CompletedPhase 3

Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13

Hungary356 participantsStarted 2022-06-24

Plain-language summary

The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in toddlers who had 2 prior doses of Prevnar 13. This study is being conducted in children who: * are between 12 to 23 months of age; * are healthy as determined by the study doctors; * have received 2 doses of Prevnar 13 during the first year in life. Participants in this study will receive either 1 dose or 2 doses of the study vaccine or 1 dose of Prevnar 13 as a shot in the muscle. During the study, participants will have to come to the study clinic to receive the vaccines and have blood sample collected. The study team will work with participants' parents or legal guardians to monitor any unwanted reactions to the vaccines. Participants are expected to take part in this study for about 1 or 3 months, for 1 dose or 2 dose schedules, respectively.

Who can participate

Age range12 Months – 23 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female toddlers ≥12 to \<24 months of age at the time of consent * Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study * 2 infant doses of Prevenar 13 prior to 12 months of age Exclusion Criteria: * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) * Major known congenital malformation or serious chronic disorder * Other chronic medical or laboratory abnormality that may increase the risk associated with study participation or, in the investigator's judgment, make the participant inappropriate for the study. * Previous vaccination with any investigational pneumococcal vaccine, or planned receipt through study participation

What they're measuring

Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination

Timeframe: Within 7 days after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)

Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination

Timeframe: Within 7 days after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)

Percentage of Participants With Adverse Events (AEs) From Last Vaccination to 1 Month After Last Vaccination

Timeframe: From last vaccination to 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)

Percentage of Participants With Serious Adverse Events (SAEs) From Last Vaccination to 1 Month After Last Vaccination

Timeframe: From last vaccination to 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)

Percentage of Participants With Predefined Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes 1 Month After Last Vaccination

Timeframe: 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)

Trial details

NCT IDNCT05408429

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-01

Results submitted2024-05-14

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