Phase 3
Completed N=385
Spanish Mixed HEXA/PENTA/HEXA Schedule (V419-010)
Neisseria meningitidis · Bacterial Infections · Virus Diseases
Source: ClinicalTrials.gov NCT01839188 ↗
Enrolled (actual)
385
Serious AEs
3.1%
Results posted
Feb 2019
Primary outcomePrimary: Percentage of Participants With an Anti-Hepatitis B Surface Antigen (HBsAg) Antibody Titer ≥10 mIU/mL — 98.9 Percentage of Participants
◆ Published Evidence
Emerging
16citations · ~2 / year
Immunogenicity and safety of a new hexavalent vaccine (DTaP5-IPV-HB-Hib) administered in a mixed primary series schedule with a pentavalent vaccine (DTaP5-IPV-Hib).
Summary
To evaluate the immune response and the safety of a primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel at 4 months of age
Primary objectives
* To demonstrate that the mixed schedule induces acceptable responses for Hepatitis B (HB) one month after completion of the mixed schedule
* To demonstrate that the mixed schedule induces acceptable responses for Haemophilus influenzae type b (Hib) one month after completion of the mixed schedule
Secondary objectives
* To describe the antibody response to all PR5I antigens one month after completion of the mixed schedule
* To describe the antibody response to meningococcal serogroup C (MCC) conjugate vaccine one month after the second dose of MenC vaccine
* To describe the safety profile after each dose of study vaccines administered
Linked Publications
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Immunogenicity and safety of a new hexavalent vaccine (DTaP5-IPV-HB-Hib) administered in a mixed primary series schedule with a pentavalent vaccine (DTaP5-IPV-Hib).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Anti-Hepatitis B Surface Antigen (HBsAg) Antibody Titer ≥10 mIU/mL |
98.9 | — |
| PRIMARY Percentage of Participants With an Anti-Polyribosylribitol Phosphate (PRP) Antibody Titer ≥0.15 µg/mL |
100.0 | — |
| SECONDARY Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen (HBsAg) |
1054.97 | — |
| SECONDARY Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate (PRP) Antigen |
8.00 | — |
| SECONDARY Geometric Mean Concentration of Antibodies to Diphtheria Toxin |
0.47 | — |
| SECONDARY Geometric Mean Concentration of Antibodies to Tetanus Toxin |
2.44 | — |
| SECONDARY Geometric Mean Concentrations of Antibodies to Pertussis Antigens |
107.46; 67.09; 56.46; 360.99 | — |
| SECONDARY Geometric Mean Titers for Antibodies to Inactivated Poliovirus 1-3 (IPV1-3) |
663.97; 1198.93; 764.64 | — |
| SECONDARY Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3) |
95.3; 100.0; 92.2; 100.0; 100.0; 100.0 | — |
| SECONDARY Geometric Mean Titer of Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibodies |
739.63 | — |
| SECONDARY Percentage of Participants With an Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibody Titer ≥8 |
99.2 | — |
| SECONDARY Percentage of Participants With a Body Temperature ≥38°C After Each Vaccination |
4.9; 6.3; 4.7 | — |
| SECONDARY Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination |
81; 65; 69; 136; 152; 97 | — |
| SECONDARY Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination |
41; 59; 85; 113; 89; 151 | — |
| SECONDARY Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination |
1; 0; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination |
1; 0; 1; 0; 2; 2 | — |
| SECONDARY Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) |
188; 131; 102; 255; 141; 88 | — |
| SECONDARY Number of Participants Experiencing an Unsolicited Systemic Adverse Event (AE) |
58; 53; 89; 163 | — |
| SECONDARY Number of Participants Experiencing a Serious Adverse Event (SAE) |
12 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy infant 46 to 74 days (both inclusive)
- Documented receipt of only one dose of monovalent hepatitis B vaccine within the 3 days after birth
- Parent(s)/legal representative able to comply with the study procedures
Exclusion Criteria
- Participation in any study with an investigational compound or device since birth
- History of congenital or acquired immunodeficiency
- Chronic illness that could interfere with study conduct or completion
- Hypersensitivity to any of the study vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines
- Contraindication to Pediacel®, NeisVac-C®, Prevenar 13®, and RotaTeq®
- History or maternal history of HBsAg seropositivity
- Coagulation disorder that contraindicate intramuscular injection
- History of vaccination with a Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acelullar or whole-cell), poliovirus, meningococcal serogroup C conjugate, pneumococcal conjugate containing vaccine(s)
- History of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, or serogroup C meningococcal infection
- Receipt of immune globulin, blood or blood-derived products since birth
- Receipt of systemic corticosteroids for more than 14 consecutive days within one month of the study start
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
Data sourced from ClinicalTrials.gov (NCT01839188) and the linked publication. 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.