CompletedPhase 3

A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

United States5,715 participantsStarted 2012-11

Plain-language summary

A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2. All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.

Who can participate

Age range10 Years – 25 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy subjects aged 10 to 25 years. Exclusion Criteria: * Previous vaccination with Hepatitis A virus vaccine * Previous vaccination with investigational meningococcal B vaccine * History of culture-proven N. meningitidis serogroup B disease * Any neuroinflammatory or autoimmune condition * Any immune defect that would prevent an effective response to the study vaccine

What they're measuring

Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study

Timeframe: Vaccination 1 up to 6 months after Vaccination 3

Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1

Timeframe: Within 30 days after Vaccination 1

Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2

Timeframe: Within 30 days after Vaccination 2

Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3

Timeframe: Within 30 days after Vaccination 3

Trial details

NCT IDNCT01352793

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-09

Results submitted2015-02-25

View on ClinicalTrials.gov More Meningitis, Meningococcal trials