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

September 8, 2017 updated by: Sanofi Pasteur, a Sanofi Company

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Espoo, Finland
        • Sanofi Pasteur MSD Investigational Site 003
      • Helsinki, Finland
        • Sanofi Pasteur MSD Investigational Site 001
      • Helsinki, Finland
        • Sanofi Pasteur MSD Investigational Site 002
      • Jarvenpaa, Finland
        • Sanofi Pasteur MSD Investigational Site 011
      • Kokkola, Finland
        • Sanofi Pasteur MSD Investigational Site 010
      • Oulu, Finland
        • Sanofi Pasteur MSD Investigational Site 004
      • Pori, Finland
        • Sanofi Pasteur MSD Investigational Site 005
      • Seinajoki, Finland
        • Sanofi Pasteur MSD Investigational Site 009
      • Tampere, Finland
        • Sanofi Pasteur MSD Investigational Site 006
      • Turku, Finland
        • Sanofi Pasteur MSD Investigational Site 007
      • Vantaa, Finland
        • Sanofi Pasteur MSD Investigational Site 008

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Pneumococcal conjugate vaccine (13-valent, adsorbed)
Biological: RotaTeq
2 mL oral administration at 2, 3 and 4 months
Other Names:
  • Human-bovine rotavirus reassortants (live) vaccine
Biological: Nimenrix
0.5 mL intramuscular injection at 12 months
Other Names:
  • 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 Names:
  • Measles, mumps and rubella vaccine (live)
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 Names:
  • 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 Names:
  • Pneumococcal conjugate vaccine (13-valent, adsorbed)
Biological: RotaTeq
2 mL oral administration at 2, 3 and 4 months
Other Names:
  • Human-bovine rotavirus reassortants (live) vaccine
Biological: Nimenrix
0.5 mL intramuscular injection at 12 months
Other Names:
  • 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 Names:
  • Measles, mumps and rubella vaccine (live)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
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
Time Frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)
Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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)
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
Time Frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster)
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
Time Frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster)
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
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)
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
Time Frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)
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
Time Frame: Month 3 (One month after dose 1 of MenC vaccine)
Month 3 (One month after dose 1 of MenC vaccine)
Solicited injection-site and systemic reactions
Time Frame: Day 1 to Day 7 following vaccination
Day 1 to Day 7 following vaccination
Unsolicited adverse events
Time Frame: Day 1 to Day 30 following vaccination
Day 1 to Day 30 following vaccination
Serious adverse events
Time Frame: From signature of the informed consent to the last visit of the subject, an expected average of 11 months
From signature of the informed consent to the last visit of the subject, an expected average of 11 months
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)
Month 12 (Pre-booster) and Month 13 (One month post-booster)
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)
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-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)
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-MenA, anti-MenC, anti-MenW-135, anti-MenY titre ≥1:8 dil
Time Frame: Month 13 (One month after MenAWCY vaccine)
Month 13 (One month after MenAWCY vaccine)
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)
Month 12 (Pre-booster) and Month 13 (One month post-booster)
Proportion of subjects with pertussis booster response
Time Frame: Month 13 (One month post-booster)
Month 13 (One month post-booster)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HXM01C
  • 2012-005547-24 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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