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

Phase 3

Completed

• Conditions: Novel 2009 Influenza H1N1
• Interventions: Biological: MF59-eH1N1_f; Biological: eH1N1_f

• Registration Number: NCT00973700
• Lead Sponsor: Novartis Vaccines

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-02
• Study First Submitted QC: 2009-09-07
• Study First Posted: 2009-09-09
• Primary Completion: 2009-10
• Study Completion: 2010-10
• Results First Submitted: 2010-10-20
• Results First Submitted QC: 2011-04-22
• Results First Posted: 2011-05-23
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-29
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 784

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
7.5adj_1_8	MF59-eH1N1_f	MF59 adjuvanted (adj) A/H1N1 on days 1 and 8
7.5adj_1_22	MF59-eH1N1_f	MF59 adjuvanted (adj) A/H1N1 on study days 1 and 22
2x7.5adj	MF59-eH1N1_f	Two doses of MF59 adjuvanted (adj) A/H1N1
15_1_22	eH1N1_f	A/H1N1 on study days 1 and 22
2x15_1_22	eH1N1_f	Two doses of A/H1N1 (one in each arm) on study days 1 and 22

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age	Day 1 to day 387	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).
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age	Day 1 to day 387	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).

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years	7 days and 21 days after each vaccination	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).
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years	Day 1 to day 387	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).
HI GMRs, in 3 to <9 Years and 9 to 17 Years	Day 1 to day 387	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).
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age	7 days after each vaccination	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.
Age Distribution at Baseline	Baseline
HI GMR, in Adults 18 to 64 Years	Day 1 to day 387	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).
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age	7 days after each vaccination	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
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age	7 days after each vaccination	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.

Trial Locations

Locations (1)

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