Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life

Novartis

Status and phase

Completed

Phase 3

Conditions

Meningococcal Meningitis

Meningococcal Disease

Treatments

Biological: Routine Vaccines

Biological: MenACWY-CRM

Study type

Interventional

Funder types

Industry

Identifiers

NCT01214837

V59_36

Details and patient eligibility

About

The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant vaccination schedule including kinetics of immune response in the early phases of the series.

Enrollment

751 patients

Sex

All

Ages

55 to 89 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Infants of both genders who are in generally good health will be eligible for this study. For infants to be enrolled, the parents/legal representatives need to provide written informed consent and to be available for all study visits.

Exclusion criteria

Serious, acute, or chronic illnesses are reasons for exclusion.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

751 participants in 3 patient groups, including a placebo group

MenACWY3

Experimental group

Description:

Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.

Treatment:

Biological: Routine Vaccines

Biological: MenACWY-CRM

MenACWY4

Experimental group

Description:

All the subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.

Treatment:

Biological: Routine Vaccines

Biological: MenACWY-CRM

Routine Vaccines

Placebo Comparator group

Description:

Subjects received routine vaccines only, including PCV-13, at 2, 4 and 6 months of age and a toddler dose at 12 months of age.

Treatment:

Biological: Routine Vaccines