Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Stratified and Controlled Clinical Trial With Split-virion, Non-adjuvanted Influenza A/H1N1 Vaccines in Healthy Pregnant Women
Brief Summary: Since October 2009, H1N1 influenza vaccine has developed and approved of immunization in population in China. However, there was little epidemiological evidence of safety when vaccinated in healthy pregnant women. The main objective of this study is to assess the safety of split-virion inactivated H1N1 vaccine without adjuvant when administered in healthy pregnant women. It is a stratified and controlled clinical trial in healthy pregnant women. And participants were included up to 226 healthy pregnant women aged 18 -35 years old who have no history of novel influenza H1N1 infection or novel influenza H1N1 vaccination. The pregnancy week ranged from 5 weeks to 32 weeks. Subjects were divided into 2 groups: vaccinated group（122） and unvaccinated group（104）. Subjects in the vaccinated group were administered one dose of 15μg H1N1 vaccine. Subjects in the unvaccinated group received no vaccine as controls. Safety will be measured by assessment of pregnancy outcomes. And observation time for pregnancy outcomes was lasting for 28 days postpartum since vaccinated; and protective effect was observed for six months.


Options:
A: Arm Label: 90 mcg of Influenza A/H7N7; Type: EXPERIMENTAL; Interventions: Biological: Influenza A/H7N7 Vaccine | Arm Label: 15 mcg of Influenza A/H7N7; Type: EXPERIMENTAL; Interventions: Biological: Influenza A/H7N7 Vaccine | Arm Label: 7.5 mcg of Influenza A/H7N7; Type: EXPERIMENTAL; Interventions: Biological: Influenza A/H7N7 Vaccine | Arm Label: 45 mcg of Influenza A/H7N7; Type: EXPERIMENTAL; Interventions: Biological: Influenza A/H7N7 Vaccine | Arm Label: Saline placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: BIOLOGICAL; Name: Influenza A/H7N7 Vaccine; Assigned to Arm(s): 15 mcg of Influenza A/H7N7, 45 mcg of Influenza A/H7N7, 7.5 mcg of Influenza A/H7N7, 90 mcg of Influenza A/H7N7 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Saline placebo
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Biological: CSL Limited Influenza Vaccine | Arm Label: 2; Type: OTHER; Interventions: Biological: Placebo | Intervention Type: BIOLOGICAL; Name: CSL Limited Influenza Vaccine; Assigned to Arm(s): 1 | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): 2
C: Arm Label: split-virion, non-adjuvanted H1N1 vaccine of 15 μg; Type: EXPERIMENTAL; Interventions: Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg | Intervention Type: BIOLOGICAL; Name: split-virion, non-adjuvanted H1N1 vaccine of 15 μg; Assigned to Arm(s): split-virion, non-adjuvanted H1N1 vaccine of 15 μg
D: Arm Label: pandemic vaccine 1; Type: EXPERIMENTAL; Interventions: Biological: pandemic vaccine 1 | Arm Label: pandemic vaccine 2; Type: EXPERIMENTAL; Interventions: Biological: pandemic vaccine 2 | Arm Label: pandemic vaccine 5; Type: EXPERIMENTAL; Interventions: Biological: pandemic vaccine 5 | Arm Label: pandemic vaccine 6; Type: EXPERIMENTAL; Interventions: Biological: pandemic vaccine 6 | Arm Label: pandemic vaccine 9; Type: EXPERIMENTAL; Interventions: Biological: pandemic vaccine 9 | Arm Label: pandemic vaccine 10; Type: EXPERIMENTAL; Interventions: Biological: pandemic vaccine 10 | Arm Label: pandemic vaccine 11; Type: EXPERIMENTAL; Interventions: Biological: pandmeic vaccine 11 | Arm Label: pandemic vaccine 12; Type: EXPERIMENTAL; Interventions: Biological: pandmeic vaccine 12 | Arm Label: pandemic vaccine 13; Type: EXPERIMENTAL; Interventions: Biological: pandmic vaccine 13 | Arm Label: placebo group 14; Type: PLACEBO_COMPARATOR; Interventions: Biological: placebo group 14 | Intervention Type: BIOLOGICAL; Name: pandemic vaccine 1; Assigned to Arm(s): pandemic vaccine 1 | Intervention Type: BIOLOGICAL; Name: pandemic vaccine 2; Assigned to Arm(s): pandemic vaccine 2 | Intervention Type: BIOLOGICAL; Name: pandemic vaccine 5; Assigned to Arm(s): pandemic vaccine 5 | Intervention Type: BIOLOGICAL; Name: pandemic vaccine 6; Assigned to Arm(s): pandemic vaccine 6 | Intervention Type: BIOLOGICAL; Name: pandemic vaccine 9; Assigned to Arm(s): pandemic vaccine 9 | Intervention Type: BIOLOGICAL; Name: pandemic vaccine 10; Assigned to Arm(s): pandemic vaccine 10 | Intervention Type: BIOLOGICAL; Name: pandmeic vaccine 11; Assigned to Arm(s): pandemic vaccine 11 | Intervention Type: BIOLOGICAL; Name: pandmeic vaccine 12; Assigned to Arm(s): pandemic vaccine 12 | Intervention Type: BIOLOGICAL; Name: pandmic vaccine 13; Assigned to Arm(s): pandemic vaccine 13 | Intervention Type: BIOLOGICAL; Name: placebo group 14; Assigned to Arm(s): placebo group 14

Answer: C