Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524414
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Randomized Double-Blind Trial to Evaluate the Safety Tolerability and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 in infants when compared to the pneumococcal vaccine that is currently in use 20vPnC Prevnar 20
To ensure that the new vaccine PG4 stays stable it is placed in a liquid mixture of sterile water and other substances a solution This study will also test if there is a difference in the safety and immune effects of the new pneumococcal vaccine when it is one type of solution compared to when it is in a different type of solution
The immune response is how the bodys cells tissues and organs work together to protect the body from infection Blood samples will be used to measure the amount of antibodies produced after the vaccination Antibodies are proteins that protect you when an unwanted germ enters the body This will help understand how well the new pneumococcal vaccine works This vaccine can possibly provide protection against pneumococcal disease Pneumococcal disease includes a variety of infections caused by a specific germ Streptococcus pneumoniae
This study is seeking participants who are
male or female infants who are 2 months of age
infants born at 36 weeks about 8 and a half months of pregnancy or later and
said to be healthy by the study doctor
There are three groups in this study All participants will be assigned to one of the three groups All study vaccines will be given as a single shot into the left thigh muscle Participants in the three groups will have 3 blood samples collected during the 1 and a half years they are in the study
The first 400 people who enter the study will be assigned to either Group 1 or Group 2 Half the participants in Group 1 and half the participants in Group 2 will receive 4 doses at 2 4 6 and 12 to 15 months of age of PG4 mixed in the first solution The other half of the participants in Groups 1 and 2 will receive 4 doses of 20vPnC Prevnar 20 at 2 4 6 and 12 to 15 months of age The main difference between Groups 1 and 2 is that participants in Group 2 will have the first blood sample collected at an earlier time than those in Group 1
Once 400 people have been assigned to Groups 1 and 2 then 100 new participants will be assigned to Group 3 Half the participants in Group 3 will receive PG4 in the second solution at 2 4 6 and 12 to 15 months of age The other half of the participants in Groups 3 will receive 4 doses of 20vPnC Prevnar 20 at 2 4 6 and 12 to 15 months of age
Participants will take part in this study for about 16 to 19 months about 1 and a half years During this time participants will have 6 study clinic visits and 1 to 2 phone calls At these study clinic visits parents or legal guardians will be asked if the participant experienced any side effects A side effect is an unintentional or unexpected reaction to a vaccine
To ensure that the new vaccine PG4 stays stable it is placed in a liquid mixture of sterile water and other substances a solution This study will also test if there is a difference in the safety and immune effects of the new pneumococcal vaccine when it is one type of solution compared to when it is in a different type of solution
The immune response is how the bodys cells tissues and organs work together to protect the body from infection Blood samples will be used to measure the amount of antibodies produced after the vaccination Antibodies are proteins that protect you when an unwanted germ enters the body This will help understand how well the new pneumococcal vaccine works This vaccine can possibly provide protection against pneumococcal disease Pneumococcal disease includes a variety of infections caused by a specific germ Streptococcus pneumoniae
This study is seeking participants who are
male or female infants who are 2 months of age
infants born at 36 weeks about 8 and a half months of pregnancy or later and
said to be healthy by the study doctor
There are three groups in this study All participants will be assigned to one of the three groups All study vaccines will be given as a single shot into the left thigh muscle Participants in the three groups will have 3 blood samples collected during the 1 and a half years they are in the study
The first 400 people who enter the study will be assigned to either Group 1 or Group 2 Half the participants in Group 1 and half the participants in Group 2 will receive 4 doses at 2 4 6 and 12 to 15 months of age of PG4 mixed in the first solution The other half of the participants in Groups 1 and 2 will receive 4 doses of 20vPnC Prevnar 20 at 2 4 6 and 12 to 15 months of age The main difference between Groups 1 and 2 is that participants in Group 2 will have the first blood sample collected at an earlier time than those in Group 1
Once 400 people have been assigned to Groups 1 and 2 then 100 new participants will be assigned to Group 3 Half the participants in Group 3 will receive PG4 in the second solution at 2 4 6 and 12 to 15 months of age The other half of the participants in Groups 3 will receive 4 doses of 20vPnC Prevnar 20 at 2 4 6 and 12 to 15 months of age
Participants will take part in this study for about 16 to 19 months about 1 and a half years During this time participants will have 6 study clinic visits and 1 to 2 phone calls At these study clinic visits parents or legal guardians will be asked if the participant experienced any side effects A side effect is an unintentional or unexpected reaction to a vaccine
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None