Immunogenicity and Safety of a Booster Dose of Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 365-569 Days Old Healthy Infants

Novartis

Status and phase: Completed; Phase 3

Conditions: Haemophilus Influenzae Type b (Hib) Infection

Treatments: Biological: Haemophilus influenzae type b (Hib) vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01226953

V37_07E1

Details and patient eligibility

About

This study will evaluate the safety and immunogenicity of booster dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 365-569 days of age

Enrollment: 660 patients

Sex: All

Ages: 365 to 569 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Infants 365-569 days of age.

Exclusion criteria

• Subjects who already received a booster dose of Hib vaccine.
• History of serious reaction(s) following vaccination.
• Any vaccination within 7 days of study vaccination.
• Known or suspected immune impairment.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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660 participants in 2 patient groups

Arm 1

Active Comparator group

Treatment:

Biological: Haemophilus influenzae type b (Hib) vaccine

Arm 2

Active Comparator group

Treatment:

Biological: Haemophilus influenzae type b (Hib) vaccine