Please select the outcome measures that correspond to the clinical trial below.
Title: Vaccination of HIV-uninfected Pregnant Women With Trivalent Influenza Vaccine in the Prevention of Influenza Illness During Early Infancy and in Mothers: Randomized Controlled Phase III Trial Evaluating Safety, Immunogenicity and Efficacy
Brief Summary: Randomised, double blind, placebo controlled trial to assess safety, immunogenicity and efficacy of Trivalent Influenza vaccine in HIV uninfected pregnant women


Options:
A: Seroconversion Rate 21 Days After the First Vaccination (21 days after the first vaccination); Seroconversion Rate 21 Days After the Second Vaccination (21 days after the second vaccination); Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination (21 days after the first vaccination); Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination (21 days after the second vaccination)
B: To measure anti-influenza systemic and mucosal antibody responses 4 weeks after administration of influenza vaccine (LAIV) to healthy subjects aged 18-49 and to compare responses in subjects receiving Lactobacillus GG (LGG) versus placebo (4 weeks)
C: The number of laboratory-confirmed influenza cases in infants born to mothers who received TIV or placebo will be used to determine efficacy of TIV vaccination of pregnant women against laboratory-confirmed influenza illness in their infants (24 weeks of age); Humoral and cell-mediated immune (CMI) responses to influenza strains in the vaccine will be measured to assess the immunogenicity of TIV in pregnant women vaccinated between 20-34 weeks of gestational age (one month post vaccination, delivery (+7 days), 24 weeks post natal)
D: Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months (Pre-vaccination (Day 0) and 21 days post-vaccination); Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months (Pre-vaccination (Day 0) and Day 21 post-vaccination); Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months (Pre-vaccination (Day 0) and 21 days post-vaccination); Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years (Pre-vaccination (Day 0) and 21 days post-vaccination); Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years (Pre-vaccination (Day 0) and Day 21 post-vaccination); Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years (Pre-vaccination (Day 0) and Day 21 post-vaccination); Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months (Days 0 to 7 post-vaccination); Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months (Days 0 to 7 post-vaccination); Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years (Days 0 to 7 post vaccination)

Answer: C