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

Haemophilus Influenzae Type b (Hib) Infection Clinical Trial

Official title:

A Phase III Open Label, Multi-Center Pediatric Study in China Comparing Booster Doses of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b (Hib) Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01025544
• Other study ID #: M37P2E1
• Status: Completed
• Phase: Phase 3
• First received: December 2, 2009
• Last updated: December 7, 2011
• Start date: September 2009
• Est. completion date: April 2010

Study information

• Verified date: December 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 846
• Est. completion date: April 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 18 Months

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Haemophilus Influenzae Type b (Hib) Infection
• Infection
• Influenza, Human

Intervention

Biological:
• Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine)
Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.
• Hiberix (Haemophilus influenzae type b (Hib) vaccine)
Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-PRP antibody levels at day 31 post booster		31 days after vaccination	No
Secondary	Solicited local and systemic reactions, AEs, and SAEs		30 days post vaccination	Yes