Trials / Completed
CompletedNCT01978093
Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age
Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine 792014 Compared to Merck & Co, Inc. Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) Vaccine in Healthy Infants and Toddlers
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Weeks – 12 Weeks
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' Hib-MenCY-TT (MenHibrix®) vaccine co-administered with Rotarix, Prevnar 13 and Havrix as compared to PedvaxHIB co-administered with Rotarix, Prevnar 13 and Havrix in infants and toddlers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Hib-MenCY-TT (MenHibrix®) | 4 doses administered intramuscularly (IM) in the right upper anterolateral thigh at Day 0, Month 2, Month 4 and Month 10-13 in the HibCY Group. |
| BIOLOGICAL | Pediarix® | 3 doses administered IM in the left upper anterolateral thigh at Day 0, Month 2 and Month 4. 2 doses administered IM in the left upper anterolateral thigh at Day 0 and Month 2 and 1 dose administered IM in the right upper anterolateral thigh at Month 4 in the PedHIB Group. |
| BIOLOGICAL | Rotarix® | 2 doses administered orally at Day 0 and Month 2 each in the HibCY Group and PedHIB Group. |
| BIOLOGICAL | Prevnar 13® | 4 doses administered IM in the left lower anterolateral thigh at Day 0, Month 2, Month 4 and Month 10-13 each in the HibCY Group and PedHIB Group. |
| BIOLOGICAL | PedvaxHIB® | 3 doses administered IM in the right upper anterolateral thigh at Day 0, Month 2 and Month 10-13 in the PedHIB Group. |
| BIOLOGICAL | Havrix® | 2 doses administered IM in the left upper anterolateral thigh at Month 10-13 and Month 16-19 each in the HibCY Group and PedHIB Group. |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2016-03-18
- Completion
- 2016-03-18
- First posted
- 2013-11-07
- Last updated
- 2018-09-14
- Results posted
- 2018-06-26
Locations
26 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01978093. Inclusion in this directory is not an endorsement.