The purpose of this study is to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers in the US.
To describe the safety profile of MenACYW conjugate vaccine and MENVEO when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers
Healthy infants will be enrolled and randomized to receive either 4 doses of MenACYW conjugate vaccine or 4 doses of the licensed control vaccine, MENVEO. All participants will receive routine vaccines as per the Advisory Committee on Immunization Practices (ACIP) recommendations.
All participants will be assessed for immunogenicity at baseline (pre-vaccination), and after completing the infant schedule and the second year of life vaccination schedule.
Safety will be assessed throughout the study period, and includes solicited injection site and systemic reactions as well as unsolicited adverse events after each vaccine injection, and serious adverse events occurring throughout the trial.
|Treatment||Hepatitis B vaccine, Hepatitis A vaccine, Pneumococcal 13-valent Conjugate Vaccine, Varicella Vaccine, MenACYW conjugate vaccine, MenACYW-135 conjugate vaccine, DTaP-IPV//Hib vaccine, Pentavalent rotavirus vaccine, Measles, mumps, rubella (MMR) vaccine|
|Clinical Study Identifier||NCT03537508|
|Sponsor||Sanofi Pasteur, a Sanofi Company|
|Last Modified on||14 January 2021|
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