Trials / Completed
CompletedNCT02853929
Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
Immunogenicity and Safety Study of a Booster Dose of GSK Biologicals' 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
- 551 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 9 Months – 19 Months
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the immunogenicity and safety of the Infanrix hexa booster dose given at 11-18 months of age to infants who received primary vaccination at 6-14 weeks. All infants in this booster study were born to pregnant women who participated in the study 116945 \[DTPA (BOOSTRIX)-047\] and having received the full primary vaccination series as per protocol requirement in study 201330 \[DTPA (BOOSTRIX)-048.
Conditions
- Diphtheria
- Hepatitis B
- Acellular Pertussis
- Haemophilus Influenzae Type b
- Tetanus
- Poliomyelitis
- Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Infanrix hexa | All subjects will receive Infanrix hexa co-administered with Prevenar13 as a booster dose. |
Timeline
- Start date
- 2016-09-19
- Primary completion
- 2019-03-19
- Completion
- 2019-03-19
- First posted
- 2016-08-03
- Last updated
- 2020-01-14
- Results posted
- 2020-01-14
Locations
29 sites across 6 countries: Australia, Canada, Czechia, Finland, Italy, Spain
Source: ClinicalTrials.gov record NCT02853929. Inclusion in this directory is not an endorsement.