Session 1: Experience from RCT’s with RSV maternal vaccines
Session Chair: Anna Seale, Gates Foundation

Vaccination of pregnant women: scientific context and scope of discussion
Flor Muñoz
Baylor College of Medicine, U.S.A.

Data and analysis from the GSK GRACE trial
Jens-Ulrich Stegmann
GSK, U.S.A.

Data and analysis from the Pfizer MATISSE trial
David Radley
Pfizer, U.S.A.

General Perspective of DSMB Chairs
Flor Muñoz
Baylor College of Medicine, U.S.A.
Kathryn Edwards
Vanderbilt University, U.S.A.
Steve Black
Global Vaccine Data Network, U.S.A.

Summary of the RSV vaccine findings on prematurity and how it informed
impact studies
Shabir Madhi
University of Witwatersrand, South Africa

Could statistical methods matter?
Stephen Evans
London School of Hygiene & Tropical Medicine, UK

Panel Discussion: Considerations from regulatory authority and vaccine
recommending bodies considerations
Marco Cavaleri
EMA, UK
James Southern
SAHPRA, South Africa
Madhava Ram Balakrishnan
AMA, South Africa
Conall Watson
UKHSA, UK
Marion Gruber
IAVI, U.S.A.

Session 2: Break Out Sessions – What can be done differently in RCT’s
Session Chair: Steve Black, Global Vaccine Data Network, U.S.A.

Introduction Breakouts: How to assess safety in RCT’s: possible endpoints/
outcomes and methodologies
Steve Black
Global Vaccine Data Network, U.S.A.

Breakout (1): what outcomes related to prematurity to look at in RCT’s
Alex Duga
CDC, Ethiopia
Flor Muñoz
Baylor College of Medicine, U.S.A.

Breakout (2): what statistical methodologies can be used

Additional analysis on the MATISSE trial
David Radley
Pfizer, U.S.A.

Breakout (2): what statistical methodologies can be used

Additional analysis on the GRACE trial
Delyth Jones
GSK, UK

Feedback from breakout sessions & Q&A
Benjamin Atkins
Global Vacccine Data Network, Australia
Flor Muñoz
Baylor College of Medicine, U.S.A.

Session 3: Looking beyond RSV vaccines
Session Chair: Janet Englund, Seattle Children’s Hospital, U.S.A.

Immunogenicity and Safety assessment of GBS-NN/NN2 in Pregnant Women
Lidia Oostvogels
Minervax, Denmark

Planned safety assessment in Pfizer’s Phase-3 GBS trial, BEATRIX
David Radley
Pfizer, U.S.A.

Safety and Immunogenicity of a two dose Ebola vaccine among pregnant
women in Rwanda
Julien Nyombayire
Center for Family Health Research, Rwanda

Mpox (MVA-BN) vaccination in pregnancy. Perspectives and challenges in
data collection in remote resource-constrained settings (PregInPoxVac)
Paulina Morales Ruiz
Global Health Institute, Belgium
Solange Milolo
University of Kinshasa, Congo

Pregnancy outcomes following maternal vaccination with recombinant
pertussis vaccines: Evidence from three observational studies in Thailand
Souad Mansouri
BioNet, Australia