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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00127855 | Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine | PHASE2 | COMPLETED | 409 | — | — | Mar 1, 2003 | Feb 12, 2004 | Aug 27, 2018 | 3 | Australia |
| NCT00129116 | 3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age | PHASE2 | COMPLETED | 388 | — | — | Mar 1, 2003 | Dec 16, 2003 | Aug 27, 2018 | 26 | Belgium, Germany |
The cut-off concentration assessed was 1 milligram per milliliter (mg/mL).
The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
| Arm | Type | Description |
|---|---|---|
| MenHibrix Formulation 1 Group | EXPERIMENTAL | Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age. |
| MenHibrix Formulation 2 Group | EXPERIMENTAL | Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age. |
| MenHibrix Formulation 3 Group | EXPERIMENTAL | Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age. |
| Menjugate Group | ACTIVE_COMPARATOR | Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age. |
| ActHIB Group | ACTIVE_COMPARATOR | Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age. |
| Menhibrix F1/Infanrix-penta Group | EXPERIMENTAL | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Menhibrix F2/Infanrix-penta Group | EXPERIMENTAL | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Menhibrix F3/Infanrix-penta Group | EXPERIMENTAL | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Menitorix/Infanrix-penta Group | EXPERIMENTAL | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Menjugate/Infanrix-hexa Group | ACTIVE_COMPARATOR | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Name | Type | Description |
|---|---|---|
| Hib-MenCY-TT vaccine (MenHibrix) | BIOLOGICAL | Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively |
| Meningitec® | BIOLOGICAL | Three doses were administered IM in right lower thigh at Months 0,2 and 4. |
| ActHIB® | BIOLOGICAL | Three doses were administered IM in left thigh at Months 0,2 and 4. |
| Infanrix® Penta | BIOLOGICAL | Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively. |
| Prevenar® | BIOLOGICAL | Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively. |
| Mencevax® ACWY | BIOLOGICAL | One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster. |
| PRP (Polyribosyl Ribitol Phosphate) | BIOLOGICAL | One dose was administered IM in deltoid region of left arm at Month 10 as booster. |
| Hib-MenCY-TT vaccine | BIOLOGICAL | Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh. |
| Hib-MenC-TT vaccine | BIOLOGICAL | Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh. |
| Menjugate ® | BIOLOGICAL | Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh. |
| Infanrix penta ® | BIOLOGICAL | Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh. |
| Infanrix hexa ® | BIOLOGICAL | Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh. |
Inclusion criteria: * A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Free of obvious health problems as established by medical history and clinical ex...