Trial Outcomes & Findings for Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines (NCT NCT01270503)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

538 participants

Primary outcome timeframe

Day 0 up to Day 30 post-vaccination

Results posted on

2014-11-14

The study participants were enrolled from 16 December 2010 through 15 November 2012 at 130 clinic centers in thePhillipines

A total of 538 participants who met all of the inclusion and none of the exclusion criteria were vaccinated in this study.

Participant milestones
Measure	Menactra® Vaccine Group Participants who received a single dose of Menactra vaccine
Overall Study STARTED	538
Overall Study COMPLETED	537
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	Menactra® Vaccine Group Participants who received a single dose of Menactra vaccine
Overall Study Lost to Follow-up	1

Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines

Baseline characteristics by cohort
Measure	Menactra® Vaccine Group n=538 Participants Participants who received a single dose of Menactra vaccine
Age, Categorical <=18 years	468 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	70 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous Age Continuous	9.3 Years STANDARD_DEVIATION 10.3 • n=5 Participants
Gender Female	272 participants n=5 Participants
Gender Male	263 participants n=5 Participants
Region of Enrollment Philippines	538 Participants n=5 Participants

Timeframe: Day 0 up to Day 30 post-vaccination

Population: Post-vaccination safety were assessed in the Safety Analysis Set.

Outcome measures
Measure	Menactra® Vaccine Group n=537 Participants Participants who received a single dose of Menactra vaccine
Safety Overview Within 30 Days in Participants Vaccinated With Menactra® Serious adverse event	0 Participants
Safety Overview Within 30 Days in Participants Vaccinated With Menactra® Non-serious related adverse event not listed in PI	2 Participants

Timeframe: Day 0 up to Day 30 post-vaccination

Population: Post-vaccination safety were assessed in the Safety Analysis Set.

Outcome measures
Measure	Menactra® Vaccine Group n=537 Participants Participants who received a single dose of Menactra vaccine
Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra® Pyrexia	2 Participants
Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra® Other non-serious related adverse events	0 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Sanofi Pasteur Inc.

Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Publication restrictions are in place

Restriction type: OTHER