Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers

Phase 3 Completed 753 enrolled GlaxoSmithKline

RandomizedParallel-groupOpen-labelPrevention

Summary

This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 in healthy infants, when co-administered with other infant vaccines, on three different dose schedules.

Timeline

Start: 2012-01-27
Primary completion: 2014-08-04
Completion: 2015-10-19

Outcome

Met primary endpoint

paper the lower limit of the 95% confidence interval for the percentage of infants with rSBA titers ≥8 was >80% for each serogroup. PMID 29784470 ↗

Publications

Dbaibo G, Tinoco Favila JC, Traskine M, Jastorff A, Van der Wielen M. Immunogenicity and safety of MenACWY-TT, a meningococcal conjugate vaccine, co-administered with routine childhood vaccine in healthy infants: A phase III, randomized study. Vaccine. 2018 Jun 27;36(28):4102-4111. doi: 10.1016/j.vaccine.2018.05.046. Epub 2018 May 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GSK134612	Vaccine	—	Intramuscular
Subject	Infanrix-IPV/HiberixTM	Unknown	—	Intramuscular
Subject	SynflorixTM	Unknown	—	Intramuscular