Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2016-000644-34-Outside-EU/EEA
EUCTR2016-000644-34-Outside-EU/EEA
Active, not recruiting
Phase 1

A phase III, open, randomised, multicentre study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ combined reduced antigen content diphtheria-tetanus toxoids and acellular pertussis vaccine (Boostrix™) and the Chinese DT vaccine, when administered as booster vaccination in healthy children aged 6-8 years who were previously vaccinated with four doses of combined diphtheria-tetanus-pertussis (DTP) vaccine in the first two years of life. - dTpa-038

GlaxoSmithKline Biologicals0 sites660 target enrollmentJune 9, 2016
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHealthy volunteers (Immunisation against diphtheria, tetanus and pertussis)MedDRA version: 19.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
DrugsBoostrix™Chinese DT vaccine (adsorbed diphtheria and tetanus toxoid (DT) vaccine)

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Healthy volunteers (Immunisation against diphtheria, tetanus and pertussis)
Sponsor
GlaxoSmithKline Biologicals
Enrollment
660
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 9, 2016
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •All subjects must satisfy the following criteria at study entry:
  • •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow\-up visits) should be enrolled in the study.
  • •A male or female between and including 6\-8 years of age at the time of the booster vaccination.
  • •Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life, as per Chinese recommendations.
  • •Written informed consent obtained from the parent/guardian of the subject.
  • •Healthy subjects as established by medical history and clinical examination before entering into the study.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 660
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range

Exclusion Criteria

  • •The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
  • •Use of any investigational or non\-registered product (drug or vaccine) other than the study vaccine within 30 days preceding booster dose of study vaccine, or planned use during the study period.
  • •Concurrently participating in another clinical study or planned participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non\-investigational product (pharmaceutical product or device).
  • •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune\-modifying drugs within six months prior to the booster vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, \>\= 0\.5 mg/kg/day. Inhaled and topical steroids are allowed).
  • •Evidence of previous booster vaccination against diphtheria, tetanus or pertussis since administration of the fourth dose of DTP vaccine in the second year of life.
  • •Planned administration/administration of a vaccine (including routine paediatric vaccines) not foreseen by the study protocol during the period starting from 30 days be\-fore booster dose of study vaccine and ending 30 days after (with the exception of OPV and hepatitis B vaccine).
  • •History of diphtheria, pertussis or tetanus diseases.
  • •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • •Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
  • •A family history of congenital or hereditary immunodeficiency.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Not Applicable
A phase IIIb, randomized, open, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine co-administered with GlaxoSmithKline Biologicals’ inactivated hepatitis A and hepatitis B vaccine adsorbed (Twinrix® Paediatric) in healthy female subjects aged 9–15 years. - HPV-029 PRIFor active immunization of females from the age of 10 years onwards for the prevention of cervical cancer by protecting against incident and persistent infections, cytological abnormalities including atypical squamous cells of undetermined significance (ASC-US), cervical intraepithelial neoplasia (CIN) and pre-cancerous lesions (CIN 2/3) caused by oncogenic human papillomavirus (HPV) types 16 and 18.
EUCTR2007-004347-30-SEGlaxoSmithKline Biologicals810
Active, not recruiting
Phase 1
A phase IIIb, randomized, open, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 AS04 vaccine co-administered with GlaxoSmithKline Biologicals’ combined reduced-antigen diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine (Boostrix® Polio) in healthy female subjects aged 10–18 years. - HPV-042In female subjects from 10 years of age onwards for the prevention of cervical cancer by protecting against incident and persistent infections, cytological abnormalities including ASC-US, cervical intraepithelial neoplasia (CIN) and pre-cancerous lesions caused by oncogenic human papillomaviruses (HPV).
EUCTR2006-003807-38-FRGlaxoSmithKline Biologicals751
Active, not recruiting
Phase 1
A multicentre study to evaluate the immunogenicity and safety of GSK Biologicals? HPV vaccine (580299) co-administered with Boostrix Polio in healthy female subjects aged 10?18 years.In female subjects from 10 years of age onwards for the prevention of cervical cancer by protecting against incident and persistent infections, cytological abnormalities including ASC-US, cervical intraepithelial neoplasia (CIN) and pre-cancerous lesions caused by oncogenic human papillomaviruses (HPV).MedDRA version: 14.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Cancer [C04]
EUCTR2006-003807-38-ESGlaxoSmithKline S.A.751
Active, not recruiting
Phase 1
A phase IIIb, randomized, open, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (Cervarix™) co-administrated with GlaxoSmithKline Biologicals’ Hepatitis B vaccine (Engerix-B™) in healthy female subjects aged 9 - 15 years. - HPV-030 PRIFor the prevention of high grade cervical intraepithelial neoplasia (CIN grades 2 and 3) and cervical cancer causally related to Human Papillomavirus (HPV) types 16 and 18
EUCTR2007-007783-14-NLGlaxoSmithKline Biologicals756
Active, not recruiting
Not Applicable
A phase IIIb, randomized, open, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (Cervarix™) co-administrated with GlaxoSmithKline Biologicals’ Hepatitis B vaccine (Engerix-B™) in healthy female subjects aged 9 - 15 years. - HPV-030 PRIFor the prevention of high grade cervical intraepithelial neoplasia (CIN grades 2 and 3) and cervical cancer causally related to Human Papillomavirus (HPV) types 16 and 18
EUCTR2007-007783-14-SEGlaxoSmithKline Biologicals756