Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, and Manufacturing Consistency of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)
Brief Summary: This study will evaluate the immunogenicity and tolerability of V503 (a multivalent human papillomavirus \[HPV\] L1 virus-like particle \[VLP\] vaccine) in preadolescent and adolescent participants between 9 and 15 years old and demonstrate the consistency of the manufactured vaccine through assessment of 3 different final manufacturing process lots of V503.

The primary hypotheses are as follows:

1. The 9-valent HPV L1 VLP vaccine when administered to preadolescent and adolescent boys and girls 9 to 15 years of age and young women 16 to 26 years of age is generally well-tolerated.
2. 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and adolescent girls 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and polymerase chain reaction (PCR)-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks post-dose 3.
3. The 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and adolescent boys 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and PCR-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3.
4. Three separate final manufacturing process (FMP) lots of the 9-valent HPV L1 VLP vaccine induce similar immune responses, as measured by anti-HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3.


Options:
A: Arm Label: Cervarix Group; Type: EXPERIMENTAL; Interventions: Biological: Cervarix | Arm Label: Aluminium Hydroxide Group; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo control | Intervention Type: BIOLOGICAL; Name: Cervarix; Assigned to Arm(s): Cervarix Group | Intervention Type: BIOLOGICAL; Name: Placebo control; Assigned to Arm(s): Aluminium Hydroxide Group
B: Arm Label: 9- to 15-Year-Old Females (Lot 1); Type: EXPERIMENTAL; Interventions: Biological: V503 | Arm Label: 9- to 15-Year-Old Females (Lot 2); Type: EXPERIMENTAL; Interventions: Biological: V503 | Arm Label: 9- to 15-Year-Old Females (Lot 3); Type: EXPERIMENTAL; Interventions: Biological: V503 | Arm Label: 9- to 15-Year-Old Males (Lot 1); Type: EXPERIMENTAL; Interventions: Biological: V503 | Arm Label: 16- to 26-Year-Old Females (Lot 1); Type: EXPERIMENTAL; Interventions: Biological: V503 | Intervention Type: BIOLOGICAL; Name: V503; Assigned to Arm(s): 16- to 26-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 2), 9- to 15-Year-Old Females (Lot 3), 9- to 15-Year-Old Males (Lot 1)
C: Arm Label: Cervarix™ & Engerix™ Group; Type: EXPERIMENTAL; Interventions: Biological: Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™), Biological: Engerix™ | Arm Label: Engerix™ Group; Type: ACTIVE_COMPARATOR; Interventions: Biological: Engerix™ | Intervention Type: BIOLOGICAL; Name: Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™); Assigned to Arm(s): Cervarix™ & Engerix™ Group | Intervention Type: BIOLOGICAL; Name: Engerix™; Assigned to Arm(s): Cervarix™ & Engerix™ Group, Engerix™ Group
D: Arm Label: Cervarix 1/Placebo Group; Type: EXPERIMENTAL; Interventions: Biological: Cervarix, Drug: Placebo | Arm Label: Cervarix 1/Placebo/Cervarix 1 Group; Type: EXPERIMENTAL; Interventions: Biological: Cervarix, Drug: Placebo | Arm Label: Cervarix 2/Placebo/Cervarix 2 Group; Type: EXPERIMENTAL; Interventions: Biological: Cervarix, Drug: Placebo | Arm Label: Cervarix 2 Group; Type: EXPERIMENTAL; Interventions: Biological: Cervarix | Intervention Type: BIOLOGICAL; Name: Cervarix; Assigned to Arm(s): Cervarix 1/Placebo Group, Cervarix 1/Placebo/Cervarix 1 Group, Cervarix 2 Group, Cervarix 2/Placebo/Cervarix 2 Group | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Cervarix 1/Placebo Group, Cervarix 1/Placebo/Cervarix 1 Group, Cervarix 2/Placebo/Cervarix 2 Group

Answer: B