Study to Evaluate the Long-term Antibody Persistence of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine (GSK134612) Versus Mencevax ACWY in Healthy Adolescents and Adults and Booster Response to MenACWY-TT Vaccine Administered at 10 Years Post-primary Vaccination

Summary

The purpose of this study is to evaluate the long-term antibody persistence from 6, 7, 8, 9 to 10 years post-administration of MenACWY-TT conjugate vaccine as compared to Mencevax ACWY when given to healthy subjects 11 to 55 years of age. In addition, the safety and immunogenicity of a booster dose of MenACWY-TT vaccine administered to all eligible subjects 10 years after the primary vaccination will be evaluated. All Filipino subjects who received the primary vaccination in the primary vaccination study 107386 (NCT00356369) will be invited to enrol in the long-term follow up and booster phase. No new subjects will be enrolled.

Timeline

Start

2014-04

Primary completion

2018-02

Completion

2018-08

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper Statistical analyses were descriptive. PMID 32552685 ↗

Publications

• Borja-Tabora CFC, Peyrani P, Webber C, Van der Wielen M, Cheuvart B, De Schrevel N, Bianco V, Aris E, Cutler M, Li P, Perez JL. A phase 2b/3b MenACWY-TT study of long-term antibody persistence after primary vaccination and immunogenicity and safety of a booster dose in individuals aged 11 through 55 years. BMC Infect Dis. 2020 Jun 18;20(1):426. doi: 10.1186/s12879-020-05104-5.

Drugs

Indications