Safety and Immunogenicity of the Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Children Aged 3 to 8 Years

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005374-33-FI

Enrollment

1225

Registered

2013-04-25

Start date

2013-06-06

Completion date

Unknown

Last updated

2014-08-28

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

Conditions

Prophylaxis of influenza in children aged 3 to 8 years MedDRA version: 14.1 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: Children aged 3 to less than 9 years on the day of inclusion. Are the trial subjects under 18? yes Number of subjects for this age range: 1225 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: Previous vaccination against influenza with the current seasonal vaccine formulation (as recommended by WHO), with either the trial vaccine or another vaccine.

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): For superiority testing: GMs of anti-HA Ab titers, as applicable, 28 days after the last vaccination. Safety description: Occurrence of: - unsolicited AE reported in the 30 minutes after each/any injection - solicited injection site reactions and systemic reactions within 7 days following each/any injection - unsolicited AEs within 28 days following each/any injection - SAEs (including AESI) throughout the trial HAI titers, neutralizing Ab titers and anti-NA titers will be measured for each influenza strain on D0 and D28 or D56 according to the vaccination schedule. ;Timepoint(s) of evaluation of this end point: 28 days after the last vaccination up to the end of the trial for follow up of SAEs.	—

Measure

Time frame

Secondary end point(s): For superiority testing: GMs of anti-HA Ab titers, as applicable, 28 days after the last vaccination. Safety description: Occurrence of: - unsolicited AE reported in the 30 minutes after each/any injection - solicited injection site reactions and systemic reactions within 7 days following each/any injection - unsolicited AEs within 28 days following each/any injection - SAEs (including AESI) throughout the trial HAI titers, neutralizing Ab titers and anti-NA titers will be measured for each influenza strain on D0 and D28 or D56 according to the vaccination schedule. ;Timepoint(s) of evaluation of this end point: 28 days after the last vaccination up to the end of the trial for follow up of SAEs.

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Primary

Measure	Time frame
Main Objective: To demonstrate non-inferiority of antibody (Ab) responses induced by QIV compared with the TIV.;Secondary Objective: • To demonstrate the superiority of the HAI antibody response to each B strain in QIV compared with the TIV that does not contain the corresponding B strain. • To describe the safety profile of QIV compared with the TIV. • To describe the immune response by HAI method, influenza virus SN method and the anti-NA immune response per vaccine group.;Primary end point(s): For non-inferiority testing: GMs of anti-HA Ab titers for the four strains, as applicable, 28 days after the last vaccination.;Timepoint(s) of evaluation of this end point: 28 days after the last vaccination	—

Measure

Time frame

Main Objective: To demonstrate non-inferiority of antibody (Ab) responses induced by QIV compared with the TIV.;Secondary Objective: • To demonstrate the superiority of the HAI antibody response to each B strain in QIV compared with the TIV that does not contain the corresponding B strain. • To describe the safety profile of QIV compared with the TIV. • To describe the immune response by HAI method, influenza virus SN method and the anti-NA immune response per vaccine group.;Primary end point(s): For non-inferiority testing: GMs of anti-HA Ab titers for the four strains, as applicable, 28 days after the last vaccination.;Timepoint(s) of evaluation of this end point: 28 days after the last vaccination

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Countries

Finland, Mexico, Poland, Russian Federation, Taiwan

Contacts

Public ContactDirector, Clinical Development

Sanofi Pasteur

stephanie.pepin@sanofipasteur.com+33(0)437 37 58 50

Outcome results

None listed

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