Phase 3
Completed N=284
Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011)
Neisseria meningitidis · Bacterial Infections · Virus Diseases
Source: ClinicalTrials.gov NCT01553279 ↗
Enrolled (actual)
284
Serious AEs
3.5%
Results posted
Mar 2019
Primary outcomePrimary: Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil One Month After MCC-TT or MCC-CRM (Part 1) — 100.0; 99.1 Percentage of Participants
Summary
The primary objectives of this study are to evaluate the immunogenicity and safety of concomitant administration of V419 (PR51) with 2 types of meningococcal serogroup C conjugate (MCC) vaccines to healthy infants at 3 and 4 months of age in terms of antibody seroprotection rate (SPR) to MCC. Participants also received a Haemophilus influenza type B (Hib)-MCC vaccination at 12 months of age. It was hypothesized that the SPR to MCC at 1 month post-dose 2 of either tetanus toxoid conjugated Meningo C (MCC-TT) or CRM197 conjugated Meningo C (MCC-CRM) vaccines would be acceptable when administered concomitantly with V419.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil One Month After MCC-TT or MCC-CRM (Part 1) |
100.0; 99.1 | — |
| SECONDARY Percentage of Participants With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody (Ab) Titre ≥0.15 µg/mL One Month After V419 Dose 3 (Part 1) |
98.9 | — |
| SECONDARY Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1) |
100.0; 96.4; 98.0; 84.5; 100.0; 99.1 | — |
| SECONDARY Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1) |
1353; 285.0; 2024.7; 1077.4 | — |
| SECONDARY Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1) |
97.8; 100.0; 96.8; 96.3; 100.0; 100.0 | — |
| SECONDARY Antibody (Ab) Geometic Mean Titres (GMTs) for Haemophilus Influenza Type B (Polyribosylribitol Phosphate [PRP]) One Month After V114 Dose 3 (Part 2) |
6.44; 8.21 | — |
| SECONDARY Antibody (Ab) Geometic Mean Titres (GMTs) for Hepatitis B Surface Antigen (HBsAg) One Month After V114 Dose 3 (Part 2) |
195.1; 247.7 | — |
| SECONDARY Antibody (Ab) Geometic Mean Titres (GMTs) for Diptheria One Month After V114 Dose 3 (Part 2) |
0.198; 0.22 | — |
| SECONDARY Antibody (Ab) Geometic Mean Titres (GMTs) for Tetanus One Month After V114 Dose 3 (Part 2) |
1.03; 0.95 | — |
| SECONDARY Antibody (Ab) Geometic Mean Titres (GMTs) for Pertussis Toxoid (PT) One Month After V114 Dose 3 (Part 2) |
131.5; 133.3 | — |
| SECONDARY Antibody (Ab) Geometic Mean Titres (GMTs) for Filamentous Haemagglutinin (FHA) One Month After V114 Dose 3 (Part 2) |
50.4; 50.1 | — |
| SECONDARY Antibody (Ab) Geometic Mean Titres (GMTs) for Pertactin (PRN) One Month After V114 Dose 3 (Part 2) |
90.4; 106.8 | — |
| SECONDARY Antibody (Ab) Geometic Mean Titres (GMTs) for Fimbrae Types 2 and 3 (FIM) One Month After V114 Dose 3 (Part 2) |
401.7; 441.7 | — |
| SECONDARY Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2) |
214; 257.9; 385.2; 400.6; 502.2; 405.1 | — |
| SECONDARY Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2) |
83.1; 40.4; 40.4; 16.0; 100.0; 97.3 | — |
| SECONDARY Antibody (Ab) Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Meningococcal Serogroup C (MCC) Vaccination (Part 2) |
50.3; 8.7; 3257.9; 580.8 | — |
| SECONDARY Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2) |
93.9; 95.4; 54.9; 56.3; 100.0; 100.0 | — |
| SECONDARY Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2) |
1.09; 1.18; 100.19; 121.00 | — |
| SECONDARY Percentage of Participants Experiencing an Adverse Event (AE) [Part 1] |
98.6; 97.2 | — |
| SECONDARY Percentage of Participants Experiencing an Injection Site (Vaccine-Related) Systemic Adverse Event (AE) [Part 1] |
98.6; 96.5 | — |
| SECONDARY Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1) |
71.1; 64.8; 63.4; 66.2; 51.4; 47.2 | — |
| SECONDARY Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1) |
6.3; 11.3 | — |
| SECONDARY Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1) |
56.3; 45.8; 41.5; 45.8; 35.9; 28.2 | — |
| SECONDARY Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1) |
1.4; 4.2; 0; 0.7; 0; 0.7 | — |
| SECONDARY Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1] |
85.9; 81.0; 63.4; 64.8; 88.0; 81.0 | — |
| SECONDARY Percentage of Participants Experiencing Increased Temperature [Part 1] |
11.3; 10.6; 1.4; 2.1; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants Experiencing a Serious Adverse Event (SAE) [Part 1] |
4.2; 2.8 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy infant 46 to 74 days of age (both inclusive)
- Parent(s)/legal representative able to comply will the study procedures
Exclusion Criteria
- Is participating in a study with an investigational compound or device since birth
- Has a history of congenital or acquired immunodeficiency
- Has a history of leukemia, lymphoma, malignant melanoma or myeloproliferative disorder
- Has a chronic illness that could interfere with study conduct or completion
- Has hypersensitivity to any of the vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or contraindication to any of the study vaccines
- Has a history, or mother has a history, of hepatitis B virus surface antigen (HBsAg) seropositivity
- Has a coagulation disorder that contraindicate intramuscular injection
- Has a history of vaccination with a hepatitis B, Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acellular or whole-cell), poliovirus, pneumococcal conjugate or polysaccharide, meningococcal serogroup C conjugate, measles, mumps, or rubella containing vaccine(s)
- Has a history of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, invasive pneumococcal, meningococcal serogroup C, measles, mumps or rubella infection
- Has received immune globulin, blood or blood-derived products, immunosuppressive agents systemic corticosteroids since birth
- Has received vaccination with an inactivated (except influenza vaccine) or conjugated or live vaccine in the last 30 days or vaccination with an inactivated influenza vaccine in the last 14 days
- Has received antipyretic, analgesic and non-steroidal anti-inflammatory medications in the last 48 hours
- Has a febrile illness or body temperature ≥38.0°C in the last 24 hours
Data sourced from ClinicalTrials.gov (NCT01553279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.