Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children

Novartis

Status and phase: Completed; Phase 3

Conditions: Haemophilus Influenzae Type b (Hib) Infection

Treatments: Biological: Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib); Biological: Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01125527

V37_06

Details and patient eligibility

About

This study will evaluate the safety and immunogenicity of single dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 13-59 months of age.

Enrollment: 700 patients

Sex: All

Ages: 13 to 59 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Infants 13-59 months of age.

Exclusion criteria

• Prior Hib vaccine administration.
• History of serious reaction(s) following vaccination.
• Any vaccination within 7 days of study vaccination.
• Known or suspected immune impairment.
• Premature (before 37th week of gestation) or birth weight less than 2500g
• For additional entry criteria please refer to the protocol.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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700 participants in 2 patient groups

Arm 1

Active Comparator group

Treatment:

Biological: Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib)

Arm 2

Active Comparator group

Treatment:

Biological: Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)