Administration of a new hexavalent vaccine (Hexavalent vaccine) with a meningococcal serogroup C conjugate vaccine in healthy infants during primary series immunisation and booster vaccinatio

• Conditions: Healthy infants 46 to 74 days of age (both inclusive); MedDRA version: 17.0Level: LLTClassification code 10054187Term: Polio immunizationSystem Organ Class: 100000004865; MedDRA version: 17.0Level: LLTClassification code 10069543Term: Hemophilus influenzae type b immunizationSystem Organ Class: 100000004865; MedDRA version: 17.0Level: LLTClassification code 10069593Term: Pertussis immunizationSystem Organ Class: 100000004865; MedDRA version: 17.0Level: LLTClassification code 10054181Term: Hepatitis B immunizationSystem Organ Class: 100000004865; MedDRA version: 17.0Level: LLTClassification code 10054180Term: Diphtheria immunizationSystem Organ Class: 100000004865; MedDRA version: 17.0Level: LLTClassification code 10054183Term: Tetanus immunizationSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2012-005547-24-FI
• Lead Sponsor: Sanofi Pasteur MSD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-29
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

PRIMARY SERIES:
1. Healthy infant 46 to 74 days of age (both inclusive)
2. Born at full term of pregnancy (=37 weeks) and/or with a birth weight=2.5 kg
3. Informed consent signed by the subject's parent(s) or legal representative
4. Subject's parent(s) or legal representative able to comply with the study procedures
such as adherence to study visits and completion of the diary cards
5. Covered by health insurance

BOOSTER:
1. Infant who received 3 doses of the hexavalent vaccine in the Primary series
2. Healthy infant from 12 months of age
3. Informed consent signed by the subject's parent(s) or legal representative
Are the trial subjects under 18? yes
Number of subjects for this age range: 350
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

PRIMARY SERIES:
1. Participation at the time of study enrolment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
2. Receipt of any vaccine in the 4 weeks preceding each study vaccination or planned receipt of a vaccine in the 4 weeks following each study vaccine administration
3. Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, meningococcal, pneumococcal, rotavirus infection
4. Know or suspected congenital, hereditary or acquired immunodeficiency or other immunosuppressive or immunodeficiency condition
5. History of seizures or encephalopathy
6. Known thrombocytopenia, as reported by the subject's parent or legal representative
7. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection
8. Chronic illness that, in the opinion of the investigators, is at a stage where it might interfere with trial conduct or completion
9. 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
10. Contraindication to any of the study vaccines as per their Summary of Product Characteristics
11. Known personal or maternal history of hepatitis B (HBs Ag) or hepatitis C seropositivity
12. History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b or meningococcal serogroup C infection
13. Receipt of immune globulin, blood or blood-derived products since birth
14. Receipt of immunosuppressive therapy or other immune-modifying drugs, such as anticancer chemotherapy or radiation therapy since birth
15. Receipt of systemic corticosteroid therapy for more than 14 consecutive days since birth
16. Identified as a natural or adopted child of the investigator or employee with direct involvement in the current study.

BOOSTER:
1. Prior (in the last 4 weeks), current or planned participation in another clinical study investigating a vaccine, drug, medical device, or medical procedure during the entire duration of the Booster vaccination
2. Receipt of a flu vaccine in the 2 weeks preceding vaccination at Visit 5 or receipt of any vaccine in the 4 weeks preceding vaccination at Visit 5 or planned receipt of a vaccine in the 4 weeks following vaccination at Visit 5
3. Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, meningococcal, pneumococcal infections with either the trial vaccine or another vaccine
4. History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b or meningococcal serogroup A, C, W or Y infection(s) confirmed either clinically, serologically, or microbiologically
5. Known or suspected hypersensitivity to any of the active substance or excipients or trace residuals of the hexavalent vaccine or the meningococcal group ACWY conjugate vaccine, to any pertussis vaccine, history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines
6. Contraindication to the hexavalent vaccine or the meningococcal group ACWY conjugate vaccine, as per their Summary of Product Characteristics
7. Receipt of imm

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified