Trials / Completed
CompletedNCT01353703
Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa™ Vaccine in Healthy Infants in India
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 224 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Weeks – 10 Weeks
- Healthy volunteers
- Accepted
Summary
This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks or a 2-4-6 months schedule.
Conditions
- Poliomyelitis
- Tetanus
- Acellular Pertussis
- Haemophilus Influenzae Type b
- Diphtheria
- Hepatitis B
- Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Infanrix hexa™ | Intramuscular, three doses |
Timeline
- Start date
- 2012-04-16
- Primary completion
- 2013-02-25
- Completion
- 2013-02-25
- First posted
- 2011-05-16
- Last updated
- 2020-01-02
- Results posted
- 2019-01-25
Locations
4 sites across 1 country: India
Source: ClinicalTrials.gov record NCT01353703. Inclusion in this directory is not an endorsement.