Immunogenicity and Safety of a Booster Dose of Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 365-569 Days Old Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01226953
First received: October 21, 2010
Last updated: December 27, 2011
Last verified: December 2011

October 21, 2010
December 27, 2011
October 2010
December 2010   (final data collection date for primary outcome measure)
Anti-PRP (polyribosyl-ribitol-phosphate) antibody levels at day 31 post last vaccination [ Time Frame: 30 days after last vaccination ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01226953 on ClinicalTrials.gov Archive Site
Solicited local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) [ Time Frame: 30 days post last vaccination ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Immunogenicity and Safety of a Booster Dose of Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 365-569 Days Old Healthy Infants
A Phase III Observer Blind Single-Coordinating Center Pediatric Study in China Comparing a Booster Dose of Vaxem™ Hib to HIBERIX® When Given as Part of a Local Dosing Regimen in Infants

This study will evaluate the safety and immunogenicity of booster dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 365-569 days of age

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Haemophilus Influenzae Type b (Hib) Infection
Biological: Haemophilus influenzae type b (Hib) vaccine
Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines
  • Active Comparator: Arm 1
    Intervention: Biological: Haemophilus influenzae type b (Hib) vaccine
  • Active Comparator: Arm 2
    Intervention: Biological: Haemophilus influenzae type b (Hib) vaccine
Jun L, Yuguo C, Zhiguo W, Jinfeng L, Huawei M, Xiuhua L, Yonggui Z, Yanhua X, Kong Y, Hongtao L, Yuliang Z. Assessment of immunogenicity and safety following primary and booster immunisation with a CRM197 -conjugated Haemophilus influenzae type B vaccine in healthy Chinese infants. Int J Clin Pract. 2013 Oct;67(10):971-8. doi: 10.1111/ijcp.12267. Epub 2013 Aug 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
660
March 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Infants 365-569 days of age.

Exclusion Criteria:

  • Subjects who already received a booster dose of Hib vaccine.
  • History of serious reaction(s) following vaccination.
  • Any vaccination within 7 days of study vaccination.
  • Known or suspected immune impairment.
Both
365 Days to 569 Days
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01226953
V37_07E1
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Not Provided
Novartis
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP