Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection for Children and Adolescents

Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection (Trivalent, Seasonal Influenza Vaccine, Active Ingredient Content: 6 μg HA/Strain/0.5 ml) for Children and Adolescents

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02387294

Enrollment

120

Registered

2015-03-13

Start date

2014-10-31

Completion date

2014-12-31

Last updated

2021-03-11

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

Conditions

Human Influenza

Keywords

immunogenicity, reduced dose, Phase III, tolerability, safety

Brief summary

Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection (trivalent, seasonal influenza vaccine, active ingredient content: 6 μg HA/strain/0.5 ml) for Children and Adolescents.

Detailed description

STUDY PERIOD: Length of enrollment: 2 weeks (estimated) Participation per subject: max. 1 month OBJECTIVES: Immunogenicity Objectives: To assess immunogenicity of a single intramuscular injection of Fluval AB Novo suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 6 μg HA/0.5 ml of seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test. Safety and Tolerability Objectives: To evaluate safety and tolerability (incidence of adverse events) of a single intramuscular injection of Fluval AB Novo suspension for injection. CLINICAL PHASE: Phase III TYPE: Interventional, prevention DESIGN: Non-controlled, open, multi-centre METHODS: In this uncontrolled, open, multi-centre immunogenicity and tolerability study subjects were enrolled into two groups according to age: Age group 1: children (3-11 years): single intramuscular injection of Fluval AB Novo 0.25 ml suspension for injection; Age group 2: adolescents (12-18 years): single intramuscular injection of Fluval AB Novo 0.5 ml suspension for injection; Subjects were observed for 30 minutes after the injection for any immediate reactions. All adolescent subjects aged 12 to 18 years and the legitimate representatives of all volunteers were requested to complete a Diary Card (DC) to record local reactions (injection site pain, erythema, swelling, induration, numbness, sensitivity and haematoma) and systemic reactions (fever, shivering, headache, malaise, fatigue, sweating, nausea, myalgia, arthralgia, dizziness and urticaria) starting on the day of vaccination on Visit 1 (Day 0) until 7 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 were evaluated by HI test. INVESTIGATIONAL MEDICINAL PRODUCT: Fluval AB Novo suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 6 μg HA/0.5 ml of seasonal A/H1N1, A/H3N2 and B influenza antigens each) with aluminium phosphate gel adjuvant. Lot No.: FL-N-05/13 CONCOMITANT VACCINES: No concomitant vaccination is permitted for the duration of the study except for post-exposure vaccination in a medical emergency (e.g. tetanus, rabies, hepatitis). STUDY POPULATION: Considering approximately 17% of drop-out (one participant out of six), in total 120 subjects (60 subjects in each age group) were enrolled in order to achieve at least 100 evaluable subjects (50 subjects in each age group).

Interventions

BIOLOGICALVaccination with Fluval AB Novo suspension for injection, half dose of a single intramuscular dose (0.25 ml)

vaccination

BIOLOGICALVaccination with Fluval AB Novo suspension for injection, single intramuscular dose (0.5 ml)

vaccination

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

parallel-group study in two paediatric age groups

Eligibility

Sex/Gender

ALL

Age

3 Years to 18 Years

Healthy volunteers

Yes

Inclusion criteria

* Children aged 3 to 11 years, adolescents aged 12 to 18 years from both sexes; * 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 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 adolescent participants aged 12 to 18 years and the legitimate representative of all volunteers to understand and comply with planned study procedures; * Adolescent participants aged 12 to 18 years and the legitimate representative of all volunteers 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
Increase 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: \> 2.5
Increase 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: \> 2.5
Increase in Geometric Mean Titre Ratio, B Strain	21-28 days after vaccination	Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement: \> 2.5
Seroconversion, A/H1N1 Strain	21-28 days after vaccination	Proportion of subjects seroconverted or had a significant increase in titres Requirement: \> 40 %
Seroconversion, A/H3N2 Strain	21-28 days after vaccination	Proportion of subjects seroconverted or had a significant increase in titres Requirement: \> 40 %
Seroconversion, B Strain	21-28 days after vaccination	Proportion of subjects seroconverted or had a significant increase in titres Requirement: \> 40 %
Seroprotection, A/H1N1 Strain	21-28 days after vaccination	Proportion of subjects seroprotected Requirement: \> 70 %
Seroprotection, A/H3N2 Strain	21-28 days after vaccination	Proportion of subjects seroprotected Requirement: \> 70 %
Seroprotection, B Strain	21-28 days after vaccination	Proportion of subjects seroprotected Requirement: \> 70 %

Participant flow

Participants by arm

Arm	Count
Age Group 1: Children (3-11 Years) Intervention: Vaccination with Fluval AB Novo suspension for injection. Dosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.	60
Age Group 2: Adolescents (12-18 Years) Intervention: Vaccination with Fluval AB Novo suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.	60
Total	120

Baseline characteristics

Characteristic	Age Group 2: Adolescents (12-18 Years)	Age Group 1: Children (3-11 Years)	Total
Age, Categorical <=18 years	60 Participants	60 Participants	120 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Age, Continuous	14.38 years STANDARD_DEVIATION 1.54	7.93 years STANDARD_DEVIATION 2.65	11.16 years STANDARD_DEVIATION 3.89
Region of Enrollment Hungary	60 Participants	60 Participants	120 Participants
Sex: Female, Male Female	30 Participants	23 Participants	53 Participants
Sex: Female, Male Male	30 Participants	37 Participants	67 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 60	0 / 60
other Total, other adverse events	59 / 60	56 / 60
serious Total, serious adverse events	0 / 60	0 / 60