Who is sponsoring NCT01527825?

NCT01527825 is sponsored by University of Witwatersrand, South Africa.

What drugs are being tested in NCT01527825?

Interventions: Trivalent influenza vaccine (seasonal), Normal saline.

What is the status of NCT01527825?

NCT01527825 is currently COMPLETED.

Last reviewed 2015-01-09 · How we verify

Immunogenicity and Safety of Different Dosing Schedules of Trivalent Influenza Vaccine in HIV-infected Pregnant Women: a Randomized Controlled Trial

NCT01527825 Phase 3 COMPLETED

The overall aim of this project is to evaluate the safety and immunogenicity of 3 different dosing options of trivalent influenza vaccine (TIV) vaccination of HIV-infected pregnant women: single dose, double dose (at same time point) and two-doses (1 month apart).

Details

Lead sponsor	University of Witwatersrand, South Africa
Phase	Phase 3
Status	COMPLETED
Enrolment	800
Start date	2012-09
Completion	2014-06

Conditions

Influenza

Interventions

Trivalent influenza vaccine (seasonal)
Normal saline

Primary outcomes

Number of participants who mount an adequate immune response one month post vaccination to a double dose compared to single dose of TIV — One month (28-35 days) post vaccination
Determine the sero-response rate to each of the vaccine viral strains, defined as post vaccination hemagglutination inhibition (HAI) levels of ≥1:40 AND ≥4 fold increase over baseline HAI levels, in HIV-infected pregnant women receiving a double strength TIV dose compared to mothers receiving a single dose of TIV one-month after completion of the dosing schedule.
Number of participants who mount an adequate immune response one month post completing vaccination to two-dose TIV administered 1 month apart, compared to single dose TIV — One month (28-35 days) post vaccination
Determine the sero-response rate to each of the vaccine viral strains, defined as post vaccination HAI levels of ≥1:40 AND ≥4 fold increase over baseline HAI levels, in HIV-infected pregnant women receiving two-doses of TIV spaced 21-35 days apart compared to women receiving a single dose of TIV one-month after completion of the dosing schedule.
Number of participants in each treatment arm who have local and/ or systemic reactions post vaccination with TIV — One week post vaccination
Evaluate the safety of the three dosing schedules of TIV in HIV-infected pregnant women vaccinated between 12-36 weeks of gestational age.

Countries

South Africa