Prediction
Okay, so I need to help modify the clinical trial's inclusion and exclusion criteria based on the supporting evidence provided.
Let me start by understanding what the original criteria are and what the evidence is saying.
The original inclusion criteria are:
1.
Aged 6 to <36 months on the day of first study vaccination.
2.
Born at full term ≥37 weeks or with a birth weight ≥2.5 kg.
3.
Informed consent from the parent(s) or guardian(s).
4.
Ability to attend all scheduled visits and comply with all trial procedures.
The original exclusion criteria are:
1.
Participation at the time of study enrollment or planned participation in another clinical trial involving a vaccine, drug, medical device, or medical procedure within 30 days.
2.
Receipt of any vaccine in the 30 days before first trial vaccination or within 3 months for subjects <12 months.
3.
Previous vaccination against influenza (in the 2016-2017 season) with any vaccine.
4.
Known or suspected congenital or acquired immunodeficiency.
5.
Receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the past 6 months.
6.
Development of immunogenicity, such as allergic reactions or an allergic reaction to a vaccine.
7.
Severe acute illness, fever ≥100.4°F (40.4°C) on the day of planned vaccination or within 7 days.
8.
Seizure or developmental delay.
9.
Congenital or acquired immunodeficiency.
10.
History of serious ARs to any influenza vaccine.
11.
Personal history of Guillain-Barré Syndrome.
12.
Known seropositivity for HIV, hepatitis B, or hepatitis C.
Now, looking at the supporting evidence, the key points are from the Sanofi Pasteur protocol version 2.0, which includes information about safety, immunogenicity, and adverse events.
The protocol mentions that the study is transitioning from version 0 to 1, so the criteria might be updated to reflect the latest version.
One important point from the evidence is that the inclusion criteria now specify that subjects must be 6 to <12 months of age on the day of the first study vaccination.
This is a change from the original 6 to <36 months.
So, I should adjust the first inclusion criterion accordingly.
Another point is about the adverse events.
The protocol mentions that there are no primary objectives for safety, but there are secondary objectives related to immunogenicity.
It also lists adverse events of special interest, including new onset of GBS, encephalitis/myelitis, etc.
However, since these are adverse events, they might not directly change the inclusion or exclusion criteria but could affect how safety is managed.
Looking at the exclusion criteria, the original mentions previous vaccination against influenza in the 2016-2017 season.
The evidence doesn't mention any changes to this, so that exclusion criterion remains.
However, the protocol does mention that the study is transitioning, so I should check if there are any other changes.
The supporting evidence doesn't indicate any changes to other inclusion or exclusion criteria beyond the age range in the first point.
Therefore, the modified inclusion criteria should have the age restricted to 6 to <12 months, while the rest of the criteria remain the same.
The exclusion criteria don't need to be changed based on the provided evidence.
I should also ensure that the language is clear and precise, avoiding any potential ambiguities.
For example, in the original inclusion criteria, the age is specified as 6 to <36 months, but the evidence suggests it should be 6 to <12 months.
So, I'll update that part.
Additionally, I should make sure that the criteria are presented in a structured and readable format, possibly using bullet points for clarity, but since the user requested the text without additional explanation, I'll just provide the modified text.
I should also check if there are any other implicit changes, such as the definition of "onset" for fever or the handling of temperatures, but since the user provided specific supporting evidence, I'll focus on that.
In summary, the key modification is changing the age range in the inclusion criteria from 6 to <36 months to 6 to <12 months.
All other criteria remain unchanged.
</think>
**Modified Inclusion Criteria:**
1.
**Age:** Subjects must be 6 to <12 months of age on the day of the first study vaccination.
2.
**Birth:** Subjects must be born at full term ≥37 weeks or have a birth weight ≥2.5 kg.
3.
**Consent:** Informed consent from the parent(s) or guardian(s) must be obtained.
4.
**Attendance:** Subjects must be able to attend all scheduled visits and comply with all trial procedures.
**Inclusion Criteria Remain Unchanged:**
- The criteria regarding the history of serious ARs, immunogenicity, and other health conditions remain the same as in the original criteria.
This modification ensures that the study adheres to the updated protocol version, focusing on the age range specified in the supporting evidence.