Study in Toddlers (12-18 Months) Comparing a Booster Dose of Vaxem Hib and Hiberix Vaccines 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: Hiberix (Haemophilus influenzae type b (Hib) vaccine); Biological: Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01025544

M37P2E1

Details and patient eligibility

About

This study will evaluate the safety and immunogenicity of booster doses of the two vaccines used to prevent Haemophilus influenzae type b infections in children 12-18 months of age.

Enrollment: 846 patients

Sex: All

Ages: 12 to 18 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Toddlers 12-18 months of age who have previously participated in study M37P2.

Exclusion criteria

• Prior Hib booster administration.
• History of serious reaction(s) following vaccination.
• 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: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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846 participants in 2 patient groups

Arm 1

Active Comparator group

Treatment:

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

Arm 2

Active Comparator group

Treatment:

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