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
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:
Haemophilus Infections
Influenza, Human
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014