Overview

This trial is active, not recruiting.

Condition infections, meningococcal
Treatment blood sampling
Phase phase 3
Sponsor GlaxoSmithKline
Start date July 2013
End date October 2017
Trial size 173 participants
Trial identifier NCT01900899, 200088, 2012-005816-25

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Subjects primed and boosted with the MenACWY-TT vaccine.
blood sampling
At 2, 3, 4, 5, 6 years after booster vaccination.
(Active Comparator)
Subjects primed and boosted with the Meningitec vaccine.
blood sampling
At 2, 3, 4, 5, 6 years after booster vaccination.

Primary Outcomes

Measure
Persistence of antibodies with respect to components of the investigational vaccine in terms of antibody titres.
time frame: 2, 3, 4, 5, 6 years after booster vaccination.

Secondary Outcomes

Measure
Persistence of antibodies with respect to components of the investigational vaccine in terms of antibody titres.
time frame: 2, 3, 4, 5, 6 years after booster vaccination.
Serious adverse events (SAEs).
time frame: 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).

Eligibility Criteria

Male or female participants from 7 years up to 12 years old.

Inclusion Criteria: 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. - 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. Exclusion Criteria: 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. - 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.

Additional Information

Official title Persistence of Antibodies After GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Children
Description The subjects in this study will be allocated to the same groups as in study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (NCT00955682). No vaccine will be administered during this long-term persistence study.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.