Trial Outcomes & Findings for Safety and Immunogenicity of a Single Dose of Intranasal Seasonal Trivalent Live-Attenuated Influenza Vaccine (NCT NCT01625689)

NCT ID: NCT01625689

Last Updated: 2015-06-01

Results Overview

PDWI: Participants meeting illness criteria, seeking care in health facility, and with wheeze identified by a study physician Illness criteria: The presence of one Category A (Fever (\>=38°C), tachypnea, danger signs (chest-indrawing, lethargy, cyanosis, inability to drink, convulsions), difficult breathing, noisy breathing, ear pain or discharge) or two Category B findings (Cough, rhinorrhea, sore throat, myalgia/arthralgia, chills, headache, irritability/decreased activity, vomiting) Wheeze: Long high-pitched whistling or musical sound on expiration heard by auscultation

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 309 participants
• Primary outcome timeframe: 6 months following vaccination
• Results posted on: 2015-06-01

Participant Flow

309 participants were consented and enrolled in the study. 9 participants were ineligible to receive study vaccination. 300 total participants were vaccinated and followed through the study period.

Participant milestones

Measure	Serum Institute of India, Ltd. (SIIL) LAIV The Serum Institute of India, Ltd. (SIIL) live attenuated influenza vaccine (LAIV) (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season	Placebo Inactive placebo was identical to SIIL LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
Overall Study STARTED	150	150
Overall Study COMPLETED	148	149
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Serum Institute of India, Ltd. (SIIL) LAIV The Serum Institute of India, Ltd. (SIIL) live attenuated influenza vaccine (LAIV) (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season	Placebo Inactive placebo was identical to SIIL LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
Overall Study Migration	2	1

Baseline Characteristics

Safety and Immunogenicity of a Single Dose of Intranasal Seasonal Trivalent Live-Attenuated Influenza Vaccine

Baseline characteristics by cohort

Measure	SIIL LAIV n=150 Participants The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season	Placebo n=150 Participants Inactive placebo was identical to the SIIL LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.	Total n=300 Participants Total of all reporting groups
Age, Categorical <=18 years	150 Participants n=5 Participants	150 Participants n=7 Participants	300 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	73 Participants n=5 Participants	66 Participants n=7 Participants	139 Participants n=5 Participants
Sex: Female, Male Male	77 Participants n=5 Participants	84 Participants n=7 Participants	161 Participants n=5 Participants
Region of Enrollment Bangladesh	150 participants n=5 Participants	150 participants n=7 Participants	300 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months following vaccination

Population: Safety analysis population

PDWI: Participants meeting illness criteria, seeking care in health facility, and with wheeze identified by a study physician

Illness criteria: The presence of one Category A (Fever (>=38°C), tachypnea, danger signs (chest-indrawing, lethargy, cyanosis, inability to drink, convulsions), difficult breathing, noisy breathing, ear pain or discharge) or two Category B findings (Cough, rhinorrhea, sore throat, myalgia/arthralgia, chills, headache, irritability/decreased activity, vomiting)

Wheeze: Long high-pitched whistling or musical sound on expiration heard by auscultation

Outcome measures

Measure	SIIL LAIV n=150 Participants The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season	Placebo n=150 Participants Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
Number of Participants With Serious Adverse Events (SAEs), All-cause Hospitalizations, and Protocol-defined Wheezing Illness (PDWI) Episodes Serious Adverse Events	6 participants	0 participants
Number of Participants With Serious Adverse Events (SAEs), All-cause Hospitalizations, and Protocol-defined Wheezing Illness (PDWI) Episodes Protocol Defined Wheezing Illness (PDWI)	13 participants	16 participants
Number of Participants With Serious Adverse Events (SAEs), All-cause Hospitalizations, and Protocol-defined Wheezing Illness (PDWI) Episodes Hospitalizations	3 participants	0 participants

PRIMARY outcome

Timeframe: 42 days following vaccination

PDWI: Participants meeting illness criteria, seeking care in health facility, and with wheeze identified by a study physician

Illness criteria: The presence of one Category A (Fever (>=38°C), tachypnea, danger signs (chest-indrawing, lethargy, cyanosis, inability to drink, convulsions), difficult breathing, noisy breathing, ear pain or discharge) or two Category B findings (Cough, rhinorrhea, sore throat, myalgia/arthralgia, chills, headache, irritability/decreased activity, vomiting)

Wheeze: Long high-pitched whistling or musical sound on expiration heard by auscultation

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Throughout study period, through at least 6 months following vaccination

Outcome measures

Measure	SIIL LAIV n=150 Participants The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season	Placebo n=150 Participants Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
Percentage of Participants With Unsolicited Adverse Events (AEs) Boil/abscess/skin infection/ulcer/cyst	7.3 percentage of participants	12.0 percentage of participants
Percentage of Participants With Unsolicited Adverse Events (AEs) Diarrheal Illness	25.3 percentage of participants	21.3 percentage of participants
Percentage of Participants With Unsolicited Adverse Events (AEs) Oral thrush	17.3 percentage of participants	12.0 percentage of participants
Percentage of Participants With Unsolicited Adverse Events (AEs) Helminthiasis	6.0 percentage of participants	7.3 percentage of participants
Percentage of Participants With Unsolicited Adverse Events (AEs) Scabies	5.3 percentage of participants	4.0 percentage of participants
Percentage of Participants With Unsolicited Adverse Events (AEs) Abdominal pain/distension	3.3 percentage of participants	4.0 percentage of participants
Percentage of Participants With Unsolicited Adverse Events (AEs) Allergy	4.0 percentage of participants	4.0 percentage of participants
Percentage of Participants With Unsolicited Adverse Events (AEs) Fungal Infection	4.0 percentage of participants	3.3 percentage of participants
Percentage of Participants With Unsolicited Adverse Events (AEs) Other	36.7 percentage of participants	34.0 percentage of participants

PRIMARY outcome

Timeframe: Through 7 days following vaccination

Population: Safety analysis population

Local reactions: Nasal discomfort, Runny nose, Stuffy nose, Sneezing, Ear pain

Systemic Reactions: Cough, Headache, Loss of Appetite, Fever, Irritability, Nausea, Sore throat, Lethargy

Outcome measures

Measure	SIIL LAIV n=150 Participants The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season	Placebo n=150 Participants Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
Percentage of Participants With Solicited Local and Systemic Reactions Headache	0.7 percentage of participants	0.0 percentage of participants
Percentage of Participants With Solicited Local and Systemic Reactions Irritability/decreased activitity	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Solicited Local and Systemic Reactions Measured fever (>=38.0)	3.3 percentage of participants	3.3 percentage of participants
Percentage of Participants With Solicited Local and Systemic Reactions Ear pain	1.3 percentage of participants	1.3 percentage of participants
Percentage of Participants With Solicited Local and Systemic Reactions Cough	6.7 percentage of participants	5.3 percentage of participants
Percentage of Participants With Solicited Local and Systemic Reactions Runny nose/nasal congestion	20.7 percentage of participants	22.7 percentage of participants
Percentage of Participants With Solicited Local and Systemic Reactions Sore throat	1.3 percentage of participants	0.0 percentage of participants
Percentage of Participants With Solicited Local and Systemic Reactions Vomiting	1.3 percentage of participants	2.0 percentage of participants
Percentage of Participants With Solicited Local and Systemic Reactions Lethargy	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Approximately 21 days post-vaccination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2, 4, and 7 days post-vaccination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months post-vaccination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months post-vaccination

Outcome measures

Outcome data not reported

Adverse Events

SIIL LAIV

Serious events: 6 serious events

Other events: 96 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 94 other events

Deaths: 0 deaths

Serious adverse events

Measure	SIIL LAIV n=150 participants at risk The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season	Placebo n=150 participants at risk Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
Injury, poisoning and procedural complications Traumatic Injury/fracture/overdose	2.7% 4/150 • Number of events 4 • Throughout study period, through at least 6 months post-vaccination.	0.00% 0/150 • Throughout study period, through at least 6 months post-vaccination.
Gastrointestinal disorders abdominal pain/gastroenteritis	1.3% 2/150 • Number of events 2 • Throughout study period, through at least 6 months post-vaccination.	0.00% 0/150 • Throughout study period, through at least 6 months post-vaccination.

Other adverse events

Measure	SIIL LAIV n=150 participants at risk The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season	Placebo n=150 participants at risk Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
Gastrointestinal disorders diarrheal illness	25.3% 38/150 • Throughout study period, through at least 6 months post-vaccination.	21.3% 32/150 • Throughout study period, through at least 6 months post-vaccination.
Infections and infestations Oral thrush	17.3% 26/150 • Throughout study period, through at least 6 months post-vaccination.	12.0% 18/150 • Throughout study period, through at least 6 months post-vaccination.
Infections and infestations Boil/Abscess/skin infection/ulcer/cyst	7.3% 11/150 • Throughout study period, through at least 6 months post-vaccination.	12.0% 18/150 • Throughout study period, through at least 6 months post-vaccination.
Infections and infestations Helminthiasis	6.0% 9/150 • Throughout study period, through at least 6 months post-vaccination.	4.7% 7/150 • Throughout study period, through at least 6 months post-vaccination.
Infections and infestations Scabies	5.3% 8/150 • Throughout study period, through at least 6 months post-vaccination.	4.0% 6/150 • Throughout study period, through at least 6 months post-vaccination.
Gastrointestinal disorders Abdominal pain/distension	3.3% 5/150 • Throughout study period, through at least 6 months post-vaccination.	4.0% 6/150 • Throughout study period, through at least 6 months post-vaccination.
General disorders Allergy	4.0% 6/150 • Throughout study period, through at least 6 months post-vaccination.	4.0% 6/150 • Throughout study period, through at least 6 months post-vaccination.
Infections and infestations Fungal Infection	4.0% 6/150 • Throughout study period, through at least 6 months post-vaccination.	3.3% 5/150 • Throughout study period, through at least 6 months post-vaccination.
Infections and infestations Other	36.7% 55/150 • Throughout study period, through at least 6 months post-vaccination.	34.0% 51/150 • Throughout study period, through at least 6 months post-vaccination.

Additional Information

Senior Clinical Research Scientist

PATH

Phone: 206-285-3500

Email: klewis@path.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60