Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months

Influenza Clinical Trial

Official title:

Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1) 2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00996307
• Other study ID #: V112_06
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 15, 2009
• Last updated: April 19, 2017
• Start date: October 2009
• Est. completion date: December 2010

Study information

• Verified date: April 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children

Recruitment information / eligibility

• Status: Completed
• Enrollment: 654
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 35 Months

Eligibility

Inclusion Criteria:

• Children 6 to 35 months of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months

Exclusion Criteria:

• History of serious disease.

• History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.

• Known or suspected impairment/alteration of immune function.

• Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination

For additional entry criteria, please refer to protocol

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• MF59-eH1N1_f
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
• MF59-eH1N1_f
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
• MF59-eH1N1_f
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
• MF59-eH1N1_f
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Vaccines	Novartis

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody Responses After the First and Second Vaccinations	CBER guidance (<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be = 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer = 1:40 should be = 70%.	21 days after each vaccination
Primary	Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination	Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination.	Day 1 to 7
Primary	Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination	Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination.	Day 22 to 28
Secondary	Immunogenicity Measurement by Geometric Mean Titers (GMT)	Immunogenicity was measured in terms of the GMT at 21 days after each vaccination.	21 days after each vaccination
Secondary	Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010	Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.	Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
Secondary	Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010	Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.	Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
Secondary	Antibody Response Based on Baseline Seropositivity	Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer = 1:10	Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
Secondary	Geometric Mean Titers (GMTs) Based on Baseline Seropositivity	Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer = 1:10 Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer = 1:10) at Baseline (Day 1 (pre-vaccination)) as compared to those who are seronegative (HI titer < 1:10).	Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
Secondary	Antibody Persistence by Geometric Mean Titers (GMT)	Immunogenicity was assessed in terms of Geometric Mean Titers (GMT at 6 months (Day 202)and 12 months (Day 387) after second vaccination.	6 months (Day 202) and 12 months (Day 387) after second vaccination