Trials / Completed
CompletedNCT02422264
Immunogenicity and Safety Study of Infanrix Hexa in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
Immunogenicity and Safety Study of GSK Biologicals' Combined Diphtheria-tetanus-acellular Pertussis-hepatitis B-inactivated Polio-virus and Haemophilus Influenzae Type b Vaccine (Infanrix Hexa™) (217744) in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 601 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Weeks – 14 Weeks
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' Infanrix hexa, given in the primary vaccination schedule to infants born to pregnant women who participated in study 116945 \[DTPA (BOOSTRIX)-047\]. This study will help us evaluate if the presence of transplacentally transferred maternal antibodies interfere with the immune response to primary vaccination with Infanrix hexa and a co-administered pneumococcal conjugate vaccine given as a part of this study in infants.
Conditions
- Acellular Pertussis
- Tetanus
- Poliomyelitis
- Diphtheria
- Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Infanrix hexa | • All subjects will receive Infanrix hexa at 2 and 4, at 3 and 5, at 2, 4 and 6 months or at 2, 3 and 4 months, depending on the immunisation schedule of the country. Infanrix hexa is administered intramuscularly to the right thigh. |
| DRUG | Prevnar13 | • All subjects will receive Infanrix hexa co-administered with Prevenar13\* at 2 and 4, at 3 and 5, at 2, 4 and 6 months or at 2, 3 and 4 months, depending on the immunisation schedule of the country. \*In some countries/regions with an Infanrix hexa 3-dose vaccination schedule, Prevenar 13 could be administered as 2-doses or 3-doses primary vaccination schedule (according to the routine national immunisation schedule). Prevnar13 is administered intramuscularly to the left thigh. |
Timeline
- Start date
- 2016-01-22
- Primary completion
- 2018-03-07
- Completion
- 2018-03-07
- First posted
- 2015-04-21
- Last updated
- 2019-07-09
- Results posted
- 2019-06-10
Locations
30 sites across 6 countries: Australia, Canada, Czechia, Finland, Italy, Spain
Source: ClinicalTrials.gov record NCT02422264. Inclusion in this directory is not an endorsement.