Clinical trial NCT01839188: Spanish Mixed HEXA/PENTA/HEXA Schedule (V419-010)
Official title: A Phase 3 Open-label Study to Evaluate the Immunogenicity and Safety of a Mixed (HEXA/PENTA/HEXA) Primary Series Schedule That Includes V419 (PR5I) at 2 and 6 Months of Age and Pediacel at 4 Months of Age.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neisseria Meningitidis
Bacterial Infections
Virus Diseases
Lead sponsor: MCM Vaccines B.V.
Sponsor class: INDUSTRY
Collaborators: name: Sanofi Pasteur, a Sanofi Company
name: Merck Sharp & Dohme LLC
First posted: 2013-04-24
Enrollment: 385
Sex: ALL
Minimum age (years): 46
Maximum age (years): 76
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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


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

Primary outcomes:
measure: Percentage of Participants With an Anti-Hepatitis B Surface Antigen (HBsAg) Antibody Titer ≥10 mIU/mL
timeFrame: Month 5 (one month after receiving Vaccination 3)
measure: Percentage of Participants With an Anti-Polyribosylribitol Phosphate (PRP) Antibody Titer ≥0.15 µg/mL
timeFrame: Month 5 (one month after receiving Vaccination 3)
Secondary outcomes:
measure: Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen (HBsAg)
timeFrame: Month 5 (one month after receiving Vaccination 3)
measure: Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate (PRP) Antigen
timeFrame: Month 5 (one month after receiving Vaccination 3)
measure: Geometric Mean Concentration of Antibodies to Diphtheria Toxin
timeFrame: Month 5 (one month after receiving Vaccination 3)
measure: Geometric Mean Concentration of Antibodies to Tetanus Toxin
timeFrame: Month 5 (one month after receiving Vaccination 3)
measure: Geometric Mean Concentrations of Antibodies to Pertussis Antigens
timeFrame: Month 5 (one month after receiving Vaccination 3)
measure: Geometric Mean Titers for Antibodies to Inactivated Poliovirus 1-3 (IPV1-3)
timeFrame: Month 5 (one month after receiving Vaccination 3)
measure: Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3)
timeFrame: Month 5 (one month after receiving Vaccination 3)
measure: Geometric Mean Titer of Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibodies
timeFrame: Month 3 (one month after receiving Vaccination 2)
measure: Percentage of Participants With an Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibody Titer ≥8
timeFrame: Month 3 (one month after receiving Vaccination 2)
measure: Percentage of Participants With a Body Temperature ≥38°C After Each Vaccination
timeFrame: Up to Day 5 following each vaccination
measure: Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination
timeFrame: Up to Day 5 following each vaccination
measure: Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination
timeFrame: Up to Day 5 following each vaccination
measure: Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination
timeFrame: Up to Day 15 following each vaccination
measure: Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination
timeFrame: Up to Day 15 following each vaccination
measure: Number of Participants Experiencing a Solicited Systemic Adverse Event (AE)
timeFrame: Up to Day 5 following each vaccination
measure: Number of Participants Experiencing an Unsolicited Systemic Adverse Event (AE)
timeFrame: Up to Day 15 following each vaccination
measure: Number of Participants Experiencing a Serious Adverse Event (SAE)
timeFrame: Up to ~6 months (at any time during the study)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Martinon-Torres F, Boisnard F, Thomas S, Sadorge C, Borrow R; PRI02C study group. 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). Vaccine. 2017 Jun 27;35(30):3764-3772. doi: 10.1016/j.vaccine.2017.05.043. Epub 2017 Jun 2.