Trials / Completed
CompletedNCT01577732
Safety of GSK Biologicals' Infanrix-IPV+HibTM Vaccine in Healthy Vietnamese Toddlers
Safety and Reactogenicity of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix-IPV+HibTM) in Healthy Vietnamese Toddlers
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 321 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 12 Months – 24 Months
- Healthy volunteers
- Accepted
Summary
This study aims to evaluate the safety and reactogenicity of a booster dose of Infanrix-IPV+Hib™ when administered to healthy Vietnamese toddlers at 12 to 24 months of age who were vaccinated previously against diphtheria, tetanus, and pertussis diseases within their first six months of lives.
Conditions
- Acellular Pertussis
- Haemophilus Influenzae Type b
- Tetanus
- Poliomyelitis
- Diphtheria
- Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Infanrix-IPV+Hib™ | Single dose administered intramuscularly (IM) into the anterolateral side of the right thigh. |
Timeline
- Start date
- 2012-12-08
- Primary completion
- 2013-04-09
- Completion
- 2013-04-09
- First posted
- 2012-04-16
- Last updated
- 2020-01-21
- Results posted
- 2014-05-05
Locations
1 site across 1 country: Vietnam
Source: ClinicalTrials.gov record NCT01577732. Inclusion in this directory is not an endorsement.