Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection

Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection (Trivalent, Seasonal Influenza Vaccine, Active Ingredient Content: 15 μgHA/Strain/0.5mL) for the Use in the Season 2013/2014 in Adult and Elderly Subjects

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01863849

Enrollment

120

Registered

2013-05-29

Start date

2013-08-22

Completion date

2013-09-17

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza Prophylaxis

Keywords

uncontrolled, open, multi-centre, immunogenicity and tolerability, two groups according to age (18-59 years and ≥60 years)

Brief summary

To assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/0.5mL of seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test.

Detailed description

Aim of the study: To assess immunogenicity and safety of Fluval AB seasonal influenza vaccine with 3 x 15 μgHA active ingredient in two age groups (18-59 years and ≥60 years) in accordance with CPMP/BWP/214/96: Note for Guidance on Harmonization of Requirements for Influenza Vaccines, 12 March 1997 Primary objective: To assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/0.5mL of seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination inhibition test. Methods: In this open label, uncontrolled, multi-centre immunogenicity and tolerability study subjects were enrolled in two groups according to age (18-59 years and ≥60 years) and assigned to the following vaccine group: Group 1: Single injection of Fluval AB suspension for injection. Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local reactions (injection site pain, erythema, swelling, induration and ecchymosis) and systemic reactions (fever, shivering, headache, malaise, fatigue, sweating, nausea, myalgia and arthralgia) started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28). Serum samples for immunogenicity assays were collected immediately before immunization on Visit 1 (Day 0) and on Visit 2 (between Day 21 and Day 28) in all subjects. Immunogenicity was evaluated by HI test.

Interventions

BIOLOGICALVaccination with Fluval AB suspension for injection

Single intramuscular injection with Fluval AB suspension for injection in both age groups

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

parallel-group, in two age groups

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Yes

Inclusion criteria

* Adult persons aged 18 to 59 years, elderly persons aged ≥60 years from both sexes, mentally competent; * Are in good health (as determined by vital signs and existing medical condition) or are in stable medical condition. Subjects will not be excluded with known adequately treated clinically significant organ or systemic diseases (e.g. asthma or diabetes), such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study; * Female volunteers aged 18-59 years (i.e. participants of childbearing potential) with a negative result from the urine pregnancy test prior to vaccination who agrees to use an acceptable contraception method or abstinence throughout the trial and not become pregnant for the duration of the study; * Capability of participants to understand and comply with planned study procedures; * Participants provide written Informed Consent (IC) prior to initiation of study procedures; * Absence of existence of any

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Change in Geometric Mean Titre Ratio, A/H1N1 Strain	21-28 days after vaccination	Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0
Change in Geometric Mean Titre Ratio, A/H3N2 Strain	21-28 days after vaccination	Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0
Change in Geometric Mean Titre Ratio, B Strain	21-28 days after vaccination	Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0
Seroconversion, A/H1N1 Strain	21-28 days after vaccination	Percentage of subjects seroconverted or had a significant increase in titres Requirement (Age group 1): \> 40 % Requirement (Age group 2): \> 30 %
Seroconversion, A/H3N2 Strain	21-28 days after vaccination	Percentage of subjects seroconverted or had a significant increase in titres Requirement (Age group 1): \> 40 % Requirement (Age group 2): \> 30 %
Seroconversion, B Strain	21-28 days after vaccination	Percentage of subjects seroconverted or had a significant increase in titres Requirement (Age group 1): \> 40 % Requirement (Age group 2): \> 30 %
Seroprotection, A/H1N1 Strain	21-28 days after vaccination	Percentage of subjects seroprotected Requirement (Age group 1): \> 70 % Requirement (Age group 2): \> 60 %
Seroprotection, A/H3N2 Strain	21-28 days after vaccination	Percentage of subjects seroprotected Requirement (Age group 1): \> 70 % Requirement (Age group 2): \> 60 %
Seroprotection, B Strain	21-28 days after vaccination	Percentage of subjects seroprotected Requirement (Age group 1): \> 70 % Requirement (Age group 2): \> 60 %

Countries

Hungary

Participant flow

Participants by arm

Arm	Count
Age Group 1: Adults (18-59 Years) Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.	59
Age Group 2: Elderly (>60 Years) Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.	60
Total	119

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	0

Baseline characteristics

Characteristic	Age Group 2: Elderly (>60 Years)	Total	Age Group 1: Adults (18-59 Years)
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	44 Participants	44 Participants	0 Participants
Age, Categorical Between 18 and 65 years	16 Participants	75 Participants	59 Participants
Age, Continuous	69.8 years STANDARD_DEVIATION 6.87	58.1 years STANDARD_DEVIATION 14.6	46.1 years STANDARD_DEVIATION 9.69
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	60 Participants	119 Participants	59 Participants
Region of Enrollment Hungary	60 Participants	119 Participants	59 Participants
Sex: Female, Male Female	31 Participants	68 Participants	37 Participants
Sex: Female, Male Male	29 Participants	51 Participants	22 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 59	0 / 60
other Total, other adverse events	51 / 59	14 / 60
serious Total, serious adverse events	0 / 59	0 / 60

Outcome results

Primary

Change in Geometric Mean Titre Ratio, A/H1N1 Strain

Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0