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

Sanofi Pasteur, a Sanofi Company350 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

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)

NeisVac-CBIOLOGICAL

0.5 mL intramuscular injection at 2 and 4 months of age

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)

RotaTeqBIOLOGICAL

2 mL oral administration at 2, 3 and 4 months

NimenrixBIOLOGICAL

0.5 mL intramuscular injection at 12 months

M-M-RVAXPROBIOLOGICAL

0.5 mL intramuscular or subcutaneous injection at 13 months of age

Eligibility

Sex: ALLMin age: 46 DaysMax age: 76 DaysHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (11)

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

Seinäjoki, Finland

Sanofi Pasteur MSD Investigational Site 006

Tampere, Finland

Sanofi Pasteur MSD Investigational Site 007

Turku, Finland

...and 1 more locations

Outcomes

Primary Outcomes

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)

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 Outcomes

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)

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)

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)

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)

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)

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

Time frame: 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

Unsolicited adverse events

Time frame: 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

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)

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)

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)

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)

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)

Proportion of subjects with pertussis booster response

Time frame: Month 13 (One month post-booster)

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

Overview

Conditions

Interventions

Eligibility

Locations (11)

Outcomes

Primary Outcomes

Secondary Outcomes