Group 2 :

1. Ray Hannif Fadillah (170103072)

2. Suratih Nusantara (170103088)

EFN 8A-B

STUDENT 1

1. Title  find the research variable by title: the independent variable and the dependent
variable
2. Author information
a. How many writers are working on?
b. And who are they?
c. Where do writers work?
d. Are they health practitioners?
3. Introduction  formulate the problem and research objectives

ANSWER :
1. Research Variable
a. independent variablea post-licensing evaluation of the safety of the Ann
arbor influenza vaccine
b. dependent variablechildren aged 24-59 months
2. Author information
a. There are 8 writers who work on it
b. Seth L. Toback, Christopher S. Ambrose, Abigail Eaton, John Hansen, Laurie
Aukes, Ned Lewis, Xionghua Wu, Roger Baxter.
c. A postmarketing
d. Are they health practitionersYes
3. Formulation of the problem
in the United States, the directly attenuated influenza vaccine (LAIV) was
initially approved for use in individuals aged 5-49 years in 2003, being expanded to
 individuals aged 2-49 years. it was 2007 that time a post-licensing commitment was
made to clarify the safety of LAIV in the eligible cohort of 2-5 year olds.
Based on this background, the problem formulation in this study is "how is the
post-licensing evaluation of the safety of the Annab influenza vaccine?”
a. general purpose
investigated a post-licensing evaluation of the safety of Ann abor influenza vaccine in
children 24-59 months of age.
b. special purpose
- describe the effect of the Ann abor influenza vaccine in children aged 24-59 months
- describe the effectiveness of the influenza vaccine strain Ann abor in children aged
24-59 months
- know the post-licensing evaluation of the safety of the Ann abor influenza vaccine

STUDENT 2

1. Methods: Summarize the methodology section that covers those elements above.
2. Results : Summarize the result of the study

ANSWER :
1. Methods
A prospective observational postmarketing study was conducted to evaluate the safety of
LAIV. Rates of medically attended events (MAEs) and serious adverse events (SAEs) in
eligible children aged 24–59 months receiving LAIV as part of routine care from October
2007 to March 2010 were compared with rates in a within-cohort self-control, as well as
matched unvaccinated and matched trivalent inactivated influenza vaccine (TIV)-
vaccinated controls. Children with asthma and other high-risk medical conditions before
vaccination were excluded. All MAEs and SAEs through 42 days postvaccination and all
hospitalizations and deaths through 6 months postvaccination were analyzed. Statistical
significance
2. Result

Atotal of 28,226 unique subjects 24–59 months of age, including 8126 subjects 24–35
months, were vaccinated with 33,443 doses of LAIV during 3 study seasons; 27,937 unique
TIV recipients, and 25,981 unique unvaccinated subjects were used as matched controls.

1. Serious adverse events through 42 days postvaccination and deaths

No deaths occurred among LAIV-vaccinated children. Thirty SAEs within 42 days
postvaccination were reported in 29 subjects, and occurred at an incidence rate of 0.91,
1.14, and 0.62 per 1000 person-months in LAIV recipients, TIV recipients, and those
unvaccinated, respectively. All SAEs were diagnosed in the hospital setting. Primary
diagnoses occurring more than once included trauma (n = 4), pneumonia (n = 4),
dehydration (n = 3), congenital anomaly (n = 2), and urinary tract infection (n = 2).Of the
SAEs occurring within 42 days postvaccination, only 2 events were considered possibly
related to LAIV. A 4-year-old boy developed fever 3 days postvaccination; a chest
radiograph revealed right middle lobe infiltrate concomitant with positive testfor
respiratory syncytial virus (RSV). The subject recovered in full. A 31-month-old boy
developed abdominal pain the same day after vaccination and was evaluated in the ED the
following day. The subject was hospitalized and diagnosed with intussusception and viral
infection; surgical reduction ofintussusception without bowel resection was performed. The
subject recovered completely.
2. Hospitalizations through 180 days postvaccination

Most common first diagnoses included trauma (n = 15), pneumonia (n = 10),

dehydration (n = 7), epilepsy (n = 4), and urinary tract infection (n = 4). Events in the
hospital setting that were significantly increased in LAIV recipients versus unvaccinated
included sleep apnea (n = 5), tonsillitis (n = 5), and any event (n = 21), all within 21 days
postvaccination.The rate of any hospitalization within 180 days postvaccination was
significantly decreased after vaccination withLAIVin3 comparisons; 1
versusunvaccinatedcontrols in the 24- to 35-month cohort and 2 versus TIV recipients for
all ages and for the 24- to 35-month cohort. For rare diagnoses potentially related to WTI,
2 hospitalizations occurred in 1 subject within 180 days postvaccination; the subject was
 admitted on 2 occasions 41 and 44 days after LAIV vaccination for a diagnosis of
transverse myelitis; neither hospitalization was judged to be related to vaccination.

3. All medically attended events

Urticaria (n = 30) occurred in LAIV recipients 36–59 months of age in the clinic
setting through 21 days postvaccination compared with 18 and 13 events in TIV-
vaccinated and unvaccinated controls, respectively; in the within-cohort analysis, 11
events occurred during the reference period of 22–42 days. Urticaria events did not cluster
within the 21-day period. Within 3 days of LAIV vaccination there were 3 cases of
urticaria, all in the clinic setting; the rate was not significantly increased or decreased in
LAIV recipients relative to control groups. No anaphylaxis events occurred within 3 days
postvaccination in LAIV recipients or any control group. One MAE was significantly
decreased among LAIV recipients in the same age group and setting across all comparison
groups: asthma/RAD within 21 days postvaccination in all subjects and in subjects 36–59
months of age in the clinic setting.

Asthma/RAD and the category of “any AW event” were decreased among LAIV
recipients in subjects 36–59 and 24–59 months of age within 21 days postvaccination
compared with all 3 control groups. Influenza was increased after LAIV in 2 comparisons
each versus unvaccinated and TIV controls within 42 days postvaccination, and decreased
after vaccination with LAIV in the within-cohort analysis in 2 comparisons. Of 193
influenza events among LAIV recipients during the study period, 191 (99%) occurred
during the 2009–2010 H1N1 influenza pandemic season. During this season, 2009
pandemic H1N1 vaccine was received by 34%, 62%, and 6% of LAIV recipients, TIV-
vaccinated, and unvaccinated controls, respectively.

After the post hoc adjustment for multiple comparisons, 81 of 304 incidence rate
comparisons remained statistically significant; 2 and 79 comparisons occurred at higher
and lower rates, respectively, after vaccination with LAIV (Table 3). Wheezing/SOB
occurred at increased rates after vaccination with LAIV in 2 comparisons versus
unvaccinated controls in those 36–59 months and 24–59 months of age within 180 days
 postvaccination; AW events occurred at lower rates after LAIV compared with
TIVvaccinated and unvaccinated controls in 42 comparisons.

STUDENT 3

1. Do vaccines affect children's health according to this study?

2. Did you find any weaknesses in this research?
3. Would you give your child this vaccine based on this safety study? state your reason?
4. What about the population of children in this study, is it big enough?

ANSWER :

1. The administration of this vaccine affects the health of children because the results
of this study show that there is no significant increase that affects health or adverse
events and health.The results of this post-licensing LAIV safety evaluation in US
children are consistent with the pre-approval clinical studies and the Vaccine
Adverse Event Reporting System report, both of which showed no significant
increase in the incidence of asthma / wheezing or other adverse outcomes among
children who had an adverse event. meet the age requirements of 24 years. –59
months receiving LAIV. So it is possible that the vaccine can be used for children.

2. The weakness in this study is the lack of formal hypothesis testing, no correction
made for multiple comparisons in the primary analysis. Among a large number
comparison, one would expect many statistically significant results just a
coincidence. Differences in the non-randomized comparison groups were fixed
though matches most likely contributed to events that occurred at a higher level
after vaccination with LAIV compared with unvaccinated controls, as well as events
which occurred to a lesser extent after LAIV compared to control vaccinated against
TIV. Recalling warnings against using LAIV in individuals with the condition
medical backenough, it is likely that controls who were vaccinated against TIV had
poor health status worse than those of LAIV recipients, even after the exclusion of
individuals with underlying medical condition that can be identified. It seems that
too, despitematching, there is a fundamental difference between LAIV recipients
 and unvaccinated controls, with unvaccinated controls being less likely to access
health care as a whole. These patterns have been observed before [1,12]. Remember
underlying bias for comparison with TIV-vaccinated and non-TIV-vaccinated
controls vaccinated, the most valuable comparison seemed to be the in-cohort
analysis, because it was controlled for many uncontrolled covariates between
different groups. Only 7 out of 83statistically significant events that increased after
LAIV were found in the cohort analysis, and no comparisons in the cohort analysis
increased after LAIV remained significant statistically after post hoc adjustment for
multiple comparisons. Twelve comparisons in the cohort analysis remained
statistically significant after adjustment and all indicates decreased rates of otitis
media, upper respiratory tract infections, or incidence Any ART after vaccination
with LAIV.

3. Yes, because the results of the study show there is no significant increase in the
incidence of asthma, it means that the vaccine can inhibit asthma in children, but
there are many side effects that occur if the child is given the vaccine even though in
the study there were no deaths in children who were vaccinated but there were Other
side effects include trauma, pneumonia, dehydration, congenital abnormalities and
urinary tract infections. Maybe if the side effects that are produced are few and are
not at risk it will be safer if given to children.

4. large enough because researchers took a population of approximately 25,000

children aged 24--59 months who were immunized with LAIV as part of the
Routine clinical practice is identified via the KP immunization register. Research
subjects with medical conditions underlying high risks such as cancer, organ
transplant, diabetes, blood disorders, disorders kidney, and cardiopulmonary
disorders (which LAIV is not recommended) were identified through a database
health care and were excluded from all cohort analyzes