants with solicited systemic adverse events (AEs)

The AEs considered are fever, irritability, loss of appetite and somnolence (sleepiness/drowsiness).

Time frame
Day 1 to Day 7
3

Number of participants with unsolicited AEs

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 to Day 30
4

Number of Participants with Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Withdrawal

Time frame
Day 1 up to trial end (Month 16)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: