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

Bacterial Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839175
• Other study ID #: HXM01C
• Secondary ID: 2012-005547-24
• Status: Completed
• Phase: Phase 3
• First received: April 19, 2013
• Last updated: September 8, 2017
• Start date: April 2013
• Est. completion date: February 2015

Study information

• Verified date: September 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: February 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 46 Days to 76 Days

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Neisseria Meningitidis
• Virus Diseases

Intervention

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)
• 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

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Proportion of subjects with pertussis vaccine response		Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)
Secondary	Proportion of subjects with an anti-MenC titre =1:8 dil		Month 3 (One month after dose 1 of MenC vaccine)
Secondary	Solicited injection-site and systemic reactions		Day 1 to Day 7 following vaccination
Secondary	Unsolicited adverse events		Day 1 to Day 30 following vaccination
Secondary	Serious adverse events		From signature of the informed consent to the last visit of the subject, an expected average of 11 months
Secondary	Proportion of subjects with an anti-polyribosylribitol phosphate concentration =1 µg/mL		Month 12 (Pre-booster) and Month 13 (One month post-booster)
Secondary	Proportion of subjects with an anti-diphtheria concentration =0.1 IU/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)
Secondary	Proportion of subjects with an anti-tetanus concentration =0.1 IU/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)
Secondary	Proportion of subjects with an anti-MenA, anti-MenC, anti-MenW-135, anti-MenY titre =1:8 dil		Month 13 (One month after MenAWCY vaccine)
Secondary	Proportion of subjects with an anti-hepatitis B concentration =10 IU/mL		Month 12 (Pre-booster) and Month 13 (One month post-booster)
Secondary	Proportion of subjects with pertussis booster response		Month 13 (One month post-booster)