Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children
Phase 3
Completed
- Conditions
- Haemophilus Influenzae Type b (Hib) Infection
- Interventions
- Biological: Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib)Biological: Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)
- Registration Number
- NCT01125527
- Lead Sponsor
- Novartis Vaccines
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 700
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib) - Arm 2 Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib) -
- Primary Outcome Measures
Name Time Method Anti-PRP antibody levels at day 31 post last vaccination 30 days after last vaccination
- Secondary Outcome Measures
Name Time Method Solicited local and systemic reactions, AEs, and SAEs 30 days post last vaccination