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MenACWY Ad · 1 trial · 1 indication
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...
MenACWY Ad is being developed for the prevention of meningococcal disease. It is an investigational product studied in healthy infants, with the goal of preventing disease caused by meningococcal bacteria. Development is at Phase 2, so it is not an approved product.
MenACWY Ad is being developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the clinical study of this product in healthy infants. The program is at Phase 2 of clinical development.
MenACWY Ad is in Phase 2 of clinical development. One Phase 2 trial has been completed, and no trials are currently active. The program has not reached later-stage development, so MenACWY Ad is investigational and is not an approved product.
MenACWY Ad was studied in the Phase 2 trial NCT00262002, titled Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants. The trial enrolled 601 healthy infants aged 2 months and older in Canada and the United Kingdom, and it has been completed.
MenACWY Ad is also known as MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation). The alternative name reflects the MenACWY-CRM component in a non adjuvanted formulation. Readers searching for MenACWY-CRM, non adjuvanted formulation are looking at the same asset.
The Phase 2 trial NCT00262002 was a controlled study of MenACWY Ad in healthy infants. It was randomized but not double blind, and it enrolled 601 participants aged 2 months and older across Canada and the United Kingdom. The study has been completed.