Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00197236 | Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months | PHASE3 | COMPLETED | 468 | — | — | Nov 11, 2003 | Dec 3, 2007 | Aug 20, 2018 | 22 | United States |
| NCT00197015 | Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children | PHASE3 | COMPLETED | 1,474 | — | — | Oct 6, 2003 | Jun 9, 2009 | Jul 31, 2018 | 42 | United States |
Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).
Subjects are defined as being anti-diphtheria, anti-tetanus and anti-PRP seroprotected if their anti-diphtheria and anti-tetanus antibody concentration is ≥ 0.1 International Units per milliliter (IU/mL) and if their anti-PRP antibody concentration is ≥ 1 microgram per milliliter (μg/mL), respectively.
Subjects are considered as being vaccine responders if they were initially seronegative and become seropositive (≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL)), or were initially seropositive and have a 2-fold increase above pre-study concentrations.
Concentrations are given as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL).
Anti-HAV antibody cut-off value assessed include 15 milli-international units per milliliter (mIU/mL).
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 150 milli-international units per milliliter (mIU/mL) for anti-measles antibodies, 28 Effective Dose 50 (ED50) for anti-mumps antibodies and 1:5 for anti-varicella antibodies.
Vaccine response is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off value assessed include 10 milli-international units per milliliter (mIU/mL).
| Arm | Type | Description |
|---|---|---|
| Havrix Group | ACTIVE_COMPARATOR | Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Infanrix + ActHIB→Havrix Group | EXPERIMENTAL | Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10. |
| Havrix + Infanrix + ActHIB Group | ACTIVE_COMPARATOR | Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9. |
| HAV Group | ACTIVE_COMPARATOR | Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9) |
| HAV+MMR+V Group | EXPERIMENTAL | Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9 |
| MMR+V→HAV Group | ACTIVE_COMPARATOR | Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5) |
| Name | Type | Description |
|---|---|---|
| Havrix™ | BIOLOGICAL | 2 intramuscular injections, 6 months apart |
| Infanrix™ | BIOLOGICAL | 1 intramuscular injection |
| ActHIB™ | BIOLOGICAL | 1 intramuscular injection |
| Havrix® | BIOLOGICAL | 2 doses administered intramuscularly |
| M-M-R®II | BIOLOGICAL | 1 dose administered subcutaneously |
| VARIVAX® | BIOLOGICAL | 1 dose administered subcutaneously |
Inclusion Criteria: * Subjects whose parents/guardians are believed by the investigator to be willing to comply with the requirements of the protocol * A male or female child 12 or 13 months of age at the time of entry into the Enrolment Phase, * Subjects must have previously received three doses e...