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

Status and phase: Completed; Phase 3

Conditions: Virus Diseases; Neisseria Meningitidis; Bacterial Infections

Treatments: Biological: M-M-RVAXPRO; Biological: NeisVac-C; Biological: Prevenar 13; Biological: RotaTeq; Biological: Nimenrix; Biological: Hexavalent vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01839175

HXM01C

2012-005547-24 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 patients

Sex: All

Ages: 46 to 76 days old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Group 1

Experimental group

Treatment:

Biological: Nimenrix

Biological: Hexavalent vaccine

Biological: RotaTeq

Biological: Prevenar 13

Biological: NeisVac-C

Biological: M-M-RVAXPRO

Group 2

Active Comparator group

Treatment:

Biological: Nimenrix

Biological: Hexavalent vaccine

Biological: RotaTeq

Biological: Prevenar 13

Biological: M-M-RVAXPRO