Last updated: 03/16/2021 10:10:05

Systematic Literature Review of Randomised Clinical Trials and Meta-Analysis of Immunological and Safety Outcomes

GSK study ID
212318
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Systematic Literature Review of Randomised Clinical Trials and Meta-Analysis of Immunological and Safety Outcomes
Trial description: The purpose of this study is to conduct a systematic literature review (SLR) to collect and pool, if feasible, immunogenicity and safety results for Infanrix hexa and Hexaxim.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
1
Primary completion date:
2019-03-06
Observational study model:
Other
Time perspective:
Other
Clinical publications:
Piyali Mukherjee, Essè Ifèbi Hervé Akpo, Anastasia Kuznetsova, Markus Knuf, Sven-Arne Silfverdal, Pope Kosalaraksa & Attila Mihalyi. Hexavalent vaccines in infants: a systematic literature review and meta-analysis of the solicited local and systemic adverse reactions of two hexavalent vaccines. Expert Rev Vaccines. 2021 Mar 4. doi: 10.1080/14760584.2021.1892493.
Medical condition
Whooping cough
Product
SB217744
Collaborators
Not applicable
Study date(s)
April 2019 to June 2019
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
Not applicable
  • Any study with a GSK’s hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B virus, inactivated poliomyelitis, and Hib conjugate vaccine
  • Any study with the following comparators: Sanofi Pasteur DTaP-IPV-HBV-PRP-T vaccine, Hexaxim or Hexyon
  • Studies that do not include the intervention of interest
  • Studies that do not include a comparator of interest
Inclusion and exclusion criteria
Inclusion criteria:

    Any study with a GSK’s hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B virus, inactivated poliomyelitis, and Hib conjugate vaccine

    • Any study with the following comparators: Sanofi Pasteur DTaP-IPV-HBV-PRP-T vaccine, Hexaxim or Hexyon
    • Direct head-to-head randomised controlled trials.
Exclusion criteria:

    Studies that do not include the intervention of interest

    • Studies that do not include a comparator of interest
    • Studies that have a different design

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Study complete
Actual primary completion date
2019-03-06
Actual study completion date
2019-03-06

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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