Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Double-blind, Randomized, Stratified and Controlled Clinical Trial With Split-virion, Adjuvanted and Non-adjuvanted Influenza A/H1N1 Vaccines in Healthy Adults, Elders, Adolescents and Children
Brief Summary: The primary safety objective of this study is to assess the safety of split- virion inactivated H1N1 vaccine with and without adjuvant when administered at the 7.5,15 or 30 mcg dose. The primary immunogenicity objective is to assess the antibody response following each dose of split- virion inactivated A(H1N1) vaccine with and without adjuvant. Participants will include up to 2200 healthy persons age 3 and older who have no history of novel influenza H1N1 2009 infection or novel influenza H1N1 2009 vaccination. This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant females, aged 3 years and older. Subjects will be stratified by elders (equal to or more than 61 years), adults (18-60 years), adolescents (12-17 years) and children (3-11 years), elders and adolescents will be randomized into 5 dose groups (adjuvanted H1N1 vaccine of 7.5,15 or 30 mcg per dose or non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose), children will be randomized into 4 dose groups (adjuvanted H1N1 vaccine of 7.5 or 15 mcg per dose or non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose), adults will be randomized into 6 dose groups (adjuvanted H1N1 vaccine of 7.5,15 or 30 mcg per dose or non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose or placebo), 110 subjects per dose and age stratum will be to receive intramuscular influenza H1N1 vaccine. The H1N1 vaccine will be administered at Day 0 and Day 21. Following immunization, safety will be measured by assessment of adverse events through 21 days following the last vaccination (Day 42 for those receiving both doses), serious adverse events and new-onset chronic medical conditions through 6 months post the final vaccination (Day 180 after second vaccination), and reactogenicity to the vaccine for 8 days (Day 0-7) following each vaccination. Immunogenicity testing will be hemagglutination inhibiting (HAI) on serum obtained on the day 21 of each vaccination (prior to vaccination), on Day 21 after first vaccination, and 21 days following the second vaccination (Day 42).


Options:
A: Intervention Type: BIOLOGICAL; Name: CAIV-T; Assigned to Arm(s): N/A
B: Arm Label: active vaccine; Type: EXPERIMENTAL; Interventions: Biological: Influenza vaccination: Influvac (SolvayPharma) | Arm Label: placebo vaccine; Type: PLACEBO_COMPARATOR; Interventions: Biological: placebo influenza vaccine | Intervention Type: BIOLOGICAL; Name: Influenza vaccination: Influvac (SolvayPharma); Assigned to Arm(s): active vaccine | Intervention Type: BIOLOGICAL; Name: placebo influenza vaccine; Assigned to Arm(s): placebo vaccine
C: Arm Label: MI plus respiratory illness; Type: N/A; Interventions: N/A
D: Arm Label: split-virion, adjuvanted H1N1 vaccine of 7.5 μg; Type: EXPERIMENTAL; Interventions: Biological: Experimental: split-virion, adjuvanted H1N1 vaccine of 7.5 μg | Arm Label: split-virion, adjuvanted H1N1 vaccine of 15 μg; Type: EXPERIMENTAL; Interventions: Biological: Experimental: split-virion, adjuvanted H1N1 vaccine of 15 μg | Arm Label: split-virion, adjuvanted H1N1 vaccine of 30 μg; Type: EXPERIMENTAL; Interventions: Biological: Experimental: split-virion, adjuvanted H1N1 vaccine of 30 μg | Arm Label: split-virion, non-adjuvanted H1N1 vaccine of 15 μg; Type: EXPERIMENTAL; Interventions: Biological: Experimental: split-virion, non-adjuvanted H1N1 vaccine of 15 μg | Arm Label: Placebo control; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo Comparator: Placebo control | Arm Label: split-virion, non-adjuvanted H1N1 vaccine of 30 μg; Type: EXPERIMENTAL; Interventions: Biological: split-virion, non-adjuvanted H1N1 vaccine of 30 μg | Intervention Type: BIOLOGICAL; Name: split-virion, non-adjuvanted H1N1 vaccine of 30 μg; Assigned to Arm(s): split-virion, non-adjuvanted H1N1 vaccine of 30 μg | Intervention Type: BIOLOGICAL; Name: Experimental: split-virion, adjuvanted H1N1 vaccine of 7.5 μg; Assigned to Arm(s): split-virion, adjuvanted H1N1 vaccine of 7.5 μg | Intervention Type: BIOLOGICAL; Name: Experimental: split-virion, adjuvanted H1N1 vaccine of 15 μg; Assigned to Arm(s): split-virion, adjuvanted H1N1 vaccine of 15 μg | Intervention Type: BIOLOGICAL; Name: Experimental: split-virion, adjuvanted H1N1 vaccine of 30 μg; Assigned to Arm(s): split-virion, adjuvanted H1N1 vaccine of 30 μg | Intervention Type: BIOLOGICAL; Name: Experimental: split-virion, non-adjuvanted H1N1 vaccine of 15 μg; Assigned to Arm(s): split-virion, non-adjuvanted H1N1 vaccine of 15 μg | Intervention Type: BIOLOGICAL; Name: Placebo Comparator: Placebo control; Assigned to Arm(s): Placebo control

Answer: D