A Phase III Efficacy Study with QIVc in Pediatric Subjects

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 5723

Inclusion Criteria

Individuals of 6 through 47 months of age on the day of informed consent.
Individuals whose parent(s)/LAR have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
Individuals who can comply with study procedures including follow-up.
Individuals in generally good health as per the Investigator’s medical judgement.
Are the trial subjects under 18? yes
Number of subjects for this age range: 3830
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

1. Acute (severe) febrile illness (see Section 4.3 Criteria for Delay of Vaccination). Enrollment could be considered if the fever is absent for 72 hours.
2. History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study.
3. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. These may include known bleeding disorders, or treatment with anticoagulants in the 3 weeks preceding vaccination.
4. A known history of Guillain-Barré Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.
5. Abnormal function of the immune system resulting from clinical conditions, which include:
a. Known or suspected congenital or acquired immunodeficiency.
b. Systemic administration of corticosteroids (PO/IV/IM) at any dose for more than 14 days, within 90 days prior to informed consent. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids is also permitted.
c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
6. Received immunoglobulins or any blood products within 180 days prior to informed consent.
7. Received an investigational or non-registered medicinal product within 30 days prior to informed consent, or intend to participate in another clinical trial during the study.
8. Participated in this trial in a prior season or is discontinued after randomization in the current season.
9. Study personnel, family and household members of study personnel should not participate.
10. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
11. Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.
12. Prior vaccination to prevent Neisseria meningitides serogroup C disease or prior infection caused by this organism.
13. Received any other vaccines than influenza vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to study vaccination or who are planning to receive any vaccine within 28 days after study vaccination.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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