Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2005-006066-34-Outside-EU/EEA
EUCTR2005-006066-34-Outside-EU/EEA
Active, not recruiting
Not Applicable

A phase III, single-blind, randomized, controlled, multinational study for the evaluation of safety of GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (Hib-MenCY-TT) compared to monovalent Haemophilus influenzae type b (Hib) control vaccine in healthy infants at 2, 4, 6, and 12 to 15 months of age. - Hib-MenCY-TT-011 & Hib-MenCY-TT-012

GlaxoSmithKline Biologicals0 sites4,429 target enrollmentJune 1, 2015
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHaemophilus influenzae type b and Neisseria meningitidis serogroups C and YMedDRA version: 18.0Level: LLTClassification code 10028911Term: Neisseria meningitidis infection NOSSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10018953Term: Haemophilus influenzae meningitisSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10018952Term: Haemophilus influenzae infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
DrugsPediarix or Infanrix penta

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y
Sponsor
GlaxoSmithKline Biologicals
Enrollment
4429
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 1, 2015
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
  • •A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
  • •Written informed consent obtained from the parent or guardian of the subject.
  • •Healthy subjects as established by medical history and clinical examination before entering into the study.
  • •Born after 36 weeks gestation.
  • •Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrolment.
  • •Infants may have received a birth dose of Bacillus Calmette\-Guérin (BCG) vaccine.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 4053
  • •F.1\.2 Adults (18\-64 years) no

Exclusion Criteria

  • •Use of any investigational or non\-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preced\-ing the first dose of study vaccine, or planned use during the study period.
  • •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune\-modifying drugs since birth.
  • •Planned administration/ administration of a vaccine not fore\-seen by the study protocol within 30 days of the first dose of study vaccine(s).
  • •Previous vaccination against Neisseria meningitidis, Haemo\-philus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
  • •In country(ies) where Prevnar will be provided by GSK Biologicals, previous vaccination with Prevnar.
  • •History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease.
  • •Any confirmed or suspected immunosuppressive or immuno\-deficient condition based on medical history and physical examination.
  • •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber.
  • •Major congenital defects or serious chronic illness.
  • •History of any neurologic disorders or seizures.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Not Applicable
A study to compare Pergoveris and GONAL-f in women who have responded poorly to previous infertiliy treatment cyclesPoor Ovarian Response i.e. a failure to respond adequately to standard ART (assisted reproductive technologies) protocols and to recruit adequate folliclesMedDRA version: 17.0Level: LLTClassification code 10033140Term: Ovarian disorder NOSSystem Organ Class: 100000004872Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
EUCTR2013-003817-16-DKMerck KGaA946
Active, not recruiting
Not Applicable
A study to compare Pergoveris and GONAL-f in women who have responded poorly to previous infertiliy treatment cyclesPoor Ovarian Response i.e. a failure to respond adequately to standard ART (assisted reproductive technologies) protocols and to recruit adequate folliclesMedDRA version: 17.1Level: LLTClassification code 10033140Term: Ovarian disorder NOSSystem Organ Class: 100000004872Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
EUCTR2013-003817-16-EEMerck KGaA946
Active, not recruiting
Not Applicable
A study to compare Pergoveris and GONAL-f in women who have responded poorly to previous infertiliy treatment cyclesPoor Ovarian Response i.e. a failure to respond adequately to standard ART (assisted reproductive technologies) protocols and to recruit adequate folliclesMedDRA version: 17.0Level: LLTClassification code 10033140Term: Ovarian disorder NOSSystem Organ Class: 100000004872Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
EUCTR2013-003817-16-LVMerck KGaA946
Not yet recruiting
Phase 3
A phase III, randomized, controlled, single-blind, multicentre, parallel arm trial to assess the efficacy and safety of Pergoveris® (follitropin alfa and lutropin alfa) and GONAL-f® (follitropin alfa) for multifollicular development as part of an assisted reproductive technology treatment cycle in poor ovarian responders, as defined by the European Society of Human Reproduction and Embryology criteriainfertilitypoor ovarian responders10033283
NL-OMON40576Merck40
Active, not recruiting
Not Applicable
A study to compare Pergoveris and GONAL-f in women who have responded poorly to previous infertiliy treatment cyclesPoor Ovarian Response i.e. a failure to respond adequately to standard ART (assisted reproductive technologies) protocols and to recruit adequate folliclesMedDRA version: 17.0Level: LLTClassification code 10033140Term: Ovarian disorder NOSSystem Organ Class: 100000004872Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
EUCTR2013-003817-16-NLMerck KGaA946