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

Haemophilus Influenzae Type b (Hib) Infection Clinical Trial

Official title:

A Phase III Observer-blind, Randomized, Controlled, Single-coordinating Center Study to Investigate Immunogenicity and Safety of a Monovalent Glycoprotein-conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children in China, According to the Recommended Regimen of 1 Dose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125527
• Other study ID #: V37_06
• Status: Completed
• Phase: Phase 3
• First received: May 14, 2010
• Last updated: November 30, 2016
• Start date: August 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 single dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 13-59 months of age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: April 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Months to 59 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Influenzae Type b (Hib) Infection

Intervention

Biological:
• Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib)
a single dose was administered
• Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)
a single dose was administered

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 last vaccination		30 days after last vaccination	No
Secondary	Solicited local and systemic reactions, AEs, and SAEs		30 days post last vaccination	Yes

External Links

•   Results for V37_06 from the Novartis Clinical Trials website