Last updated: 07/09/2019 15:10:16
Pfizer completed the acquisition of GSK's vaccine Nimenrix on 01-October-2015. The sponsorship for this clinical study was transferred from GSK to Pfizer as of 12-April-2016.The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. The most up to date information is available on: www.clinicaltrials.gov. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results
Persistence of antibodies after GSK Biologicals’ meningococcal vaccine GSK134612 in healthy children
GSK study ID
200088
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: Persistence of antibodies after GSK Biologicals’ meningococcal vaccine GSK134612 in healthy children
Trial description: The purpose of this study is to evaluate the long-term antibody persistence as well as safety of GSK Biologicals’ MenACWY-TT vaccine versus Meningitec up to 6 years after booster vaccination administered in healthy 5 year old children in the study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (NCT00955682), who were primed with the same vaccine in the study MENACWY-TT-039 (NCT00474266) at 12 through 23 months of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Persistence of antibodies with respect to components of the investigational vaccine in terms of antibody titres.
Timeframe: 2, 3, 4, 5, 6 years after booster vaccination.
Secondary outcomes:
Persistence of antibodies with respect to components of the investigational vaccine in terms of antibody titres.
Timeframe: 2, 3, 4, 5, 6 years after booster vaccination.
Serious adverse events (SAEs).
Timeframe: From the subject’s last visit in study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (NCT00955682) up to each yearly visit in the current study (i.e. 2, 3, 4, 5 and 6 years post booster vaccination).
Interventions:
Procedure: Blood Sampling
Enrollment:
194
Observational study model:
Not applicable
Primary completion date:
2015-12-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Infections, Meningococcal
Product
GSK134612A
Collaborators
Not applicable
Study date(s)
July 2013 to November 2015
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
7 - 12 Years
Accepts healthy volunteers
Yes
- All subjects must satisfy ALL the following criteria at study entry:
- Subjects’ parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- Child in care.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects’ parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- A male or female who has received primary and booster vaccination with the MenACWY-TT or Meningitec vaccines in studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036), respectively.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
All subjects must satisfy ALL the following criteria at study entry:
Exclusion criteria:
- Child in care.
- History of meningococcal disease.
- Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036).
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
No longer a GSK study
Actual primary completion date
2015-12-11
Actual study completion date
2015-12-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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