Submission Type: BLA    Submission ID: 125296/0    Office: OVRR

Product: Adenovirus Vaccine Live Oral Type 4 and Type 7

Applicant: Teva Women's Health, Inc.

Telecon Date/Time: 26-Jan-2011 10:41 AM        Initiated by FDA? Yes

Communication Category:  Information Request

Author: Helen Gemignani

Telecon Summary: Request for concurrence of 506B PMCs.

Record of Telephone Conversation, Jan. 26, 2011 - Adenovirus 

FDA Participants: Helen Gemignani

Non-FDA Participants: Valerie Mulligan

Telecon Body:

We acknowledge your written commitments as described in your protocol submitted on September 13, 2010, as outlined below. Please inform CBER of your concurrence to these postmarketing commitments as well as the proposed timelines for final protocol submissions, study/trial completion, and submission of final reports.

Postmarketing Studies subject to reporting requirements of 21 CFR 601.70.
1.To conduct a postmarketing sentinel surveillance study to detect potential safety signals and to monitor and analyze uncommon and unexpected medical events occurring within 42 days following vaccination in the first 100,000 military recruits exposed to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral, during the first year post-approval through the use of the Defense Medical Surveillance System (DMSS). You commit to provide a final study report by September 30, 2012.
2.Final protocol submission date:  September 13, 2010
3.Study/trial completion date:                   March 31, 2012
4.Final Report Submission date:   September 30, 2012
 
5.To conduct a prospective Pregnancy Registry study of pregnant women exposed to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral, and their live born offspring through the first year of life to detect potential safety signals. Approximately 340 live births are anticipated to be enrolled in an estimate of 2-4 years. The Pregnancy Registry Status Report will be submitted to CBER annually. The final study report will be submitted 6 months after the follow-up of the last subject is completed and no later than March 31, 2017.
6.Final protocol submission date:  September 13, 2010
7.Study/trial completion date:                   September 30, 2016
8.Final Report Submission date:   March 31, 2017
 
9.To conduct a surveillance study for vaccine-associated febrile respiratory illness (FRI) due to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral, viral shedding. Vaccine viral shedding will be evaluated using data from the Naval Health Research Center (NHRC) Febrile Respiratory Illness Surveillance Program. The NHRC FRI data will be reviewed on a monthly basis. The proportion of FRI subjects positive for Adenovirus Type 4 and Type 7 will be evaluated on a quarterly basis and cumulatively throughout the study period to identify if there are upward trends or unusual patterns of adenovirus FRI indicating a potential signal for the transmission of the virus to the respiratory tract, thereby resulting in FRI. This surveillance will be conducted concurrently with the Sentinel Surveillance Plan which covers the first 100,000 recruits exposed to the vaccine during the first year post-approval. The final report will be submitted with the Sentinel Surveillance study final report by September 30, 2012.

Final protocol submission date:  September 13, 2010
Study/trial completion date:                   March 31, 2012
Final Report Submission date:   September 30, 2012
