NCT02885246

Prevalence, Strain Circulation and Disease Burden Study of Seasonal Influenza A and B in Panama, Selected Countries of Central America and the Caribbean From the Year 2010 to 2015

Completed Results posted Last updated 6 April 2020

What this trial tests

trial testing Data collection in Influenza, Human in 1,839 participants. Completed in 17 September 2018.

Timeline

11 September 2017

Primary endpoint
17 September 2018

17 September 2018

Quick facts

Lead sponsor	GlaxoSmithKline
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,839
Start date	11 September 2017
Primary completion	17 September 2018
Estimated completion	17 September 2018
Sites	1 location across Panama

Drugs / interventions tested

• Data collection — full drug profile →

Conditions studied

• Influenza, Human — all drugs for Influenza, Human →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Eligibility, any sex, with Influenza, Human. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Seasonal Influenza A and /or B Cases by Age Group, in Panama (Using the Data Reported Via National Influenza Surveillance Program) Primary · From January 2011 to December 2017

The case definition of Influenza was any clinical specimen confirmed by a positive laboratory test. Cases were stratified by the following age categories: less than (\<) 2 years; 2-4 years; 5-19 years; 20-39 years; 40-59 years; greater than of equal to (≥) 60 years and Unspecified age, instead of \<1, 1-4, 5-9, 10-14, 15-19, 20-24, 25-44, 45-49, 50-59, 60-64 and ≥ 65 years, as initially described in the Protocol. Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.

Influenza A <2 years

Group	Value	95% CI
Influenza Virus Positive Group	448

Influenza B <2 years

Group	Value	95% CI
Influenza Virus Positive Group	120

Influenza A 2-4 years

Group	Value	95% CI
Influenza Virus Positive Group	123

Influenza B 2-4 years

Group	Value	95% CI
Influenza Virus Positive Group	47

Influenza A 5-19 years

Group	Value	95% CI
Influenza Virus Positive Group	170

Influenza B 5-19 years

Group	Value	95% CI
Influenza Virus Positive Group	113

Influenza A 20-39 years

Group	Value	95% CI
Influenza Virus Positive Group	274

Influenza B 20-39 years

Group	Value	95% CI
Influenza Virus Positive Group	39

Number of Seasonal Influenza A Cases by Virus Subtypes, in Panama (Using the Data Reported Via National Influenza Surveillance Program) Among All Influenza Cases A and/or B Primary · From January 2011 to December 2017

The case definition of Influenza was any clinical specimen confirmed by a positive laboratory test. Cases were stratified by virus subtype (H1N1 and H3N2) and the following age categories: less than (\<) 2 years; 2-4 years; 5-19 years; 20-39 years; 40-59 years; greater than of equal to (≥) 60 years. Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.

H1N1 <2 years

Group	Value	95% CI
Influenza Virus Positive Group	259

H3N2 <2 years

Group	Value	95% CI
Influenza Virus Positive Group	189

H1N1 2-4 years

Group	Value	95% CI
Influenza Virus Positive Group	80

H3N2 2-4 years

Group	Value	95% CI
Influenza Virus Positive Group	43

H1N1 5-19 years

Group	Value	95% CI
Influenza Virus Positive Group	119

H3N2 5-19 years

Group	Value	95% CI
Influenza Virus Positive Group	51

H1N1 20-39 years

Group	Value	95% CI
Influenza Virus Positive Group	199

H3N2 20-39 years

Group	Value	95% CI
Influenza Virus Positive Group	75

Number of Seasonal Influenza B Cases by Strain Lineage, in Panama (Using the Data Reported Via National Influenza Surveillance Program) Among All Influenza Cases A and/or B Primary · From January 2011 to December 2017

The case definition of Influenza was any clinical specimen confirmed by a positive laboratory test. Cases were stratified by lineage (Victoria and Yamagata) and the following age categories: less than (\<) 2 years; 2-4 years; 5-19 years; 20-39 years; 40-59 years; greater than of equal to (≥) 60 years. Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.

Victoria < 2 years

Group	Value	95% CI
Influenza Virus Positive Group	90

Yamagata < 2 years

Group	Value	95% CI
Influenza Virus Positive Group	30

Victoria 2-4 years

Group	Value	95% CI
Influenza Virus Positive Group	36

Yamagata 2-4 years

Group	Value	95% CI
Influenza Virus Positive Group	11

Victoria 5-19 years

Group	Value	95% CI
Influenza Virus Positive Group	84

Yamagata 5-19 years

Group	Value	95% CI
Influenza Virus Positive Group	29

Victoria 20-39 years

Group	Value	95% CI
Influenza Virus Positive Group	30

Yamagata 20-39 years

Group	Value	95% CI
Influenza Virus Positive Group	9

Number of Cases With Laboratory Confirmed Diagnosis Seasonal Influenza A and/or B Who Experienced Clinical Features (Clinical Symptoms) Secondary · From January 2011 to December 2017

The signs and symptoms assessed were: Fever, Cough, Sore throat, Rhinorrhea, Dyspnea, Vomiting, Diarrhea, Myalgias, Nausea, Headache, Wheezing, Apnea, Tachypnea, Polypnea, Arthralgia, Chest Pain, Convulsion, Hyporexia, Weakness, Irritability, Odynophagia, Abdominal pain, Conjunctivitis, Cyanosis and Chills. Each sign and symptom was assessed in four categories: yes = presence of sign/symptom; no = absence of sign/symptom; form not filled = no epi surveillance form available; and unspecified= no data on the Epi surveillance form. Analysis related to duration of the illness was not performed as

Fever-Yes (2011)

Group	Value	95% CI
Influenza Virus Positive Group	41

Fever-No (2011)

Group	Value	95% CI
Influenza Virus Positive Group	4

Fever-Form not filled (2011)

Group	Value	95% CI
Influenza Virus Positive Group	0

Fever-Unspecified (2011)

Group	Value	95% CI
Influenza Virus Positive Group	2

Cough-Yes (2011)

Group	Value	95% CI
Influenza Virus Positive Group	40

Cough-No (2011)

Group	Value	95% CI
Influenza Virus Positive Group	4

Cough-Form not filled (2011)

Group	Value	95% CI
Influenza Virus Positive Group	0

Cough-Unspecified (2011)

Group	Value	95% CI
Influenza Virus Positive Group	3

Number of Cases With Laboratory Confirmed Diagnosis Seasonal Influenza A and/or B Who Experienced Outcomes (Complications) Secondary · From January 2011 to December 2017

The outcomes were categorized as follows: Outpatient, Hospitalised, Dead or Unspecified (i.e. missing data on the epidemiology surveillance form). Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.

Outpatient (2011)

Group	Value	95% CI
Influenza Virus Positive Group	37

Hospitalised (2011)

Group	Value	95% CI
Influenza Virus Positive Group	10

Dead (2011)

Group	Value	95% CI
Influenza Virus Positive Group	0

Unspecified (2011)

Group	Value	95% CI
Influenza Virus Positive Group	0

Outpatient (2012)

Group	Value	95% CI
Influenza Virus Positive Group	132

Hospitalised (2012)

Group	Value	95% CI
Influenza Virus Positive Group	79

Dead (2012)

Group	Value	95% CI
Influenza Virus Positive Group	0

Unspecified (2012)

Group	Value	95% CI
Influenza Virus Positive Group	64

Number of Seasonal Influenza A and /or B Cases by Southern Hemisphere, Within Different Seasons From 2011 to 2017 Secondary · Within the Southern hemisphere influenza seasons (May to October of each year 2011-2017)

The cases were stratified by influenza type and Southern hemisphere Influenza seasonal period (May-October of each year 2011-2017). Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.

Influenza A (May-Oct 2011)

Group	Value	95% CI
Influenza Virus Positive Group	41

Influenza B (May-Oct 2011)

Group	Value	95% CI
Influenza Virus Positive Group	0

Influenza A (May-Oct 2012)

Group	Value	95% CI
Influenza Virus Positive Group	93

Influenza B (May-Oct 2012)

Group	Value	95% CI
Influenza Virus Positive Group	172

Influenza A (May-Oct 2013)

Group	Value	95% CI
Influenza Virus Positive Group	177

Influenza B (May-Oct 2013)

Group	Value	95% CI
Influenza Virus Positive Group	0

Influenza A (May-Oct 2014)

Group	Value	95% CI
Influenza Virus Positive Group	50

Influenza B (May-Oct 2014)

Group	Value	95% CI
Influenza Virus Positive Group	54

Number of Seasonal Influenza A and /or B Cases by Region, Within Study Period From 2011 to 2017 Secondary · From January 2011 to December 2017

The cases were stratified by region. Regions were classified as follows: West, Central, Panama, Northeast, Unspecified (= region unknown). Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.

Influenza A (West)

Group	Value	95% CI
Influenza Virus Positive Group	345

Influenza B (West)

Group	Value	95% CI
Influenza Virus Positive Group	82

Influenza A (Central)

Group	Value	95% CI
Influenza Virus Positive Group	244

Influenza B (Central)

Group	Value	95% CI
Influenza Virus Positive Group	64

Influenza A (Panama)

Group	Value	95% CI
Influenza Virus Positive Group	805

Influenza B (Panama)

Group	Value	95% CI
Influenza Virus Positive Group	201

Influenza A (Northeast)

Group	Value	95% CI
Influenza Virus Positive Group	48

Influenza B (Northeast)

Group	Value	95% CI
Influenza Virus Positive Group	12

Number of Influenza Cases Caused by B- Strain and Presented by B-lineage and by Region Among All Influenza Cases A and/or B Secondary · From January 2011 to December 2017

The cases were stratified by lineage (Victoria and Yamagata) and region. Regions were classified as follows: West, Central, Panama, Northeast, Unspecified (= region unknown). Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.

Victoria (West)

Group	Value	95% CI
Influenza Virus Positive Group	61

Yamagata (West)

Group	Value	95% CI
Influenza Virus Positive Group	21

Victoria (Central)

Group	Value	95% CI
Influenza Virus Positive Group	48

Yamagata (Central)

Group	Value	95% CI
Influenza Virus Positive Group	16

Victoria (Panama)

Group	Value	95% CI
Influenza Virus Positive Group	138

Yamagata (Panama)

Group	Value	95% CI
Influenza Virus Positive Group	63

Victoria (Northeast)

Group	Value	95% CI
Influenza Virus Positive Group	5

Yamagata (Northeast)

Group	Value	95% CI
Influenza Virus Positive Group	7

Number of Circulating Influenza B Lineage Positive Specimens Mismatch With the B-strain Vaccine Recommendation, Among the Number of Influenza B Positive Specimens, by Influenza Seasons Secondary · Within the Southern hemisphere influenza seasons (May to October of each year 2011-2017)

Comparison of characteristics of the influenza B-infection Victoria (V) or Yamagata (Y) as observed in the database and the B-strain included in the trivalent influenza vaccine expressed as the number of cases with B-lineage-level mismatch between trivalent seasonal influenza vaccines and circulating viruses observed during the study period. Categories are defined as follows: e.g. for the first category:"V.(B/Brisbane/60/2008)vsVictoria-May-Oct 2011" corresponds to Southern hemisphere influenza season of "May-Oct 2011" with vaccine recommendation: "Victoria (B/Brisbane/60/2008-like virus)" com

V.(B/Brisbane/60/2008)vsVictoria-May-Oct 2012

Group	Value	95% CI
Influenza Virus Positive Group	172

V.(B/Brisbane/60/2008)vsYamagata-May-Oct 2012

Group	Value	95% CI
Influenza Virus Positive Group	0

Y.(B/Massachusetts/2/2012)vsVictoria-May-Oct 2014

Group	Value	95% CI
Influenza Virus Positive Group	0

Y.(B/Massachusetts/2/2012)vsYamagata-May-Oct 2014

Group	Value	95% CI
Influenza Virus Positive Group	54

Sponsor's own description

The purpose of this study is to assess the prevalence, strain circulation and disease burden of seasonal Influenza A and B in Panama, selected countries of Central America and the Caribbean from the Year 2010 to 2015.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.