Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)

A Randomized, Open Label, Single Center, Dose- and Regimen-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Children and Adults Ages 3 to 64 Years

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children, adolescents, and adults.

Study Overview

• Status: Completed
• Conditions: Novel 2009 Influenza H1N1
• Intervention / Treatment: Biological: MF59-eH1N1_f; Biological: eH1N1_f

• Study Type: Interventional
• Enrollment (Actual): 784
• Phase: Phase 3

Contacts and Locations

Study Locations

• Costa Rica
  • San Jose, Costa Rica
    • Instituto de Atencion Pediatrica, Avenida 0-2 Calle 22, Paseo Colon del Restaurante La, Bastilla 50 metros Sur, Edificio 5.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 64 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children, adolescents, and adults 3 to 64 years 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2x7.5adj; Two doses of MF59 adjuvanted (adj) A/H1N1	Biological: MF59-eH1N1_f; MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
Experimental: 7.5adj_1_8; MF59 adjuvanted (adj) A/H1N1 on days 1 and 8	Biological: MF59-eH1N1_f; MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
Experimental: 7.5adj_1_22; MF59 adjuvanted (adj) A/H1N1 on study days 1 and 22	Biological: MF59-eH1N1_f; MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
Experimental: 15_1_22; A/H1N1 on study days 1 and 22	Biological: eH1N1_f; Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal
Experimental: 2x15_1_22; Two doses of A/H1N1 (one in each arm) on study days 1 and 22	Biological: eH1N1_f; Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age	Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS).	Day 1 to day 387
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age	Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. Analyses were performed on the Per-Protocol set (PPS).	Day 1 to day 387

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age Distribution at Baseline		Baseline
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years	Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS).	Day 1 to day 387
HI GMRs, in 3 to <9 Years and 9 to 17 Years	Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the the per-protocol set (PPS).	Day 1 to day 387
HI GMR, in Adults 18 to 64 Years	Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the Per-Protocol Set (PPS).	Day 1 to day 387
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years	Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the per-protocol set (PPS).	7 days and 21 days after each vaccination
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age	Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to <9 years of age). Postvac: postvaccination; Analges: analgesics; Antipyr: antipyretics. The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination	7 days after each vaccination
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age	Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age). Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination.	7 days after each vaccination
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age	Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age). Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination. The analyses were performed on the safety set.	7 days after each vaccination

Collaborators and Investigators

• Sponsor: Novartis Vaccines
• Investigators: Study Director: Novartis Vaccines, Novartis Vaccines

Publications and helpful links

General Publications

• Arguedas A, Soley C, Abdelnour A, Sales V, Lindert K, Della Cioppa G, Clemens R; Costa Rican H1N1 Vaccine Study Group. Assessment of the safety, tolerability and kinetics of the immune response to A/H1N1v vaccine formulations with and without adjuvant in healthy pediatric subjects from 3 through 17 years of age. Hum Vaccin. 2011 Jan 1;7(1):58-66. doi: 10.4161/hv.7.1.13411. Epub 2011 Jan 1.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: September 2, 2009
• First Submitted That Met QC Criteria: September 7, 2009
• First Posted (Estimate): September 9, 2009

Study Record Updates

• Last Update Posted (Estimate): December 2, 2015
• Last Update Submitted That Met QC Criteria: October 29, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Vaccine; Adjuvant; Flu; Swine Flu
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: V112_04