Immunogenicity and Lot-to-Lot Consistency Study of a Quadrivalent Influenza Vaccine in Adult and Elderly Subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000785-21-DE

Enrollment

2224

Registered

2014-05-20

Start date

2014-07-24

Completion date

Unknown

Last updated

2016-04-25

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

Conditions

Prevention of influenza infection in adults from 18 years of age MedDRA version: 17.0 Level: LLT Classification code 10022001 Term: Influenza (epidemic) System Organ Class: 100000004862

Interventions

Product Code: 481 Pharmaceutical Form: Suspension for injection in pre-filled syringe INN or Proposed INN: Influenza virus (split virion, inactivated) A/H1N1-like strain Other descriptive name: INFLUE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Individuals aged over 18 years old on the day of inclusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1112 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1112

Exclusion criteria

Exclusion criteria: • Receipt of any vaccine in the 4 weeks preceding trial vaccination or planned receipt of any vaccine in the 3 weeks following trial vaccination • Previous vaccination against influenza with the 2014 Southern Hemisphere formulation or the 2014-2015 Northern Hemisphere vaccine with either the trial vaccine or another vaccine in the previous 6 months • Subject is pregnant, or lactating, or of childbearing potential

Design outcomes

Primary

Measure	Time frame
Main Objective: • Immunogenicity: Lot Consistency To demonstrate equivalence of immune response induced by the 3 different industrial lots of Quadrivalent Influenza Vaccine (QIV) for each strain • Immunogenicity: Non-inferiority To demonstrate the non-inferiority of immune response induced by QIV compared with Trivalent Influenza Vaccine (TIV) for each strain;Secondary Objective: Immunogenicity: • To confirm the superiority of immune response to each B strain in QIV compared with the TIV that does not contain the corresponding B strain. • To describe the immune response of QIV Safety: • To describe the safety profile of QIV and TIV;Primary end point(s): Hemagglutinin (HA) antibody titers for the strains contained in the vaccine of the considered group, 21 days after vaccination. Geometric mean of titers (GMTs) will be used as the primary parameter;Timepoint(s) of evaluation of this end point: 21 days after vaccination	—

Measure

Time frame

Main Objective: • Immunogenicity: Lot Consistency To demonstrate equivalence of immune response induced by the 3 different industrial lots of Quadrivalent Influenza Vaccine (QIV) for each strain • Immunogenicity: Non-inferiority To demonstrate the non-inferiority of immune response induced by QIV compared with Trivalent Influenza Vaccine (TIV) for each strain;Secondary Objective: Immunogenicity: • To confirm the superiority of immune response to each B strain in QIV compared with the TIV that does not contain the corresponding B strain. • To describe the immune response of QIV Safety: • To describe the safety profile of QIV and TIV;Primary end point(s): Hemagglutinin (HA) antibody titers for the strains contained in the vaccine of the considered group, 21 days after vaccination. Geometric mean of titers (GMTs) will be used as the primary parameter;Timepoint(s) of evaluation of this end point: 21 days after vaccination

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Secondary

Measure	Time frame
Secondary end point(s): • Immunogenicity: Immune responses in all groups for each influenza strain (HAI) on D0 and D21 Comparison of immune response at Day 21 between QIV and TIV (common strains and B strains not in TIV) • Safety: Adverse Event (AE) and Serious Adverse Events (SAEs) throughout the study;Timepoint(s) of evaluation of this end point: • Immunogenicity: 0 and 21 days after vaccination • Safety: - unsolicited systemic AEs in the 30 min after injection - solicited Adverse Reactions (ARs) within 7days following injection - unsolicited AEs within 21days following injection - EMA criteria: in the 3 days following injection	—

Measure

Time frame

Secondary end point(s): • Immunogenicity: Immune responses in all groups for each influenza strain (HAI) on D0 and D21 Comparison of immune response at Day 21 between QIV and TIV (common strains and B strains not in TIV) • Safety: Adverse Event (AE) and Serious Adverse Events (SAEs) throughout the study;Timepoint(s) of evaluation of this end point: • Immunogenicity: 0 and 21 days after vaccination • Safety: - unsolicited systemic AEs in the 30 min after injection - solicited Adverse Reactions (ARs) within 7days following injection - unsolicited AEs within 21days following injection - EMA criteria: in the 3 days following injection

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Countries

Belgium, Germany

Contacts

Public ContactDirector, Clinical Development

Sanofi Pasteur

stephanie.pepin@sanofipasteur.com+33(0)437375850

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026