Phase 3 N=10,644 Randomized Quadruple-blind Prevention

Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.

Influenza Virus

Bottom Line

View on ClinicalTrials.gov: NCT01964989 ↗

Enrolled (actual)

10,644

Serious AEs

4.5%

Results posted

Mar 2023

Primary outcome: Primary: Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age — 256; 252; 7; 17 Number of cases

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) (Biological); Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV) (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Seqirus
Primary completion: Oct 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age	256; 252; 7; 17; 200; 196	—
SECONDARY Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age.	55; 79; 115; 119; 141; 133	—
SECONDARY Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age	140; 146; 31; 48; 64; 68	—
SECONDARY Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects at High Risk of Influenza Complications	244; 233; 12; 19; 130; 136	—
SECONDARY Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Naive and Non-naive Subjects Separately	160; 170; 96; 82; 80; 101	—
SECONDARY Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age at ≥7 Days and at ≥14 Days After First Vaccination up to the Day of Second Vaccination in Vaccine naïve Subjects Only	16; 35; 8; 27	—
SECONDARY Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age Occurring at ≥7 Days and ≤21 Days After Last Vaccination, in All Subjects.	4; 15	—
SECONDARY Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age	40.08; 39.49; 996.40; 522.50; 351.59; 189.43	—
SECONDARY Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age	483.55; 172.92; 1065.19; 553.57; 742.82; 342.90	—
SECONDARY Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age	35.34; 48.29; 31.64; 45.12; 988.65; 906.86	—
SECONDARY Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age	24.96; 13.09; 21.68; 12.67; 18.08; 8.25	—
SECONDARY Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Seroconversion (SC) Rates and Difference in SC Rates at 21 Days in Subjects ≥6 to <72 Months of Age	81.9; 73.7; 78.4; 73.2; 86.0; 64.7	—
SECONDARY Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 and Percentage Differences at 180 Days After Last Vaccination in Subjects ≥6 to <72 Months of Age	97.1; 85.6; 98.1; 90.2; 66.6; 44.7	—
SECONDARY Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age	97.3; 89.5; 96.5; 86.8; 94.0; 77.9	—
SECONDARY Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Geometric Mean Titers (GMTs) in Subjects ≥6 to <72 Months of Age	7.46; 6.52; 576.84; 297.70; 145.89; 67.24	—
SECONDARY Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Heterologous Strains in Terms of Seroconversion (SC) Rates in Subjects ≥6 to <72 Months of Age	2.7; 1.4; 86.0; 73.4; 82.7; 59.9	—
SECONDARY Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 in Subjects ≥6 to <72 Months of Age	6.1; 3.4; 99.3; 93.1; 88.8; 68.2	—
SECONDARY Safety Endpoint: Number of Subjects With Solicited Local and Systemic AEs	3748; 3242; 2651; 2188; 2714; 2174	—
SECONDARY Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs	3576; 3543; 686; 533; 234; 230	—
SECONDARY Healthcare Utilization and Health Economic Endpoints: Number of Days of Daycare, School or Preschool Missed by Subjects Associated With RT-PCR-confirmed Influenza	2.1; 2.2	—
SECONDARY Healthcare Utilization and Health Economic Endpoint: Number of Medical Visit for Respiratory Illness Associated With RT-PCR-confirmed Influenza	1.0; 1.0	—
SECONDARY Healthcare Utilization and Health Economic Endpoint: Number of Employment Days Missed by Parent(s)/Guardian(s) of Subjects With RT-PCR-confirmed Influenza	1.0; 1.0	—
SECONDARY Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2.	34; 32; 0; 1; 27; 29	—

Summary

Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to <72 Months of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season.

Eligibility Criteria

Inclusion Criteria

Children, males and females, healthy or at high risk of complications from influenza, between ≥6 months to <72 months of age
Documented consent provided by the subject's parent(s)/legal guardian(s)
Subjects and/or subject's parent(s)/legal guardian(s) able to comply with all study procedures.

Exclusion Criteria

Children with history of allergy to vaccine components.
Additional eligibility criteria may be discussed by contacting the site

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01964989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.