Trial Outcomes & Findings for Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen (NCT NCT01003288)

Results Overview

Solicited adverse events were collected on side reactions form which were filled in for 21 days after pandemic or seasonal vaccination.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

255 participants

Primary outcome timeframe

21 days after vaccination

Results posted on

2019-11-18

Participant Flow

HCW working at Haukeland University Hospital during the influenza pandemic in 2009

Participant milestones

Participant milestones
Measure	Pandemic Influenza Vaccine (H1N1)v Pandemrix: Vaccination Pandemrix suspension and emulsion for emulsion for injection. 1 dose (0.5 ml) contains Split influenza virus, inactivated, containing antigen 3.75 micrograms of A/California/7/2009 (H1N1)v-like strain (X-179A) \* Pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Overall Study STARTED	255
Overall Study COMPLETED	255
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Health Care Workers n=251 Participants Received one or two doses of pandemic vaccine during 2009 pandemic and susbequent seasonal vaccination was optional	Hypogammaglobulinaemic Patients n=4 Participants Received two doses of pandemic vaccine	Total n=255 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	251 Participants n=99 Participants	4 Participants n=107 Participants	255 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Female	195 Participants n=99 Participants	3 Participants n=107 Participants	198 Participants n=206 Participants
Sex: Female, Male Male	56 Participants n=99 Participants	1 Participants n=107 Participants	57 Participants n=206 Participants
Region of Enrollment Norway	251 participants n=99 Participants	4 participants n=107 Participants	255 participants n=206 Participants

PRIMARY outcome

Timeframe: 21 days after vaccination

Population: solicited adverse event forms were collected from the volunteers

Solicited adverse events were collected on side reactions form which were filled in for 21 days after pandemic or seasonal vaccination.

Outcome measures

Outcome measures
Measure	Pandemic Vaccine n=255 Participants Pandemic Vaccine in HCW
Number of Participants With Local and Systemic Adverse Events	207 participants

SECONDARY outcome

Timeframe: 7, 14, 21 days post vaccination and long term follow up for 5 years

Population: Only HCW 251 were assessed for HI antibodies at 21 days post vaccination

Antibody responses were measured using the HI assay to evaluate the rapidity and long term duration of the response

Outcome measures

Outcome measures
Measure	Pandemic Vaccine n=251 Participants Pandemic Vaccine in HCW
Number of Participants With Immunogenicity as Determined Using Haemagglutination Inhibition Assay	251 participants

Adverse Events

Pandemic Vaccine

Serious events: 0 serious events

Other events: 196 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pandemic Vaccine n=255 participants at risk HCW vaccinated with pandemic vaccine
Infections and infestations pain at injection site	76.9% 196/255 • Number of events 196 • 5 year follow up

Additional Information

Professor Rebecca Cox

University of Bergen

Phone: +4755974668

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place