A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants

Novartis

Status and phase: Completed; Phase 3

Conditions: Meningitis, Meningococcal

Treatments: Biological: Meningococcal ACWY Conjugate Vaccine; Biological: MMR-V; Biological: Rotavirus; Biological: DTaP-IPV-HBV; Biological: DTaP; Biological: HAV; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: Hib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00474526

V59P14

Details and patient eligibility

About

This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.

Enrollment: 4,545 patients

Sex: All

Ages: 2 to 2 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy term 2-month-old infants for whom a parent/legal representative has given written informed consent.

Exclusion criteria

• Subjects with a previous or suspected disease caused by Neisseria meningitidis, Corynebacterium diphtheriae, Clostridium tetani, Poliovirus, Hepatitis B, Haemophilus influenzae type b (Hib), Pneumococcus or Bordetella pertussis; previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) or prior vaccination with Diptheria, Tetanus, Pertussis (acellular or whole cell), inactivated polio vaccineIPV or oral polio vaccineOPV, H. influenzae type b (Hib) or Pneumococcus; who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W-135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth; Any serious acute, chronic or progressive disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,545 participants in 17 patient groups

US1A (MenACWY-CRM + Infant Vaccines)

Experimental group

Description:

Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Treatment:

Biological: Pneumococcal 7-valent Conjugate Vaccine

Biological: Hib

Biological: HAV

Biological: DTaP-IPV-HBV

Biological: MMR-V

Biological: Rotavirus

Biological: Meningococcal ACWY Conjugate Vaccine

US1B (MenACWY-CRM + Infant Vaccines)

Experimental group

Description:

Received vaccines: MenACWY: 2, 4, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Treatment:

Biological: Pneumococcal 7-valent Conjugate Vaccine

Biological: Hib

Biological: HAV

Biological: DTaP-IPV-HBV

Biological: MMR-V

Biological: Rotavirus

Biological: Meningococcal ACWY Conjugate Vaccine

US2 (Infant Vaccines Only)

Experimental group

Description:

Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Treatment:

Biological: Pneumococcal 7-valent Conjugate Vaccine

Biological: Hib

Biological: HAV

Biological: DTaP-IPV-HBV

Biological: MMR-V

Biological: Rotavirus

Biological: Meningococcal ACWY Conjugate Vaccine

US3 (MenACWY-CRM + Infant Vaccines)

Experimental group

Description:

Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Treatment:

Biological: Pneumococcal 7-valent Conjugate Vaccine

Biological: Hib

Biological: HAV

Biological: DTaP-IPV-HBV

Biological: MMR-V

Biological: Rotavirus

Biological: Meningococcal ACWY Conjugate Vaccine

US4A (Infant Vaccines Only)

Experimental group

Description:

Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Treatment:

Biological: Hib

Biological: HAV

Biological: DTaP-IPV-HBV

Biological: MMR-V

Biological: Rotavirus

Biological: Meningococcal ACWY Conjugate Vaccine

US4B (Infant Vaccines Only)

Experimental group

Description:

Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Treatment:

Biological: Pneumococcal 7-valent Conjugate Vaccine

Biological: Hib

Biological: HAV

Biological: DTaP-IPV-HBV

Biological: MMR-V

Biological: Rotavirus

Biological: Meningococcal ACWY Conjugate Vaccine

US4C (Infant Vaccines Only)

Experimental group

Description:

Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Treatment:

Biological: Pneumococcal 7-valent Conjugate Vaccine

Biological: Hib

Biological: HAV

Biological: DTaP-IPV-HBV

Biological: MMR-V

Biological: Rotavirus

Biological: Meningococcal ACWY Conjugate Vaccine

LA1A (MenACWY-CRM + Infant Vaccines)

Experimental group

Description:

Received vaccines: MenACWY: 2, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Treatment:

Biological: Pneumococcal 7-valent Conjugate Vaccine

Biological: Hib

Biological: HAV

Biological: DTaP-IPV-HBV

Biological: MMR-V

Biological: Rotavirus

Biological: Meningococcal ACWY Conjugate Vaccine

LA1B (MenACWY-CRM + Infant Vaccines)

Experimental group

Description:

Received vaccines: MenACWY: 2, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Treatment:

Biological: Pneumococcal 7-valent Conjugate Vaccine

Biological: Hib

Biological: HAV

Biological: DTaP-IPV-HBV

Biological: MMR-V

Biological: Rotavirus

Biological: Meningococcal ACWY Conjugate Vaccine

LA2 (Infant Vaccines Only)

Experimental group

Description:

Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Treatment:

Biological: Pneumococcal 7-valent Conjugate Vaccine

Biological: Hib

Biological: HAV

Biological: DTaP-IPV-HBV

Biological: MMR-V

Biological: Rotavirus

Biological: Meningococcal ACWY Conjugate Vaccine

LA3A (MenACWY-CRM + Infant Vaccines)

Experimental group

Description:

Received vaccines: MenACWY: 2, 4, 6, and 16 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months

Treatment:

Biological: Pneumococcal 7-valent Conjugate Vaccine

Biological: Hib

Biological: HAV

Biological: DTaP

Biological: DTaP-IPV-HBV

Biological: MMR-V

Biological: Rotavirus

Biological: Meningococcal ACWY Conjugate Vaccine

LA3B (MenACWY-CRM + Infant Vaccines)

Experimental group

Description:

Received vaccines: MenACWY: 2, 4, 6, and 17 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months

Treatment:

Biological: Pneumococcal 7-valent Conjugate Vaccine

Biological: Hib

Biological: HAV

Biological: DTaP

Biological: DTaP-IPV-HBV

Biological: MMR-V

Biological: Rotavirus

Biological: Meningococcal ACWY Conjugate Vaccine

LA4 (Infant Vaccines Only)

Experimental group

Description:

Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 15 months Pneumococcal, HAV, and MMR-V: 12 months

Treatment:

Biological: Pneumococcal 7-valent Conjugate Vaccine

Biological: Hib

Biological: HAV

Biological: DTaP

Biological: DTaP-IPV-HBV

Biological: MMR-V

Biological: Rotavirus

Biological: Meningococcal ACWY Conjugate Vaccine

LA5 (MenACWY-CRM + Infant Vaccines)

Experimental group

Description:

Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Treatment:

Biological: Pneumococcal 7-valent Conjugate Vaccine

Biological: Hib

Biological: HAV

Biological: DTaP-IPV-HBV

Biological: MMR-V

Biological: Rotavirus

Biological: Meningococcal ACWY Conjugate Vaccine

LA6A (Infant Vaccines Only)

Experimental group

Description:

Received vaccines: MenACWY: 12, and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Treatment:

Biological: Pneumococcal 7-valent Conjugate Vaccine

Biological: Hib

Biological: HAV

Biological: DTaP-IPV-HBV

Biological: MMR-V

Biological: Rotavirus

Biological: Meningococcal ACWY Conjugate Vaccine

LA6B (Infant Vaccines Only)

Experimental group

Description:

Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Treatment:

Biological: Pneumococcal 7-valent Conjugate Vaccine

Biological: Hib

Biological: HAV

Biological: DTaP-IPV-HBV

Biological: MMR-V

Biological: Rotavirus

Biological: Meningococcal ACWY Conjugate Vaccine

LA6C (Infant Vaccines Only)

Experimental group

Description:

Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Treatment:

Biological: Pneumococcal 7-valent Conjugate Vaccine

Biological: Hib

Biological: HAV

Biological: DTaP-IPV-HBV

Biological: Rotavirus

Biological: Meningococcal ACWY Conjugate Vaccine