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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00262002 | Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants | PHASE2 | COMPLETED | 601 | — | — | Sep 1, 2004 | Oct 1, 2006 | Jun 18, 2014 | 3 | Canada, United Kingdom |
Immunogenicity was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥ 1:4 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at the baseline and 1 month after primary vaccination by groups.
| Arm | Type | Description |
|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | EXPERIMENTAL | Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age in the UK group. A fourth dose of MenACWY Ad+ was given at 12 months of age. |
| UK24+ (MenACWY Ad+ at 2, 4 m) | EXPERIMENTAL | Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age. |
| UKMenC (Menjugate at 2, 4 m) | EXPERIMENTAL | Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age. |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | EXPERIMENTAL | Three doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age of the Canadian group (Prevnar at 6 months was optional and was given if available).One subgroup of subjects was given a reduced dose (1/5) of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age. |
| CA24+ (MenACWY Ad+ at 2, 4 m) | EXPERIMENTAL | Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose (1/5) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age. |
| UK24- (MenACWY Ad- at 2, 4 m) | EXPERIMENTAL | Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age. |
| CA24- (MenACWY Ad- at 2, 4 m) | EXPERIMENTAL | Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age. |
| Name | Type | Description |
|---|---|---|
| MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation) | BIOLOGICAL | MenACWY-CRM conjugate vaccine formulated without adjuvant was injected IM (intramuscularly) in the anterolateral area of the right thigh. |
| MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation) | BIOLOGICAL | MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh. |
| MenACWY PS (MenACWY-CRM, polysaccharide vaccine) | BIOLOGICAL | MenACWY polysaccharide vaccine was injected in the anterolateral area of the right thigh. |
| HBV (Hepatitis B vaccine) | BIOLOGICAL | Hepatitis B vaccine at 2, 4, 6 months of age administered IM in the anterolateral area of the left thigh. |
| Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197) | BIOLOGICAL | Prevnar was administered IM in the anterolateral area of the left thigh. |
| MMR (Measles, Mumps and Rubella vaccine) | BIOLOGICAL | MMR at 12 month of age, administered in the left arm. |
| DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine) | BIOLOGICAL | DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh. |
| Menjugate (Men C conjugated vaccine) | BIOLOGICAL | Menjugate was injected IM in the anterolateral area of the right thigh. |
Inclusion Criteria Individuals eligible for enrollment in this study were male, and female infants: * Who were healthy 2-month old infants (55-89 days, inclusive) born after full term pregnancy with an estimated gestational age ≥ 37 weeks, and a birth weight ≥ 2.5 kg; * For whom a parent/legal gua...