Efficacy and Immunogenicity Study of Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Healthy Children Aged 6 to 35 Months

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001231-51-IT

Enrollment

9000

Registered

2014-03-13

Start date

2014-05-20

Completion date

Unknown

Last updated

2017-01-31

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 children aged 6 to 35 months MedDRA version: 16.1 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: Healthy children aged 6 to less than 36 months not previously vaccinated against influenza. Are the trial subjects under 18? yes Number of subjects for this age range: 9000 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: “At risk” children according to the definition from the Advisory Committee on Immunization Practices (ACIP).

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the efficacy of QIV as compared to non-influenza vaccine;Secondary Objective: Efficacy Immunogenicity (immunogenicity subset): • To demonstrate the non-inferiority of immune response induced by QIV compared with TIV • To demonstrate the superiority of immune response (HAI) to each B strain in QIV compared with the TIV that does not contain the corresponding B strain. • To assess immune response of a booster dose of QIV one year after 2 doses of QIV • To describe the immune response (by HAI, SN method and ELLA method). Safety: • To describe the safety profile of QIV compared to TIV. Correlates of Protection: • To assess potential immunologic correlates of protection.;Primary end point(s): Incidence of laboratory confirmed influenza (at least 14 days after last vaccination) caused by any influenza viral types/subtypes, in association with a protocol-defined Influenza Like Illness (ILI) with QIV as compared to non-influenza vaccine;Timepoint(s) of evaluation of this end point: = 14 days after last vaccination	—

Measure

Time frame

Main Objective: To demonstrate the efficacy of QIV as compared to non-influenza vaccine;Secondary Objective: Efficacy Immunogenicity (immunogenicity subset): • To demonstrate the non-inferiority of immune response induced by QIV compared with TIV • To demonstrate the superiority of immune response (HAI) to each B strain in QIV compared with the TIV that does not contain the corresponding B strain. • To assess immune response of a booster dose of QIV one year after 2 doses of QIV • To describe the immune response (by HAI, SN method and ELLA method). Safety: • To describe the safety profile of QIV compared to TIV. Correlates of Protection: • To assess potential immunologic correlates of protection.;Primary end point(s): Incidence of laboratory confirmed influenza (at least 14 days after last vaccination) caused by any influenza viral types/subtypes, in association with a protocol-defined Influenza Like Illness (ILI) with QIV as compared to non-influenza vaccine;Timepoint(s) of evaluation of this end point: = 14 days after last vaccination

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Secondary

Measure	Time frame
Secondary end point(s): Efficacy: Incidence of laboratory-confirmed influenza illness due to any of the 4 vaccine strains, in association with a protocol-defined ILI with QIV group as compared to non-influenza vaccine group. Immunogenicity: Immune responses in all groups for each influenza strain (HAI, SN, anti-NA) on D0 and D56 (all patients for HAI, subset of patients (at least 80 per group for SN and at least 50 per group for anti-NA) Comparison of immune response at Day 56 between QIV and TIV (common strains and B strains not in TIV) Immune response after booster administration Safety: AE and SAEs throughout the study Correlates of Protection: exploration of immune responses in relation to occurrences of laboratory confirmed influenza, 28 days after the last vaccination. ;Timepoint(s) of evaluation of this end point: Efficacy: = 14 days after last vaccination Immunogenicity: 0 and 28 days after last vaccination (D56) Safety: - unsolicited AEs in the 30 min after each/any injection - solicited ARs within 7days following each/any injection - unsolicited AEs within 28days following each/any injection - EMA criteria: in the 3 days following each/any injection	—

Measure

Time frame

Secondary end point(s): Efficacy: Incidence of laboratory-confirmed influenza illness due to any of the 4 vaccine strains, in association with a protocol-defined ILI with QIV group as compared to non-influenza vaccine group. Immunogenicity: Immune responses in all groups for each influenza strain (HAI, SN, anti-NA) on D0 and D56 (all patients for HAI, subset of patients (at least 80 per group for SN and at least 50 per group for anti-NA) Comparison of immune response at Day 56 between QIV and TIV (common strains and B strains not in TIV) Immune response after booster administration Safety: AE and SAEs throughout the study Correlates of Protection: exploration of immune responses in relation to occurrences of laboratory confirmed influenza, 28 days after the last vaccination. ;Timepoint(s) of evaluation of this end point: Efficacy: = 14 days after last vaccination Immunogenicity: 0 and 28 days after last vaccination (D56) Safety: - unsolicited AEs in the 30 min after each/any injection - solicited ARs within 7days following each/any injection - unsolicited AEs within 28days following each/any injection - EMA criteria: in the 3 days following each/any injection

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Countries

Dominican Republic, France, Germany, Greece, Honduras, Italy, Philippines, Romania, South Africa, Spain, Turkey

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