NCT01839175

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

1.2 years

First QC Date

April 19, 2013

Last Update Submit

September 8, 2017

Conditions

Neisseria MeningitidisBacterial InfectionsVirus Diseases

Outcome Measures

Primary Outcomes (2)

  • Proportion of subjects with an anti-hepatitis B concentration ≥10 IU/mL

    Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)

  • Proportion of subjects with an anti-MenC titre ≥1:8 dil

    Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)

Secondary Outcomes (15)

  • Proportion of subjects with an anti-polyribosylribitol phosphate concentration ≥0.15 µg/mL

    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)

  • Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL

    Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster)

  • Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL

    Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster)

  • Proportion of subjects with an anti-inactivated poliovirus 1, 2, 3 titre ≥1:8 dil

    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)

  • Proportion of subjects with pertussis vaccine response

    Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)

  • +10 more secondary outcomes

Study Arms (2)

Group 1

EXPERIMENTAL
Biological: Hexavalent vaccineBiological: NeisVac-CBiological: Prevenar 13Biological: RotaTeqBiological: NimenrixBiological: M-M-RVAXPRO

Group 2

ACTIVE COMPARATOR
Biological: Hexavalent vaccineBiological: Prevenar 13Biological: RotaTeqBiological: NimenrixBiological: M-M-RVAXPRO

Interventions

Hexavalent vaccineBIOLOGICAL

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)

Also known as: Diphtheria, tetanus, pertussis, hepatitis B,, poliomyelitis and Haemophilus influenzae type b conjugate vaccine (adsorbed).
Group 1Group 2
NeisVac-CBIOLOGICAL

0.5 mL intramuscular injection at 2 and 4 months of age

Also known as: Meningococcal group C polysaccharide conjugate vaccine adsorbed
Group 1
Prevenar 13BIOLOGICAL

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)

Also known as: Pneumococcal conjugate vaccine (13-valent, adsorbed)
Group 1Group 2
RotaTeqBIOLOGICAL

2 mL oral administration at 2, 3 and 4 months

Also known as: Human-bovine rotavirus reassortants (live) vaccine
Group 1Group 2
NimenrixBIOLOGICAL

0.5 mL intramuscular injection at 12 months

Also known as: Meningococcal group A, C, W-135 and Y conjugate vaccine
Group 1Group 2
M-M-RVAXPROBIOLOGICAL

0.5 mL intramuscular or subcutaneous injection at 13 months of age

Also known as: Measles, mumps and rubella vaccine (live)
Group 1Group 2

Eligibility Criteria

Age46 Days - 76 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Sanofi Pasteur MSD Investigational Site 003

Espoo, Finland

Location

Sanofi Pasteur MSD Investigational Site 001

Helsinki, Finland

Location

Sanofi Pasteur MSD Investigational Site 002

Helsinki, Finland

Location

Sanofi Pasteur MSD Investigational Site 011

Jarvenpaa, Finland

Location

Sanofi Pasteur MSD Investigational Site 010

Kokkola, Finland

Location

Sanofi Pasteur MSD Investigational Site 004

Oulu, Finland

Location

Sanofi Pasteur MSD Investigational Site 005

Pori, Finland

Location

Sanofi Pasteur MSD Investigational Site 009

Seinäjoki, Finland

Location

Sanofi Pasteur MSD Investigational Site 006

Tampere, Finland

Location

Sanofi Pasteur MSD Investigational Site 007

Turku, Finland

Location

Sanofi Pasteur MSD Investigational Site 008

Vantaa, Finland

Location

Related Publications (2)

  • 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.

    PMID: 30471953DERIVED

  • 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.

    PMID: 27939054DERIVED

MeSH Terms

Conditions

Bacterial InfectionsVirus Diseases

Interventions

Vaccines, CombinedTetanus ToxoidHepatitis B Vaccines13-valent pneumococcal vaccinePneumococcal VaccinesRotaTeqVaccinesMeasles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Biological ProductsComplex MixturesToxoidsViral Hepatitis VaccinesViral VaccinesStreptococcal VaccinesBacterial VaccinesMeasles VaccineMumps VaccineRubella Vaccine

Study Officials

  • Medical Director

    Sanofi Pasteur, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2013

First Posted

April 24, 2013

Study Start

April 1, 2013

Primary Completion

July 1, 2014

Study Completion

February 1, 2015

Last Updated

September 11, 2017

Record last verified: 2017-09

Locations

FI(11)