Safety and Immunogenicity of a Four Influenza Vaccines in Children Ages 6 Months Old to Less Than 48 Months Old

Seqirus

Status and phase: Completed; Phase 2; Phase 1

Conditions: Influenza

Treatments: Biological: Trivalent influenza vaccine-licensed; Biological: Trivalent influenza vaccine (TIVc)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02035696

V58P16

2013-002081-39 (EudraCT Number)

Details and patient eligibility

About

To evaluate the safety and immunogenicity of four influenza vaccines in children 6 months to < 48 months of age

Enrollment: 671 patients

Sex: All

Ages: 6 to 48 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subject, male or female, 6 through < 48 months of age at the time of enrollment, who has never previously received an influenza vaccine
• Individual who has a parent or guardian that can give written informed consent after understanding the nature of the study and are available for follow-up

Exclusion criteria

• Individuals recently vaccinated against influenza
• Subjects with contraindications to receive influenza vaccine

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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671 participants in 4 patient groups

TIVc-High Dose

Experimental group

Description:

Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine

Treatment:

Biological: Trivalent influenza vaccine (TIVc)

TIVc-Full Dose

Experimental group

Description:

Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine

Treatment:

Biological: Trivalent influenza vaccine (TIVc)

TIVc- Half Dose

Experimental group

Description:

Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine

Treatment:

Biological: Trivalent influenza vaccine (TIVc)

TIVe

Active Comparator group

Description:

Subjects (6 to \<48 months old) received two doses of TIVe vaccine(IM/0.25mL -for ages 6 to \<36 months and IM/ 0.5 mL -for ages 36 to \<48 months)

Treatment:

Biological: Trivalent influenza vaccine-licensed