Phase 2 N=662 Randomized Single-blind Prevention

Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Children

Pandemic H5N1 Influenza

Bottom Line

View on ClinicalTrials.gov: NCT01776554 ↗

Enrolled (actual)

662

Serious AEs

2.9%

Results posted

Apr 2015

Primary outcome: Primary: The Percentages Of Subjects Aged 6 to <36 Months, Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain — 1; 0; 98; 94 Percentages of subjects

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Adjuvanted H5N1 pandemic influenza vaccine (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Novartis Vaccines
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY The Percentages Of Subjects Aged 6 to <36 Months, Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain	1; 0; 98; 94	—
PRIMARY The Percentages Of Subjects Aged 3 to <9 Years, Achieving HI Titers ≥40 Against A/H5N1 Strain	0; 0; 98; 86	—
PRIMARY The Percentages Of Subjects Aged 9 to <18 Years, Achieving HI Titers ≥40 Against A/H5N1 Strain	2; 1; 92; 79	—
PRIMARY The Percentages Of Subjects Aged 6 to <36 Months, Achieving Seroconversion Against A/H5N1 Strain	58; 36; 99; 94; 73; 61	—
PRIMARY The Percentages Of Subjects Aged 3 to <9 Years, Achieving Seroconversion Against A/H5N1 Strain	43; 41; 98; 86; 45; 22	—
PRIMARY The Percentages Of Subjects Aged 9 to <18 Years, Achieving Seroconversion Against A/H5N1 Strain	54; 36; 92; 79; 29; 16	—
PRIMARY Number of Subjects (6 Month - <6 Years) Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination	89; 92; 4; 2; 2; 2	—
PRIMARY Number of Subjects (≥6 Years - 17 Years) Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination	111; 115; 2; 0; 4; 2	—
PRIMARY Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination	149; 156; 15; 12; 8; 11	—
SECONDARY Geometric Mean Ratios Against A/H5N1 Strain Following 2-Dose Vaccination Schedule Of Either Low Dose Or High Dose AH5N1c Vaccine in Subjects Aged 6 to <36 Months.	12; 4.56; 302; 116; 52; 19	—
SECONDARY Geometric Mean Ratios Against A/H5N1 Strain Following 2-Dose Vaccination Schedule Of Either Low Dose Or High Dose AH5N1c Vaccine in Subjects Aged 3 to <9 Years.	9.81; 8.22; 249; 73; 11; 4.62	—
SECONDARY Geometric Mean Ratios Against A/H5N1 Strain Following 2-Dose Vaccination Schedule Of Either Low Dose Or High Dose AH5N1c Vaccine in Subjects Aged 9 to <18 Years.	15; 6.74; 186; 58; 4.05; 2.64	—
SECONDARY Percentages Of Subjects Aged 6 to <36 Months, With HI Titers ≥40 Against A/H5N1 Strain	1; 0; 58; 36; 98; 94	—
SECONDARY Percentages Of Subjects Aged 3 to <9 Years, With HI Titers ≥40 Against A/H5N1 Strain	0; 0; 43; 41; 98; 86	—
SECONDARY Percentages Of Subjects Aged 9 to <18 Years, With HI Titers ≥40 Against A/H5N1 Strain	2; 1; 54; 37; 92; 79	—
SECONDARY The Percentages Of Subjects Aged 6 to <36 Months, Achieving Seroconversion Against A/H5N1 Strain	58; 36; 99; 94; 73; 61	—
SECONDARY The Percentages Of Subjects Aged 3 to <9 Years, Achieving Seroconversion Against A/H5N1 Strain	43; 41; 98; 86; 45; 22	—
SECONDARY The Percentages Of Subjects Aged 9 to <18 Years, Achieving Seroconversion Against A/H5N1 Strain	54; 36; 92; 79; 29; 16	—

Summary

Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in children.

Eligibility Criteria

Inclusion Criteria

Healthy pediatric subjects 6 months to 17 years of age,
Individuals' parent(s) or legal guardian(s) willing to provide written informed consent,
Individuals in good health,
Individuals/Individuals' parent(s)/legal guardian(s) willing to allow for serum samples to be stored beyond the study period,
Individuals willing to provide informed assent (where applicable).

Exclusion Criteria

Individuals' parent(s)/legal guardian(s) not able to understand and follow study procedures,
History of any significant illness,
History of any chronic medical condition or progressive disease,
Presence of medically significant cancer,
Known or suspected impairment/alteration of immune function,
Presence of any progressive or severe neurologic disorder,
Presence of any bleeding disorders or conditions that prolongs bleeding time,
History of allergy to vaccine components,
Receipt of any other investigational product within 30 days prior to entry into the study,
History of previous H5N1 vaccination,
Receipt of any other type of seasonal vaccination within 2 months prior to entry into the study,
Receipt of any other vaccine within 2 weeks prior to entry into the study,
Body temperature ≥38°C (≥100.4° F) and/or acute illness within 3 days of intended study vaccination,
Pregnant or breast feeding,
Females of childbearing potential refusing to use acceptable method of birth control,
Body mass index (BMI) ≥ 35 kg/m2,
History of drug or alcohol abuse,
Any planned surgery during study period,
Individuals conducting the study and their immediate family members,
Individuals with behavioral or cognitive impairment or psychiatric diseases,
Individuals diagnosed with any growth disorders.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01776554). 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.