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NCT01896739
A Multicentre, Comparative, Open-label, Randomized, Phase III Study to Assess the Immunogenicity and Safety of EutravacTMinj (DTaP-HB Combined Vaccine) Administered at 2,4, 6 Months of Age Compared With DTaP Vaccine at 2, 4, 6 Months of Age Combined Administered Monovalent Hepatitis B Vaccine Administered at Birth, 1, 6 Months of Age in Healthy Infants.
Phase 3 trial testing Eutravac in Healthy Infants in 289 participants. Completed in 1 November 2011.
1 November 2011
Quick facts
| Lead sponsor | LG Life Sciences |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 289 |
| Start date | 1 August 2009 |
| Primary completion | 1 November 2011 |
| Estimated completion | 1 November 2011 |
| Sites | 7 locations across South Korea |
Drugs / interventions tested
- Eutravac — full drug profile →
Conditions studied
- Healthy Infants — all drugs for Healthy Infants →
Sponsor
LG Life Sciences — full company profile →
Who can join
Under 6 Months, any sex, with Healthy Infants. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Seroprotection rate
Time frame: After final immunisation at 4-8 weeks
Sponsor's own description
To evaluate and compare the immunogenicity of Eutravac (Diphtheria-Tetanus-acellular Pertussis \[DTaP\] Hepatitis B \[HB\] combined) vaccine with separate but simultaneous administrations of DTaP and HB vaccine each administered to healthy infants, as measured by seroprotection/vaccine response rates 4-8 weeks post-final immunisation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01896739
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Healthy Infants
Currently open trials in the same condition.
- NCT07054216 — Probiotic for Infants · NA · recruiting
- NCT06789484 — Characterization of the Gastrointestinal Microbiota in Newborn Infants · NA · recruiting
Other LG Life Sciences trials
Trials by the same sponsor.
- NCT02831361 — Trial to Evaluate the Efficacy and Safety of Gemigliptin Compared With Placebo Added on Insulin Alone or on Insulin in C · Phase 3 · completed
- NCT03015909 — Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj. · Phase 4 · completed
- NCT02746380 — A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy · Phase 3 · completed
- NCT02290301 — An Observational Study to Evaluate Cardiovascular Outcomes of T2DM PatientsTreated With Gemigliptin · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01896739 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by LG Life Sciences
- Last refreshed: 8 July 2013
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01896739.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing