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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01025544
First received: December 2, 2009
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Haemophilus Influenzae Type b (Hib) Infection
Biological: Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine)
Biological: Hiberix (Haemophilus influenzae type b (Hib) vaccine)
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Anti-PRP antibody levels at day 31 post booster [ Time Frame: 31 days after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Solicited local and systemic reactions, AEs, and SAEs [ Time Frame: 30 days post vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 846
Study Start Date: September 2009
Study Completion Date: April 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 Biological: Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine)
Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.
Active Comparator: Arm 2 Biological: Hiberix (Haemophilus influenzae type b (Hib) vaccine)
Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.

  Eligibility

Ages Eligible for Study:   12 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01025544

Locations
China
Hebei Province, China
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Basel 41 61 324 1111
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01025544     History of Changes
Other Study ID Numbers: M37P2E1
Study First Received: December 2, 2009
Last Updated: December 7, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Novartis:
Haemophilus influenzae type b (Hib)
Vaccine
Booster

Additional relevant MeSH terms:
Infection
Communicable Diseases
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014