A Phase III Open-label Randomised Study to Evaluate the Immunogenicity and Safety of the Concomitant Administration of a New Hexavalent DTaP-IPV-HepB-PRP-T Combined Vaccine (Hexavalent Vaccine) Given at 2, 3, and 4 Months of Age With a Meningococcal Serogroup C Conjugate (MenC) Vaccine Given at 2 and 4 Months of Age
Hexavalent vaccine
+ NeisVac-C
+ Prevenar 13
Bacterial Infections and Mycoses+1
+ Infections
+ Bacterial Infections
Prevention Study
Summary
Study start date: April 1, 2013
Actual date on which the first participant was enrolled.Primary Series Secondary objectives To describe the antibody response to all the hexavalent vaccine antigens one month after the third dose of the hexavalent vaccine when given concomitantly or not to MenC To describe the antibody response to MenC vaccine when a MenC vaccine is given concomitantly with the hexavalent vaccine, one month after the first and the second dose of MenC vaccine To describe the safety profile of the hexavalent vaccine after each and any injection when given concomitantly or not with a MenC vaccine Booster Secondary objectives To describe the antibody (Ab) persistence at 12 months of age for the hexavalent valences following a 3-dose primary vaccination at 2, 3 and 4 months of age (prior to administration of a booster dose) To describe the safety of a booster dose of the hexavalent vaccine and of a meningococcal group ACWY conjugate (MenACWY) vaccine either co-administered at 12 months of age or given separately.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.350 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Healthy infant 46 to 74 days of age (both inclusive) Born at full term of pregnancy (≥37 weeks) and/or with a birth weight≥2.5 kg Subject's parent(s) or legal representative able to comply with the study procedures Exclusion Criteria: Participation in another clinical study investigating a vaccine, drug, medical device, or medical procedure Receipt of any vaccine in the 4 weeks preceding each study vaccination Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, meningococcal, pneumococcal, rotavirus infection Know or suspected congenital, hereditary or acquired immunodeficiency History of seizures or encephalopathy Known thrombocytopenia Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection Chronic illness that could interfere with trial conduct or completion Known or suspected hypersensitivity to any of the study vaccines' active substance or excipients or history of a life-threatening reaction to a vaccine(s) containing the same substances as the study vaccines Contraindication to any of the study vaccines Known personal or maternal history of hepatitis B or hepatitis C seropositivity History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b or meningococcal serogroup C infection Receipt of immune globulin, blood or blood-derived products, immunosuppressive drugs, systemic corticosteroid since birth Identified as a natural or adopted child of the investigator or employee with direct involvement in the current study.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 11 locations
Sanofi Pasteur MSD Investigational Site 003
Espoo, FinlandOpen Sanofi Pasteur MSD Investigational Site 003 in Google MapsSanofi Pasteur MSD Investigational Site 001
Helsinki, FinlandSanofi Pasteur MSD Investigational Site 002
Helsinki, FinlandSanofi Pasteur MSD Investigational Site 011
Jarvenpaa, Finland