Concomitant Administration of a New Hexavalent Vaccine With a Meningococcal Serogroup C Conjugate Vaccine in Healthy Infants During Primary Series Immunisation Followed by Booster Vaccination
NCT ID: NCT01839175
Last Updated: 2017-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
350 participants
INTERVENTIONAL
2013-04-30
2015-02-28
Brief Summary
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* To demonstrate that the concomitant administration of the hexavalent vaccine with a meningococcal serogroup C conjugate vaccine is non inferior to the administration of the hexavalent vaccine without a MenC vaccine concomitantly in term of seroprotection rate for hepatitis B one month after the third dose of the hexavalent vaccine
* To demonstrate that the concomitant administration of a MenC vaccine with the hexavalent vaccine induces an acceptable response for MenC in term of seroprotection rate (SPR) one month after the second dose of MenC
Booster Primary objectives
\- To describe the immunogenicity 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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1
Hexavalent vaccine
0.5 mL intramuscular injection at 2, 3 and 4 months of age (primary series) 0.5 mL intramuscular injection at 12 or 13 months of age (booster)
NeisVac-C
0.5 mL intramuscular injection at 2 and 4 months of age
Prevenar 13
0.5 mL intramuscular injection at 2 and 4 months of age (primary series) 0.5 mL intramuscular injection at 13 months of age (booster)
RotaTeq
2 mL oral administration at 2, 3 and 4 months
Nimenrix
0.5 mL intramuscular injection at 12 months
M-M-RVAXPRO
0.5 mL intramuscular or subcutaneous injection at 13 months of age
Group 2
Hexavalent vaccine
0.5 mL intramuscular injection at 2, 3 and 4 months of age (primary series) 0.5 mL intramuscular injection at 12 or 13 months of age (booster)
Prevenar 13
0.5 mL intramuscular injection at 2 and 4 months of age (primary series) 0.5 mL intramuscular injection at 13 months of age (booster)
RotaTeq
2 mL oral administration at 2, 3 and 4 months
Nimenrix
0.5 mL intramuscular injection at 12 months
M-M-RVAXPRO
0.5 mL intramuscular or subcutaneous injection at 13 months of age
Interventions
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Hexavalent vaccine
0.5 mL intramuscular injection at 2, 3 and 4 months of age (primary series) 0.5 mL intramuscular injection at 12 or 13 months of age (booster)
NeisVac-C
0.5 mL intramuscular injection at 2 and 4 months of age
Prevenar 13
0.5 mL intramuscular injection at 2 and 4 months of age (primary series) 0.5 mL intramuscular injection at 13 months of age (booster)
RotaTeq
2 mL oral administration at 2, 3 and 4 months
Nimenrix
0.5 mL intramuscular injection at 12 months
M-M-RVAXPRO
0.5 mL intramuscular or subcutaneous injection at 13 months of age
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
46 Days
76 Days
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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Sanofi Pasteur MSD Investigational Site 003
Espoo, , Finland
Sanofi Pasteur MSD Investigational Site 001
Helsinki, , Finland
Sanofi Pasteur MSD Investigational Site 002
Helsinki, , Finland
Sanofi Pasteur MSD Investigational Site 011
Järvenpää, , Finland
Sanofi Pasteur MSD Investigational Site 010
Kokkola, , Finland
Sanofi Pasteur MSD Investigational Site 004
Oulu, , Finland
Sanofi Pasteur MSD Investigational Site 005
Pori, , Finland
Sanofi Pasteur MSD Investigational Site 009
Seinäjoki, , Finland
Sanofi Pasteur MSD Investigational Site 006
Tampere, , Finland
Sanofi Pasteur MSD Investigational Site 007
Turku, , Finland
Sanofi Pasteur MSD Investigational Site 008
Vantaa, , Finland
Countries
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References
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Vesikari T, Borrow R, Da Costa X, Thomas S, Eymin C, Boisnard F, Lockhart S. Concomitant administration of a fully liquid ready-to-use DTaP-IPV-HB-PRP-T hexavalent vaccine with a meningococcal ACWY conjugate vaccine in toddlers. Vaccine. 2018 Dec 18;36(52):8019-8027. doi: 10.1016/j.vaccine.2018.10.100. Epub 2018 Nov 22.
Vesikari T, Borrow R, Da Costa X, Richard P, Eymin C, Boisnard F, Lockhart S. Concomitant administration of a fully liquid, ready-to-use DTaP-IPV-HB-PRP-T hexavalent vaccine with a meningococcal serogroup C conjugate vaccine in infants. Vaccine. 2017 Jan 11;35(3):452-458. doi: 10.1016/j.vaccine.2016.11.053. Epub 2016 Dec 9.
Other Identifiers
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2012-005547-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HXM01C
Identifier Type: -
Identifier Source: org_study_id
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