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

• Register: EUCTR
• Last refreshed on: 31 October 2016
• Main ID: EUCTR2013-001231-51-ES
• Date of registration: 04/04/2014
• Prospective Registration: Yes
• Primary sponsor: Sanofi Pasteur
• Public title: Efficacy and Immunogenicity Study of Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Healthy Children Aged 6 to 35 Months
• Scientific title: Efficacy and Immunogenicity Study of Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Healthy Children Aged 6 to 35 Months
• Date of first enrolment: 13/06/2014
• Target sample size: 9000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001231-51
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: observer-blind (except for TIV groups which will be open-label) If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Coordinating Investigator
• Affiliation: Hospital Infantil La Paz

• Name: Coordinating Investigator
• Affiliation: Hospital Infantil La Paz

Key inclusion & exclusion 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:
?At risk? children according to the definition from the Advisory Committee on Immunization Practices (ACIP).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

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

Intervention(s)

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: INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 30-
INN or Proposed INN: Influenza virus ( split virion, inactivated) A/H3N2-like strain
Other descriptive name: INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 30-
INN or Proposed INN: Influenza virus ( split virion, inactivated) B-like strain (Victoria lineage)
Other descriptive name: INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 30-
INN or Proposed INN: Influenza virus ( split virion, inactivated) B-like strain (Yamagata lineage)
Other descriptive name: INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 30-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Intramuscular use

Trade Name: Vaxigrip
Product Name: Vaxigrip
Product Code: 314
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: INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 30-
INN or Proposed INN: Influenza virus ( split virion, inactivated) A/H3N2-like strain
Other descriptive name: INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 30-
INN or Proposed INN: Influe

Primary Outcome(s)

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

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.

Secondary Outcome(s)

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

Secondary ID(s)

2013-001231-51-IT

GQM05

Source(s) of Monetary Support

Sanofi Pasteur