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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT01839175
First received: April 19, 2013
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

Primary Series Primary objectives

  • 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.


Condition Intervention Phase
Neisseria Meningitidis
Bacterial Infections
Virus Diseases
Biological: Hexavalent vaccine
Biological: NeisVac-C
Biological: Prevenar 13
Biological: RotaTeq
Biological: Nimenrix
Biological: M-M-RVAXPRO
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi Pasteur MSD:

Primary Outcome Measures:
  • Proportion of subjects with an anti-hepatitis B concentration ≥10 IU/mL [ Time Frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine) ] [ Designated as safety issue: No ]
  • Proportion of subjects with an anti-MenC titre ≥1:8 dil [ Time Frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with an anti-polyribosylribitol phosphate concentration ≥0.15 µg/mL [ Time Frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) and Month 13 (One month post-booster) ] [ Designated as safety issue: No ]
  • Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL [ Time Frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) ] [ Designated as safety issue: No ]
  • Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL [ Time Frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) ] [ Designated as safety issue: No ]
  • Proportion of subjects with an anti-inactivated poliovirus 1, 2, 3 titre ≥1:8 dil [ Time Frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) and Month 13 (One month post-booster) ] [ Designated as safety issue: No ]
  • Proportion of subjects with pertussis vaccine response [ Time Frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine) ] [ Designated as safety issue: No ]
  • Proportion of subjects with an anti-MenC titre ≥1:8 dil [ Time Frame: Month 3 (One month after dose 1 of MenC vaccine) ] [ Designated as safety issue: No ]
  • Solicited injection-site and systemic reactions [ Time Frame: Day 1 to Day 7 following vaccination ] [ Designated as safety issue: Yes ]
  • Unsolicited adverse events [ Time Frame: Day 1 to Day 30 following vaccination ] [ Designated as safety issue: Yes ]
  • Serious adverse events [ Time Frame: From signature of the informed consent to the last visit of the subject, an expected average of 11 months ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with an anti-polyribosylribitol phosphate concentration ≥1 µg/mL [ Time Frame: Month 12 (Pre-booster) and Month 13 (One month post-booster) ] [ Designated as safety issue: No ]
  • Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL [ Time Frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) and Month 13 (One month post-booster) ] [ Designated as safety issue: No ]
  • Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL [ Time Frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) and Month 13 (One month post-booster) ] [ Designated as safety issue: No ]
  • Proportion of subjects with an anti-MenA, anti-MenC, anti-MenW-135, anti-MenY titre ≥1:8 dil [ Time Frame: Month 13 (One month after MenAWCY vaccine) ] [ Designated as safety issue: No ]
  • Proportion of subjects with an anti-hepatitis B concentration ≥10 IU/mL [ Time Frame: Month 12 (Pre-booster) and Month 13 (One month post-booster) ] [ Designated as safety issue: No ]
  • Proportion of subjects with pertussis booster response [ Time Frame: Month 13 (One month post-booster) ] [ Designated as safety issue: No ]

Enrollment: 350
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Biological: 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)
Other Names:
  • Diphtheria, tetanus, pertussis, hepatitis B,
  • poliomyelitis and Haemophilus influenzae type b conjugate vaccine (adsorbed).
Biological: NeisVac-C
0.5 mL intramuscular injection at 2 and 4 months of age
Other Name: Meningococcal group C polysaccharide conjugate vaccine adsorbed
Biological: 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)
Other Name: Pneumococcal conjugate vaccine (13-valent, adsorbed)
Biological: RotaTeq
2 mL oral administration at 2, 3 and 4 months
Other Name: Human-bovine rotavirus reassortants (live) vaccine
Biological: Nimenrix
0.5 mL intramuscular injection at 12 months
Other Name: Meningococcal group A, C, W-135 and Y conjugate vaccine
Biological: M-M-RVAXPRO
0.5 mL intramuscular or subcutaneous injection at 13 months of age
Other Name: Measles, mumps and rubella vaccine (live)
Active Comparator: Group 2 Biological: 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)
Other Names:
  • Diphtheria, tetanus, pertussis, hepatitis B,
  • poliomyelitis and Haemophilus influenzae type b conjugate vaccine (adsorbed).
Biological: 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)
Other Name: Pneumococcal conjugate vaccine (13-valent, adsorbed)
Biological: RotaTeq
2 mL oral administration at 2, 3 and 4 months
Other Name: Human-bovine rotavirus reassortants (live) vaccine
Biological: Nimenrix
0.5 mL intramuscular injection at 12 months
Other Name: Meningococcal group A, C, W-135 and Y conjugate vaccine
Biological: M-M-RVAXPRO
0.5 mL intramuscular or subcutaneous injection at 13 months of age
Other Name: Measles, mumps and rubella vaccine (live)

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   46 Days to 76 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01839175

Locations
Finland
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
Jarvenpaa, 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
Seinajoki, 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
Sponsors and Collaborators
Sanofi Pasteur MSD
Sanofi Pasteur, a Sanofi Company
  More Information

No publications provided

Responsible Party: Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT01839175     History of Changes
Other Study ID Numbers: HXM01C, 2012-005547-24
Study First Received: April 19, 2013
Last Updated: March 18, 2014
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Bacterial Infections
Virus Diseases

ClinicalTrials.gov processed this record on April 15, 2014