A Phase 3 interventional study of MenACWY-CRM and DTaP-IPV/Hib in Meningococcal Disease, sponsored by Novartis Vaccines. Completed at 46 sites in 3 countries. Open to participants aged 55 Days to 89 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-21.
Sponsored by Novartis Vaccines · Phase 3, Interventional, and Prevention
This Phase 3 study is designed to demonstrate the safety and immunogenicity of MenACWY and non-interference of concomitant routine vaccines by MenACWY in an infant age group.
219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.
This study's enrollment of 529 is above the median of 450 across 190 interventional studies indexed under Meningococcal Infections.
Browse Meningococcal Infections studies →Novartis Vaccines is the lead sponsor of 161 studies on the registry; none are open to participants now.
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Subjects were in good health as determined by:
Exclusion Criteria:
Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months of age. Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
Biological: MenACWY-CRM · Biological: DTaP-IPV/Hib · Biological: HBV · Biological: PCV · Biological: MMR
Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months. In addition subjects were offered a dose of MenACWY-CRM at 18 months as a benefit of participating in this study. However, blood was not drawn for immunogenicity analysis after this dose.
Biological: DTaP-IPV/Hib · Biological: HBV · Biological: PCV · Biological: MMR
One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2, 4, 6 and 12 months of age as IM injections in the anterolateral area of the thigh.
IM injections of 3 doses of 0.5 mL each of DTaP-IPV/Hib supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.
Also known as: Combined diphtheria, tetanus toxoid, acellular pertussis and inactivated polio vaccine containing Haemophilus influenzae type B vaccine; Pentacel
IM injections of 3 doses of 0.5 mL each of HBV supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.
Also known as: Hepatitis B virus vaccine; Engerix-B
IM injections of 4 doses of 0.5 mL each of PCV supplied in prefilled vial were administered at 2, 4, 6 and 12 months of age in the anterolateral area of the thigh.
Also known as: Heptavalent Streptococcus pneumonia vaccine; Prevnar (PCV-7); Prevnar 13 (PCV-13)
Subcutaneous (SC) injection of 1 dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 12 months of age in the anterolateral area of the thigh.
Also known as: Measles, mumps, and rubella vaccine; M-M-R II
Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 against meningococcal serogroup A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age. The immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8, at one month after toddler vaccination, was greater than 85% for the serogroup C, W, or Y and greater than 80% for the serogroup A.
Time frame: Baseline and one month after fourth-dose of MenACWY-CRM
hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Immunogenicity was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal serogroup A, C, W and Y, at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age.
Time frame: Baseline and one month after fourth-dose of MenACWY-CRM
Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroup A, C, W and Y, before (baseline) and one month after 3 infant doses of MenACWY-CRM administered at 2, 4 and 6 months of age. Percentage of subjects who achieved at least four-fold rise in hSBA titers against serogroup A, C, W and Y was measured one month after 3 infant doses of MenACWY-CRM.
Time frame: Baseline and one month after third infant dose of MenACWY-CRM
hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Immunogenicity was measured as the hSBA GMTs directed against meningococcal serogroups A, C, W and Y before (baseline) and one month after 3 infants doses of MenACWY-CRM administered at 2, 4 and 6 months of age.
Time frame: Baseline and one month after third infant dose of MenACWY-CRM
Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
The immune seroresponse to routine concomitant vaccination was measured as the percentages of subjects with pre-specified cut-off limit of ≥0.1 IU/mL (Diphtheria and Tetanus); ≥0.15 μg/mL (Hib); ≥0.35 μg/mL (Pneumococcal antigens, PnC); and ≥10 mIU/mL (Hepatitis B), evaluated using enzyme-linked immunosorbent assay (ELISA) at one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age. The immune response to pertussis antigens (PT, FHA, Pertactin, FIM) was measured as percentage of subjects with seroresponse (in initially seronegative infants, ≥4 times the lower limit of quantification (LLQ); in initially seropositive infants, at least 4 times prevaccination concentration) by ELISA and percentage of subjects with titer ≥1:8 (Polio types 1, 2, and 3) by neutralization test (NT) one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age.
Time frame: One month after third dose of routine infant series vaccination
Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
The immune response was measured as the geometric mean concentrations (GMCs) of antibodies directed against diphtheria, tetanus, pertussis (PT, FHA, Pertactin, FIM), hepatitis B, Hib, polio (type 1, 2 and 3) and pneumococcal (PnC 4, 6B, 9V, 14, 18C, 19F and 23F) antigens when routine vaccines are administered concomitantly with MenACWY-CRM compared with when routine vaccines are given alone, one month after 3 doses of infant series vaccination at 2, 4 and 6 months of age.
Time frame: One month after third dose of routine infant series vaccination
Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone
Immunogenicity was measured as the GMCs of anti-pneumococcal antibodies against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age administered concomitantly with MenACWY-CRM compared with PCV given alone.
Time frame: One month after PCV toddler vaccination
Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone
The immune seroresponse was measured as the percentage of subjects with anti-pneumococcal antigen antibodies ≥0.35 μg/mL against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age when administered concomitantly with MenACWY-CRM compared with PCV given alone.
Time frame: One month after PCV toddler vaccination
Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
The antibody persistence was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.
Time frame: Baseline and Six months after third infant dose of MenACWY-CRM
Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
The antibody persistence was measured as the hSBA GMTs directed against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.
Time frame: Baseline and Six months after third infant dose of MenACWY-CRM
Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
The immune response was measured as the percentage of subjects who achieved four-fold increase in hSBA titers against meningococcal serogroup A, C, W and Y one month after toddler dose of MenACWY-CRM administered at 12 months of age as compared to hSBA titers before the toddler vaccination.
Time frame: One month after MenACWY-CRM toddler vaccination
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Safety of the study vaccines (MenACWY-CRM and other routine vaccines) was assessed in terms of the number of subjects who reported adverse events (AEs) and/or serious AEs per vaccine group at the following time points: entire study period, after infants vaccination (up to 7 months), between 2- and 4-months, between 4- and 6-months, between 6- and 12-months, between 7- and 12-months, 28 days after 12-month vaccination, and between 29 days after 12-month vaccination and study termination. Solicited reactions were not collected during this study. The safety analyses also included any AEs observed by study personnel within 15 minutes following vaccination. All AEs and SAEs were judged by the investigator as whether probably related, possibly related, or not related to vaccine.
Time frame: From day 1 to 18 months
Subjects were enrolled at 42 study sites in the United States, 3 sites in Australia and 1 site in Canada.
| Milestone | MenACWY-CRM + Routine Vaccines | Routine Vaccines |
|---|---|---|
| Started | 258 | 271 |
| Completed | 213 | 201 |
| Not completed | 45 | 70 |
| Withdrew: Adverse event | 2 | 5 |
| Withdrew: Withdrawal by subject | 16 | 24 |
| Withdrew: Lost to follow-up | 15 | 24 |
| Withdrew: Protocol violation | 1 | 2 |
| Withdrew: Inappropriate enrollment | 2 | 0 |
| Withdrew: Administrative reason | 9 | 15 |
Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 against meningococcal serogroup A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age. The immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8, at one month after toddler vaccination, was greater than 85% for the serogroup C, W, or Y and greater than 80% for the serogroup A.
| Percentage of subjects | MenACWY-CRM + Routine Vaccines | Routine Vaccines |
|---|---|---|
| Serogroup A - Baseline (N=170,178) | 2 (0 to 5) | 1 (0.014 to 3) |
| Serogroup A - Post-4th dose (N=168,175) | 89 (83 to 93) | 2 (0 to 5) |
| Serogroup C - Baseline (N=166,174) | 7 (3 to 12) | 7 (4 to 12) |
| Serogroup C - Post-4th dose (N=156,171) | 95 (90 to 98) | 2 (1 to 6) |
| Serogroup W - Baseline (N=152,164) | 13 (8 to 20) | 15 (10 to 21) |
| Serogroup W - Post-4th dose (N=153,165) | 97 (93 to 99) | 7 (3 to 12) |
| Serogroup Y - Baseline (N=144,150) | 8 (4 to 13) | 4 (1 to 9) |
| Serogroup Y - Post-4th dose (N=153,159) | 96 (92 to 99) | 1 (0 to 4) |
Immunogenicity was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal serogroup A, C, W and Y, at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age.
| Titers | MenACWY-CRM + Routine Vaccines | Routine Vaccines |
|---|---|---|
| Serogroup A - Baseline (N=139,145) | 2.07 (1.98 to 2.16) | 2.01 (1.99 to 2.03) |
| Serogroup A - Post-4th dose (N=168,175) | 54 (44 to 67) | 1.87 (1.55 to 2.27) |
| Serogroup C - Baseline (N=126,136) | 2.49 (2.2 to 2.83) | 2.44 (2.2 to 2.7) |
| Serogroup C - Post-4th dose (N=156,171) | 135 (107 to 171) | 1.94 (1.56 to 2.4) |
| Serogroup W - Baseline (N=113,126) | 2.99 (2.49 to 3.6) | 2.97 (2.52 to 3.51) |
| Serogroup W - Post-4th dose (N=153,165) | 215 (167 to 277) | 2.15 (1.77 to 2.6) |
| Serogroup Y - Baseline (N=108,113) | 2.43 (2.19 to 2.71) | 2.32 (2.13 to 2.52) |
| Serogroup Y - Post-4th dose (N=153,159) | 185 (148 to 233) | 1.89 (1.56 to 2.29) |
Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroup A, C, W and Y, before (baseline) and one month after 3 infant doses of MenACWY-CRM administered at 2, 4 and 6 months of age. Percentage of subjects who achieved at least four-fold rise in hSBA titers against serogroup A, C, W and Y was measured one month after 3 infant doses of MenACWY-CRM.
| Percentage of subjects | MenACWY-CRM + Routine Vaccines | Routine Vaccines |
|---|---|---|
| Serogroup A - hSBA ≥1:8-Baseline (N=170,178) | 2 (0 to 5) | 1 (0.014 to 3) |
| Serogroup A - hSBA ≥1:8 -Post-3rd dose(N=202,208) | 76 (69 to 81) | 1 (0 to 4) |
| Serogroup C - hSBA ≥1:8 -Baseline(N=166,174) | 7 (3 to 12) | 7 (4 to 12) |
| Serogroup C - hSBA ≥1:8 -Post-3rd dose(N=199,206) | 94 (90 to 97) | 1 (0 to 4) |
| Serogroup W - hSBA ≥1:8 -Baseline(N=152,164) | 13 (8 to 20) | 15 (10 to 21) |
| Serogroup W - hSBA ≥1:8 -Post-3rd dose(N=194,202) | 98 (95 to 99) | 3 (1 to 7) |
| Serogroup Y - hSBA ≥1:8 -Baseline(N=144,150) | 8 (4 to 13) | 4 (1 to 9) |
| Serogroup Y - hSBA ≥1:8 -Post-3rd dose(N=188,196) | 94 (89 to 97) | 3 (1 to 6) |
| Serogroup A - 4-fold rise-Post-3rd dose(N=170,177) | 78 (71 to 84) | 2 (0 to 5) |
| Serogroup C - 4-fold rise-Post-3rd dose(N=164,171) | 94 (89 to 97) | 1 (0 to 4) |
| Serogroup W - 4-fold rise-Post-3rd dose(N=147,158) | 93 (87 to 96) | 2 (0 to 5) |
| Serogroup Y -4-fold rise-Post-3rd dose(N=135,142) | 93 (87 to 96) | 2 (0 to 6) |
Immunogenicity was measured as the hSBA GMTs directed against meningococcal serogroups A, C, W and Y before (baseline) and one month after 3 infants doses of MenACWY-CRM administered at 2, 4 and 6 months of age.
| Titers | MenACWY-CRM + Routine Vaccines | Routine Vaccines |
|---|---|---|
| Serogroup A - Baseline (N=170,178) | 2.09 (2 to 2.18) | 2.05 (1.98 to 2.12) |
| Serogroup A - Post-3rd dose (N=202,208) | 21 (17 to 26) | 2.08 (1.99 to 2.17) |
| Serogroup C - Baseline (N=166,174) | 2.49 (2.25 to 2.76) | 2.39 (2.18 to 2.61) |
| Serogroup C - Post-3rd dose (N=199,206) | 74 (62 to 87) | 1.94 (1.64 to 2.3) |
| Serogroup W - Baseline (N=152,164) | 2.94 (2.52 to 3.43) | 2.98 (2.58 to 3.45) |
| Serogroup W - Post-3rd dose (N=194,202) | 79 (67 to 92) | 1.94 (1.68 to 2.24) |
| Serogroup Y - Baseline (N=144,150) | 2.52 (2.28 to 2.77) | 2.26 (2.12 to 2.41) |
| Serogroup Y - Post-3rd dose (N=188,196) | 51 (43 to 61) | 2.13 (2.02 to 2.25) |
The immune seroresponse to routine concomitant vaccination was measured as the percentages of subjects with pre-specified cut-off limit of ≥0.1 IU/mL (Diphtheria and Tetanus); ≥0.15 μg/mL (Hib); ≥0.35 μg/mL (Pneumococcal antigens, PnC); and ≥10 mIU/mL (Hepatitis B), evaluated using enzyme-linked immunosorbent assay (ELISA) at one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age. The immune response to pertussis antigens (PT, FHA, Pertactin, FIM) was measured as percentage of subjects with seroresponse (in initially seronegative infants, ≥4 times the lower limit of quantification (LLQ); in initially seropositive infants, at least 4 times prevaccination concentration) by ELISA and percentage of subjects with titer ≥1:8 (Polio types 1, 2, and 3) by neutralization test (NT) one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age.
| Percentage of subjects | MenACWY-CRM + Routine Vaccines | Routine Vaccines |
|---|---|---|
| Diphtheria (≥0.1 IU/mL) (N=207,218) | 99 (96 to 100) | 99 (96 to 100) |
| Tetanus (≥0.1 IU/mL) (N=207,218) | 97 (94 to 99) | 97 (93 to 99) |
| PT (N=185,191) | 77 (71 to 83) | 81 (75 to 86) |
| FHA (N=185,191) | 70 (63 to 76) | 65 (58 to 72) |
| Pertactin (N=185,191) | 73 (66 to 79) | 73 (66 to 79) |
| FIM (N=185,191) | 74 (67 to 80) | 76 (69 to 82) |
| Polio Type 1 - ≥1:8 (N=115,113) | 99 (95 to 100) | 98 (94 to 100) |
| Polio Type 2 - ≥1:8 (N=185,179) | 100 (98 to 100) | 99 (97 to 100) |
| Polio Type 3 - ≥1:8 (N=164,162) | 99 (97 to 100) | 100 (98 to 100) |
| Hepatitis B - ≥10 mIU/mL (N=138,148) | 96 (92 to 99) | 97 (92 to 99) |
| PRP-Hib - ≥0.15 μg/mL (N=187,194) | 95 (90 to 97) | 89 (84 to 93) |
| PnC 4 - ≥0.35 μg/mL (N=183,178) | 99 (96 to 100) | 98 (94 to 99) |
| PnC 6B - ≥0.35 μg/mL (N=183,178) | 86 (80 to 91) | 90 (84 to 94) |
| PnC 9V - ≥0.35 μg/mL (N=183,178) | 91 (86 to 95) | 94 (90 to 97) |
| PnC 14 - ≥0.35 μg/mL (N=183,178) | 99 (96 to 100) | 99 (96 to 100) |
| PnC 18C - ≥0.35 μg/mL (N=183,178) | 95 (90 to 97) | 97 (94 to 99) |
| PnC 19F - ≥0.35 μg/mL (N=183,178) | 100 (98 to 100) | 97 (93 to 99) |
| PnC 23F - ≥0.35 μg/mL (N=183,178) | 89 (83 to 89) | 94 (89 to 97) |
The immune response was measured as the geometric mean concentrations (GMCs) of antibodies directed against diphtheria, tetanus, pertussis (PT, FHA, Pertactin, FIM), hepatitis B, Hib, polio (type 1, 2 and 3) and pneumococcal (PnC 4, 6B, 9V, 14, 18C, 19F and 23F) antigens when routine vaccines are administered concomitantly with MenACWY-CRM compared with when routine vaccines are given alone, one month after 3 doses of infant series vaccination at 2, 4 and 6 months of age.
| μg/mL | MenACWY-CRM + Routine Vaccines | Routine Vaccines |
|---|---|---|
| Diphtheria (N=207,218) | 0.7 (0.63 to 0.78) | 0.85 (0.76 to 0.94) |
| Tetanus (N=207,218) | 0.8 (0.7 to 0.91) | 0.67 (0.59 to 0.76) |
| PT (N=185,191) | 25 (21 to 30) | 24 (21 to 29) |
| FHA (N=185,191) | 48 (43 to 54) | 47 (42 to 52) |
| Pertactin (N=185,191) | 56 (47 to 65) | 54 (46 to 62) |
| FIM (N=185,191) | 133 (113 to 157) | 122 (105 to 143) |
| Polio Type 1 (N=115,113) | 149 (115 to 194) | 117 (89 to 152) |
| Polio Type 2 (N=185,179) | 210 (178 to 246) | 185 (156 to 218) |
| Polio Type 3 (N=164,162) | 457 (367 to 569) | 402 (321 to 504) |
| Hepatitis B (N=138,148) | 394 (284 to 546) | 402 (289 to 558) |
| Hib (N=187,194) | 3.75 (2.92 to 4.82) | 2.76 (2.16 to 3.53) |
| PnC 4 (N=183,178) | 1.3 (1.16 to 1.46) | 1.45 (1.29 to 1.63) |
| PnC 6B (N=183,178) | 1.42 (1.17 to 1.72) | 1.79 (1.47 to 2.18) |
| PnC 9V (N=183,178) | 0.95 (0.84 to 1.08) | 1.2 (1.05 to 1.36) |
| PnC 14 (N=183,178) | 6.31 (5.45 to 7.31) | 6.61 (5.69 to 7.68) |
| PnC 18C (N=183,178) | 1.36 (1.2 to 1.55) | 1.42 (1.24 to 1.62) |
| PnC 19F (N=183,178) | 1.84 (1.63 to 2.08) | 2.04 (1.8 to 2.32) |
| PnC 23F (N=183,178) | 1.15 (0.99 to 1.35) | 1.33 (1.13 to 1.56) |
Immunogenicity was measured as the GMCs of anti-pneumococcal antibodies against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age administered concomitantly with MenACWY-CRM compared with PCV given alone.
| μg/mL | MenACWY-CRM + Routine Vaccines | Routine Vaccines |
|---|---|---|
| PnC 4 (N=161,170) | 1.57 (1.35 to 1.82) | 1.6 (1.39 to 1.85) |
| PnC 6B (N=161,170) | 5.92 (5.05 to 6.95) | 7.8 (6.69 to 9.09) |
| PnC 9V (N=161,170) | 1.67 (1.44 to 1.93) | 1.91 (1.66 to 2.19) |
| PnC 14 (N=161,170) | 7.9 (6.73 to 9.28) | 7.61 (6.52 to 8.88) |
| PnC 18C (N=161,170) | 1.79 (1.55 to 2.08) | 1.8 (1.57 to 2.08) |
| PnC 19F (N=161,170) | 5.03 (4.36 to 5.82) | 5.68 (4.95 to 6.53) |
| PnC 23F (N=161,170) | 3.3 (2.8 to 3.89) | 3.91 (3.34 to 4.57) |
The immune seroresponse was measured as the percentage of subjects with anti-pneumococcal antigen antibodies ≥0.35 μg/mL against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age when administered concomitantly with MenACWY-CRM compared with PCV given alone.
| Percentage of subjects | MenACWY-CRM + Routine Vaccines | Routine Vaccines |
|---|---|---|
| PnC 4 (N=161,170) | 93 (88 to 97) | 96 (92 to 98) |
| PnC 6B (N=161,170) | 99 (97 to 100) | 98 (95 to 100) |
| PnC 9V (N=161,170) | 97 (93 to 99) | 96 (92 to 98) |
| PnC 14 (N=161,170) | 99 (96 to 100) | 99 (97 to 100) |
| PnC 18C (N=161,170) | 96 (92 to 99) | 98 (94 to 99) |
| PnC 19F (N=161,169) | 99 (96 to 100) | 100 (98 to 100) |
| PnC 23F (N=161,170) | 99 (97 to 100) | 98 (94 to 99) |
The antibody persistence was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.
| Percentage of subjects | MenACWY-CRM + Routine Vaccines | Routine Vaccines |
|---|---|---|
| Serogroup A - Baseline (N=139, 145) | 1 (0 to 5) | 0 (0 to 3) |
| Serogroup A - 6 mo Post-3rd dose (N=168,175) | 7 (4 to 12) | 2 (0 to 5) |
| Serogroup C - Baseline (N=126,136) | 7 (3 to 13) | 8 (4 to 14) |
| Serogroup C - 6 mo Post-3rd dose (N=156,171) | 37 (30 to 45) | 2 (1 to 6) |
| Serogroup W - Baseline (N=152,164) | 15 (9 to 23) | 15 (9 to 23) |
| Serogroup W - 6 mo Post-3rd dose (N=153,165) | 70 (62 to 77) | 5 (2 to 9) |
| Serogroup Y - Baseline (N=108,113) | 6 (3 to 13) | 5 (2 to 11) |
| Serogroup Y - 6 mo Post-3rd dose (N=153,159) | 53 (45 to 61) | 3 (1 to 6) |
The antibody persistence was measured as the hSBA GMTs directed against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.
| Titers | MenACWY-CRM + Routine Vaccines | Routine Vaccines |
|---|---|---|
| Serogroup A - Baseline (N=139, 145) | 2.07 (1.98 to 2.16) | 2.01 (1.99 to 2.03) |
| Serogroup A - 6 mo Post-3rd dose (N=168,175) | 2.52 (2.26 to 2.82) | 2.12 (2.0 to 2.25) |
| Serogroup C - Baseline (N=126,136) | 2.49 (2.2 to 2.83) | 2.44 (2.2 to 2.7) |
| Serogroup C - 6 mo Post-3rd dose (N=156,171) | 5.98 (4.81 to 7.43) | 2.15 (2.02 to 2.3) |
| Serogroup W - Baseline (N=113,126) | 2.99 (2.49 to 3.6) | 2.97 (2.52 to 3.51) |
| Serogroup W - 6 mo Post-3rd dose (N=153,165) | 15 (12 to 18) | 2.23 (2.06 to 2.4) |
| Serogroup Y - Baseline (N=108,113) | 2.43 (2.19 to 2.71) | 2.32 (2.13 to 2.52) |
| Serogroup Y - 6 mo Post-3rd dose (N=153,159) | 8.39 (6.9 to 10) | 2.09 (2.0 to 2.19) |
The immune response was measured as the percentage of subjects who achieved four-fold increase in hSBA titers against meningococcal serogroup A, C, W and Y one month after toddler dose of MenACWY-CRM administered at 12 months of age as compared to hSBA titers before the toddler vaccination.
| Percentage of subjects | MenACWY-CRM + Routine Vaccines | Routine Vaccines |
|---|---|---|
| Serogroup A (N=168,175) | 89 (83 to 93) | 1 (0.014 to 3) |
| Serogroup C (N=156,171) | 92 (87 to 96) | 1 (0 to 4) |
| Serogroup W (N=153,165) | 95 (91 to 98) | 2 (1 to 6) |
| Serogroup Y (N=153,159) | 96 (92 to 99) | 1 (0.016 to 3) |
Safety of the study vaccines (MenACWY-CRM and other routine vaccines) was assessed in terms of the number of subjects who reported adverse events (AEs) and/or serious AEs per vaccine group at the following time points: entire study period, after infants vaccination (up to 7 months), between 2- and 4-months, between 4- and 6-months, between 6- and 12-months, between 7- and 12-months, 28 days after 12-month vaccination, and between 29 days after 12-month vaccination and study termination. Solicited reactions were not collected during this study. The safety analyses also included any AEs observed by study personnel within 15 minutes following vaccination. All AEs and SAEs were judged by the investigator as whether probably related, possibly related, or not related to vaccine.
| Number of subjects | MenACWY-CRM + Routine Vaccines | Routine Vaccines |
|---|---|---|
| Entire study - Any AEs | 228 | 239 |
| Entire study - At least possibly related AEs | 6 | 2 |
| Entire study - Serious AEs | 21 | 20 |
| Up to 7 months - Any AEs | 183 | 189 |
| Up to 7 months - At least possibly related AEs | 6 | 1 |
| Up to 7 months - Serious AEs | 7 | 8 |
| Between 2- and 4-months - Any AEs | 99 | 105 |
| Between 2- & 4-mo - At least possibly related AEs | 1 | 0 |
| Between 2- and 4-months - Serious AEs | 5 | 5 |
| Between 4- and 6-months - Any AEs | 118 | 114 |
| Between 4- & 6-mo - At least possibly related AEs | 3 | 0 |
| Between 4- and 6-months - Serious AEs | 2 | 2 |
| Between 6- and 12-months - Any AEs | 187 | 197 |
| Between 6- & 12-mo - At least possibly related AEs | 2 | 1 |
| Between 6- and 12-months - Serious AEs | 10 | 2 |
| Between 7- and 12-months - Any AEs | 175 | 181 |
| Between 7- & 12-mo - At least possibly related AEs | 0 | 0 |
| Between 7- and 12-months - Serious AEs | 9 | 2 |
| 28 days post-toddler - Any AEs | 80 | 78 |
| 28 days post-toddler-At least possibly related AEs | 0 | 0 |
| 28 days post-toddler - Serious AEs | 1 | 1 |
| Between 29 days and study termination - Any AEs | 137 | 137 |
| B/w 29 days & study terminat-Possibly related AEs | 0 | 0 |
| Between 29 days and study termination - SeriousAEs | 7 | 11 |
Collected over Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MenACWY-CRM + Routine Vaccines | — | 21/255 (8.2%) | 216/255 (84.7%) |
| Routine Vaccines | — | 20/270 (7.4%) | 227/270 (84.1%) |
| Event | MenACWY-CRM + Routine Vaccines | Routine Vaccines |
|---|---|---|
| BronchiolitisInfections and infestations | 4/255 | 2/270 |
| Respiratory syncytial virus bronchiolitisInfections and infestations | 3/255 | 2/270 |
| Croup infectiousInfections and infestations | 1/255 | 3/270 |
| PneumoniaInfections and infestations | 2/255 | 1/270 |
| AbscessInfections and infestations | 0/255 | 2/270 |
| CellulitisInfections and infestations | 0/255 | 2/270 |
| Urinary tract infectionInfections and infestations | 0/255 | 2/270 |
| LaryngomalaciaCongenital, familial and genetic disorders | 1/255 | 0/270 |
| Impaired gastric emptyingGastrointestinal disorders | 1/255 | 0/270 |
| Meningitis enteroviralInfections and infestations | 1/255 | 0/270 |
| Event | MenACWY-CRM + Routine Vaccines | Routine Vaccines |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 144/255 | 154/270 |
| Otitis mediaInfections and infestations | 100/255 | 106/270 |
| ConjunctivitisEye disorders | 58/255 | 52/270 |
| Viral infectionInfections and infestations | 36/255 | 51/270 |
| PyrexiaGeneral disorders | 43/255 | 45/270 |
| GastroenteritisInfections and infestations | 38/255 | 32/270 |
| BronchiolitisInfections and infestations | 37/255 | 40/270 |
| Dermatitis diaperSkin and subcutaneous tissue disorders | 33/255 | 40/270 |
| CoughRespiratory, thoracic and mediastinal disorders | 34/255 | 27/270 |
| Otitis media acuteInfections and infestations | 31/255 | 31/270 |
Analysis was performed on all enrolled subjects.
| Age, Continuous(Days) | MenACWY-CRM + Routine Vaccines | Routine Vaccines | Total |
|---|---|---|---|
| Mean | 64.7 ± 6.5 | 65.4 ± 7.4 | 65.1 ± 7.0 |
| Sex: Female, Male(Participants) | MenACWY-CRM + Routine Vaccines | Routine Vaccines | Total |
|---|---|---|---|
| Female | 125 | 130 | 255 |
| Male | 133 | 141 | 274 |
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