CompletedPhase 3

Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Children, Adolescents and Adults in Russia

Russia198 participantsStarted 2012-11

Plain-language summary

To evaluate the immune response and safety following a single dose of Novartis Meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy children, adolescents and adults in Russia.

Who can participate

Age range2 Years

SexALL

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Inclusion criteria

✓. Who were of any gender, from the age of 2 years and above at the time of visit 1, and to whom the nature of the study had been described and:
✓. Who the investigator believed that the subject and/or his or her parent/legal representative could and would comply with the requirements of the protocol (e.g., completion of the Diary Card, return for follow-up visit).
✓. Who were in good health as determined by
✓. Who had a negative urine pregnancy test for female subjects from 11 years of age.

Exclusion criteria

✕. Who were unwilling or unable to give written informed assent or consent to participate in the study.
✕. Who were perceived to be unreliable or unavailable for the duration of the study period.
✕. Who had a previous confirmed or suspected disease caused by N meningitidis.
✕. Who had household contact with and/or intimate exposure to an individual with culture-proven N meningitidis infection within 60 days prior to enrollment.
✕. Who had previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
✕. Who were pregnant or breast feeding (female subjects).
✕. Who had received any investigational or non-registered product (drug or vaccine) within 28 days prior to enrollment or who expected to receive an investigational drug or vaccine prior to the completion of the study.
✕. Who had received any vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who were planning to receive any vaccine within 30 days from the study vaccines.

What they're measuring

Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination

Timeframe: Day 29

Trial details

NCT IDNCT01725217

SponsorNovartis Vaccines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-03

Results submitted2014-02-03

View on ClinicalTrials.gov More Meningococcal Disease trials