Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Study Evaluating the Immunogenicity and Safety of MeMuRu-OKA Vaccine and Measles-mumps-rubella Vaccine (Priorix™) Co-administered With Varicella Vaccine (Varilrix™) in Children Primed With Measles-mumps-rubella Vaccine
Brief Summary: As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in most industrialised countries and varicella vaccination is now being introduced in many countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine was developed for administration convenience and improved compliance to vaccination. To account for situations where children have received a first dose of MMR vaccine without varicella, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of the second dose of MMR vaccine. A second dose of the monovalent varicella vaccine will be given to all children participating to this trial since there is a current debate on the need of a second dose to induce a full protection against varicella.


Options:
A: Reduce burden of illness due to herpes zoster (HZ) (Incidence of postherpetic neuralgia (PHN), where PHN is defined as HZ-associated pain greater than or equal to 3 persisting or appearing more than 30 days after the onset of the HZ rash)
B: Varicella seroconversion and MMR titres at 42-56 days after first vaccination
C: Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Vaccine-related AE After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2 (Up to Day 46 (for 4 days following ProQuad® Dose 2)); Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Injection-site Rash of Interest AE After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Vaccine-related Systemic AE After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Mumps-like Illness After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Serious AE (SAE) After ProQuad® Dose 2 (Up to Day 84 (up to 42 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2 (Up to Day 84 (up to 42 days after ProQuad® Dose 2))
D: Antibody Response to Hepatitis A - Participants With a Serological Response (4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)); Antibody Response to Varicella - Participants With a Serological Response (6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)); Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers (6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)); Participants With 1 or More Systemic Adverse Experience (6 weeks post dose 1); Participants With 1 or More Systemic Adverse Experience (4 weeks post dose 2); Participants With 1 or More Systemic Adverse Experience. (6 months); Participants With 1 or More Injection-site Adverse Experience (6 weeks post dose 1); Participants With 1 or More Injection-site Adverse Experience (4 weeks post dose 2); Participants With 1 or More Injection-site Adverse Experience (6 months); Participants With Elevated Temperature (≥102.2F/ ≥39.0C) (6 weeks post dose 1); Participants With Elevated Temperature (≥102.2F/ ≥39.0C) (4 weeks post dose 2); Participants With Elevated Temperature (≥102.2F/ ≥39.0C) (6 months); Participants With 1 or More Serious Vaccine-related Adverse Experience (6 weeks post dose 1); Participants With 1 or More Serious Vaccine-related Adverse Experience (4 weeks post dose 2); Participants With 1 or More Serious Vaccine-related Adverse Experience (6 months)

Answer: B