Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mencevax · 1 trial · 2 indications
Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (\< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8).
Grade 3 symptom was defined as symptom that prevented normal, everyday activities.
| Arm | Type | Description |
|---|---|---|
| Nimenrix Group | EXPERIMENTAL | Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| Mencevax ACWY Group | ACTIVE_COMPARATOR | Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm. |
| Name | Type | Description |
|---|---|---|
| Nimenrix | BIOLOGICAL | Single dose, intramuscular injection |
| Mencevax | BIOLOGICAL | Single dose, subcutaneous injection |
Inclusion Criteria: * Subjects who the investigator believes that their parents or guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 2 and 10 years of age at the time of vaccination. * Written informed consent obtained from the parent or...