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Completed

NCT Number: NCT01896739

A Phase III Study to Assess the Immunogenicity and Safety of Eutravac (DTap-HB Combined Vaccine) With DTaP and Hepatitis B Vaccines in Healthy Infants

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.

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Key information

Conditions

Healthy Infants

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Daejeon St. Mary's Hospital, Daejeon, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Were healthy, male or female infants born at full term pregnancy (≥37 weeks) with a birth weight ≥2.5 kg to mothers with a negative HBsAg serology, documented prior to giving birth as per routine, site-specific ante-natal care procedures.
  • Signed parental or legally acceptable representative's informed consent was obtained

Exclusion criteria

  • Evidence of an acute febrile illness with axillary temperature ≥37.5℃ on the day of the vaccination. Infants with symptoms of minor illness eg, mild gastroenteritis, mild upper respiratory tract infection and who did not have a temperature ≥37.5℃ on the day of the vaccination could be included at the Investigator's discretion
  • History of diphtheria, tetanus, pertussis or hepatitis B disease
  • History of any vaccine-related hypersensitivity or anaphylactic reaction after previous administration of Euvax B

Treatment and study plan

Eutravac

Biological

Other names: LG DTaP Vaccine Inj. (DTaP), Euvax B (Hepatitis B), Hepavax (Hepatitis B)

Primary outcomes

  1. Seroprotection rate

    Time frame: After final immunisation at 4-8 weeks

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study title

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.

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 11, 2013
Registry last updated
Jul 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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