Phase 3
N=1,315
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)
Bacterial Infections · Virus Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01480258 ↗Enrolled (actual)
1,315
Serious AEs
1.2%
Results posted
Apr 2019
Primary outcome: Primary: Acceptability of Antibody (Ab) Response or Seroresponse Rates to All Antigens Contained in PR5I Vaccine One Month After the Toddler Dose of PR5I (11 to 12 Months of Age) — 89.87; 98.14; 98.64; 99.83 Percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PR5I (Biological); Rotavirus vaccine (Biological); Prevenar 13™ (Biological); INFANRIX™ hexa (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- MCM Vaccines B.V.
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability of Antibody (Ab) Response or Seroresponse Rates to All Antigens Contained in PR5I Vaccine One Month After the Toddler Dose of PR5I (11 to 12 Months of Age) |
89.87; 98.14; 98.64; 99.83; 99.12; 97.42 | <0.001 sig |
| SECONDARY Non-inferiority of Antibody (Ab) Response Rate to Haemophilus Influenzae Type b (PRP) One Month After the 2nd Dose of PR5I (4 Months of Age) as Compared With INFANRIX Hexa |
72.86; 26.66 | <0.001 sig |
| SECONDARY Superiority of Antibody (Ab) Response Rates to Haemophilus Influenzae Type b (PRP) One Month After the 2nd Dose of PR5I (4 Months of Age) as Compared With INFANRIX Hexa |
72.86; 26.66 | <0.001 sig |
| SECONDARY Non-inferiority Ab Response Rates to PR5I Antigens One Month After the Toddler Dose of PR5I (11 to 12 Months of Age) as Compared With INFANRIX Hexa |
89.80; 91.06; 98.14; 98.73; 98.62; 99.83 | <0.001 sig |
| SECONDARY Non-inferiority of Rotavirus Response (Geometric Mean Titer, GMT) One Month After the 2nd Dose of Rotarix (4 Months of Age) Administered Concomitantly With PR5I Versus INFANRIX Hexa |
96.41; 122.24 | 0.011 sig |
| SECONDARY Number of Participants Who Experienced an Adverse Event (AE) From Day 1 to Day 15 After Any Vaccination |
99.5; 99.2; 99.5; 98.8; 90.8; 88.2 | — |
| SECONDARY Percentage of Participants Reporting Solicited ISRs From D1 to D5 After Any Vaccination |
68.6; 60.4; 73.4; 70.0; 56.8; 49.3 | — |
| SECONDARY Percentage of Participants Reporting Unsolicited ISRs From D1 to D15 After Any Vaccination |
0.9; 2.0; 1.8; 1.8; 15.8; 13.2 | — |
| SECONDARY Percentage of Participants Reporting Solicited Adverse Events (AEs) From D1 to D5 After Any Vaccination |
89.3; 87.1; 65.8; 62.2; 91.6; 89.4 | — |
Summary
This study will determine whether participants who receive V419 (PR5I) at 2, 4, and 11 to 12 months of age have an acceptable response to the vaccine. This study will also determine whether the immune response to V419 is similar to that of participants who received a licensed vaccine control. The primary hypothesis is that participants who receive PR5I at 2, 4, and 11 to 12 months have an acceptable response rate to all PR5I-contained antigens at one month after the Toddler dose of PR5I.
Eligibility Criteria
Inclusion Criteria
- Healthy infant able to attend all study visits
- Parent(s)/legal representative are able to read, understand, and complete study questionnaires
Exclusion Criteria
- History of congenital or acquired immunodeficiency
- Received or is expected to receive immunosuppressive agents or systemic immunomodulatory steroids
- History of leukemia, lymphoma, malignant melanoma, or myeloproliferative disorder
- Hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or concomitant study vaccines
- Has any chronic illness that could interfere with study conduct or completion
- Received any immune globulin, blood, or blood-derived products since birth
- Received a dose of hepatitis B vaccine prior to study entry
- Vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, Haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus vaccine, or combination thereof
- Fever within 24 hours prior to enrollment
- Received any non-study vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 14 days or more prior to enrolment
- Has a coagulation disorder
- Has developmental delay or neurological disorder
- Participant or his/her mother has a medical history of hepatitis B surface antigens (HBsAg) seropositivity
- History of Haemophilus influenzae type b, hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus gastroenteritis, or invasive pneumococcal infection
Data sourced from ClinicalTrials.gov (NCT01480258). 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.