A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
ConditionPneumococcal Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age42-98
SponsorPfizer
About this trial
The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in infants when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®).
This study will test if the new pneumococcal vaccine is as safe as the one that is currently in use. This new vaccine can possibly provide additional protection against germs that cause pneumococcal disease that are not included in the vaccines that are currently given to infants. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae.
There are two groups in this study. All participants will be assigned to one of the two groups. This study is seeking participants who are:
\- infants who are about 2 months of age
About 2400 infants will be assigned by chance to one of the two groups to receive either PG4 (new vaccine) or 20vPnC (currently in use) into the left thigh muscle at 2, 4, 6, and 12 to 15 months of age.
Infants will take part in this study for about 16 to 19 months (about 1 and a half years). During this time, infants will have 6 study clinic visits and 1 phone call. At these study clinic visits, parent(s)/legal guardian(s) will be asked if the infant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Infants who are about 2 months of age
Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Disqualifiers
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 acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
Trial design
Design model
Parallel
Treatments tested in this trial
PG4
Biological/VaccineMultivalent Pneumococcal Vaccine
20-valent pneumococcal conjugate vaccine (20vPnC)
Biological/Vaccine20-valent pneumococcal conjugate vaccine (20vPnC)
Treatment groups
2,400 Participants
are divided into 2 treatment groupsGroup A: 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)Active comparator 1 intervention
Group B: PG4 (intramuscular)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of participants reporting local reactions within 7 days after each dose
Prompted local reactions after each dose
Time frame
Day 72
Percentage of participants reporting systemic events within 7 days after each dose
Prompted systemic events after each dose
Time frame
Day 73
Percentage of participants reporting adverse events (AEs) from Dose 1 to 1 month after Dose 3
AEs occurring from Dose 1 to 1 month after Dose 3
Time frame
Dose 1 to 1 month after Dose 34
Percentage of participants reporting AEs from Dose 4 to 1 month after Dose 4
AEs occurring from Dose 4 to 1 month after Dose 4
Time frame
Dose 4 to 1 month after Dose 4 Source ClinicalTrials.gov