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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

Primary Purpose

Neisseria Meningitidis, Bacterial Infections, Virus Diseases

Status
Completed
Phase
Phase 3
Locations
Finland
Study Type
Interventional
Intervention
Hexavalent vaccine
NeisVac-C
Prevenar 13
RotaTeq
Nimenrix
M-M-RVAXPRO
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neisseria Meningitidis

Eligibility Criteria

46 Days - 76 Days (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sanofi Pasteur MSD Investigational Site 003
  • Sanofi Pasteur MSD Investigational Site 001
  • Sanofi Pasteur MSD Investigational Site 002
  • Sanofi Pasteur MSD Investigational Site 011
  • Sanofi Pasteur MSD Investigational Site 010
  • Sanofi Pasteur MSD Investigational Site 004
  • Sanofi Pasteur MSD Investigational Site 005
  • Sanofi Pasteur MSD Investigational Site 009
  • Sanofi Pasteur MSD Investigational Site 006
  • Sanofi Pasteur MSD Investigational Site 007
  • Sanofi Pasteur MSD Investigational Site 008

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Outcomes

Primary Outcome Measures

Proportion of subjects with an anti-hepatitis B concentration ≥10 IU/mL
Proportion of subjects with an anti-MenC titre ≥1:8 dil

Secondary Outcome Measures

Proportion of subjects with an anti-polyribosylribitol phosphate concentration ≥0.15 µg/mL
Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL
Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL
Proportion of subjects with an anti-inactivated poliovirus 1, 2, 3 titre ≥1:8 dil
Proportion of subjects with pertussis vaccine response
Proportion of subjects with an anti-MenC titre ≥1:8 dil
Solicited injection-site and systemic reactions
Unsolicited adverse events
Serious adverse events
Proportion of subjects with an anti-polyribosylribitol phosphate concentration ≥1 µg/mL
Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL
Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL
Proportion of subjects with an anti-MenA, anti-MenC, anti-MenW-135, anti-MenY titre ≥1:8 dil
Proportion of subjects with an anti-hepatitis B concentration ≥10 IU/mL
Proportion of subjects with pertussis booster response

Full Information

First Posted
April 19, 2013
Last Updated
September 8, 2017
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT01839175
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neisseria Meningitidis, Bacterial Infections, Virus Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Title
Group 2
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Hexavalent vaccine
Other Intervention Name(s)
Diphtheria, tetanus, pertussis, hepatitis B,, poliomyelitis and Haemophilus influenzae type b conjugate vaccine (adsorbed).
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
NeisVac-C
Other Intervention Name(s)
Meningococcal group C polysaccharide conjugate vaccine adsorbed
Intervention Description
0.5 mL intramuscular injection at 2 and 4 months of age
Intervention Type
Biological
Intervention Name(s)
Prevenar 13
Other Intervention Name(s)
Pneumococcal conjugate vaccine (13-valent, adsorbed)
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
RotaTeq
Other Intervention Name(s)
Human-bovine rotavirus reassortants (live) vaccine
Intervention Description
2 mL oral administration at 2, 3 and 4 months
Intervention Type
Biological
Intervention Name(s)
Nimenrix
Other Intervention Name(s)
Meningococcal group A, C, W-135 and Y conjugate vaccine
Intervention Description
0.5 mL intramuscular injection at 12 months
Intervention Type
Biological
Intervention Name(s)
M-M-RVAXPRO
Other Intervention Name(s)
Measles, mumps and rubella vaccine (live)
Intervention Description
0.5 mL intramuscular or subcutaneous injection at 13 months of age
Primary Outcome Measure Information:
Title
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)
Title
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)
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
Proportion of subjects with an anti-MenC titre ≥1:8 dil
Time Frame
Month 3 (One month after dose 1 of MenC vaccine)
Title
Solicited injection-site and systemic reactions
Time Frame
Day 1 to Day 7 following vaccination
Title
Unsolicited adverse events
Time Frame
Day 1 to Day 30 following vaccination
Title
Serious adverse events
Time Frame
From signature of the informed consent to the last visit of the subject, an expected average of 11 months
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
Proportion of subjects with pertussis booster response
Time Frame
Month 13 (One month post-booster)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
46 Days
Maximum Age & Unit of Time
76 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi Pasteur MSD Investigational Site 003
City
Espoo
Country
Finland
Facility Name
Sanofi Pasteur MSD Investigational Site 001
City
Helsinki
Country
Finland
Facility Name
Sanofi Pasteur MSD Investigational Site 002
City
Helsinki
Country
Finland
Facility Name
Sanofi Pasteur MSD Investigational Site 011
City
Jarvenpaa
Country
Finland
Facility Name
Sanofi Pasteur MSD Investigational Site 010
City
Kokkola
Country
Finland
Facility Name
Sanofi Pasteur MSD Investigational Site 004
City
Oulu
Country
Finland
Facility Name
Sanofi Pasteur MSD Investigational Site 005
City
Pori
Country
Finland
Facility Name
Sanofi Pasteur MSD Investigational Site 009
City
Seinajoki
Country
Finland
Facility Name
Sanofi Pasteur MSD Investigational Site 006
City
Tampere
Country
Finland
Facility Name
Sanofi Pasteur MSD Investigational Site 007
City
Turku
Country
Finland
Facility Name
Sanofi Pasteur MSD Investigational Site 008
City
Vantaa
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
30471953
Citation
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.
Results Reference
derived
PubMed Identifier
27939054
Citation
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.
Results Reference
derived

Learn more about this trial

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

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