Study in Infants (6-12 Months) Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Vaccine Versus a Tetanus Toxoid-Conjugated Vaccine Available for the Prevention of Haemophilus Influenzae Type b Infections in China

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

NCT01044316

V37_07

Details and patient eligibility

About

This study will evaluate the safety and efficacy of two doses of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 6-12 months of age.

Enrollment: 670 patients

Sex: All

Ages: 6 to 12 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Infants 6-12 months of age.

Exclusion criteria

• Prior Hib vaccine administration.
• History of serious reaction(s) following vaccination.
• Any vaccination within 14 days of study vaccination.
• Known or suspected immune impairment.
• For additional entry criteria please refer to the protocol.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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670 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