Dataset Information

A Phase 3, Double-Blind, Randomized, Active Controlled Study to Evaluate the Safety of MenAfriVac in Healthy Malians.

ABSTRACT:

Background

A safe, affordable, and highly immunogenic meningococcal A conjugate vaccine (PsA-TT, MenAfriVac) was developed to control epidemic group A meningitis in Africa. Documentation of the safety specifications of the PsA-TT vaccine was warranted, with sufficient exposure to detect potential rare vaccine-related adverse reactions.

Methods

This phase 3, double-blind, randomized, active controlled clinical study was designed to evaluate the safety--primarily vaccine-related serious adverse events (SAEs)--up to 3 months after administration of a single dose of the PsA-TT vaccine to subjects aged 1-29 years in Mali. Safety outcomes were also compared to those following a single dose of a licensed meningococcal ACWY polysaccharide vaccine (PsACWY).

Results

No vaccine-related SAEs occurred during the 3 months of follow-up of 4004 subjects vaccinated with a single dose of PsA-TT. When compared to PsACWY (1996 subjects), tenderness at the injection site appeared to be more frequent in the PsA-TT group. However, rates of local induration, systemic reactions, adverse events (AEs), and SAEs were similar in both groups, and unsolicited AEs and SAEs were all unrelated to the study vaccines.

Conclusions

The study confirmed on a large scale the excellent safety profile of a single dose of PsA-TT when administered to its entire target population of 1-29 years of age.

Clinical trials registration

PACTR ATMR201003000191317.

SUBMITTER: Tapia MD

PROVIDER: S-EPMC4639507 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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Publications

A Phase 3, Double-Blind, Randomized, Active Controlled Study to Evaluate the Safety of MenAfriVac in Healthy Malians.

Tapia Milagritos D MD Sow Samba O SO Haidara Fadima Cheick FC Diallo Fatoumata F Doumbia Moussa M Enwere Godwin C GC Paranjape Gandhali G Hervé Jacques J Bouma Enricke E Parulekar Varsha V Martellet Lionel L Chaumont Julie J Plikaytis Brian D BD Tang Yuxiao Y Kulkarni Prasad S PS Hartmann Katharina K Preziosi Marie-Pierre MP

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20151101

<h4>Background</h4>A safe, affordable, and highly immunogenic meningococcal A conjugate vaccine (PsA-TT, MenAfriVac) was developed to control epidemic group A meningitis in Africa. Documentation of the safety specifications of the PsA-TT vaccine was warranted, with sufficient exposure to detect potential rare vaccine-related adverse reactions.<h4>Methods</h4>This phase 3, double-blind, randomized, active controlled clinical study was designed to evaluate the safety--primarily vaccine-related ser ...[more]

PMID: 26553682

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Dataset Information

A Phase 3, Double-Blind, Randomized, Active Controlled Study to Evaluate the Safety of MenAfriVac in Healthy Malians.

Background

Methods

Results

Conclusions

Clinical trials registration

Publications

A Phase 3, Double-Blind, Randomized, Active Controlled Study to Evaluate the Safety of MenAfriVac in Healthy Malians.

Similar Datasets

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