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Clinical Trials/EUCTR2018-003451-38-GB
EUCTR2018-003451-38-GB
Active, not recruiting
Phase 1

Immunogenicity and reactogenicity of concomitantly administered hexavalent and Group B meningococcal vaccines in infancy. - The 6-in-1 Vaccine Study

Clinical Trials and Research Governance (CTRG)0 sites240 target enrollmentJanuary 31, 2019
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DrugsINFANRIX-HEXAVaxelis (DTaP -HB-IPV-Hib)

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Clinical Trials and Research Governance (CTRG)
Enrollment
240
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 31, 2019
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Clinical Trials and Research Governance (CTRG)

Eligibility Criteria

Inclusion Criteria

  • •For recruitment to all study groups, participants MUST FULFILL each of the below criterion:
  • •Parents/legal guardians are over 16 years of age, and are willing and able to consent to enrol their child/children in the study
  • •Parents/legal guardians able comply with the requirements of the trial protocol and have internet access for the duration of the study
  • •Parents/legal guardians are willing to allow their General Practitioner, health visitor and consultant, if appropriate, to be notified of participation in the trial.
  • •Participants born at greater than or equal to 37 weeks gestation
  • •Participants are due to receive their primary immunisations, aged 8 to 13 weeks (i.e. the day the child turns 13 weeks of age) at enrolment
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 240
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range 0

Exclusion Criteria

  • •The participant may not enter the trial IF ANY of the following apply:
  • •Parents/legal guardians of children are on the delegation log of this study
  • •Confirmed or suspected immunodeficiency
  • •Fulfil any of the contraindications to vaccination as specified in The Green Book
  • •Confirmed anaphylactic reaction/s to any constituent/s or excipient/s of the vaccine(s)
  • •Confirmed anaphylactic reaction to neomycin, streptomycin or polymyxin B (which may be present in trace amounts in the tetanus vaccine), kanamycin, histidine, sodium chloride or sucrose (which may be present in trace amounts in the Meningococcal B vaccine) or to gelatin (which may be present in trace amounts in the MMR vaccine)
  • •Latex hypersensitivity (the syringe cap of the Meningococcal B vaccine Bexsero may contain natural rubber latex)
  • •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
  • •Thrombocytopenia or any other bleeding disorders.
  • •Child is currently participating in another interventional clinical trial

Outcomes

Primary Outcomes

Not specified

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