Regulatory considerations in the clinical development of vaccines indicated for use during pregnancy

Vaccine

Volumn 33, Issue 8, 2015, Pages 966-972

  Roberts, Jeffrey N ^a   Gruber, Marion F ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Clinical development; Pregnancy; Regulations

Indexed keywords

VACCINE;

DRUG APPROVAL; DRUG CONTRAINDICATION; DRUG EFFICACY; DRUG INDICATION; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; IMMUNOGENICITY; PREGNANCY; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; REVIEW; UNITED STATES; ADULT; CLINICAL TRIAL (TOPIC); FEMALE; HUMAN; IMMUNOLOGY; INFECTION CONTROL; LEGISLATION AND JURISPRUDENCE; PREGNANCY COMPLICATIONS, INFECTIOUS; STANDARDS;

ADULT; CLINICAL TRIALS AS TOPIC; COMMUNICABLE DISEASE CONTROL; FEMALE; HUMANS; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; VACCINES;

EID: 84922867433     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2014.12.068     Document Type: Review

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